Trial Outcomes & Findings for Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis (NCT NCT01095250)
NCT ID: NCT01095250
Last Updated: 2015-11-03
Results Overview
No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
baseline to 28 weeks
Results posted on
2015-11-03
Participant Flow
Disposition of the 31 randomized patients is summarized in the table below. As a consequence of the early termination, few patients (N=31) were randomized into this study. Of these, 30 patients were discontinued due to administrative reasons (30 patients due to study termination and also one due to misrandomization). One patient withdrew consent.
As a consequence of the early termination, few patients (N=31) were randomized into this study. Of these, 30 patients were discontinued due to administrative reasons (30 patients due to study termination, including one due to misrandomization. One patient withdrew consent.
Participant milestones
| Measure |
AIN457 300mg s.c Every 2 Weeks
AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
|
AIN457 300mg s.c. Every 4 Weeks
AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
|
AIN457 150mg s.c Every 4 Weeks
AIN457 150 mg subcutaneously at baseline and Week 2, then every 4 weeks.
|
Placebo s.c Every 2 Weeks
Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
8
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
8
|
5
|
Reasons for withdrawal
| Measure |
AIN457 300mg s.c Every 2 Weeks
AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
|
AIN457 300mg s.c. Every 4 Weeks
AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
|
AIN457 150mg s.c Every 4 Weeks
AIN457 150 mg subcutaneously at baseline and Week 2, then every 4 weeks.
|
Placebo s.c Every 2 Weeks
Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
|
|---|---|---|---|---|
|
Overall Study
administrative reasons
|
8
|
10
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
Baseline characteristics by cohort
| Measure |
AIN457 300mg s.c Every 2 Weeks
n=8 Participants
AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
|
AIN457 300mg s.c. Every 4 Weeks
n=10 Participants
AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
|
AIN457 150mg s.c Every 4 Weeks
n=8 Participants
AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
|
Placebo s.c Every 2 Weeks
n=5 Participants
Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.5 Years
STANDARD_DEVIATION 21.13 • n=5 Participants
|
46.9 Years
STANDARD_DEVIATION 12.80 • n=7 Participants
|
44.6 Years
STANDARD_DEVIATION 15.99 • n=5 Participants
|
50.6 Years
STANDARD_DEVIATION 12.99 • n=4 Participants
|
47.1 Years
STANDARD_DEVIATION 15.47 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Switzerland
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Israel
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Region of Enrollment
Singapore
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline to 28 weeksPopulation: The results of Study CAIN457C2303 did not meet the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.
No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 28 weeksNo patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 28 weeksNo patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 28 weeksNo patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 28 weeksNo patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 28 weeksNo patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Outcome measures
Outcome data not reported
Adverse Events
AIN457 300mg Every 2 Weeks
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
AIN457 300mg Every 4 Weeks
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
AIN457 150mg Every 4 Weeks
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Every 2 Weeks
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457 300mg Every 2 Weeks
n=8 participants at risk
AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks
|
AIN457 300mg Every 4 Weeks
n=10 participants at risk
AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
|
AIN457 150mg Every 4 Weeks
n=8 participants at risk
AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
|
Placebo Every 2 Weeks
n=4 participants at risk
Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
10.0%
1/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
10.0%
1/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Injury, poisoning and procedural complications
Overdose
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
Other adverse events
| Measure |
AIN457 300mg Every 2 Weeks
n=8 participants at risk
AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks
|
AIN457 300mg Every 4 Weeks
n=10 participants at risk
AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
|
AIN457 150mg Every 4 Weeks
n=8 participants at risk
AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
|
Placebo Every 2 Weeks
n=4 participants at risk
Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
|
|---|---|---|---|---|
|
Eye disorders
Blepharitis (Fellow eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Eye disorders
Blepharitis (Study eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Eye disorders
Cataract (Fellow eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Eye disorders
Cataract nuclear (Fellow eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Eye disorders
Cataract nuclear (Study eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Eye disorders
Glaucoma (Fellow eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
10.0%
1/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Eye disorders
Lacrimation increased (Fellow eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Eye disorders
Lacrimation increased (Study eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Eye disorders
Ocular sarcoidosis (Fellow eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Eye disorders
Ocular sarcoidosis (Study eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
10.0%
1/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
General disorders
Pyrexia
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Immune system disorders
Seasonal allergy
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Infections and infestations
Gastroenteritis
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Infections and infestations
Influenza
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
10.0%
1/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Injury, poisoning and procedural complications
Cataract traumatic (Fellow eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Injury, poisoning and procedural complications
Eye injury (Fellow eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Investigations
Intraocular pressure increased (Fellow eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Investigations
Intraocular pressure increased (Study eye)
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Investigations
Weight increased
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
10.0%
1/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Investigations
White blood cell count increased
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
10.0%
1/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Nervous system disorders
Headache
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Psychiatric disorders
Intentional self-injury
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
25.0%
1/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
10.0%
1/10
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/8
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
0.00%
0/4
One patient in the placebo arm was a misrandomized patient and did not receive any treatment and is not included in the adverse events section.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER