Trial Outcomes & Findings for A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis (NCT NCT03051217)
NCT ID: NCT03051217
Last Updated: 2022-01-04
Results Overview
The PASI75 response assessments were based on at least 75 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
127 participants
Primary outcome timeframe
Week 16
Results posted on
2022-01-04
Participant Flow
The study started to enroll patients in February 2017 and concluded in January 2019.
The study included a 5 Week Screening Period, an Initial Period up to Week 16, a Maintenance Period up to Week 52 and a Safety Follow-up Period up to Week 60. Participant Flow refers to the Randomized Set (RS)
Participant milestones
| Measure |
Placebo
This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period.
|
CZP 200 mg Q2W
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period.
|
CZP 400 mg Q2W
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period.
|
Placebo/Placebo
This arm consisted of participants who were initially randomized to Placebo during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive Placebo during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
|
CZP 400 mg Q2W/CZP 400 mg Q2W
This arm consisted of participants who were initially randomized to CZP 400 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
|
CZP 200 mg Q2W/CZP 200 mg Q2W
This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 200 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
|
CZP 200 mg Q2W/CZP 400 mg Q4W
This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 400 mg Q4W, with Placebo administered on alternate dosing weeks to maintain the blind, during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
|
|---|---|---|---|---|---|---|---|
|
Initial Period (Week 0 to Week 16)
STARTED
|
26
|
48
|
53
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
COMPLETED
|
23
|
46
|
51
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
NOT COMPLETED
|
3
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 52)
STARTED
|
0
|
0
|
0
|
23
|
51
|
26
|
20
|
|
Maintenance Period (Week 16 to Week 52)
Received Escape Treatment
|
0
|
0
|
0
|
21
|
3
|
7
|
3
|
|
Maintenance Period (Week 16 to Week 52)
COMPLETED
|
0
|
0
|
0
|
20
|
48
|
24
|
19
|
|
Maintenance Period (Week 16 to Week 52)
NOT COMPLETED
|
0
|
0
|
0
|
3
|
3
|
2
|
1
|
Reasons for withdrawal
| Measure |
Placebo
This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period.
|
CZP 200 mg Q2W
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period.
|
CZP 400 mg Q2W
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period.
|
Placebo/Placebo
This arm consisted of participants who were initially randomized to Placebo during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive Placebo during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
|
CZP 400 mg Q2W/CZP 400 mg Q2W
This arm consisted of participants who were initially randomized to CZP 400 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
|
CZP 200 mg Q2W/CZP 200 mg Q2W
This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 200 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
|
CZP 200 mg Q2W/CZP 400 mg Q4W
This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 400 mg Q4W, with Placebo administered on alternate dosing weeks to maintain the blind, during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
|
|---|---|---|---|---|---|---|---|
|
Initial Period (Week 0 to Week 16)
Adverse Event
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 52)
Adverse Event
|
0
|
0
|
0
|
1
|
2
|
1
|
1
|
|
Maintenance Period (Week 16 to Week 52)
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 52)
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 52)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 52)
Difficulty in going to hospital
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=26 Participants
This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period.
|
CZP 200 mg Q2W
n=48 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period.
|
CZP 400 mg Q2W
n=53 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period.
|
Total Title
n=127 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
|
24 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Continuous
|
47.93 years
STANDARD_DEVIATION 11.37 • n=5 Participants
|
48.43 years
STANDARD_DEVIATION 13.47 • n=7 Participants
|
52.43 years
STANDARD_DEVIATION 11.59 • n=5 Participants
|
50.00 years
STANDARD_DEVIATION 12.37 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese only)
|
26 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The Full Analysis Set (FAS) consisted of all participants in the Randomized Set (RS) who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
The PASI75 response assessments were based on at least 75 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Placebo (FAS)
n=26 Participants
This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).
|
CZP 200 mg Q2W (FAS)
n=48 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.
|
CZP 400 mg Q2W (FAS)
n=53 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
|
|---|---|---|---|
|
Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
|
7.9 percentage of participants
|
73.0 percentage of participants
|
87.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
Outcome measures
| Measure |
Placebo (FAS)
n=26 Participants
This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).
|
CZP 200 mg Q2W (FAS)
n=48 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.
|
CZP 400 mg Q2W (FAS)
n=53 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
|
|---|---|---|---|
|
Percentage of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2-category Improvement) at Week 16
|
0.0 percentage of participants
|
52.7 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
The PASI90 response assessments were based on at least 90 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Placebo (FAS)
n=26 Participants
This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).
|
CZP 200 mg Q2W (FAS)
n=48 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.
|
CZP 400 mg Q2W (FAS)
n=53 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
|
|---|---|---|---|
|
Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
|
0.2 percentage of participants
|
53.8 percentage of participants
|
75.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit. Missing data were handled using the last observation carried forward (LOCF) method for the DLQI.
This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The DLQI is a subject-reported questionnaire designed for use in adult participants with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asked participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (\>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=\<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).
Outcome measures
| Measure |
Placebo (FAS)
n=26 Participants
This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).
|
CZP 200 mg Q2W (FAS)
n=48 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.
|
CZP 400 mg Q2W (FAS)
n=53 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
|
|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
|
-0.3 Scores on a scale
Standard Error 1.0
|
-6.8 Scores on a scale
Standard Error 0.7
|
-6.8 Scores on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit. Missing data were handled using the last observation carried forward (LOCF) method for the Itch Numeric Rating Scale.
This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The Itch Numeric Rating Scale (NRS) has been developed as a simple, single item instrument to assess the patient-reported severity of itch at its most intense during the past 24h period. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to PSO in the past 24h period on an 11-point scale anchored at 0, representing "no itching" and 10, representing "worst itch imaginable" (Kimball et al, 2016).
Outcome measures
| Measure |
Placebo (FAS)
n=26 Participants
This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).
|
CZP 200 mg Q2W (FAS)
n=48 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.
|
CZP 400 mg Q2W (FAS)
n=53 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
|
|---|---|---|---|
|
Change From Baseline in Itch Numeric Rating Scale at Week 16
|
0.2 Scores on a scale
Standard Error 0.5
|
-2.9 Scores on a scale
Standard Error 0.4
|
-4.0 Scores on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Blood samples were collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all participants in the RS who took at least 1 dose of the study medication and provided at least 1 quantifiable CZP plasma concentration.
Plasma concentration was expressed in micrograms per milliliter (μg/mL). Values below Lower Limit of Quantification (LLOQ) were set to half the LLOQ to present summaries. The geometric mean and geometric coefficient of variation were only displayed if at least 2/3 of the data were above the LLOQ.
Outcome measures
| Measure |
Placebo (FAS)
n=28 Participants
This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).
|
CZP 200 mg Q2W (FAS)
n=53 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.
|
CZP 400 mg Q2W (FAS)
n=20 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
|
|---|---|---|---|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Baseline
|
NA µg/mL
Geometric Coefficient of Variation NA
Values were below the level of detection.
|
NA µg/mL
Geometric Coefficient of Variation NA
Values were below the level of detection.
|
NA µg/mL
Geometric Coefficient of Variation NA
Values were below the level of detection.
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Week 2
|
34.6417 µg/mL
Geometric Coefficient of Variation 28.3
|
35.2588 µg/mL
Geometric Coefficient of Variation 25.2
|
33.2026 µg/mL
Geometric Coefficient of Variation 26.0
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Week 4
|
47.9241 µg/mL
Geometric Coefficient of Variation 45.6
|
47.0462 µg/mL
Geometric Coefficient of Variation 35.7
|
48.3634 µg/mL
Geometric Coefficient of Variation 21.3
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Week 6
|
36.3003 µg/mL
Geometric Coefficient of Variation 286.7
|
41.2410 µg/mL
Geometric Coefficient of Variation 183.0
|
52.4876 µg/mL
Geometric Coefficient of Variation 38.0
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Week 8
|
21.9292 µg/mL
Geometric Coefficient of Variation 621.4
|
39.9282 µg/mL
Geometric Coefficient of Variation 243.7
|
33.4139 µg/mL
Geometric Coefficient of Variation 69.0
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Week 12
|
16.1907 µg/mL
Geometric Coefficient of Variation 300.7
|
46.9934 µg/mL
Geometric Coefficient of Variation 189.3
|
23.8437 µg/mL
Geometric Coefficient of Variation 105.9
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Week 16
|
14.5995 µg/mL
Geometric Coefficient of Variation 405.5
|
48.3156 µg/mL
Geometric Coefficient of Variation 183.8
|
18.1204 µg/mL
Geometric Coefficient of Variation 381.8
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Week 24
|
26.2596 µg/mL
Geometric Coefficient of Variation 52.8
|
51.6911 µg/mL
Geometric Coefficient of Variation 118.2
|
7.7206 µg/mL
Geometric Coefficient of Variation 1747.5
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Week 32
|
26.9398 µg/mL
Geometric Coefficient of Variation 48.8
|
44.5749 µg/mL
Geometric Coefficient of Variation 177.2
|
8.4148 µg/mL
Geometric Coefficient of Variation 1245.6
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Week 40
|
22.2790 µg/mL
Geometric Coefficient of Variation 68.3
|
50.9685 µg/mL
Geometric Coefficient of Variation 53.3
|
16.7013 µg/mL
Geometric Coefficient of Variation 231.1
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Week 52
|
20.4541 µg/mL
Geometric Coefficient of Variation 90.8
|
54.1341 µg/mL
Geometric Coefficient of Variation 43.4
|
15.9290 µg/mL
Geometric Coefficient of Variation 149.1
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Early Withdrawal
|
0.8342 µg/mL
Geometric Coefficient of Variation 5520.7
|
0.6115 µg/mL
Geometric Coefficient of Variation 49802.8
|
—
|
|
Plasma Concentration of Certolizumab Pegol (CZP)
Safety Follow-Up
|
0.1739 µg/mL
Geometric Coefficient of Variation 757.5
|
0.3760 µg/mL
Geometric Coefficient of Variation 1460.3
|
0.1407 µg/mL
Geometric Coefficient of Variation 714.5
|
SECONDARY outcome
Timeframe: Blood samples will be collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all participants in the RS who took at least 1 dose of the study medication and provided at least 1 quantifiable CZP plasma concentration.
A pre-anti-drug (CZP) antibody (ADA) positive subject was defined as having a confirmed positive sample at Baseline. A pre-ADA negative subject was defined as having a Screening below the cut point (BCP) sample, or a screening above the cut point (ACP) sample, but not confirmed positive at Baseline. A treatment-emergent ADA positive subject was defined as either 1) pre-ADA negative subjects having at least 1 ADA confirmed positive sample or 2) pre-ADA positive subjects with at least 1 sample with greater then or equal to (\>=) 1.67-fold increase from Baseline on CZP treatment.
Outcome measures
| Measure |
Placebo (FAS)
n=28 Participants
This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).
|
CZP 200 mg Q2W (FAS)
n=53 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.
|
CZP 400 mg Q2W (FAS)
n=20 Participants
This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
|
|---|---|---|---|
|
Percentage of Participants With Positive Anti-Certolizumab Pegol-antibody Levels in Plasma
|
100 percentage of participants
|
96.2 percentage of participants
|
90.0 percentage of participants
|
Adverse Events
Placebo (SS)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
CZP 200mg Q2W (SS)
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
CZP 400mg Q4W (SS)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
CZP 200 mg Q2W + CZP 400 mg Q4W (SS)
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
CZP 400 mg Q2W (SS)
Serious events: 6 serious events
Other events: 45 other events
Deaths: 0 deaths
All CZP (SS)
Serious events: 8 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (SS)
n=26 participants at risk
This arm consisted of participants who received at least one dose of Placebo subcutaneous (sc) injection every two weeks (Q2W) during the study. Participants formed the Safety Set (SS).
|
CZP 200mg Q2W (SS)
n=72 participants at risk
This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 200 mg every two weeks (Q2W) during the study. Participants formed the SS.
|
CZP 400mg Q4W (SS)
n=20 participants at risk
This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every four weeks (Q4W) during the study. Participants formed the SS.
|
CZP 200 mg Q2W + CZP 400 mg Q4W (SS)
n=72 participants at risk
This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 200 mg every two weeks (Q2W) and at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every four weeks (Q4W) during the study. Participants formed the SS.
|
CZP 400 mg Q2W (SS)
n=64 participants at risk
This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the study. Participants formed the SS.
|
All CZP (SS)
n=122 participants at risk
This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection regardless of the dose during the study. Participants formed the SS.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Gastrointestinal disorders
Large intestine polyp
|
3.8%
1/26 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Gastrointestinal disorders
Dental cyst
|
3.8%
1/26 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/122 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
3.1%
2/64 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
2/122 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
Other adverse events
| Measure |
Placebo (SS)
n=26 participants at risk
This arm consisted of participants who received at least one dose of Placebo subcutaneous (sc) injection every two weeks (Q2W) during the study. Participants formed the Safety Set (SS).
|
CZP 200mg Q2W (SS)
n=72 participants at risk
This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 200 mg every two weeks (Q2W) during the study. Participants formed the SS.
|
CZP 400mg Q4W (SS)
n=20 participants at risk
This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every four weeks (Q4W) during the study. Participants formed the SS.
|
CZP 200 mg Q2W + CZP 400 mg Q4W (SS)
n=72 participants at risk
This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 200 mg every two weeks (Q2W) and at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every four weeks (Q4W) during the study. Participants formed the SS.
|
CZP 400 mg Q2W (SS)
n=64 participants at risk
This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the study. Participants formed the SS.
|
All CZP (SS)
n=122 participants at risk
This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection regardless of the dose during the study. Participants formed the SS.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.6%
4/72 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
4.1%
5/122 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
4.2%
3/72 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
3.3%
4/122 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
4.2%
3/72 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
4.7%
3/64 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
4.9%
6/122 • Number of events 7 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Infections and infestations
Myringitis
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Infections and infestations
Influenza
|
11.5%
3/26 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
3.1%
2/64 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
3.3%
4/122 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
6.2%
4/64 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
4.1%
5/122 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Infections and infestations
Body tinea
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Infections and infestations
Nasopharyngitis
|
23.1%
6/26 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
31.9%
23/72 • Number of events 24 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
30.0%
6/20 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
34.7%
25/72 • Number of events 30 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
43.8%
28/64 • Number of events 48 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
43.4%
53/122 • Number of events 78 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
7.7%
2/26 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/122 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Investigations
Cell marker increased
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
2/122 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.6%
4/72 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
4.7%
3/64 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.7%
7/122 • Number of events 9 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
7.7%
2/26 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
2/122 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
10.0%
2/20 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.6%
4/72 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
6.2%
4/64 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.7%
7/122 • Number of events 10 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
4.2%
3/72 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.5%
3/122 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
2/122 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.6%
4/72 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.6%
4/72 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
4.7%
3/64 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.7%
7/122 • Number of events 9 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
6.9%
5/72 • Number of events 7 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
6.9%
5/72 • Number of events 7 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
6.2%
4/64 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
7.4%
9/122 • Number of events 11 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
6.2%
4/64 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
4.9%
6/122 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
3.1%
2/64 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
3.3%
4/122 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
2/26 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.8%
2/72 • Number of events 3 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.6%
1/64 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
2.5%
3/122 • Number of events 4 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
23.1%
6/26 • Number of events 6 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
11.1%
8/72 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/20 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
11.1%
8/72 • Number of events 8 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
7.8%
5/64 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
10.7%
13/122 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/26 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/72 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
5.0%
1/20 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
1.4%
1/72 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.00%
0/64 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
0.82%
1/122 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).
Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60