Trial Outcomes & Findings for Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (NCT NCT01087762)
NCT ID: NCT01087762
Last Updated: 2018-08-01
Results Overview
The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains: * Patient's Global Assessment of Disease Activity * Pain assessment (total spinal pain) * Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) * Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
325 participants
Primary outcome timeframe
Week 12
Results posted on
2018-08-01
Participant Flow
This is a multicenter study with 128 sites in North America, Latin America, Western Europe, and Central/Eastern Europe. 325 subjects are included in Randomized Set (RS) shown in Participant Flow for the interim period, and 315 for the final analysis (10 subjects dropped out before receiving a CZP dose), which is an Intention-to-Treat (ITT) dataset.
Patients with positive Tuberculosis (TB) tests within Screening Period, but no signs and symptoms of active TB had to be treated with prophylactic TB treatment for at least 4 weeks prior to first study drug administration.
Participant milestones
| Measure |
Placebo
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
All CZP 200 mg
All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
All CZP 400 mg
All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|---|
|
Double Blind Period (Weeks 0-24)
STARTED
|
107
|
111
|
107
|
0
|
0
|
|
Double Blind Period (Weeks 0-24)
COMPLETED
|
95
|
105
|
98
|
0
|
0
|
|
Double Blind Period (Weeks 0-24)
NOT COMPLETED
|
12
|
6
|
9
|
0
|
0
|
|
Open-Label Period (Weeks 48-204)
STARTED
|
0
|
0
|
0
|
158
|
157
|
|
Open-Label Period (Weeks 48-204)
COMPLETED
|
0
|
0
|
0
|
99
|
100
|
|
Open-Label Period (Weeks 48-204)
NOT COMPLETED
|
0
|
0
|
0
|
59
|
57
|
Reasons for withdrawal
| Measure |
Placebo
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
All CZP 200 mg
All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
All CZP 400 mg
All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|---|
|
Double Blind Period (Weeks 0-24)
Lack of Efficacy
|
2
|
0
|
3
|
0
|
0
|
|
Double Blind Period (Weeks 0-24)
Protocol Violation
|
6
|
0
|
1
|
0
|
0
|
|
Double Blind Period (Weeks 0-24)
Lost to Follow-up
|
1
|
2
|
1
|
0
|
0
|
|
Double Blind Period (Weeks 0-24)
Withdrawal by Subject
|
1
|
2
|
1
|
0
|
0
|
|
Double Blind Period (Weeks 0-24)
SAE, non-fatal
|
2
|
2
|
3
|
0
|
0
|
|
Open-Label Period (Weeks 48-204)
Lack of Efficacy
|
0
|
0
|
0
|
4
|
14
|
|
Open-Label Period (Weeks 48-204)
Protocol Violation
|
0
|
0
|
0
|
1
|
1
|
|
Open-Label Period (Weeks 48-204)
Lost to Follow-up
|
0
|
0
|
0
|
5
|
2
|
|
Open-Label Period (Weeks 48-204)
Withdrawal by Subject
|
0
|
0
|
0
|
22
|
15
|
|
Open-Label Period (Weeks 48-204)
Other
|
0
|
0
|
0
|
2
|
4
|
|
Open-Label Period (Weeks 48-204)
SAE, non-fatal
|
0
|
0
|
0
|
7
|
4
|
|
Open-Label Period (Weeks 48-204)
AE, non-serious non-fatal
|
0
|
0
|
0
|
16
|
13
|
|
Open-Label Period (Weeks 48-204)
SAE, non-fatal + AE, non-serious/fatal
|
0
|
0
|
0
|
2
|
4
|
Baseline Characteristics
Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=107 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W
n=111 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W
n=107 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
Total Title
n=325 Participants
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
102 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
317 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Continuous
Mean age
|
39.9 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
39.1 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 39.9 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Weight
|
82.142 kilogram (kg)
STANDARD_DEVIATION 18.147 • n=5 Participants
|
79.305 kilogram (kg)
STANDARD_DEVIATION 18.599 • n=7 Participants
|
83.893 kilogram (kg)
STANDARD_DEVIATION 18.855 • n=5 Participants
|
81.757 kilogram (kg)
STANDARD_DEVIATION 18.576 • n=4 Participants
|
|
Height
|
170.704 centimeter (cm)
STANDARD_DEVIATION 9.692 • n=5 Participants
|
171.769 centimeter (cm)
STANDARD_DEVIATION 10.171 • n=7 Participants
|
172.753 centimeter (cm)
STANDARD_DEVIATION 9.607 • n=5 Participants
|
171.739 centimeter (cm)
STANDARD_DEVIATION 9.834 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.
The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains: * Patient's Global Assessment of Disease Activity * Pain assessment (total spinal pain) * Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) * Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).
Outcome measures
| Measure |
Placebo (FAS)
n=107 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W (FAS)
n=111 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W (FAS)
n=107 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
n=218 Participants
This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|
|
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12
|
38.3 percentage of participants
Interval 29.1 to 47.5
|
57.7 percentage of participants
Interval 48.5 to 66.8
|
63.6 percentage of participants
Interval 54.4 to 72.7
|
60.6 percentage of participants
Interval 54.1 to 67.0
|
SECONDARY outcome
Timeframe: Week 24Population: Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.
The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains: * Patient's Global Assessment of Disease Activity * Pain assessment (total spinal pain) * Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) * Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit).
Outcome measures
| Measure |
Placebo (FAS)
n=107 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W (FAS)
n=111 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W (FAS)
n=107 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
n=218 Participants
This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|
|
Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24
|
29.0 percentage of participants
Interval 20.4 to 37.6
|
66.7 percentage of participants
Interval 57.9 to 75.4
|
70.1 percentage of participants
Interval 61.4 to 78.8
|
68.3 percentage of participants
Interval 62.2 to 74.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.
The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ("Easy") to 10 ("Impossible"). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Outcome measures
| Measure |
Placebo (FAS)
n=107 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W (FAS)
n=111 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W (FAS)
n=107 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
n=218 Participants
This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|
|
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12
|
-0.53 units on a scale
Interval -0.96 to -0.1
|
-2.01 units on a scale
Interval -2.48 to -1.55
|
-2.02 units on a scale
Interval -2.5 to -1.55
|
-2.02 units on a scale
Interval -2.4 to -1.63
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.
The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ("Easy") to 10 ("Impossible"). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Outcome measures
| Measure |
Placebo (FAS)
n=107 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W (FAS)
n=111 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W (FAS)
n=107 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
n=218 Participants
This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|
|
Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
|
-0.40 units on a scale
Interval -0.85 to 0.06
|
-2.36 units on a scale
Interval -2.85 to -1.87
|
-2.20 units on a scale
Interval -2.7 to -1.7
|
-2.28 units on a scale
Interval -2.68 to -1.87
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.
The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Outcome measures
| Measure |
Placebo (FAS)
n=107 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W (FAS)
n=111 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W (FAS)
n=107 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
n=218 Participants
This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|
|
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12
|
-1.22 units on a scale
Interval -1.65 to -0.78
|
-2.82 units on a scale
Interval -3.29 to -2.35
|
-2.80 units on a scale
Interval -3.28 to -2.33
|
-2.81 units on a scale
Interval -3.2 to -2.43
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.
The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Outcome measures
| Measure |
Placebo (FAS)
n=107 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W (FAS)
n=111 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W (FAS)
n=107 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
n=218 Participants
This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|
|
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
|
-1.05 units on a scale
Interval -1.5 to -0.6
|
-3.08 units on a scale
Interval -3.57 to -2.6
|
-3.01 units on a scale
Interval -3.5 to -2.52
|
-3.05 units on a scale
Interval -3.45 to -2.65
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.
The BASMI characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Outcome measures
| Measure |
Placebo (FAS)
n=107 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W (FAS)
n=111 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W (FAS)
n=107 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
n=218 Participants
This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|
|
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12
|
-0.13 units on a scale
Interval -0.31 to 0.05
|
-0.60 units on a scale
Interval -0.79 to -0.4
|
-0.46 units on a scale
Interval -0.66 to -0.26
|
-0.53 units on a scale
Interval -0.69 to -0.37
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.
The BASMI characterizes the spinal mobility of subjects with axial SpA and AS. It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Outcome measures
| Measure |
Placebo (FAS)
n=107 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W (FAS)
n=111 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W (FAS)
n=107 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
n=218 Participants
This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|
|
Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24
|
-0.07 units on a scale
Interval -0.27 to 0.12
|
-0.54 units on a scale
Interval -0.75 to -0.34
|
-0.49 units on a scale
Interval -0.7 to -0.28
|
-0.52 units on a scale
Interval -0.69 to -0.34
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 148 are included in this analysis.
The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. A VU is defined as the region between 2 virtual lines through the middle of each vertebra. Active inflammation is scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. Total spine ASspiMRI-a score in the Berlin modification can range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.
Outcome measures
| Measure |
Placebo (FAS)
n=49 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W (FAS)
n=47 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W (FAS)
n=52 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
n=99 Participants
This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|
|
Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12
|
0.39 units on a scale
Standard Deviation 4.04
|
-3.39 units on a scale
Standard Deviation 5.59
|
-2.16 units on a scale
Standard Deviation 3.61
|
-2.74 units on a scale
Standard Deviation 4.67
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Population: The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 140 are included in this analysis.
The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. A negative value in SPARCC change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.
Outcome measures
| Measure |
Placebo (FAS)
n=45 Participants
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
CZP 200 mg Q2W (FAS)
n=45 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
CZP 400 mg Q4W (FAS)
n=50 Participants
Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.
Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)
n=95 Participants
This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.
Subjects in both CZP arms received additional placebo injections to maintain the study blind.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
|---|---|---|---|---|
|
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12
|
-1.33 units on a scale
Standard Deviation 8.33
|
-3.61 units on a scale
Standard Deviation 6.94
|
-4.98 units on a scale
Standard Deviation 8.47
|
-4.33 units on a scale
Standard Deviation 7.77
|
Adverse Events
All CZP 200 mg (Safety Analysis)
Serious events: 35 serious events
Other events: 142 other events
Deaths: 0 deaths
All CZP 400 mg (Safety Analysis)
Serious events: 34 serious events
Other events: 127 other events
Deaths: 0 deaths
All CZP 200 mg + 400 mg
Serious events: 69 serious events
Other events: 269 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All CZP 200 mg (Safety Analysis)
n=158 participants at risk
All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
All CZP 400 mg (Safety Analysis)
n=157 participants at risk
All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
All CZP 200 mg + 400 mg
n=315 participants at risk
This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg and arm All CZP 400 mg.
|
Placebo
n=107 participants at risk
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Blood and lymphatic system disorders
Paratracheal lymphadenopathy
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Cardiac disorders
Coronary artery disease
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Cardiac disorders
Atrial fibrillation
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Eye disorders
Retinal vein occlusion
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
1.9%
3/157 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.95%
3/315 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
1.3%
2/157 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.63%
2/315 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
General disorders
Chest pain
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.63%
2/315 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
General disorders
Non-cardiac chest pain
|
1.3%
2/158 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.63%
2/315 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
1.9%
2/107 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
1.3%
2/157 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.63%
2/315 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Hepatobiliary disorders
Cholelithiasis migration
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Hepatobiliary disorders
Hepatitis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Appendicitis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Mycobacterial infection
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.63%
2/315 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Cellulitis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Haemophilus infection
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Pneumonia legionella
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Pneumonia
|
1.9%
3/158 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.95%
3/315 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Latent tuberculosis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Acute sinusitis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Laryngitis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Investigations
Weight decreased
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.63%
2/315 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
3/158 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.95%
3/315 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesterol granuloma
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Morton's neuroma
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.3%
2/158 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.63%
2/315 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Psychiatric disorders
Major depression
|
0.63%
1/158 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.63%
2/315 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Psychiatric disorders
Hallucination
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Psychiatric disorders
Psychotic disorder
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Psychiatric disorders
Conversion disorder
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary
|
0.63%
1/158 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.63%
1/158 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar damage
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.64%
1/157 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Surgical and medical procedures
Bone graft
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Surgical and medical procedures
Abortion induced
|
0.63%
1/158 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.32%
1/315 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/315 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/158 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/157 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/315 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
Other adverse events
| Measure |
All CZP 200 mg (Safety Analysis)
n=158 participants at risk
All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
|
All CZP 400 mg (Safety Analysis)
n=157 participants at risk
All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.
Placebo : Matching Placebo to CZP injection.
CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
|
All CZP 200 mg + 400 mg
n=315 participants at risk
This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg and arm All CZP 400 mg.
|
Placebo
n=107 participants at risk
Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.
After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).
Placebo : Matching Placebo to CZP injection.
|
|---|---|---|---|---|
|
Eye disorders
Uveitis
|
7.0%
11/158 • Number of events 15 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.1%
8/157 • Number of events 12 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
6.0%
19/315 • Number of events 27 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Eye disorders
Conjunctivitis
|
3.2%
5/158 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.1%
8/157 • Number of events 9 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.1%
13/315 • Number of events 15 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.3%
10/158 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
12.7%
20/157 • Number of events 26 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
9.5%
30/315 • Number of events 39 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Gastrointestinal disorders
Gastritis
|
5.1%
8/158 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
3.2%
5/157 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.1%
13/315 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Immune system disorders
Seasonal allergy
|
4.4%
7/158 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.1%
8/157 • Number of events 11 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.8%
15/315 • Number of events 19 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Nasopharyngitis
|
29.7%
47/158 • Number of events 80 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
27.4%
43/157 • Number of events 83 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
28.6%
90/315 • Number of events 163 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
6.5%
7/107 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
35/158 • Number of events 53 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
17.8%
28/157 • Number of events 58 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
20.0%
63/315 • Number of events 111 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
2.8%
3/107 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Bronchitis
|
15.2%
24/158 • Number of events 28 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
10.8%
17/157 • Number of events 18 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
13.0%
41/315 • Number of events 46 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Pharyngitis
|
15.2%
24/158 • Number of events 36 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.0%
11/157 • Number of events 17 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
11.1%
35/315 • Number of events 53 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Sinusitis
|
10.8%
17/158 • Number of events 21 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.1%
8/157 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.9%
25/315 • Number of events 31 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Urinary tract infection
|
6.3%
10/158 • Number of events 17 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.0%
11/157 • Number of events 15 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
6.7%
21/315 • Number of events 32 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
3.7%
4/107 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Rhinitis
|
9.5%
15/158 • Number of events 22 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
3.8%
6/157 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
6.7%
21/315 • Number of events 30 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Influenza
|
5.7%
9/158 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.0%
11/157 • Number of events 14 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
6.3%
20/315 • Number of events 24 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Tonsillitis
|
5.1%
8/158 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.7%
9/157 • Number of events 11 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.4%
17/315 • Number of events 21 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Oral herpes
|
5.7%
9/158 • Number of events 23 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
3.8%
6/157 • Number of events 7 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.8%
15/315 • Number of events 30 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Cystitis
|
5.1%
8/158 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
3.8%
6/157 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.4%
14/315 • Number of events 21 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Gastroenteritis
|
3.2%
5/158 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.7%
9/157 • Number of events 9 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.4%
14/315 • Number of events 14 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Infections and infestations
Viral infection
|
5.7%
9/158 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
2.5%
4/157 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.1%
13/315 • Number of events 14 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.3%
10/158 • Number of events 18 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.7%
9/157 • Number of events 11 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
6.0%
19/315 • Number of events 29 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.9%
14/158 • Number of events 16 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
10.8%
17/157 • Number of events 23 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
9.8%
31/315 • Number of events 39 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
1.9%
2/107 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
11/158 • Number of events 14 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.1%
8/157 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
6.0%
19/315 • Number of events 24 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Investigations
Tuberculin test positive
|
5.1%
8/158 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.5%
7/157 • Number of events 7 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.8%
15/315 • Number of events 15 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Investigations
Aspartate aminotransferase increased
|
3.8%
6/158 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.1%
8/157 • Number of events 9 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.4%
14/315 • Number of events 15 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.9%
22/158 • Number of events 42 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.0%
11/157 • Number of events 20 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
10.5%
33/315 • Number of events 62 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
14/158 • Number of events 18 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.0%
11/157 • Number of events 19 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.9%
25/315 • Number of events 37 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
7.6%
12/158 • Number of events 22 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
8.3%
13/157 • Number of events 14 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.9%
25/315 • Number of events 36 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
7.0%
11/158 • Number of events 17 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
3.2%
5/157 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.1%
16/315 • Number of events 25 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
10/158 • Number of events 11 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
1.9%
3/157 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.1%
13/315 • Number of events 15 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Nervous system disorders
Headache
|
10.8%
17/158 • Number of events 25 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
11.5%
18/157 • Number of events 31 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
11.1%
35/315 • Number of events 56 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
6.5%
7/107 • Number of events 11 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Psychiatric disorders
Depression
|
5.7%
9/158 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
2.5%
4/157 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.1%
13/315 • Number of events 15 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
13/158 • Number of events 16 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.0%
11/157 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.6%
24/315 • Number of events 29 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.6%
12/158 • Number of events 15 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
3.8%
6/157 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.7%
18/315 • Number of events 21 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.0%
11/158 • Number of events 15 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
8.9%
14/157 • Number of events 18 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.9%
25/315 • Number of events 33 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
1.9%
2/107 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.1%
8/158 • Number of events 14 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
3.8%
6/157 • Number of events 9 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
4.4%
14/315 • Number of events 23 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.5%
4/158 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
5.1%
8/157 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
3.8%
12/315 • Number of events 19 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
0.00%
0/107 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
|
Vascular disorders
Hypertension
|
12.7%
20/158 • Number of events 26 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
7.0%
11/157 • Number of events 11 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
9.8%
31/315 • Number of events 37 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
3.7%
4/107 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until study end (Week 204). AEs refer to the Safety Set including all randomized subjects who took at least 1 dose of CZP.
As per study design, placebo arm subjects shifted either at Week 16 or 24 to CZP treatment. For the Placebo (PBO) group, CZP data from PBO subjects are not utilized. The All CZP 200 mg + 400 mg group shows CZP 200 mg, CZP 400 mg and the escaped PBO subjects with their CZP data.
|
Additional Information
UCB
Cares
Phone: +1887822
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60