Trial Outcomes & Findings for Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis (NCT NCT01583374)
NCT ID: NCT01583374
Last Updated: 2020-05-12
Results Overview
ASAS 20 was defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are: 1. Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale \[NRS\]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active 2. Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = "no pain" and the right-hand box = "most severe pain" 3. Function (Bath AS Functional Index \[BASFI\] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability 4. Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
490 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2020-05-12
Participant Flow
The study enrolled participants at 88 study sites and in 18 countries (Australia, Austria, Bulgaria, Czech Republic, Estonia, France, Germany, Hungary, the Netherlands, Poland, Romania, Russia, Slovakia, Spain, the United Kingdom, Canada, Sweden, and the United States \[US\]).
Randomized participants were stratified by the following 2 parameters: 1. C-Reactive Protein (CRP) concentration (normal: ≤ 1.5 mg/dL or elevated: \> 1.5 mg/dL) at screening; 2. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \< 6.0 or BASDAI score ≥ 6.0 at baseline.
Participant milestones
| Measure |
Placebo
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase continued to receive 20 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Apremilast 30 mg
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Placebo / Apremilast 30 mg Early Escape (EE)
Participants initially randomized to receive placebo tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the Assessment of SpondyloArthritis International Society (ASAS) domains at Week 16 were transitioned to 30 mg apremilast tablets BID and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Placebo/Apremilast 30 mg Crossover (XO)
Participants initially randomized to placebo tablets BID in the 24-week placebo controlled phase were transitioned to 30 mg apremilast tablets BID at Week 24 and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Apremilast 30 mg /Apremilast 30 mg EE
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase who did not have at least 20% improvement or a ≥ 1-unit improvement from baseline in 2 of the 4 ASAS domains at Week 16 continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Apremilast 20 mg /Apremilast 30 mg EE
Participants initially randomized to 20 mg apremilast tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the ASAS domains at Week 16 were transitioned to 30 mg apremilast tablets BID and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Apremilast 30 mg /Apremilast 30 mg Second Escape (SE)
Participants initially randomized to 30 mg apremilast tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the ASAS domains from baseline at Week 24 continued to receive 30 mg apremilast tablets BID (second escape) for up to 4.5 years in the long-term extension phase.
|
Apremilast 20 mg/Apremilast 30 mg SE
Participants initially randomized to 20 mg apremilast tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the ASAS domains at Week 24 were transitioned to 30 mg apremilast tablets BID (second escape) and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Placebo-controlled Phase (Week 0-24)
STARTED
|
164
|
163
|
163
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
Received Treatment
|
164
|
163
|
163
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
Completed Week 16
|
150
|
151
|
144
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
Early Escape at Week 16
|
51
|
49
|
49
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
COMPLETED
|
145
|
147
|
138
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
NOT COMPLETED
|
19
|
16
|
25
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Phase (Weeks 24 to 52)
STARTED
|
0
|
74
|
65
|
47
|
91
|
48
|
48
|
25
|
23
|
|
Extension Phase (Weeks 24 to 52)
COMPLETED
|
0
|
69
|
61
|
41
|
85
|
43
|
43
|
22
|
21
|
|
Extension Phase (Weeks 24 to 52)
NOT COMPLETED
|
0
|
5
|
4
|
6
|
6
|
5
|
5
|
3
|
2
|
|
Long-Term Extension Phase Weeks 52-260
STARTED
|
0
|
66
|
61
|
35
|
81
|
39
|
38
|
21
|
20
|
|
Long-Term Extension Phase Weeks 52-260
COMPLETED
|
0
|
40
|
41
|
22
|
50
|
22
|
20
|
12
|
10
|
|
Long-Term Extension Phase Weeks 52-260
NOT COMPLETED
|
0
|
26
|
20
|
13
|
31
|
17
|
18
|
9
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase continued to receive 20 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Apremilast 30 mg
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase, continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Placebo / Apremilast 30 mg Early Escape (EE)
Participants initially randomized to receive placebo tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the Assessment of SpondyloArthritis International Society (ASAS) domains at Week 16 were transitioned to 30 mg apremilast tablets BID and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Placebo/Apremilast 30 mg Crossover (XO)
Participants initially randomized to placebo tablets BID in the 24-week placebo controlled phase were transitioned to 30 mg apremilast tablets BID at Week 24 and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Apremilast 30 mg /Apremilast 30 mg EE
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase who did not have at least 20% improvement or a ≥ 1-unit improvement from baseline in 2 of the 4 ASAS domains at Week 16 continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Apremilast 20 mg /Apremilast 30 mg EE
Participants initially randomized to 20 mg apremilast tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the ASAS domains at Week 16 were transitioned to 30 mg apremilast tablets BID and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Apremilast 30 mg /Apremilast 30 mg Second Escape (SE)
Participants initially randomized to 30 mg apremilast tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the ASAS domains from baseline at Week 24 continued to receive 30 mg apremilast tablets BID (second escape) for up to 4.5 years in the long-term extension phase.
|
Apremilast 20 mg/Apremilast 30 mg SE
Participants initially randomized to 20 mg apremilast tablets BID who did not have at least 20% improvement or ≥ 1 unit improvement from baseline in 2 out of 4 of the ASAS domains at Week 24 were transitioned to 30 mg apremilast tablets BID (second escape) and continued to receive 30 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
|---|---|---|---|---|---|---|---|---|---|
|
Placebo-controlled Phase (Week 0-24)
Adverse Event
|
6
|
7
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
Lack of Efficacy
|
3
|
2
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
Non-compliance with Study Drug
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
Withdrawal by Subject
|
8
|
3
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
Lost to Follow-up
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
Protocol Violation
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo-controlled Phase (Week 0-24)
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Extension Phase (Weeks 24 to 52)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Extension Phase (Weeks 24 to 52)
Adverse Event
|
0
|
1
|
2
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Extension Phase (Weeks 24 to 52)
Lack of Efficacy
|
0
|
2
|
0
|
6
|
3
|
2
|
5
|
1
|
2
|
|
Extension Phase (Weeks 24 to 52)
Non-compliance study drug
|
0
|
2
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Extension Phase (Weeks 24 to 52)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
|
Long-Term Extension Phase Weeks 52-260
Adverse Event
|
0
|
5
|
2
|
2
|
6
|
2
|
2
|
3
|
1
|
|
Long-Term Extension Phase Weeks 52-260
Lack of Efficacy
|
0
|
4
|
6
|
7
|
10
|
7
|
4
|
2
|
4
|
|
Long-Term Extension Phase Weeks 52-260
Noncomplinace with Study Drug
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Long-Term Extension Phase Weeks 52-260
Withdrawal by Subject
|
0
|
11
|
11
|
1
|
12
|
7
|
5
|
3
|
3
|
|
Long-Term Extension Phase Weeks 52-260
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Long-Term Extension Phase Weeks 52-260
Lost to Follow-up
|
0
|
1
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Long-Term Extension Phase Weeks 52-260
Miscellaneous
|
0
|
5
|
1
|
2
|
0
|
1
|
5
|
0
|
1
|
Baseline Characteristics
Three participants did not have baseline BASMI data.
Baseline characteristics by cohort
| Measure |
Placebo
n=164 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=163 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase continued to receive 20 mg apremilast tablets BID for up to 4.5 years in the long-term extension phase.
|
Apremilast 30 mg
n=163 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Total
n=490 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 12.89 • n=164 Participants
|
45.2 years
STANDARD_DEVIATION 11.90 • n=163 Participants
|
44.8 years
STANDARD_DEVIATION 11.75 • n=163 Participants
|
44.7 years
STANDARD_DEVIATION 12.18 • n=490 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=164 Participants
|
42 Participants
n=163 Participants
|
56 Participants
n=163 Participants
|
138 Participants
n=490 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=164 Participants
|
121 Participants
n=163 Participants
|
107 Participants
n=163 Participants
|
352 Participants
n=490 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=164 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=163 Participants
|
7 Participants
n=490 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
158 Participants
n=164 Participants
|
159 Participants
n=163 Participants
|
162 Participants
n=163 Participants
|
479 Participants
n=490 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=164 Participants
|
3 Participants
n=163 Participants
|
0 Participants
n=163 Participants
|
4 Participants
n=490 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=164 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=490 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=164 Participants
|
2 Participants
n=163 Participants
|
0 Participants
n=163 Participants
|
4 Participants
n=490 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=164 Participants
|
2 Participants
n=163 Participants
|
2 Participants
n=163 Participants
|
5 Participants
n=490 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=164 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=163 Participants
|
1 Participants
n=490 Participants
|
|
Race/Ethnicity, Customized
White
|
158 Participants
n=164 Participants
|
154 Participants
n=163 Participants
|
158 Participants
n=163 Participants
|
470 Participants
n=490 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=164 Participants
|
2 Participants
n=163 Participants
|
3 Participants
n=163 Participants
|
6 Participants
n=490 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=164 Participants
|
3 Participants
n=163 Participants
|
0 Participants
n=163 Participants
|
4 Participants
n=490 Participants
|
|
Duration of Ankylosing Spondylitis (Lower Back Pain and Stiffness)
|
10.40 years
STANDARD_DEVIATION 10.375 • n=164 Participants
|
11.06 years
STANDARD_DEVIATION 11.302 • n=163 Participants
|
10.32 years
STANDARD_DEVIATION 9.887 • n=163 Participants
|
10.60 years
STANDARD_DEVIATION 10.521 • n=490 Participants
|
|
Duration of Ankylosing Spondylitis
≤ 2 years
|
41 Participants
n=164 Participants
|
48 Participants
n=163 Participants
|
40 Participants
n=163 Participants
|
129 Participants
n=490 Participants
|
|
Duration of Ankylosing Spondylitis
>2 to ≤ 5 years
|
29 Participants
n=164 Participants
|
23 Participants
n=163 Participants
|
26 Participants
n=163 Participants
|
78 Participants
n=490 Participants
|
|
Duration of Ankylosing Spondylitis
>5 to ≤ 10 years
|
33 Participants
n=164 Participants
|
29 Participants
n=163 Participants
|
33 Participants
n=163 Participants
|
95 Participants
n=490 Participants
|
|
Duration of Ankylosing Spondylitis
>10 years
|
61 Participants
n=164 Participants
|
63 Participants
n=163 Participants
|
64 Participants
n=163 Participants
|
188 Participants
n=490 Participants
|
|
Baseline Bath Ankylosing Spondylitis Functional Index (BASFI) Score (0 - 10 NRS)
|
5.76 Units on a Scale
STANDARD_DEVIATION 2.194 • n=164 Participants
|
5.75 Units on a Scale
STANDARD_DEVIATION 2.061 • n=163 Participants
|
5.65 Units on a Scale
STANDARD_DEVIATION 2.100 • n=163 Participants
|
5.72 Units on a Scale
STANDARD_DEVIATION 2.115 • n=490 Participants
|
|
Baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (0 - 10 NRS)
|
6.45 Units on a Scale
STANDARD_DEVIATION 1.319 • n=164 Participants
|
6.46 Units on a Scale
STANDARD_DEVIATION 1.352 • n=163 Participants
|
6.37 Units on a Scale
STANDARD_DEVIATION 1.357 • n=163 Participants
|
6.42 Units on a Scale
STANDARD_DEVIATION 1.341 • n=490 Participants
|
|
Baseline Bath Ankylosing Spondylitis Metrology Index (BASMI)-Linear Score (0 - 10 NRS)
|
4.36 Units on a Scale
STANDARD_DEVIATION 1.608 • n=163 Participants • Three participants did not have baseline BASMI data.
|
4.63 Units on a Scale
STANDARD_DEVIATION 1.721 • n=163 Participants • Three participants did not have baseline BASMI data.
|
4.41 Units on a Scale
STANDARD_DEVIATION 1.700 • n=161 Participants • Three participants did not have baseline BASMI data.
|
4.47 Units on a Scale
STANDARD_DEVIATION 1.678 • n=487 Participants • Three participants did not have baseline BASMI data.
|
|
Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score (0-18)
|
9.10 Units on a Scale
STANDARD_DEVIATION 4.639 • n=164 Participants • Four participants did not have a baseline ASQoL score.
|
8.38 Units on a Scale
STANDARD_DEVIATION 4.548 • n=162 Participants • Four participants did not have a baseline ASQoL score.
|
8.62 Units on a Scale
STANDARD_DEVIATION 4.935 • n=160 Participants • Four participants did not have a baseline ASQoL score.
|
8.50 Units on a Scale
STANDARD_DEVIATION 4.738 • n=486 Participants • Four participants did not have a baseline ASQoL score.
|
|
Baseline Physical Component Summary Score of Medical Outcome Study Short Form 36-Item Survey
|
32.57 Units on a Scale
STANDARD_DEVIATION 7.821 • n=164 Participants • Five participants did not have a baseline SF-36 Physical Component Summary score.
|
31.89 Units on a Scale
STANDARD_DEVIATION 8.561 • n=162 Participants • Five participants did not have a baseline SF-36 Physical Component Summary score.
|
32.16 Units on a Scale
STANDARD_DEVIATION 8.846 • n=159 Participants • Five participants did not have a baseline SF-36 Physical Component Summary score.
|
32.20 Units on a Scale
STANDARD_DEVIATION 8.402 • n=485 Participants • Five participants did not have a baseline SF-36 Physical Component Summary score.
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: The mITT population included participants who were randomized and received at least one dose of investigation product (IP). Participants who discontinued early due to lack of efficacy were counted as nonresponders, and last observation carried forward (LOCF) imputation was used for participants who discontinued for other reasons.
ASAS 20 was defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are: 1. Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale \[NRS\]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active 2. Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = "no pain" and the right-hand box = "most severe pain" 3. Function (Bath AS Functional Index \[BASFI\] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability 4. Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)
Outcome measures
| Measure |
Placebo
n=164 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=163 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg
n=163 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg/ Apremilast 30 mg
Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
|
Apremilast 20 mg/Apremilast 20 mg
Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16
|
36.6 Percentage of Participants
|
35.0 Percentage of Participants
|
32.5 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The mITT population included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations
The BASFI is a composite score based on a self-administered survey of 10 questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the degree of mobility and functional ability. The survey consists of 8 questions regarding function in AS and the last 2 reflect the ability to manage everyday life. The patient marks a box with an X on a 0 to 10 unit NRS for 10 questions; the left-hand box of 0 = easy; the right-hand box = impossible. The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. The overall score is the mean of the 10 items and ranges from 0 to 10. A higher score correlates to reduced functional ability.
Outcome measures
| Measure |
Placebo
n=162 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=163 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg
n=160 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg/ Apremilast 30 mg
Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
|
Apremilast 20 mg/Apremilast 20 mg
Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
|
|---|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
|
-0.94 Units on a Scale
Standard Error 0.136
|
-1.11 Units on a Scale
Standard Error 0.137
|
-0.99 Units on a Scale
Standard Error 0.138
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The mITT population included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations.
The BASDAI is a composite score based on a participant self-administered survey of six questions measured using a 0 to 10 unit numerical rating scale (NRS) that assessed the participants' five major symptoms of AS: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. The participant was asked to mark the box with an X on a 0 to 10 unit NRS for each of the 6 questions. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater was considered to be indicative of active AS disease.
Outcome measures
| Measure |
Placebo
n=164 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=162 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg
n=160 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg/ Apremilast 30 mg
Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
|
Apremilast 20 mg/Apremilast 20 mg
Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
|
|---|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
|
-1.21 Units on a Scale
Standard Error 0.136
|
-1.30 Units on a Scale
Standard Error 0.136
|
-1.18 Units on a Scale
Standard Error 0.137
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The mITT population included participants who were randomized and received at least one dose of investigation product (IP). Participants who discontinued early due to lack of efficacy were counted as nonresponders, and last observation carried forward (LOCF) imputation was used for participants who discontinued for other reasons.
ASAS 20 was defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are: 1. Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale \[NRS\]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active 2. Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = "no pain" and the right-hand box = "most severe pain" 3. Function (Bath AS Functional Index \[BASFI\] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability 4. Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)
Outcome measures
| Measure |
Placebo
n=164 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=163 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg
n=163 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg/ Apremilast 30 mg
Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
|
Apremilast 20 mg/Apremilast 20 mg
Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24
|
31.7 Percentage of Participants
|
36.2 Percentage of Participants
|
33.7 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The mITT included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations.
The ASQoL is a validated disease specific patient reported outcomes instrument to assess the impact of ankylosing spondylitis on the quality of life of individuals with emphasis on the ability of the person to fulfill his or her needs. It consisted of 18 items requesting a yes (score=1) or no (score=0) response to questions related to the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. The summary score ranges 0-18 with higher scores indicating worse quality of life.
Outcome measures
| Measure |
Placebo
n=160 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=161 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg
n=156 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg/ Apremilast 30 mg
Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
|
Apremilast 20 mg/Apremilast 20 mg
Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score at Week 24
|
-1.77 Units on a Scale
Standard Error 0.278
|
-1.50 Units on a Scale
Standard Error 0.278
|
-1.52 Units on a Scale
Standard Error 0.281
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The mITT included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations.
The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) was a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores (based on US general population with mean of 50 and standard deviation of 10) were used in analyses. Higher scores indicate a higher level of functioning. The PCS encompasses physical functioning, role-physical, and bodily pain, as well as general health and vitality. A positive change from baseline score indicates an improvement
Outcome measures
| Measure |
Placebo
n=160 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=161 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg
n=155 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg/ Apremilast 30 mg
Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
|
Apremilast 20 mg/Apremilast 20 mg
Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24
|
3.50 Units on a Scale
Standard Error 0.553
|
3.46 Units on a Scale
Standard Error 0.551
|
3.79 Units on a Scale
Standard Error 0.559
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The mITT population included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations
The BASMI-Linear was designed to assess axial status (ie, cervical, dorsal and lumbar spine, hips, and pelvic soft tissue) and to define clinically significant changes in spinal movement. Five dimensions of movement (lateral lumbar flexion, tragus to wall, forward lumbar flexion, maximal intermalleolar distance, and cervical rotation) were measured and normalized on 0 to 10 unit NRS. The average of these scores was the total BASMI score, ranging from 0-10 with higher values indicating more severe limitation in spinal mobility.
Outcome measures
| Measure |
Placebo
n=163 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=162 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg
n=158 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg/ Apremilast 30 mg
Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
|
Apremilast 20 mg/Apremilast 20 mg
Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
|
|---|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24
|
-0.19 Units on a Scale
Standard Error 0.042
|
-0.16 Units on a Scale
Standard Error 0.043
|
-0.13 Units on a Scale
Standard Error 0.043
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 104 and 260Population: The radiograph subset analysis population included randomized participants who received at least one dose of IP and had at least a baseline radiograph available. Includes apremilast participants as treated who had a baseline and at least one post-baseline score. Missing scores were imputed using the LOCF.
The Modified Stoke Ankylosing Spondylitis Spine Score is a scoring method used to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine. The m-SASSS scores 0-3. 0 = No abnormality, 1 = Erosion, Sclerosis or Squaring, 2 = Syndesmophyte, 3 = Total bony Bridging at each Site. An increase in the m-SASSS indicated a worsening of AS disease.
Outcome measures
| Measure |
Placebo
n=83 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=84 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg
n=79 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg/ Apremilast 30 mg
n=35 Participants
Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
|
Apremilast 20 mg/Apremilast 20 mg
n=48 Participants
Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260
Week 104
|
0.99 Units on a Scale
Standard Deviation 3.018
|
0.65 Units on a Scale
Standard Deviation 2.453
|
0.98 Units on a Scale
Standard Deviation 3.768
|
0.82 Units on a Scale
Standard Deviation 2.435
|
1.12 Units on a Scale
Standard Deviation 3.417
|
|
Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260
Week 260
|
3.14 Units on a Scale
Standard Deviation 8.292
|
1.79 Units on a Scale
Standard Deviation 6.997
|
1.92 Units on a Scale
Standard Deviation 7.363
|
2.21 Units on a Scale
Standard Deviation 5.959
|
3.83 Units on a Scale
Standard Deviation 9.652
|
SECONDARY outcome
Timeframe: From Week 0 to Week 24; the median duration of exposure was 23.57 weeks for the placebo arm, 23.71 weeks for the apremilast 20 mg arm and 24.00 weeks for the apremilast 30 mg arm.Population: Safety population includes all participants who were randomized and received at least one dose of IP. Includes data through Week 16 for placebo-treated and apremilast 20 mg BID treated participants who escaped early and data up to Week 24 for all other participants.
A TEAE was an adverse event (AE) with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. A serious AE = results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; or constitutes an important medical event. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = symptoms causing severe pain discomfort.
Outcome measures
| Measure |
Placebo
n=164 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=163 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg
n=163 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg/ Apremilast 30 mg
Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
|
Apremilast 20 mg/Apremilast 20 mg
Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Any Serious Drug-related TEAE
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Any TEAE Leading to Drug Interruption
|
14 Participants
|
13 Participants
|
14 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Any TEAE Leading to Drug Withdrawal
|
7 Participants
|
11 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Any Treatment Emergent Adverse Event
|
83 Participants
|
91 Participants
|
88 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Any Drug-related TEAE
|
24 Participants
|
44 Participants
|
51 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Any Severe TEAE
|
0 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Any Serious TEAE
|
1 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Any TEAE Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 to week 260; overall mean duration of exposure to apremilast 20 mg and 30 mg BID was 160.96 weeksPopulation: Apremilast Subjects as Treated (AAT) were those who received at least 1 dose of apremilast at any time during the study. Participants were included in the treatment group corresponding to the apremilast dosing regimen they actually received, irrespective of the treatment group to which they were randomized or re-randomized.
A TEAE was an adverse event (AE) with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. A serious AE = results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; or constitutes an important medical event. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = symptoms causing severe pain discomfort.
Outcome measures
| Measure |
Placebo
n=163 Participants
Participants initially randomized to receive placebo tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg
n=72 Participants
Participants initially randomized to 20 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg
n=305 Participants
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg/ Apremilast 30 mg
Participants who were initially randomized to 20 mg apremilast tablets BID at Week 0 and transitioned to 30 mg apremilast tablets BID at either Week 16 or Week 24 through to Week 260.
|
Apremilast 20 mg/Apremilast 20 mg
Participants who were initially randomized to receive 20 mg apremilast PO BID at Week 0 and continued to receive 20 mg apremilast PO BID through to Week 260 without the transition to 30 mg apremilast PO BID.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
Any Treatment Emergent Adverse Event
|
114 Participants
|
47 Participants
|
239 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
Any Severe TEAE
|
5 Participants
|
8 Participants
|
23 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
Any Serious TEAE
|
12 Participants
|
8 Participants
|
41 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
Any TEAE Leading to Drug Interruption
|
22 Participants
|
11 Participants
|
51 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
Any TEAE Leading to Drug Withdrawal
|
18 Participants
|
4 Participants
|
34 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
Any TEAE Leading to Death
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
Adverse Events
Placebo (Weeks 0-24) Placebo-Controlled Phase
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Apremilast 20 mg BID (Weeks 0-24) Placebo-Controlled Phase
Serious events: 3 serious events
Other events: 58 other events
Deaths: 0 deaths
Apremilast 30 mg BID (Weeks 0-24) Placebo-Controlled Phase
Serious events: 6 serious events
Other events: 57 other events
Deaths: 0 deaths
Apremilast 20 mg BID (APR Exposure Period)
Serious events: 12 serious events
Other events: 82 other events
Deaths: 0 deaths
Apremilast 20/30 mg BID (APR Exposure Period)
Serious events: 8 serious events
Other events: 38 other events
Deaths: 1 deaths
Apremilast 30 mg BID (APR Exposure Period)
Serious events: 41 serious events
Other events: 168 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo (Weeks 0-24) Placebo-Controlled Phase
n=164 participants at risk
Participants randomized to placebo tablets twice daily (BID) in the 24-week placebo-controlled phase.
|
Apremilast 20 mg BID (Weeks 0-24) Placebo-Controlled Phase
n=163 participants at risk
Participants initially randomized to 20 mg apremilast tablets (APR) BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg BID (Weeks 0-24) Placebo-Controlled Phase
n=163 participants at risk
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg BID (APR Exposure Period)
n=163 participants at risk
Participants who received 20 mg apremilast tablets BID only in the study. This also includes participants who initially received APR 20 BID and switched to APR 30 BID treatment.
Only the TEAEs that occurred during the 20 mg apremilast BID dose were included.
|
Apremilast 20/30 mg BID (APR Exposure Period)
n=72 participants at risk
Participants who initially received 20 mg apremilast tablets BID at Week 0 who escaped to 30 mg apremilast BID. Only the TEAEs that occurred during the 20 mg apremilast BID dose were included.
|
Apremilast 30 mg BID (APR Exposure Period)
n=305 participants at risk
Participants initially randomized to 30 mg apremilast tablets BID at Week 0 and participants who received placebo at Week 0 who escaped to 30 mg apremilast tablets BID. Only the TEAEs that occurred during the 30 mg apremilast BID dose were included.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Endocrine disorders
Goitre
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Eye disorders
Strabismus
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Eye disorders
Uveitis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.66%
2/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
General disorders
Chest pain
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
General disorders
Device failure
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
General disorders
Pyrexia
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Infections and infestations
Infected bites
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.61%
1/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Psychiatric disorders
Depression
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.66%
2/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.33%
1/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
Other adverse events
| Measure |
Placebo (Weeks 0-24) Placebo-Controlled Phase
n=164 participants at risk
Participants randomized to placebo tablets twice daily (BID) in the 24-week placebo-controlled phase.
|
Apremilast 20 mg BID (Weeks 0-24) Placebo-Controlled Phase
n=163 participants at risk
Participants initially randomized to 20 mg apremilast tablets (APR) BID in the 24-week placebo-controlled phase.
|
Apremilast 30 mg BID (Weeks 0-24) Placebo-Controlled Phase
n=163 participants at risk
Participants initially randomized to 30 mg apremilast tablets BID in the 24-week placebo-controlled phase.
|
Apremilast 20 mg BID (APR Exposure Period)
n=163 participants at risk
Participants who received 20 mg apremilast tablets BID only in the study. This also includes participants who initially received APR 20 BID and switched to APR 30 BID treatment.
Only the TEAEs that occurred during the 20 mg apremilast BID dose were included.
|
Apremilast 20/30 mg BID (APR Exposure Period)
n=72 participants at risk
Participants who initially received 20 mg apremilast tablets BID at Week 0 who escaped to 30 mg apremilast BID. Only the TEAEs that occurred during the 20 mg apremilast BID dose were included.
|
Apremilast 30 mg BID (APR Exposure Period)
n=305 participants at risk
Participants initially randomized to 30 mg apremilast tablets BID at Week 0 and participants who received placebo at Week 0 who escaped to 30 mg apremilast tablets BID. Only the TEAEs that occurred during the 30 mg apremilast BID dose were included.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Iridocyclitis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.2%
2/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.6%
4/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
2.6%
8/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
4/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.8%
3/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.5%
9/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
4.3%
7/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.4%
1/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.2%
16/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
7/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
13.5%
22/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
10.4%
17/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
16.0%
26/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.6%
4/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
12.5%
38/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.2%
2/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.2%
2/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.8%
3/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.8%
3/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.6%
4/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.98%
3/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
7/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
6.1%
10/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
8.6%
14/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
8.0%
13/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
8.3%
6/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
9.2%
28/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Infections and infestations
Bronchitis
|
0.61%
1/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
2.5%
4/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.2%
2/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
4.9%
8/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
8.3%
6/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
3.3%
10/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
6/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.5%
9/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
4.3%
7/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
15.3%
25/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
13.9%
10/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
18.0%
55/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Infections and infestations
Sinusitis
|
0.61%
1/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.2%
2/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
4.3%
7/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
6.9%
5/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
3.3%
10/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
8/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
4.3%
7/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
4.9%
8/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
10.4%
17/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
11.1%
8/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
10.5%
32/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.2%
2/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
3.7%
6/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.6%
4/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
3.9%
12/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.61%
1/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
2.5%
4/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
3.1%
5/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.6%
4/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.3%
4/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.2%
2/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.6%
4/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.98%
3/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.61%
1/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
0.00%
0/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.2%
2/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.6%
4/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
1.6%
5/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Nervous system disorders
Headache
|
4.9%
8/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
5.5%
9/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
9.8%
16/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
6.7%
11/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
6.9%
5/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
9.2%
28/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
|
Vascular disorders
Hypertension
|
2.4%
4/164 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
2.5%
4/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
3.7%
6/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
3.7%
6/163 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
2.8%
2/72 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
6.9%
21/305 • AEs were reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants. AEs were reported for the apremilast (APR) exposure period from Week 0 to Week 260, irrespective of when the APR started (Week 0, 16 or 24). The median duration of treatment was 24, 163, and 216 weeks in the Apremilast 20 mg, Apremilast 20/30 mg and Apremilast 30 mg treatment groups respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation generally sixty (60) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
- Publication restrictions are in place
Restriction type: OTHER