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Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO) (Camellia)

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ClinicalTrials.gov Identifier: NCT01976312
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : April 24, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Central Retinal Vein Occlusion
Interventions Other: Sham injection
Drug: Ranibizumab 0.5 mg
Enrollment 252
Recruitment Details A total of 253 patients were randomized to this study, 191 patients to the ranibizumab group and 62 patients to the sham group. One patient randomized to the ranibizumab group was excluded from all analyses as informed consent was obtained after first study procedures were performed. Therefore, this patient not included in randomized set.
Pre-assignment Details

This study consisted of the 3 periods (Screening period: Day −14 to Day −1; treatment period:

Day 1 to Month 11; post-treatment period: Month 11 to Month 12). At Baseline (Visit 2, Day 1), eligible patients were randomized in a 3:1 ratio to one of the treatment arms

Arm/Group Title Ranibizumab 0.5 mg Sham Injection
Hide Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
Period Title: Overall Study
Started 190 62
Completed 3 Months 186 60
Discontinued Study Prior to 3 Months 4 2
Completed 173 [1] 53 [1]
Not Completed 17 9
Reason Not Completed
Pregnancy             0             1
Lost to Follow-up             2             0
Withdrawal by Subject             7             2
Adverse Event             6             6
Protocol Violation             2             0
[1]
Completed study at 12 months
Arm/Group Title Ranibizumab 0.5 mg Sham Injection Total
Hide Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections Total of all reporting groups
Overall Number of Baseline Participants 190 62 252
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants 62 participants 252 participants
54.1  (12.64) 54.1  (13.29) 54.1  (12.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 62 participants 252 participants
Female
88
  46.3%
29
  46.8%
117
  46.4%
Male
102
  53.7%
33
  53.2%
135
  53.6%
1.Primary Outcome
Title Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3
Hide Description

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.

Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline.

Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Arm/Group Title Ranibizumab 0.5 mg Sham Injection
Hide Arm/Group Description:
PRN intravitreal injection
As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
Overall Number of Participants Analyzed 188 62
Mean (Standard Deviation)
Unit of Measure: Letters
11.3  (10.77) -2.7  (13.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranibizumab 0.5 mg, Sham Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12
Hide Description Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline
Time Frame Baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Arm/Group Title Ranibizumab 0.5 mg Sham Injection
Hide Arm/Group Description:
PRN intravitreal injection
As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
Overall Number of Participants Analyzed 188 62
Mean (Standard Deviation)
Unit of Measure: Letters
12.4  (11.43) 3.2  (14.62)
3.Secondary Outcome
Title Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time
Hide Description Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline
Time Frame Month 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Arm/Group Title Ranibizumab 0.5 mg Sham Injection
Hide Arm/Group Description:
PRN intravitreal injection
As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
Overall Number of Participants Analyzed 188 62
Mean (Standard Deviation)
Unit of Measure: Letters
Month 1 9.6  (10.2) -0.9  (12.17)
Month 2 11.6  (12.39) -3.4  (16.04)
Month 3 12.6  (12.01) -3.8  (17.02)
Month 4 10.7  (12.56) 2.8  (15.26)
Month 5 11.7  (12.62) 3.9  (15.26)
Month 6 12.3  (13.10) 3.8  (17.20)
Month 7 12.9  (13.36) 5.0  (16.71)
Month 8 12.4  (14.01) 6.0  (16.01)
Month 9 13.1  (15.10) 5.6  (16.95)
Month 10 13.5  (14.13) 5.9  (16.77)
Month 11 14.2  (13.15) 6.8  (16.30)
Month 12 14.5  (14.25) 6.5  (17.10)
4.Secondary Outcome
Title Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time
Hide Description OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center.
Time Frame Month 1 to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Arm/Group Title Ranibizumab 0.5 mg Sham Injection
Hide Arm/Group Description:
PRN intravitreal injection
As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
Overall Number of Participants Analyzed 188 62
Mean (Standard Deviation)
Unit of Measure: microns
Month 1 -393.7  (275.13) -13.3  (207.55)
Month 2 -412.6  (297.50) -7.9  (196.65)
Month 3 -433.3  (290.84) -84.4  (274.98)
Month 4 -367.8  (305.26) -364.8  (250.48)
Month 5 -407.0  (309.58) -369.6  (273.92)
Month 6 -426.6  (294.63) -372.3  (301.24)
Month 7 -421.5  (316.14) -392.7  (288.74)
Month 8 -398.9  (299.67) -405.2  (289.49)
Month 9 -422.1  (311.57) -393.5  (323.50)
Month 10 -431.7  (300.95) -395.2  (309.67)
Month 11 -438.1  (295.53) -417.4  (288.08)
Month 12 -441.7  (306.53) -416.4  (294.08)
5.Secondary Outcome
Title Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time
Hide Description Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.
Time Frame Month 1 to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Arm/Group Title Ranibizumab 0.5 mg Sham Injection
Hide Arm/Group Description:
PRN intravitreal injection
As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
Overall Number of Participants Analyzed 188 62
Measure Type: Number
Unit of Measure: Participants
Month 1 Gain of >=5 letters 141 17
Month 1 Gain of >=10 letters 94 6
Month 1 Gain of >=15 letters 56 2
Month 1 Gain of >=30 letters 3 0
Month 2 Gain of >=5 letters 150 18
Month 2 Gain of >=10 letters 119 11
Month 2 Gain of >=15 letters 74 3
Month 2 Gain of >=30 letters 9 0
Month 3 Gain of >=5 letters 153 19
Month 3 Gain of >=10 letters 117 11
Month 3 Gain of >=15 letters 76 4
Month 3 Gain of >=30 letters 12 0
Month 4 Gain of >=5 letters 138 31
Month 4 Gain of >=10 letters 107 21
Month 4 Gain of >=15 letters 68 11
Month 4 Gain of >=30 letters 14 2
Month 5 Gain of >=5 letters 143 34
Month 5 Gain of >=10 letters 116 23
Month 5 Gain of >=15 letters 80 13
Month 5 Gain of >=30 letters 13 1
Month 6 Gain of >=5 letters 147 39
Month 6 Gain of >=10 letters 121 28
Month 6 Gain of >=15 letters 87 12
Month 6 Gain of >=30 letters 14 13
Month 7 Gain of >=5 letters 152 37
Month 7 Gain of >=10 letters 121 29
Month 7 Gain of >=15 letters 91 14
Month 7 Gain of >=30 letters 14 3
Month 8 Gain of >=5 letters 143 39
Month 8 Gain of >=10 letters 127 28
Month 8 Gain of >=15 letters 95 19
Month 8 Gain of >=30 letters 16 3
Month 9 Gain of >=5 letters 147 40
Month 9 Gain of >=10 letters 126 26
Month 9 Gain of >=15 letters 94 17
Month 9 Gain of >=30 letters 17 3
Month 10 Gain of >=5 letters 152 39
Month 10 Gain of >=10 letters 128 29
Month 10 Gain of >=15 letters 95 16
Month 10 Gain of >=30 letters 18 4
Month 11 Gain of >=5 letters 153 40
Month 11 Gain of >=10 letters 134 29
Month 11 Gain of >=15 letters 101 19
Month 11 Gain of >=30 letters 18 4
Month 12 Gain of >=5 letters 151 39
Month 12 Gain of >=10 letters 131 30
Month 12 Gain of >=15 letters 99 21
Month 12 Gain of >=30 letters 24 3
6.Secondary Outcome
Title Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time
Hide Description Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.
Time Frame Month 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Arm/Group Title Ranibizumab 0.5 mg Sham Injection
Hide Arm/Group Description:
PRN intravitreal injection
As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
Overall Number of Participants Analyzed 188 62
Measure Type: Number
Unit of Measure: Participants
Month 1, Loss of < 15 letters 185 57
Month 2, Loss of < 15 letters 182 53
Month 3, Loss of < 15 letters 182 51
Month 4, Loss of < 15 letters 179 55
Month 5, Loss of < 15 letters 182 56
Month 6, Loss of < 15 letters 180 53
Month 7, Loss of < 15 letters 181 55
Month 8, Loss of < 15 letters 177 55
Month 9, Loss of < 15 letters 177 56
Month 10, Loss of < 15 letters 180 56
Month 11, Loss of < 15 letters 183 56
Month 12, Loss of < 15 letters 182 55
7.Secondary Outcome
Title The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline
Hide Description The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.
Time Frame Month 3,6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n= is the number of patients with a value for both baseline and the specific post-baseline visit.
Arm/Group Title Ranibizumab 0.5 mg Sham Injection
Hide Arm/Group Description:
PRN intravitreal injection
As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
Overall Number of Participants Analyzed 190 62
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Month 3 Number Analyzed 186 participants 61 participants
4.4  (12.54) 0.1  (13.78)
Month 6 Number Analyzed 179 participants 57 participants
6.7  (15.02) 2.9  (13.33)
Month 12 Number Analyzed 173 participants 53 participants
8.2  (13.70) 3.2  (15.34)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Set consisted of all patients who received at least one application of study treatment and had at least one post-Baseline safety assessment. Patients were analyzed according to the treatment received. The statement that a patient had no AEs also constituted a safety assessment.
 
Arm/Group Title Ranibizumab 0.5 mg Sham With Ranibizumab 0.5 mg Sham Without Ranibizumab 0.5 mg
Hide Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections Sham without Ranibizumab 0.5mg(hereafter referred to as sham group up to Month 3 and sham without ranibizumab after Month 3
All-Cause Mortality
Ranibizumab 0.5 mg Sham With Ranibizumab 0.5 mg Sham Without Ranibizumab 0.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ranibizumab 0.5 mg Sham With Ranibizumab 0.5 mg Sham Without Ranibizumab 0.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/190 (5.79%)   5/56 (8.93%)   1/5 (20.00%) 
Cardiac disorders       
Acute myocardial infarction  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Left ventricular dysfunction  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Eye disorders       
Angle closure glaucoma  1  2/190 (1.05%)  1/56 (1.79%)  0/5 (0.00%) 
Keratitis  1  1/190 (0.53%)  0/56 (0.00%)  0/5 (0.00%) 
Macular fibrosis  1  0/190 (0.00%)  0/56 (0.00%)  1/5 (20.00%) 
Gastrointestinal disorders       
Gastric ulcer  1  1/190 (0.53%)  0/56 (0.00%)  0/5 (0.00%) 
Infections and infestations       
Endophthalmitis  1  1/190 (0.53%)  0/56 (0.00%)  0/5 (0.00%) 
Herpes zoster  1  1/190 (0.53%)  0/56 (0.00%)  0/5 (0.00%) 
Urinary tract infection  1  1/190 (0.53%)  0/56 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications       
Wrist fracture  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Inflammatory pseudotumour  1  1/190 (0.53%)  0/56 (0.00%)  0/5 (0.00%) 
Schwannoma  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Nervous system disorders       
Haemorrhage intracranial  1  1/190 (0.53%)  0/56 (0.00%)  0/5 (0.00%) 
Transient ischaemic attack  1  1/190 (0.53%)  0/56 (0.00%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Mediastinal cyst  1  1/190 (0.53%)  0/56 (0.00%)  0/5 (0.00%) 
Pulmonary arterial hypertension  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ranibizumab 0.5 mg Sham With Ranibizumab 0.5 mg Sham Without Ranibizumab 0.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   96/190 (50.53%)   32/56 (57.14%)   3/5 (60.00%) 
Cardiac disorders       
Cardiovascular insufficiency  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Eye disorders       
Asthenopia  1  2/190 (1.05%)  0/56 (0.00%)  1/5 (20.00%) 
Cataract  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Conjunctival haemorrhage  1  17/190 (8.95%)  3/56 (5.36%)  0/5 (0.00%) 
Conjunctival hyperaemia  1  3/190 (1.58%)  1/56 (1.79%)  0/5 (0.00%) 
Conjunctival oedema  1  2/190 (1.05%)  0/56 (0.00%)  0/5 (0.00%) 
Cystoid macular oedema  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Dry eye  1  7/190 (3.68%)  1/56 (1.79%)  1/5 (20.00%) 
Eye discharge  1  1/190 (0.53%)  1/56 (1.79%)  0/5 (0.00%) 
Eye irritation  1  4/190 (2.11%)  0/56 (0.00%)  0/5 (0.00%) 
Eye pain  1  4/190 (2.11%)  2/56 (3.57%)  1/5 (20.00%) 
Eye pruritus  1  2/190 (1.05%)  1/56 (1.79%)  0/5 (0.00%) 
Eye swelling  1  4/190 (2.11%)  0/56 (0.00%)  0/5 (0.00%) 
Foreign body sensation in eyes  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Glaucoma  1  2/190 (1.05%)  0/56 (0.00%)  1/5 (20.00%) 
Iris neovascularisation  1  0/190 (0.00%)  2/56 (3.57%)  1/5 (20.00%) 
Lacrimation increased  1  2/190 (1.05%)  0/56 (0.00%)  0/5 (0.00%) 
Macular fibrosis  1  2/190 (1.05%)  0/56 (0.00%)  0/5 (0.00%) 
Macular oedema  1  1/190 (0.53%)  3/56 (5.36%)  0/5 (0.00%) 
Ocular discomfort  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Ocular hyperaemia  1  9/190 (4.74%)  2/56 (3.57%)  0/5 (0.00%) 
Ocular hypertension  1  2/190 (1.05%)  4/56 (7.14%)  0/5 (0.00%) 
Retinal haemorrhage  1  1/190 (0.53%)  5/56 (8.93%)  0/5 (0.00%) 
Retinal ischaemia  1  2/190 (1.05%)  1/56 (1.79%)  0/5 (0.00%) 
Retinal neovascularisation  1  1/190 (0.53%)  1/56 (1.79%)  0/5 (0.00%) 
Retinal vein occlusion  1  2/190 (1.05%)  2/56 (3.57%)  0/5 (0.00%) 
Vision blurred  1  9/190 (4.74%)  1/56 (1.79%)  0/5 (0.00%) 
Visual acuity reduced  1  9/190 (4.74%)  3/56 (5.36%)  1/5 (20.00%) 
Vitreal cells  1  2/190 (1.05%)  0/56 (0.00%)  0/5 (0.00%) 
Vitreous detachment  1  1/190 (0.53%)  0/56 (0.00%)  1/5 (20.00%) 
Vitreous floaters  1  3/190 (1.58%)  0/56 (0.00%)  0/5 (0.00%) 
Vitreous haemorrhage  1  1/190 (0.53%)  1/56 (1.79%)  0/5 (0.00%) 
Gastrointestinal disorders       
Abdominal distension  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Abdominal pain upper  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Constipation  1  2/190 (1.05%)  0/56 (0.00%)  0/5 (0.00%) 
Diarrhoea  1  4/190 (2.11%)  1/56 (1.79%)  0/5 (0.00%) 
Gastritis  1  3/190 (1.58%)  0/56 (0.00%)  0/5 (0.00%) 
General disorders       
Malaise  1  2/190 (1.05%)  0/56 (0.00%)  0/5 (0.00%) 
Infections and infestations       
Conjunctivitis  1  9/190 (4.74%)  4/56 (7.14%)  0/5 (0.00%) 
Dacryocystitis  1  0/190 (0.00%)  0/56 (0.00%)  1/5 (20.00%) 
Hordeolum  1  1/190 (0.53%)  1/56 (1.79%)  0/5 (0.00%) 
Nasopharyngitis  1  19/190 (10.00%)  5/56 (8.93%)  0/5 (0.00%) 
Pharyngitis  1  5/190 (2.63%)  1/56 (1.79%)  0/5 (0.00%) 
Upper respiratory tract infection  1  13/190 (6.84%)  2/56 (3.57%)  0/5 (0.00%) 
Urinary tract infection  1  4/190 (2.11%)  0/56 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Ligament sprain  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Spinal compression fracture  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Wrist fracture  1  1/190 (0.53%)  1/56 (1.79%)  0/5 (0.00%) 
Investigations       
Activated partial thromboplastin time prolonged  1  1/190 (0.53%)  1/56 (1.79%)  0/5 (0.00%) 
Intraocular pressure increased  1  10/190 (5.26%)  1/56 (1.79%)  0/5 (0.00%) 
Platelet count decreased  1  1/190 (0.53%)  1/56 (1.79%)  0/5 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  3/190 (1.58%)  1/56 (1.79%)  0/5 (0.00%) 
Type 2 diabetes mellitus  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  2/190 (1.05%)  0/56 (0.00%)  0/5 (0.00%) 
Back pain  1  2/190 (1.05%)  1/56 (1.79%)  0/5 (0.00%) 
Neck pain  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Osteoporosis  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Nervous system disorders       
Dizziness  1  1/190 (0.53%)  1/56 (1.79%)  0/5 (0.00%) 
Headache  1  2/190 (1.05%)  0/56 (0.00%)  0/5 (0.00%) 
Paraesthesia  1  0/190 (0.00%)  0/56 (0.00%)  1/5 (20.00%) 
Psychiatric disorders       
Insomnia  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  6/190 (3.16%)  3/56 (5.36%)  0/5 (0.00%) 
Oropharyngeal pain  1  2/190 (1.05%)  2/56 (3.57%)  1/5 (20.00%) 
Throat irritation  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  0/190 (0.00%)  1/56 (1.79%)  0/5 (0.00%) 
Vascular disorders       
Hypertension  1  11/190 (5.79%)  4/56 (7.14%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
Results Point of Contact
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01976312     History of Changes
Other Study ID Numbers: CRFB002E2302
First Submitted: October 18, 2013
First Posted: November 5, 2013
Results First Submitted: March 13, 2017
Results First Posted: April 24, 2017
Last Update Posted: May 30, 2017