Trial Outcomes & Findings for Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol (NCT NCT01190410)
NCT ID: NCT01190410
Last Updated: 2020-12-17
Results Overview
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
During study treatment (up to 303 weeks)
Results posted on
2020-12-17
Participant Flow
The study started to enroll patients in August 2010 and concluded in November 2017.
The study included an Open Label treatment period, having 16 subjects enrolled in the Safety Set (SS) shown in the Participant Flow.
Participant milestones
| Measure |
Certolizumab Pegol: Low-dose Group (Weight Adjusted)
200 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 100 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: High-dose Group (Weight Adjusted)
400 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 200 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
12
|
|
Overall Study
Re-Induction
|
0
|
2
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
9
|
Reasons for withdrawal
| Measure |
Certolizumab Pegol: Low-dose Group (Weight Adjusted)
200 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 100 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: High-dose Group (Weight Adjusted)
400 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 200 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Administrative decision
|
1
|
0
|
|
Overall Study
PI discretion
|
0
|
2
|
Baseline Characteristics
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
Baseline characteristics by cohort
| Measure |
Certolizumab Pegol: Low-dose Group (Weight Adjusted)
n=4 Participants
200 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 100 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: High-dose Group (Weight Adjusted)
n=12 Participants
400 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 200 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Total Title
n=16 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
13.5 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
13.8 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During study treatment (up to 303 weeks)Population: The Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Outcome measures
| Measure |
Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS)
n=4 Participants
200 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 100 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS)
n=10 Participants
400 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 200 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: Re-Induction Group - (SS)
n=2 Participants
If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject's weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to \< 40 kg, regardless of the subject's previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
|---|---|---|---|
|
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)
Subjects
|
2 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During study treatment (up to 303 weeks)Population: The Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Outcome measures
| Measure |
Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS)
n=4 Participants
200 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 100 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS)
n=10 Participants
400 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 200 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: Re-Induction Group - (SS)
n=2 Participants
If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject's weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to \< 40 kg, regardless of the subject's previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
|---|---|---|---|
|
Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE)
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the time of completion or termination visit (up to 298 weeks)Population: The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
Anti-nuclear antibodies (ANA) are autoantibodies. ANA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
Outcome measures
| Measure |
Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS)
n=3 Participants
200 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 100 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS)
n=10 Participants
400 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 200 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: Re-Induction Group - (SS)
If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject's weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to \< 40 kg, regardless of the subject's previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
|---|---|---|---|
|
Number of Subjects Who Develop Anti-nuclear Antibodies During the Study
|
0 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: At the time of completion or termination visit (up to 298 weeks)Population: The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.
Anti-dsDNA are autoantibodies. Anti-dsDNA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
Outcome measures
| Measure |
Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS)
n=3 Participants
200 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 100 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS)
n=10 Participants
400 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 200 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: Re-Induction Group - (SS)
If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject's weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to \< 40 kg, regardless of the subject's previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
|---|---|---|---|
|
Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study
Subjects
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At the time of completion or termination visit (up to 298 weeks)Population: The Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of study treatment in this study and who had at least 1 efficacy measurement after the first injection of this study.
Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10)
Outcome measures
| Measure |
Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS)
n=3 Participants
200 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 100 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS)
n=9 Participants
400 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 200 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: Re-Induction Group - (SS)
If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject's weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to \< 40 kg, regardless of the subject's previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
|---|---|---|---|
|
Percentage of Subjects in Clinical Remission
|
100 Percentage of particpiants
|
44.4 Percentage of particpiants
|
—
|
Adverse Events
Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Certolizumab Pegol: Re-Induction Group - (SS)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS)
n=4 participants at risk
200 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 100 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS)
n=10 participants at risk
400 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 200 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: Re-Induction Group - (SS)
n=2 participants at risk
If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject's weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to \< 40 kg, regardless of the subject's previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
50.0%
1/2 • Number of events 1 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Infections and infestations
Anal abscess
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
50.0%
1/2 • Number of events 1 • During study treatment (up to 303 weeks)
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Infections and infestations
Pancreatitis viral
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
Other adverse events
| Measure |
Certolizumab Pegol: Low-dose Group (Weight Adjusted) - (SS)
n=4 participants at risk
200 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 100 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: High-dose Group (Weight Adjusted) - (SS)
n=10 participants at risk
400 mg administered subcutaneously every 4 weeks for subjects \>= 40 kg or 200 mg for subjects 20 to \< 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
Certolizumab Pegol: Re-Induction Group - (SS)
n=2 participants at risk
If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject's weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to \< 40 kg, regardless of the subject's previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
40.0%
4/10 • Number of events 5 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
20.0%
2/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
50.0%
1/2 • Number of events 1 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
50.0%
1/2 • Number of events 1 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
50.0%
1/2 • Number of events 1 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Oesophagitis
|
25.0%
1/4 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
General disorders
Chest pain
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
General disorders
Chills
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
General disorders
Pain
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
20.0%
2/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Infections and infestations
Furuncle
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
50.0%
1/2 • Number of events 1 • During study treatment (up to 303 weeks)
|
|
Infections and infestations
Localised infection
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
50.0%
1/2 • Number of events 1 • During study treatment (up to 303 weeks)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
50.0%
1/2 • Number of events 1 • During study treatment (up to 303 weeks)
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
50.0%
1/2 • Number of events 1 • During study treatment (up to 303 weeks)
|
|
Investigations
Ultrasound abdomen
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Investigations
Vitamin D decreased
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
20.0%
2/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 5 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 3 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Psychiatric disorders
Enuresis
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
50.0%
1/2 • Number of events 1 • During study treatment (up to 303 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dysmenorrhoea
|
25.0%
1/4 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 6 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
25.0%
1/4 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/10 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 1 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • During study treatment (up to 303 weeks)
|
10.0%
1/10 • Number of events 2 • During study treatment (up to 303 weeks)
|
0.00%
0/2 • During study treatment (up to 303 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60