Trial Outcomes & Findings for Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (NCT NCT00356408)
NCT ID: NCT00356408
Last Updated: 2018-08-09
Results Overview
Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
106 participants
Primary outcome timeframe
During this study (maximum 122 weeks)
Results posted on
2018-08-09
Participant Flow
The study was started in January 2007 with recruitment occurring in the United States, Germany, and Canada. The study had last patient last visit in February of 2010.
Participant milestones
| Measure |
CDP870 400 mg
Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
CDP870 400 mg
Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Lack of Efficacy
|
36
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Other: Principal investigator discretion
|
3
|
|
Overall Study
Other: Sponsor request
|
1
|
|
Overall Study
Other: Azathioprine stopped
|
1
|
|
Overall Study
Other: Failed to meet Inc/Exc criteria
|
1
|
|
Overall Study
Other: Subject chose commerical dosing
|
1
|
Baseline Characteristics
Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease
Baseline characteristics by cohort
| Measure |
Placebo/Completer
n=14 Participants
Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
|
CDP870/Completer
n=16 Participants
CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
|
Placebo/Non-completer
n=40 Participants
Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
|
CDP870/Non-completer
n=33 Participants
CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Continuous
|
44.00 years
STANDARD_DEVIATION 12.53 • n=5 Participants
|
39.31 years
STANDARD_DEVIATION 12.83 • n=7 Participants
|
38.44 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
41.38 years
STANDARD_DEVIATION 13.75 • n=4 Participants
|
40.27 years
STANDARD_DEVIATION 13.39 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
31 participants
n=5 Participants
|
21 participants
n=4 Participants
|
70 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
10 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During this study (maximum 122 weeks)Population: All subjects in the the Intent to Treat (ITT) population are included in this analysis.
Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
Outcome measures
| Measure |
Placebo/Completer
n=14 Participants
Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
|
CDP870/Completer
n=16 Participants
CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
|
Placebo/Non-completer
n=40 Participants
Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
|
CDP870/Non-completer
n=33 Participants
CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
|
|---|---|---|---|---|
|
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
|
12 subjects
|
15 subjects
|
32 subjects
|
30 subjects
|
SECONDARY outcome
Timeframe: Week 34 in this studyPopulation: All subjects in the the Intent to Treat (ITT) population are included in this analysis.
Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.
Outcome measures
| Measure |
Placebo/Completer
n=14 Participants
Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
|
CDP870/Completer
n=16 Participants
CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
|
Placebo/Non-completer
n=40 Participants
Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
|
CDP870/Non-completer
n=33 Participants
CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
|
|---|---|---|---|---|
|
Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.
|
28.6 percentage of subjects
|
37.5 percentage of subjects
|
35.0 percentage of subjects
|
3.0 percentage of subjects
|
Adverse Events
Placebo/Completer
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
CDP870/Completer
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo/Non-completer
Serious events: 6 serious events
Other events: 31 other events
Deaths: 0 deaths
CDP870/Non-completer
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
CDP870 400 mg (Overall)
Serious events: 15 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Completer
n=14 participants at risk
Placebo Completer: Placebo subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
|
CDP870/Completer
n=16 participants at risk
CDP870 Completer: CDP870 subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
|
Placebo/Non-completer
n=40 participants at risk
Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
|
CDP870/Non-completer
n=33 participants at risk
CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
|
CDP870 400 mg (Overall)
n=103 participants at risk
Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Crohn's Disease
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
7.5%
3/40 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
4.9%
5/103 • Number of events 8 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Intestinal Fistula
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
7.1%
1/14 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Perianal Abscess
|
14.3%
2/14 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Abscess
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Abdominal Abscess
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Injury, poisoning and procedural complications
Anastomotic Leak
|
7.1%
1/14 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Renal and urinary disorders
Renal Failure
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Renal and urinary disorders
Renal Failure Acute
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
Other adverse events
| Measure |
Placebo/Completer
n=14 participants at risk
Placebo Completer: Placebo subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
|
CDP870/Completer
n=16 participants at risk
CDP870 Completer: CDP870 subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
|
Placebo/Non-completer
n=40 participants at risk
Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
|
CDP870/Non-completer
n=33 participants at risk
CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
|
CDP870 400 mg (Overall)
n=103 participants at risk
Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
3.9%
4/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
7.5%
3/40 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
3.9%
4/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Crohn's Disease
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
20.0%
8/40 • Number of events 11 • Duration of the study, maximum of 122 Weeks
|
33.3%
11/33 • Number of events 13 • Duration of the study, maximum of 122 Weeks
|
21.4%
22/103 • Number of events 27 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
18.2%
6/33 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
10.7%
11/103 • Number of events 11 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
2/14 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
9.1%
3/33 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
8.7%
9/103 • Number of events 11 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
10.0%
4/40 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
9.1%
3/33 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
7.8%
8/103 • Number of events 8 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
7.5%
3/40 • Number of events 11 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
6.8%
7/103 • Number of events 16 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Abdominal Distension
|
14.3%
2/14 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
5.8%
6/103 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
14.3%
2/14 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
5.8%
6/103 • Number of events 8 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
7.5%
3/40 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
4.9%
5/103 • Number of events 7 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
4.9%
5/103 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
3.9%
4/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Tooth Impacted
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Food Poisoning
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Gastrointestinal Hypomotility
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Gastrointestinal disorders
Dental Discomfort
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
10.0%
4/40 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
7.8%
8/103 • Number of events 9 • Duration of the study, maximum of 122 Weeks
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
5.8%
6/103 • Number of events 8 • Duration of the study, maximum of 122 Weeks
|
|
General disorders
Oedema Peripheral
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
3.9%
4/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
General disorders
Influenza Like Illness
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
3.9%
4/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
General disorders
Chills
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
General disorders
Injection Site Pain
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 5 • Duration of the study, maximum of 122 Weeks
|
|
General disorders
Injection Site Irritation
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
General disorders
Injection Site Erythema
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
15.0%
6/40 • Number of events 7 • Duration of the study, maximum of 122 Weeks
|
15.2%
5/33 • Number of events 7 • Duration of the study, maximum of 122 Weeks
|
13.6%
14/103 • Number of events 17 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
2/14 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
17.5%
7/40 • Number of events 9 • Duration of the study, maximum of 122 Weeks
|
9.1%
3/33 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
11.7%
12/103 • Number of events 15 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
18.8%
3/16 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
12.5%
5/40 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
9.7%
10/103 • Number of events 12 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
10.0%
4/40 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
12.1%
4/33 • Number of events 5 • Duration of the study, maximum of 122 Weeks
|
7.8%
8/103 • Number of events 9 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
10.0%
4/40 • Number of events 7 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.8%
7/103 • Number of events 10 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Gastroenteritis Viral
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
3.9%
4/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
9.1%
3/33 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Viral Infection
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Abdominal Abscess
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Infections and infestations
Onychomycosis
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Injury, poisoning and procedural complications
Exposure To Toxic Agent
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Investigations
Heart Rate Increased
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Investigations
Blood Creatinine Abnormal
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Investigations
Hepatic Enzyme Abnormal
|
7.1%
1/14 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
25.0%
4/16 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
20.0%
8/40 • Number of events 11 • Duration of the study, maximum of 122 Weeks
|
21.2%
7/33 • Number of events 8 • Duration of the study, maximum of 122 Weeks
|
18.4%
19/103 • Number of events 25 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
18.8%
3/16 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
7.5%
3/40 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.8%
7/103 • Number of events 8 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
7.5%
3/40 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
4.9%
5/103 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 5 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Fatigue
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
12.5%
5/40 • Number of events 7 • Duration of the study, maximum of 122 Weeks
|
15.2%
5/33 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
10.7%
11/103 • Number of events 14 • Duration of the study, maximum of 122 Weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
10.0%
4/40 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
9.1%
3/33 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
6.8%
7/103 • Number of events 7 • Duration of the study, maximum of 122 Weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 12 • Duration of the study, maximum of 122 Weeks
|
5.8%
6/103 • Number of events 17 • Duration of the study, maximum of 122 Weeks
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
5.8%
6/103 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
3.9%
4/103 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
|
Psychiatric disorders
Stress
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Psychiatric disorders
Agitation
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Renal and urinary disorders
Oliguria
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
10.0%
4/40 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
5.8%
6/103 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
2.9%
3/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
12.5%
2/16 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • Number of events 3 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
9.1%
3/33 • Number of events 4 • Duration of the study, maximum of 122 Weeks
|
5.8%
6/103 • Number of events 9 • Duration of the study, maximum of 122 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
3.0%
1/33 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/14 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
2.5%
1/40 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
1.9%
2/103 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
|
Skin and subcutaneous tissue disorders
Vascular Skin Disorder
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/16 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/40 • Duration of the study, maximum of 122 Weeks
|
0.00%
0/33 • Duration of the study, maximum of 122 Weeks
|
0.97%
1/103 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
6.2%
1/16 • Number of events 1 • Duration of the study, maximum of 122 Weeks
|
5.0%
2/40 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
6.1%
2/33 • Number of events 2 • Duration of the study, maximum of 122 Weeks
|
5.8%
6/103 • Number of events 6 • Duration of the study, maximum of 122 Weeks
|
Additional Information
UCB (Study Director)
UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER