Trial Outcomes & Findings for Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis. (NCT NCT01232283)
NCT ID: NCT01232283
Last Updated: 2022-03-15
Results Overview
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
413 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2022-03-15
Participant Flow
The study was conducted at 46 study centers in 9 countries.
Participants were eligible who had moderate to severe plaque psoriasis.
Participant milestones
| Measure |
Apremilast
Participants initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
|
Placebo
Participants initially randomized to identically matching placebo tablets (PBO) BID during the Placebo controlled Phase (Weeks 0-16)
|
Apremilast-Apremilast
Participants who were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32).
|
Placebo-Apremilast
Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32).
|
APR-APR-Re-randomized to PBO
Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to placebo during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost their PASI-50 improvement achieved at Week 32, were switched back to apremilast 30 mg BID at the time the loss was observed. Those participants who did not lose their PASI-50 response remained on placebo until Week 52. All participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received apremilast 30 mg BID for the remainder of their participation.
|
APR-APR Re-randomized to APR
Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to apremilast during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation.
|
APR-APR-APR + Optional Topicals/Phototherapy
Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered non-responders (ie, having a response of \<PASI-50), remained on apremilast 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation.
|
PBO-APR-APR + Optional Topicals/Phototherapy
Participants who were initially randomized to placebo BID during the 16-week Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32). At week 32, all participants were to maintain apremilast 30 mg BID; those who were non-responders (having a response of \<PASI-50), remained on apremilast 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these non-responders received additional topicals or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation
|
Apremilast (Long-Term Extension Phase)
Participants who were initially randomized to APR 30 mg BID during the 16-week placebo-controlled phase (Weeks 0-16) continued receiving APR 30 mg BID through the Maintenance Phase (weeks 16-32) and apremilast 30 mg tablets or placebo during the Randomized Withdrawal Phase were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
|
Placebo-Apremilast (Long-term Extension)
Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were switched at Week 16 to apremilast 30 mg BID during the Maintenance Phase, received apremilast 30 mg PO BID during the Randomized Withdrawal Phase and then received apremilast 30 mg tablets BID in the long-term extension phase from weeks 52-260.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Placebo Controlled Phase (Weeks 0-16)
STARTED
|
275
|
138
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Phase (Weeks 0-16)
Received Apremilast
|
272
|
136
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Phase (Weeks 0-16)
COMPLETED
|
239
|
112
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Phase (Weeks 0-16)
NOT COMPLETED
|
36
|
26
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Weeks16-32)
STARTED
|
0
|
0
|
234
|
108
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Weeks16-32)
COMPLETED
|
0
|
0
|
194
|
100
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Weeks16-32)
NOT COMPLETED
|
0
|
0
|
40
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
STARTED
|
0
|
0
|
0
|
0
|
62
|
61
|
58
|
96
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
Treated With APR+ Topicals/Phototherapy
|
0
|
0
|
0
|
0
|
0
|
0
|
28
|
17
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
COMPLETED
|
0
|
0
|
0
|
0
|
50
|
56
|
41
|
84
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
12
|
5
|
17
|
12
|
0
|
0
|
|
Long-Term Extension Phase (Weeks 52-260)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
137
|
80
|
|
Long-Term Extension Phase (Weeks 52-260)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
29
|
19
|
|
Long-Term Extension Phase (Weeks 52-260)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
108
|
61
|
Reasons for withdrawal
| Measure |
Apremilast
Participants initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
|
Placebo
Participants initially randomized to identically matching placebo tablets (PBO) BID during the Placebo controlled Phase (Weeks 0-16)
|
Apremilast-Apremilast
Participants who were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32).
|
Placebo-Apremilast
Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32).
|
APR-APR-Re-randomized to PBO
Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to placebo during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost their PASI-50 improvement achieved at Week 32, were switched back to apremilast 30 mg BID at the time the loss was observed. Those participants who did not lose their PASI-50 response remained on placebo until Week 52. All participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received apremilast 30 mg BID for the remainder of their participation.
|
APR-APR Re-randomized to APR
Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to apremilast during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation.
|
APR-APR-APR + Optional Topicals/Phototherapy
Participants who were initially randomized to apremilast 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with apremilast 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered non-responders (ie, having a response of \<PASI-50), remained on apremilast 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation.
|
PBO-APR-APR + Optional Topicals/Phototherapy
Participants who were initially randomized to placebo BID during the 16-week Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to apremilast 30 mg BID and continued dosing with apremilast 30 mg BID during the Maintenance Phase (Weeks 16-32). At week 32, all participants were to maintain apremilast 30 mg BID; those who were non-responders (having a response of \<PASI-50), remained on apremilast 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these non-responders received additional topicals or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on apremilast 30 mg BID for the remainder of their participation
|
Apremilast (Long-Term Extension Phase)
Participants who were initially randomized to APR 30 mg BID during the 16-week placebo-controlled phase (Weeks 0-16) continued receiving APR 30 mg BID through the Maintenance Phase (weeks 16-32) and apremilast 30 mg tablets or placebo during the Randomized Withdrawal Phase were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
|
Placebo-Apremilast (Long-term Extension)
Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were switched at Week 16 to apremilast 30 mg BID during the Maintenance Phase, received apremilast 30 mg PO BID during the Randomized Withdrawal Phase and then received apremilast 30 mg tablets BID in the long-term extension phase from weeks 52-260.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Placebo Controlled Phase (Weeks 0-16)
Adverse Event
|
12
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Phase (Weeks 0-16)
Lack of Efficacy
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Phase (Weeks 0-16)
Noncompliance with study drug
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Phase (Weeks 0-16)
Withdrawal by Subject
|
9
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Phase (Weeks 0-16)
Lost to Follow-up
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Phase (Weeks 0-16)
Protocol Violation
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Controlled Phase (Weeks 0-16)
Other
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Weeks16-32)
Adverse Event
|
0
|
0
|
8
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Weeks16-32)
Lack of Efficacy
|
0
|
0
|
19
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Weeks16-32)
Non-compliance with study drug
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Weeks16-32)
Withdrawal by Subject
|
0
|
0
|
7
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Weeks16-32)
Lost to Follow-up
|
0
|
0
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Phase (Weeks16-32)
Other
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
1
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
4
|
0
|
13
|
5
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
4
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
1
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Randomized Withdrawal Phase(Weeks 32-52)
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Long-Term Extension Phase (Weeks 52-260)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
6
|
|
Long-Term Extension Phase (Weeks 52-260)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
46
|
30
|
|
Long-Term Extension Phase (Weeks 52-260)
Non-compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
|
Long-Term Extension Phase (Weeks 52-260)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
30
|
14
|
|
Long-Term Extension Phase (Weeks 52-260)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
6
|
|
Long-Term Extension Phase (Weeks 52-260)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Long-Term Extension Phase (Weeks 52-260)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Long-Term Extension Phase (Weeks 52-260)
Miscellaneous
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
3
|
Baseline Characteristics
Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.
Baseline characteristics by cohort
| Measure |
Apremilast
n=274 Participants
Participants were initially randomized to Apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=137 Participants
Participants were initially randomized to placebo tablets BID during the Placebo controlled Phase (weeks 0-16).
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 13.38 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 13.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 participants
n=5 Participants
|
2 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
250 participants
n=5 Participants
|
128 participants
n=7 Participants
|
378 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other-not specified
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Duration of Plaque Psoriasis
|
17.94 years
STANDARD_DEVIATION 11.367 • n=5 Participants
|
18.68 years
STANDARD_DEVIATION 12.088 • n=7 Participants
|
18.19 years
STANDARD_DEVIATION 11.602 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used. .
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.
Outcome measures
| Measure |
Apremilast
n=274 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=137 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline
|
28.8 percentage of participants
|
5.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.
The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator must have factored in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign was averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.
Outcome measures
| Measure |
Apremilast
n=274 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=137 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline
|
20.4 percentage of participants
|
4.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Participants with a baseline value and at least 1 postbaseline value were included. Last observation carried forward imputation was used.
BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100\*(visit BSA - baseline BSA) / baseline BSA (%).
Outcome measures
| Measure |
Apremilast
n=269 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=136 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Percent Change From Baseline in the Affected Body Surface Area (BSA) at Week 16
|
-48.40 percent change
Standard Error 2.636
|
-6.25 percent change
Standard Error 3.710
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: FAS consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.
Psoriasis Area Severity Index (PASI) scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing.
Outcome measures
| Measure |
Apremilast
n=269 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=136 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16
|
-50.8 percent change
Standard Error 2.23
|
-16.0 percent change
Standard Error 3.15
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.
PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.
Outcome measures
| Measure |
Apremilast
n=274 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=137 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline
|
55.5 Percentage of Participants
|
19.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.
The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value - baseline value.
Outcome measures
| Measure |
Apremilast
n=268 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=133 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16
|
-33.5 units on a scale
Standard Error 2.08
|
-12.2 units on a scale
Standard Error 2.95
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included
DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Outcome measures
| Measure |
Apremilast
n=267 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=131 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
|
-6.7 units on a scale
Standard Error 0.37
|
-2.7 units on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.
The SF-36 was a 36-item general health instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.
Outcome measures
| Measure |
Apremilast
n=267 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=131 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16
|
2.60 units on a scale
Standard Error 0.563
|
-0.03 units on a scale
Standard Error 0.804
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. See Outcome measure #1 for further description. sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See Outcome Measure #2 for further description.
Outcome measures
| Measure |
Apremilast
n=274 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=137 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline
|
18.6 percentage of participants
|
4.4 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 32 to Week 52Population: Analysis population consisted of participants who were re-randomized to placebo or Apremilast 30mg BID at Week 32.
Time to loss was the time between the re-randomization date and the date of the first assessment with loss of 50% PASI improvement (event), or the time between the re-randomization date and the date of the last PASI assessment in the randomized withdrawal phase prior to addition of topical/phototherapy or other effective psoriasis therapies, or resumption of apremilast 30 mg BID, or discontinuation, or Week 52 if no loss (censored), whichever was earlier
Outcome measures
| Measure |
Apremilast
n=62 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=61 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Time to Loss of Effect (Loss of 50% Improvement in PASI Score Obtained at Week 32 Compared to Baseline) During the Randomized Treatment Withdrawal Phase
|
12.4 Weeks
Interval 8.3 to 20.1
|
21.9 Weeks
The confidence interval was not calculated because there was no sufficient information from data for the confidence interval estimate
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)
An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.
Outcome measures
| Measure |
Apremilast
n=272 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=136 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase
Any TEAE
|
185 participants
|
82 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase
Any drug related TEAE
|
106 participants
|
29 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase
Any Severe TEAE
|
12 participants
|
6 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase
Any Serious TEAE
|
5 participants
|
3 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase
Any TEAE leading to drug interruption
|
16 participants
|
4 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase
Any TEAE leading to drug withdrawal
|
15 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 16Population: Safety population, included all participants who were randomized and received at least one dose of IP. Participants with a PASI ≥ 125% of Baseline score after last dose who did not have psoriasis rebound captured as a Treatment Emergent Adverse Event.
Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. \[1\] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. \[2\] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. \[3\] PASI \>= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in \[1\] and/or \[2\].
Outcome measures
| Measure |
Apremilast
n=272 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
n=136 Participants
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase
Participants with any psoriasis flare
|
3 participants
|
7 participants
|
|
Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase
Participants with any psoriasis rebound
|
1 participants
|
0 participants
|
|
Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase
PASI ≥ 125% of Baseline score after last dose
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 260; The mean duration of exposure was 100.66 weeks.Population: Apremilast participants as treated, which includes all participants who were randomized to (at Week 0) or treated with (at Week 16) apremilast 30 mg BID, and received at least one dose of apremilast after randomization or Week 16.
The Apremilast-exposure Period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. Adverse events that started after 28 days of initiating placebo and before resuming apremilast treatment in the Randomized Treatment Withdrawal Phase (Weeks 32 to 52) were excluded in the Apremilast-exposure phase. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.
Outcome measures
| Measure |
Apremilast
n=380 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260
Any TEAE
|
316 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260
Any Drug-Related TEAE
|
165 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260
Any Severe TEAE
|
58 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260
Any Serious TEAE
|
44 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260
Any Serious Drug-Related TEAE
|
8 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260
Any TEAE Leading to Drug Interruption
|
56 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260
Any TEAE Leading to Drug Withdrawal
|
45 participants
|
—
|
|
Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260
Any TEAE Leading to Death
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 260Population: The apremilast subjects as treated population, which includes all participants who were randomized to (at Week 0) or treated with (at Week 16) apremilast 30 mg BID, and received at least one dose of apremilast after randomization or Week 16.
Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. \[1\] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. \[2\] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. \[3\] PASI \>= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in \[1\] and/or \[2\].
Outcome measures
| Measure |
Apremilast
n=272 Participants
Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
Placebo
Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
|
|---|---|---|
|
Number of Participants With Psoriasis Flare or Rebound in the Apremilast-Exposure Period
Participants with any psoriasis flare
|
25 participants
|
—
|
|
Number of Participants With Psoriasis Flare or Rebound in the Apremilast-Exposure Period
Participants with any psoriasis rebound
|
11 participants
|
—
|
|
Number of Participants With Psoriasis Flare or Rebound in the Apremilast-Exposure Period
PASI ≥ 125% of Baseline score after last dose
|
12 participants
|
—
|
Adverse Events
Placebo: Weeks 0-16 (PBO-Controlled Phase)
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
Apremilast: Weeks 0-16 (PBO-Controlled Phase)
Serious events: 5 serious events
Other events: 128 other events
Deaths: 0 deaths
APR-APR-PBO: Weeks 32-52 (Randomized Withdrawal Phase)
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Apremilast: Weeks 0-260 (APR- Exposure Period )
Serious events: 44 serious events
Other events: 234 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo: Weeks 0-16 (PBO-Controlled Phase)
n=136 participants at risk
Participants randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
|
Apremilast: Weeks 0-16 (PBO-Controlled Phase)
n=272 participants at risk
Participants randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
|
APR-APR-PBO: Weeks 32-52 (Randomized Withdrawal Phase)
n=62 participants at risk
Participants re-randomized to placebo tablets BID at Week 32. Includes data from Week 32 up to Week 52 when participants received placebo treatment.
|
Apremilast: Weeks 0-260 (APR- Exposure Period )
n=380 participants at risk
Participants who received apremilast 30 mg tablets BID, regardless of when the apremilast exposure started (at Week 0 or at Week 16), up until Week 260. Adverse events associated with apremilast 30 mg treatment up to Week 260 were included. AEs that started more than 28 days after placebo treatment and prior to resuming apremilast were excluded for participants who were re-randomized to Placebo at Week 32.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Cardiac disorders
Palpitations
|
0.74%
1/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Eye disorders
Cataract
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Eye disorders
Maculopathy
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.37%
1/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.37%
1/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.74%
1/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.53%
2/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Infections and infestations
Lung abscess
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Investigations
Helicobacter test positive
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.37%
1/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.53%
2/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.37%
1/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.6%
1/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.6%
1/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Nervous system disorders
Syncope
|
0.74%
1/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Psychiatric disorders
Personality disorder
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.37%
1/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.37%
1/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.37%
1/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.53%
2/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.26%
1/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
Other adverse events
| Measure |
Placebo: Weeks 0-16 (PBO-Controlled Phase)
n=136 participants at risk
Participants randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
|
Apremilast: Weeks 0-16 (PBO-Controlled Phase)
n=272 participants at risk
Participants randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
|
APR-APR-PBO: Weeks 32-52 (Randomized Withdrawal Phase)
n=62 participants at risk
Participants re-randomized to placebo tablets BID at Week 32. Includes data from Week 32 up to Week 52 when participants received placebo treatment.
|
Apremilast: Weeks 0-260 (APR- Exposure Period )
n=380 participants at risk
Participants who received apremilast 30 mg tablets BID, regardless of when the apremilast exposure started (at Week 0 or at Week 16), up until Week 260. Adverse events associated with apremilast 30 mg treatment up to Week 260 were included. AEs that started more than 28 days after placebo treatment and prior to resuming apremilast were excluded for participants who were re-randomized to Placebo at Week 32.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
8/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
15.8%
43/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.6%
1/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
16.3%
62/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.6%
9/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
18.4%
50/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
3.2%
2/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
17.9%
68/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
5/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
5.1%
14/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
7.1%
27/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.5%
4/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.6%
1/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
7.6%
29/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
6/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
7.4%
20/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
8.1%
5/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
18.2%
69/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
6/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
4.8%
13/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.6%
1/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
13.9%
53/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.8%
5/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.6%
1/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
5.8%
22/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
2/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.8%
5/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
3.2%
2/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
6.8%
26/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
2.2%
6/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
3.2%
2/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
8.2%
31/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
2/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
2.2%
6/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.6%
1/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
5.0%
19/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Nervous system disorders
Headache
|
0.74%
1/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
6.2%
17/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
7.4%
28/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Nervous system disorders
Tension headache
|
1.5%
2/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
7.4%
20/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
0.00%
0/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
8.2%
31/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.1%
7/136 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.1%
3/272 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
1.6%
1/62 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
6.3%
24/380 • AEs are reported at: 1. Weeks 0-16: PBO-controlled phase 2. Weeks 32-52 Randomized Withdrawal participants re-randomized to PBO at Week 32 3. Weeks 0-260 APR-exposure period for participants randomized or switched to APR at any time during the study
During the PBO-controlled Phase (Weeks 0-16), the mean duration of treatment for those randomized to APR 30 BID or PBO at Week 0, was 14.0 and 14.6, respectively; for those re-randomized to PBO at Week 32, the mean duration of PBO was 11.6 weeks; during the APR-Exposure Period (Weeks 0-260), the mean duration of exposure to APR was 100.66 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
- Publication restrictions are in place
Restriction type: OTHER