Trial Outcomes & Findings for The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents (NCT NCT00899678)
NCT ID: NCT00899678
Last Updated: 2018-08-07
Results Overview
Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
Week 62
Results posted on
2018-08-07
Participant Flow
The Participant Flow refers to the Safety Set (SS) population. The Safety Population includes all subjects enrolled who received at least 1 injection of study treatment.
During an Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W). Subjects who showed a clinical response at Week 6 were randomized in a 1:1 ratio to one of 2 dose groups. Subjects who did not respond at Week 6 were withdrawn from the study.
Participant milestones
| Measure |
Induction Only
Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
* 400 mg for subjects ≥ 40 kg
* 200 mg for subjects 20 to \< 40 kg
|
Maintenance Low-Dose
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|---|
|
Induction Period (Weeks 0 to 6)
STARTED
|
27
|
37
|
35
|
|
Induction Period (Weeks 0 to 6)
COMPLETED
|
2
|
37
|
35
|
|
Induction Period (Weeks 0 to 6)
NOT COMPLETED
|
25
|
0
|
0
|
|
Maintenance Period (Weeks 8 to 62)
STARTED
|
0
|
37
|
35
|
|
Maintenance Period (Weeks 8 to 62)
COMPLETED
|
0
|
12
|
7
|
|
Maintenance Period (Weeks 8 to 62)
NOT COMPLETED
|
0
|
25
|
28
|
Reasons for withdrawal
| Measure |
Induction Only
Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
* 400 mg for subjects ≥ 40 kg
* 200 mg for subjects 20 to \< 40 kg
|
Maintenance Low-Dose
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|---|
|
Induction Period (Weeks 0 to 6)
Adverse Event
|
6
|
0
|
0
|
|
Induction Period (Weeks 0 to 6)
Lack of Efficacy
|
17
|
0
|
0
|
|
Induction Period (Weeks 0 to 6)
Protocol Violation
|
1
|
0
|
0
|
|
Induction Period (Weeks 0 to 6)
Other reason
|
1
|
0
|
0
|
|
Maintenance Period (Weeks 8 to 62)
Adverse Event
|
0
|
10
|
5
|
|
Maintenance Period (Weeks 8 to 62)
Lack of Efficacy
|
0
|
11
|
18
|
|
Maintenance Period (Weeks 8 to 62)
Protocol Violation
|
0
|
1
|
1
|
|
Maintenance Period (Weeks 8 to 62)
Withdrawal by Subject
|
0
|
1
|
2
|
|
Maintenance Period (Weeks 8 to 62)
Other reason
|
0
|
2
|
2
|
Baseline Characteristics
The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents
Baseline characteristics by cohort
| Measure |
Induction Only
n=27 Participants
Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
* 400 mg for subjects ≥ 40 kg
* 200 mg for subjects 20 to \< 40 kg
|
Maintenance Low-Dose
n=37 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=35 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
6-11 years
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Age, Customized
12-17 years
|
21 participants
n=5 Participants
|
28 participants
n=7 Participants
|
27 participants
n=5 Participants
|
76 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Age, Continuous
|
13.8 years
STANDARD_DEVIATION 2.67 • n=5 Participants
|
13.2 years
STANDARD_DEVIATION 2.41 • n=7 Participants
|
13.4 years
STANDARD_DEVIATION 2.46 • n=5 Participants
|
13.4 years
STANDARD_DEVIATION 2.48 • n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaskan Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
22 participants
n=5 Participants
|
32 participants
n=7 Participants
|
27 participants
n=5 Participants
|
81 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other / Mixed
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Weight
|
46.50 kilogram
STANDARD_DEVIATION 12.565 • n=5 Participants
|
45.67 kilogram
STANDARD_DEVIATION 14.638 • n=7 Participants
|
50.35 kilogram
STANDARD_DEVIATION 18.569 • n=5 Participants
|
47.55 kilogram
STANDARD_DEVIATION 15.642 • n=4 Participants
|
|
Height
|
157.46 centimeter
STANDARD_DEVIATION 13.841 • n=5 Participants
|
155.32 centimeter
STANDARD_DEVIATION 13.589 • n=7 Participants
|
157.22 centimeter
STANDARD_DEVIATION 13.320 • n=5 Participants
|
156.57 centimeter
STANDARD_DEVIATION 13.460 • n=4 Participants
|
|
Body Mass Index (BMI)
|
18.39 kilogram per square meter
STANDARD_DEVIATION 2.504 • n=5 Participants
|
18.51 kilogram per square meter
STANDARD_DEVIATION 3.531 • n=7 Participants
|
19.79 kilogram per square meter
STANDARD_DEVIATION 4.897 • n=5 Participants
|
18.93 kilogram per square meter
STANDARD_DEVIATION 3.869 • n=4 Participants
|
|
Body Surface Area (BSA)
|
1.42 square meter
STANDARD_DEVIATION 0.250 • n=5 Participants
|
1.39 square meter
STANDARD_DEVIATION 0.272 • n=7 Participants
|
1.47 square meter
STANDARD_DEVIATION 0.319 • n=5 Participants
|
1.43 square meter
STANDARD_DEVIATION 0.283 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 62Population: Full Analysis Set (FAS) population
Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Outcome measures
| Measure |
Maintenance Low-Dose
n=37 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=35 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
Percentage of Subjects in Clinical Remission at Week 62
|
24.3 percentage of participants
Interval 10.5 to 38.1
|
17.1 percentage of participants
Interval 4.7 to 29.6
|
SECONDARY outcome
Timeframe: Week 62Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High-Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.
The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Outcome measures
| Measure |
Maintenance Low-Dose
n=11 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=7 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62
|
8.18 Score on a scale
Standard Deviation 6.900
|
7.14 Score on a scale
Standard Deviation 7.830
|
SECONDARY outcome
Timeframe: From Week 0 to Week 62Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.
The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. A negative value in change from Baseline indicates an improvement from Baseline to Week 62.
Outcome measures
| Measure |
Maintenance Low-Dose
n=11 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=7 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)
|
-29.77 units on a scale
Standard Deviation 8.097
|
-27.14 units on a scale
Standard Deviation 5.669
|
SECONDARY outcome
Timeframe: From Week 0 to Week 62Population: Full Analysis Set (FAS) population
Clinical response is defined as a decrease from Week 0 in Pediatric Crohn's Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Outcome measures
| Measure |
Maintenance Low-Dose
n=37 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=35 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)
|
29.7 percentage of participants
Interval 15.0 to 44.5
|
20.0 percentage of participants
Interval 6.7 to 33.3
|
SECONDARY outcome
Timeframe: Week 62Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.
The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD)
Outcome measures
| Measure |
Maintenance Low-Dose
n=11 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=7 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
C-Reactive Protein (CRP) Levels at Week 62
|
7.2 mg/L
Interval 2.5 to 20.7
|
5.8 mg/L
Interval 2.1 to 15.7
|
SECONDARY outcome
Timeframe: From Week 0 to Week 62Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.
The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD). Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator.
Outcome measures
| Measure |
Maintenance Low-Dose
n=11 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=7 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)
|
0.49 ratio
Interval 0.17 to 1.41
|
1.84 ratio
Interval 0.27 to 12.71
|
SECONDARY outcome
Timeframe: Week 62Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).
The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).
Outcome measures
| Measure |
Maintenance Low-Dose
n=12 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=7 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
Erythrocyte Sedimentation Rate (ESR) at Week 62
|
20.9 mm/h
Interval 11.8 to 37.2
|
25.2 mm/h
Interval 12.3 to 51.7
|
SECONDARY outcome
Timeframe: From Week 0 to Week 62Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).
The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD). Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator.
Outcome measures
| Measure |
Maintenance Low-Dose
n=12 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=7 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)
|
0.57 ratio
Interval 0.31 to 1.04
|
1.08 ratio
Interval 0.39 to 3.02
|
SECONDARY outcome
Timeframe: From Week 0 to Week 62Population: Full Analysis Analysis (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 10 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Growth scores.
The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development.
Outcome measures
| Measure |
Maintenance Low-Dose
n=10 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=7 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Increase from Stage I to Stage II
|
2 participants
|
0 participants
|
|
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Increase from Stage I to Stage III
|
1 participants
|
1 participants
|
|
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Increase from Stage II to Stage III
|
0 participants
|
1 participants
|
|
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Increase from Stage III to Stage IV
|
2 participants
|
0 participants
|
|
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Increase from Stage IV to Stage V
|
0 participants
|
1 participants
|
|
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Decrease from Stage IV to Stage III
|
1 participants
|
1 participants
|
|
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Subjects remained in Stage I
|
0 participants
|
1 participants
|
|
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Subjects remained in Stage III
|
0 participants
|
2 participants
|
|
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Subjects remained in Stage IV
|
1 participants
|
0 participants
|
|
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
Subjects remained in Stage V
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From Week 2 up to Week 8Population: Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.
Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject's dose.
Outcome measures
| Measure |
Maintenance Low-Dose
n=21 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=20 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
Percentage of Subjects Who Initiated Steroid Tapering
|
71.4 percentage of subjects
Interval 52.1 to 90.8
|
65.0 percentage of subjects
Interval 44.1 to 85.9
|
SECONDARY outcome
Timeframe: Last/Withdrawal Visit (up to Week 62)Population: Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.
Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn's Disease Activity index (PCDAI) data is available.
Outcome measures
| Measure |
Maintenance Low-Dose
n=21 Participants
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=20 Participants
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
|---|---|---|
|
Percentage of Subjects in Corticosteroid-free Remission at the End of the Study
|
23.8 percentage of paticipants
Interval 5.6 to 42.0
|
15.0 percentage of paticipants
Interval 0.0 to 30.6
|
Adverse Events
Induction Period
Serious events: 6 serious events
Other events: 59 other events
Deaths: 0 deaths
Maintenance Low-Dose
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Maintenance High-Dose
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Overall Study
Serious events: 14 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction Period
n=99 participants at risk
Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
* 400 mg for subjects ≥ 40 kg
* 200 mg for subjects 20 to \< 40 kg
|
Maintenance Low-Dose
n=37 participants at risk
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=35 participants at risk
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Overall Study
n=99 participants at risk
Overall Study comprises Induction Period and Maintenance Period (Week -6 to Week 62).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Crohn's disease
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Haematochezia
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
General disorders
Pyrexia
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Gastroenteritis viral
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Salmonellosis
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Viral infection
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Investigations
Weight decreased
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
Other adverse events
| Measure |
Induction Period
n=99 participants at risk
Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
* 400 mg for subjects ≥ 40 kg
* 200 mg for subjects 20 to \< 40 kg
|
Maintenance Low-Dose
n=37 participants at risk
Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Maintenance High-Dose
n=35 participants at risk
Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
|
Overall Study
n=99 participants at risk
Overall Study comprises Induction Period and Maintenance Period (Week -6 to Week 62).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
4/99 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
11.4%
4/35 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
10.1%
10/99 • Number of events 12 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
4/99 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
13.5%
5/37 • Number of events 5 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
9.1%
9/99 • Number of events 12 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
3/99 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
7.1%
7/99 • Number of events 7 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
13.5%
5/37 • Number of events 7 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
20.0%
7/35 • Number of events 8 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
12.1%
12/99 • Number of events 15 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
7/99 • Number of events 7 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 5 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.6%
3/35 • Number of events 7 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
12.1%
12/99 • Number of events 19 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.4%
2/37 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.1%
5/99 • Number of events 6 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.6%
3/35 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
8/99 • Number of events 8 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
6/99 • Number of events 8 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
10.1%
10/99 • Number of events 13 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
2/99 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.1%
5/99 • Number of events 6 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Toothache
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
3.0%
3/99 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
6/99 • Number of events 7 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
17.1%
6/35 • Number of events 10 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
13.1%
13/99 • Number of events 20 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
General disorders
Fatigue
|
3.0%
3/99 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
6.1%
6/99 • Number of events 7 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
General disorders
Injection site pain
|
22.2%
22/99 • Number of events 55 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
10.8%
4/37 • Number of events 17 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
17.1%
6/35 • Number of events 36 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
22.2%
22/99 • Number of events 108 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
General disorders
Pyrexia
|
9.1%
9/99 • Number of events 15 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
16.2%
6/37 • Number of events 7 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
25.7%
9/35 • Number of events 9 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
20.2%
20/99 • Number of events 31 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Ear infection
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.4%
2/37 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
4.0%
4/99 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Influenza
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
6.1%
6/99 • Number of events 7 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
5/99 • Number of events 5 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
8/99 • Number of events 8 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Pharyngitis
|
1.0%
1/99 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.4%
2/37 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
3.0%
3/99 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Sinusitis
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.1%
5/99 • Number of events 6 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
21.6%
8/37 • Number of events 9 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
10.1%
10/99 • Number of events 11 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Infections and infestations
Viral infection
|
2.0%
2/99 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
10.8%
4/37 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.6%
3/35 • Number of events 5 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
9.1%
9/99 • Number of events 12 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.4%
2/37 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.4%
2/37 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/37 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Investigations
Weight decreased
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.4%
2/37 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
4.0%
4/99 • Number of events 7 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
4/99 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
8/99 • Number of events 8 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
6/99 • Number of events 7 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
10.8%
4/37 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
12.1%
12/99 • Number of events 13 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.4%
2/37 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Nervous system disorders
Headache
|
9.1%
9/99 • Number of events 12 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
10.8%
4/37 • Number of events 10 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.6%
3/35 • Number of events 4 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
12.1%
12/99 • Number of events 26 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
5/99 • Number of events 5 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 5 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
8/99 • Number of events 13 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
5/99 • Number of events 5 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.4%
2/37 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
8/99 • Number of events 9 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/99 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.7%
2/35 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
3.0%
3/99 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.0%
3/99 • Number of events 3 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.7%
1/37 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
2.9%
1/35 • Number of events 1 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.1%
5/99 • Number of events 5 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
2/99 • Number of events 2 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
8.1%
3/37 • Number of events 6 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
0.00%
0/35 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
5.1%
5/99 • Number of events 8 • Adverse Events (AEs) were collected over 68 weeks (from Week -6 to Week 62).
Adverse Events (AEs) refer to the Safety Set (SS) population. All subjects in the Safety Population (n=99) participated in the Induction Period. There were 27 subjects who did not continue into the Maintenance Period.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60