Trial Outcomes & Findings for Phase III Study in Refractory Behcet's Disease (NCT NCT00995709)
NCT ID: NCT00995709
Last Updated: 2015-08-31
Results Overview
Patients number of occurences during a 24 week period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
118 participants
Primary outcome timeframe
24 weeks
Results posted on
2015-08-31
Participant Flow
Participant milestones
| Measure |
AIN457C 300 mg Every 2 Week Dosage Regimen
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457C 300 mg Monthly Dosage Regimen
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
One patient in the AIN457 300 mg monthly group (PID 0161/00002) was randomized; however, this patient did not meet eligibility criteria and never received study medication
|
Placebo to AIN457C
Placebo was administered in 2 s.c. injections
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
39
|
|
Overall Study
COMPLETED
|
32
|
31
|
34
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
5
|
Reasons for withdrawal
| Measure |
AIN457C 300 mg Every 2 Week Dosage Regimen
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457C 300 mg Monthly Dosage Regimen
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
One patient in the AIN457 300 mg monthly group (PID 0161/00002) was randomized; however, this patient did not meet eligibility criteria and never received study medication
|
Placebo to AIN457C
Placebo was administered in 2 s.c. injections
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
Baseline Characteristics
Phase III Study in Refractory Behcet's Disease
Baseline characteristics by cohort
| Measure |
AIN457C 300 mg Every 2 Week Dosage Regimen
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457C 300 mg Monthly Dosage Regimen (a)
n=40 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
|
Placebo to AIN457C
n=39 Participants
Placebo was administered in 2 s.c. injections
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.2 Years
STANDARD_DEVIATION 10.96 • n=5 Participants
|
34.0 Years
STANDARD_DEVIATION 11.86 • n=7 Participants
|
32.5 Years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
34.2 Years
STANDARD_DEVIATION 11.09 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Egypt
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Jordan
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Tunisia
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Hong Kong
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
Singapore
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 24Population: Full Analysis Set
Outcome measures
| Measure |
AIN457C 300 mg Every 2 Week Dosage Regimen
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457C 300 mg Monthly Dosage Regimen (a)
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
|
Placebo to AIN457C
n=39 Participants
Placebo was administered in 2 s.c. injections
|
|---|---|---|---|
|
Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment
|
7.7 Ocular Exacerbations
Standard Deviation 22.40
|
11.5 Ocular Exacerbations
Standard Deviation 28.19
|
7.7 Ocular Exacerbations
Standard Deviation 22.35
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Full analysis set
Patients number of occurences during a 24 week period.
Outcome measures
| Measure |
AIN457C 300 mg Every 2 Week Dosage Regimen
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457C 300 mg Monthly Dosage Regimen (a)
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
|
Placebo to AIN457C
n=39 Participants
Placebo was administered in 2 s.c. injections
|
|---|---|---|---|
|
Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment
0 recurrences
|
15 Participants
|
15 Participants
|
11 Participants
|
|
Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment
1 recurrence
|
8 Participants
|
14 Participants
|
13 Participants
|
|
Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment
2 recurrences
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment
3 or more recurrences
|
8 Participants
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set
For each corticosteroid medication, dose of the corticosteroid was first converted to a prednisone-equivalent dose. To determine the prednisone equivalent dose, the corticosteroid dose was multiplied by a conversion factor. . The total prednisone equivalent dose was calculated as the sum of the prednisone equivalent doses of all corticosteroids. Consequently, the total converted prednisone equivalent dose was used to obtain the immunosuppressive score. The key secondary efficacy variable was the change in total post-baseline immunosuppressive medication score from baseline.The score is actually the prednisoone equivalents taken by patient as calculated by conversion table. A reduction in prenisone or prenisone equivalents is a positive outcome. An increase in the number of prednisone equivalents suggests that the treatment is not efficacious or that there is disease progression. A score of 0 would be the lowest ( no steriods taken) and the upper limit is indeterminate.
Outcome measures
| Measure |
AIN457C 300 mg Every 2 Week Dosage Regimen
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457C 300 mg Monthly Dosage Regimen (a)
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
|
Placebo to AIN457C
n=39 Participants
Placebo was administered in 2 s.c. injections
|
|---|---|---|---|
|
Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)
Baseline Score (n=39,39,39)
|
7.769 immunosuppressive medication score
Standard Deviation 4.306
|
10.11 immunosuppressive medication score
Standard Deviation 5.3236
|
9.231 immunosuppressive medication score
Standard Deviation 3.8064
|
|
Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)
Week 24 (n=34,32,34)
|
7.441 immunosuppressive medication score
Standard Deviation 4.4641
|
10.09 immunosuppressive medication score
Standard Deviation 5.3331
|
8.722 immunosuppressive medication score
Standard Deviation 3.2027
|
|
Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)
LOCF (n=39,39,39)
|
7.769 immunosuppressive medication score
Standard Deviation 4.3036
|
10.11 immunosuppressive medication score
Standard Deviation 5.3236
|
9.231 immunosuppressive medication score
Standard Deviation 3.8064
|
SECONDARY outcome
Timeframe: baseline, and wk 24 (end of study)Population: (Full Analysis Set)
Optical coherence tomography (OCT) is amedical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media (e.g., biological tissue). OCT is based on low-coherence interferometry, typically employing near-infrared light. The use of relatively long wavelength light allows it to penetrate into the scattering medium. OCT is a noninvasive procedure that uses optical interferometry to visualize the structures within the retina. Following dilation of the pupil, a light source operating at 850nm provides probe illumination which is split and detected with and without the refraction of the retinal tissues. Cross-sectional imaging is accomplished in 1.3 second by acquiring a sequence of interferometric A-scans. A false color tomogram of optical reflectivity is produced by the computer. Central foveal thickness will be the primary variable derived from OCT. A increase in thickness could translate to disease progression.
Outcome measures
| Measure |
AIN457C 300 mg Every 2 Week Dosage Regimen
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457C 300 mg Monthly Dosage Regimen (a)
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
|
Placebo to AIN457C
n=39 Participants
Placebo was administered in 2 s.c. injections
|
|---|---|---|---|
|
To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet's Disease as Determined by Optical Coherence Tomography.
|
-26.5 change from baseline : micrometers
Standard Deviation 131.32
|
3.6 change from baseline : micrometers
Standard Deviation 75.29
|
-49.4 change from baseline : micrometers
Standard Deviation 174.25
|
SECONDARY outcome
Timeframe: screening, and wk 24 (end of study)Population: Full Analysis Set
The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. Scores range from 0 to 100, with higher scores indicating better visual function.
Outcome measures
| Measure |
AIN457C 300 mg Every 2 Week Dosage Regimen
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457C 300 mg Monthly Dosage Regimen (a)
n=39 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
|
Placebo to AIN457C
n=39 Participants
Placebo was administered in 2 s.c. injections
|
|---|---|---|---|
|
To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.
Baseline (n= 38,35,39)
|
62.46 Score
Standard Deviation 21.817
|
64.17 Score
Standard Deviation 25.549
|
62.11 Score
Standard Deviation 24.416
|
|
To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.
Week 24 (n=38,35,38)
|
66.09 Score
Standard Deviation 24.295
|
73.68 Score
Standard Deviation 22.634
|
69.29 Score
Standard Deviation 21.858
|
SECONDARY outcome
Timeframe: baseline and wk 24 (end of study)Population: Full Analysis set
The BDCAF scores oral and genital ulceration, skin, joint and gastrointestinal involvement, presence of fatigue and headache according to the duration of symptoms. The presence and type of large-vessel and central nervous system (CNS) involvement are documented. Eye activity was deemed present if there was a history of blurring of vision or if the eye was painful or red. . The BDCAF score was calculated by adding the score of each index and ranged between 0 and 12 A reduction in score signifies a lessening of the disease.
Outcome measures
| Measure |
AIN457C 300 mg Every 2 Week Dosage Regimen
n=16 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457C 300 mg Monthly Dosage Regimen (a)
n=17 Participants
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
|
Placebo to AIN457C
n=19 Participants
Placebo was administered in 2 s.c. injections
|
|---|---|---|---|
|
To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet's Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet's Disease Current Activity Form.
|
-1.3 change from baseline score
Standard Deviation 1.81
|
-1.7 change from baseline score
Standard Deviation 1.49
|
-1.1 change from baseline score
Standard Deviation 1.22
|
Adverse Events
AIN457 300mg Every 2 Weeks
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
AIN457 300mg Monthly
Serious events: 8 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457 300mg Every 2 Weeks
n=39 participants at risk
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457 300mg Monthly
n=39 participants at risk
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
Placebo
n=39 participants at risk
Placebo was administered in 2 s.c. injections
|
|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Eye disorders
Cataract cortical (Fellow eye)
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Eye disorders
Cataract nuclear (Fellow eye)
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Eye disorders
Cataract subcapsular (Fellow eye)
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Eye disorders
Choroiditis (Fellow eye)
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Eye disorders
Glaucoma (Fellow eye)
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Eye disorders
Retinal infiltrates (Fellow eye)
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Eye disorders
Retinal infiltrates (Study eye)
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Eye disorders
Uveitis (Fellow eye)
|
2.6%
1/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Eye disorders
Uveitis (Study eye)
|
0.00%
0/39
|
2.6%
1/39
|
2.6%
1/39
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
General disorders
Fatigue
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Immune system disorders
Behcet's syndrome
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Immune system disorders
Behcet's syndrome (Fellow eye)
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Immune system disorders
Behcet's syndrome (Study eye)
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Infections and infestations
Folliculitis
|
5.1%
2/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Infections and infestations
Hypopyon (Fellow eye)
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Investigations
Intraocular pressure increased (Fellow eye)
|
0.00%
0/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Investigations
Weight decreased
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.6%
1/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/39
|
2.6%
1/39
|
0.00%
0/39
|
Other adverse events
| Measure |
AIN457 300mg Every 2 Weeks
n=39 participants at risk
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
AIN457 300mg Monthly
n=39 participants at risk
AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
|
Placebo
n=39 participants at risk
Placebo was administered in 2 s.c. injections
|
|---|---|---|---|
|
Eye disorders
Cataract subcapsular (Fellow eye)
|
7.7%
3/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Eye disorders
Cataract subcapsular (Study eye)
|
10.3%
4/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Eye disorders
Eye pain (Study eye)
|
2.6%
1/39
|
5.1%
2/39
|
5.1%
2/39
|
|
Eye disorders
Retinal vasculitis (Study eye)
|
5.1%
2/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Eye disorders
Vision blurred (Fellow eye)
|
0.00%
0/39
|
15.4%
6/39
|
2.6%
1/39
|
|
Eye disorders
Vision blurred (Study eye)
|
0.00%
0/39
|
2.6%
1/39
|
7.7%
3/39
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
10.3%
4/39
|
5.1%
2/39
|
2.6%
1/39
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.1%
2/39
|
5.1%
2/39
|
2.6%
1/39
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
7.7%
3/39
|
5.1%
2/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/39
|
7.7%
3/39
|
2.6%
1/39
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Gastrointestinal disorders
Nausea
|
10.3%
4/39
|
7.7%
3/39
|
5.1%
2/39
|
|
Gastrointestinal disorders
Toothache
|
5.1%
2/39
|
2.6%
1/39
|
0.00%
0/39
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39
|
0.00%
0/39
|
7.7%
3/39
|
|
General disorders
Fatigue
|
5.1%
2/39
|
5.1%
2/39
|
10.3%
4/39
|
|
General disorders
Non-cardiac chest pain
|
5.1%
2/39
|
0.00%
0/39
|
2.6%
1/39
|
|
General disorders
Oedema peripheral
|
7.7%
3/39
|
2.6%
1/39
|
0.00%
0/39
|
|
General disorders
Pyrexia
|
15.4%
6/39
|
5.1%
2/39
|
10.3%
4/39
|
|
Infections and infestations
Conjunctivitis infective (Study eye)
|
2.6%
1/39
|
5.1%
2/39
|
2.6%
1/39
|
|
Infections and infestations
Influenza
|
5.1%
2/39
|
10.3%
4/39
|
2.6%
1/39
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
1/39
|
5.1%
2/39
|
2.6%
1/39
|
|
Infections and infestations
Rash pustular
|
5.1%
2/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Infections and infestations
Sinusitis
|
0.00%
0/39
|
5.1%
2/39
|
2.6%
1/39
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
3/39
|
10.3%
4/39
|
2.6%
1/39
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Investigations
Blood glucose increased
|
0.00%
0/39
|
5.1%
2/39
|
0.00%
0/39
|
|
Investigations
Intraocular pressure increased (Study eye)
|
5.1%
2/39
|
5.1%
2/39
|
0.00%
0/39
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
4/39
|
7.7%
3/39
|
7.7%
3/39
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
3/39
|
2.6%
1/39
|
2.6%
1/39
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39
|
7.7%
3/39
|
0.00%
0/39
|
|
Nervous system disorders
Headache
|
23.1%
9/39
|
15.4%
6/39
|
23.1%
9/39
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/39
|
7.7%
3/39
|
0.00%
0/39
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
2/39
|
0.00%
0/39
|
0.00%
0/39
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
1/39
|
2.6%
1/39
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
5.1%
2/39
|
0.00%
0/39
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/39
|
0.00%
0/39
|
5.1%
2/39
|
|
Vascular disorders
Hypertension
|
2.6%
1/39
|
5.1%
2/39
|
0.00%
0/39
|
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