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Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus (RETAIN)

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ClinicalTrials.gov Identifier: NCT01171976
Recruitment Status : Completed
First Posted : July 29, 2010
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Diabetic Macular Edema
Intervention Drug: Ranibizumab
Enrollment 373
Recruitment Details A total of 373 patients with macular edema and visual impairment secondary to DME were enrolled. A total of 372 patients were randomized. One patient was excluded from all analyses due to administrative problems
Pre-assignment Details Antimicrobial eye drops were dispensed at each study visit (PRN ranibizumab) or at visits with scheduled injections (TE ranibizumab + laser or TE ranibizumab alone).
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description Patients received an injection ranibizumab and laser therapy. Patients received an intravitreal injection ranibizumab Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Period Title: Overall Study
Started 121 128 123
Safety Set 126 [1] 126 [2] 118 [3]
Completed 107 117 108
Not Completed 14 11 15
Reason Not Completed
Protocol Violation             0             0             1
Death             2             4             1
Lost to Follow-up             4             0             2
Withdrawal by Subject             1             5             6
Abnormal test result             1             0             0
Adverse Event             6             2             5
[1]
Include 4 from PRN and 3 from TE alone who got laser treatment, exclude 2 with no laser treatment.
[2]
Exclude 1 who did not get drug and 3 got laser treatment, include 2 from 1st arm with no laser
[3]
Exclude 1 who did not get drug and 4 got laser treatment
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg Total
Hide Arm/Group Description Patients received an injection ranibizumab and laser therapy. Patients received an intravitreal injection ranibizumab Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease. Total of all reporting groups
Overall Number of Baseline Participants 121 128 123 372
Hide Baseline Analysis Population Description
The Randomized Set comprised all randomized patients, ie those given a randomization number.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 128 participants 123 participants 372 participants
63.7  (9.07) 63.0  (9.83) 64.5  (9.66) 63.7  (9.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 128 participants 123 participants 372 participants
Female
43
  35.5%
51
  39.8%
46
  37.4%
140
  37.6%
Male
78
  64.5%
77
  60.2%
77
  62.6%
232
  62.4%
1.Primary Outcome
Title Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
Hide Description Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Time Frame Baseline to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description:
Patients received an injection ranibizumab and laser therapy.
Patients received an intravitreal injection ranibizumab
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Overall Number of Participants Analyzed 117 125 117
Mean (Standard Deviation)
Unit of Measure: Letters
Baseline 62.3  (11.50) 64.1  (10.52) 65.1  (10.08)
Average Month 1 to Month 12 68.25  (11.057) 70.28  (10.284) 71.32  (9.984)
Average Change from Baseline 5.91  (5.532) 6.14  (5.717) 6.20  (6.005)
2.Secondary Outcome
Title Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24
Hide Description Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Time Frame Baseline to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description:
Patients received an injection ranibizumab and laser therapy.
Patients received an intravitreal injection ranibizumab
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Overall Number of Participants Analyzed 117 125 117
Mean (Standard Deviation)
Unit of Measure: Letters
Baseline 62.3  (11.50) 64.1  (10.52) 65.1  (10.08)
Average Month 1 to Month 24 69.12  (11.261) 70.72  (10.924) 72.09  (10.141)
Average Change from Baseline 6.78  (5.986) 6.58  (7.070) 6.97  (6.430)
3.Secondary Outcome
Title Visual Acuity of the Study Eye: Change From Baseline at Month 12
Hide Description Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description:
Patients received an injection ranibizumab and laser therapy.
Patients received an intravitreal injection ranibizumab
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Overall Number of Participants Analyzed 117 125 117
Mean (Standard Deviation)
Unit of Measure: Letters
Baseline 62.3  (11.50) 65.1  (10.52) 65.1  (10.08)
Month 12 69.13  (11.945) 70.93  (11.742) 72.56  (11.592)
Change from Baseline 6.79  (6.999) 6.80  (8.726) 7.44  (8.457)
4.Secondary Outcome
Title Visual Acuity of the Study Eye: Change From Baseline at Month 24
Hide Description Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description:
Patients received an injection ranibizumab and laser therapy.
Patients received an intravitreal injection ranibizumab
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Overall Number of Participants Analyzed 117 125 117
Mean (Standard Deviation)
Unit of Measure: Letters
Baseline 62.3  (11.50) 64.1  (10.52) 65.1  (10.08)
Month 24 70.64  (12.315) 70.62  (13.481) 73.18  (11.872)
Change from Baseline 8.30  (8.129) 6.49  (10.854) 8.06  (8.462)
5.Secondary Outcome
Title Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12
Hide Description Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description:
Patients received an injection ranibizumab and laser therapy.
Patients received an intravitreal injection ranibizumab
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Overall Number of Participants Analyzed 117 125 117
Measure Type: Number
Unit of Measure: Percentage of patients
Gain of >= 1 letter 82.9 84.8 83.8
Gain of >= 5 letters 59.0 60.8 70.1
Gain of >= 10 letters 32.5 42.4 39.3
Gain of >= 15 letters 19.7 30.4 26.5
Loss of >= 5 letters 3.4 4.0 3.4
Loss of >= 10 letters 0.0 2.4 0.9
Loss of >= 15 letters 0.0 1.6 0.9
6.Secondary Outcome
Title Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24
Hide Description Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
Time Frame Baseline, 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description:
Patients received an injection ranibizumab and laser therapy.
Patients received an intravitreal injection ranibizumab
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Overall Number of Participants Analyzed 117 125 117
Measure Type: Number
Unit of Measure: Percentage of pateints
Gain of >= 1 letter 87.2 84.0 90.6
Gain of >= 5 letters 69.2 62.4 76.1
Gain of >= 10 letters 43.6 40.8 45.3
Gain of >= 15 letters 25.6 28.0 30.8
Loss of >= 5 letters 4.3 8.0 5.1
Loss of >= 10 letters 2.6 7.2 3.4
Loss of >= 15 letters 0.9 4.0 2.6
7.Secondary Outcome
Title Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12
Hide Description High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description:
Patients received an injection ranibizumab and laser therapy.
Patients received an intravitreal injection ranibizumab
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Overall Number of Participants Analyzed 117 125 117
Mean (Standard Deviation)
Unit of Measure: Percent Change
-27.09  (22.992) -24.35  (22.027) -23.16  (22.362)
8.Secondary Outcome
Title Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24
Hide Description High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Time Frame Baseline and 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description:
Patients received an injection ranibizumab and laser therapy.
Patients received an intravitreal injection ranibizumab
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Overall Number of Participants Analyzed 117 125 117
Mean (Standard Deviation)
Unit of Measure: Percent Change
-32.03  (25.628) -24.98  (26.414) -24.97  (26.678)
9.Secondary Outcome
Title Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24
Hide Description The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm. Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning
Time Frame Baseline, Month 12 and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description:
Patients received an injection ranibizumab and laser therapy.
Patients received an intravitreal injection ranibizumab
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Overall Number of Participants Analyzed 117 125 117
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline (n=116,122,114) 75.32  (17.317) 75.47  (17.105) 77.07  (18.581)
Change from baseline at Month 12 (n=116,122,114) 4.60  (10.905) 3.95  (10.941) 5.41  (12.063)
Change from baseline at month 24 (n=116,122,114) 4.06  (11.859) 2.31  (13.270) 5.96  (12.389)
10.Secondary Outcome
Title EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24
Hide Description The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire. It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1= "no problems", 2="some problems" and 3="extreme problems" . A composite health index was then defined by combining the levels for each dimension. Overall, 243 health states are possible. For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction
Time Frame Baseline, Month 12 and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.
Arm/Group Title TE Ranibizumad 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description:
Patients received an injection ranibizumab and laser therapy.
Patients received an intravitreal injection ranibizumab
Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Overall Number of Participants Analyzed 117 125 117
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 71.4  (17.36) 70.7  (16.10) 72.2  (13.24)
Change from Baseline at Month 12 (n=115,123,113) 0.47  (16.487) 0.91  (13.422) 2.52  (14.431)
Change from Baseline at Month 24 (n=115,123,113) 1.35  (17.464) 0.11  (14.755) 1.98  (14.812)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Set consisted of all patients who received at least one administration of study treatment in the study eye and had at least one post-baseline safety assessment.
 
Arm/Group Title TE Ranibizumab 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Hide Arm/Group Description Patients received an injection ranibizumab and laser therapy. Patients received an intravitreal injection ranibizumab Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
All-Cause Mortality
TE Ranibizumab 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
TE Ranibizumab 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/126 (26.98%)   29/126 (23.02%)   26/118 (22.03%) 
Blood and lymphatic system disorders       
Anaemia  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Hypocoagulable state  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Cardiac disorders       
Acute myocardial infarction  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Angina pectoris  1  1/126 (0.79%)  1/126 (0.79%)  0/118 (0.00%) 
Atrial fibrillation  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Atrioventricular block  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Bradycardia  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Cardiac failure  1  1/126 (0.79%)  0/126 (0.00%)  1/118 (0.85%) 
Cardiac failure acute  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Cardiac failure congestive  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Cardiovascular disorder  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Coronary artery disease  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Myocardial infarction  1  4/126 (3.17%)  1/126 (0.79%)  1/118 (0.85%) 
Myocardial ischaemia  1  0/126 (0.00%)  2/126 (1.59%)  1/118 (0.85%) 
Congenital, familial and genetic disorders       
Hydrocele  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Hypertrophic cardiomyopathy  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Ear and labyrinth disorders       
Meniere's disease  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Eye disorders       
Cataract (Fellow eye)  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Macular fibrosis (Treated non-study eye)  1  1/126 (0.79%)  0/126 (0.00%)  1/118 (0.85%) 
Vitreous adhesions (Treated non-study eye)  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Vitreous haemorrhage (Study eye)  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Gastrointestinal disorders       
Abdominal hernia  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Ascites  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Duodenitis  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Gastrointestinal haemorrhage  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Pancreatitis chronic  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Small intestine ulcer  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Tooth loss  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
General disorders       
Chest pain  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Malaise  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Oedema peripheral  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Hepatobiliary disorders       
Bile duct stenosis  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Cholecystitis  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Cholelithiasis  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Gallbladder perforation  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Hepatic cirrhosis  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Jaundice cholestatic  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Infections and infestations       
Acarodermatitis  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Bacterascites  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Cellulitis  1  1/126 (0.79%)  0/126 (0.00%)  1/118 (0.85%) 
Diabetic gangrene  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Endophthalmitis (Study eye)  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Endophthalmitis (Treated non-study eye)  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Gastroenteritis viral  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Infected skin ulcer  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Lower respiratory tract infection  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Orchitis  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Pneumonia  1  3/126 (2.38%)  1/126 (0.79%)  0/118 (0.00%) 
Renal abscess  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Urinary tract infection  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Wound infection  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Craniocerebral injury  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Facial bones fracture  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Fibula fracture  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Foot fracture  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Joint dislocation  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Meniscus injury  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Patella fracture  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Periorbital haematoma (Study eye)  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Rib fracture  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Scapula fracture  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Investigations       
Blood glucose increased  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Blood urine present  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
International normalised ratio increased  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  1/126 (0.79%)  1/126 (0.79%)  0/118 (0.00%) 
Diabetes mellitus inadequate control  1  1/126 (0.79%)  1/126 (0.79%)  1/118 (0.85%) 
Hyperglycaemia  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Hypoglycaemia  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Ketoacidosis  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Musculoskeletal chest pain  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Osteoarthritis  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Rhabdomyolysis  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Hepatic cancer  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Lung adenocarcinoma  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Lung neoplasm malignant  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Metastases to peritoneum  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Metastases to soft tissue  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Ovarian cancer  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Pancreatic carcinoma  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Pancreatic carcinoma metastatic  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Prostate cancer  1  0/126 (0.00%)  0/126 (0.00%)  2/118 (1.69%) 
Squamous cell carcinoma  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Nervous system disorders       
Aphasia  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Carotid artery stenosis  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Cerebral infarction  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Cerebrovascular accident  1  1/126 (0.79%)  2/126 (1.59%)  3/118 (2.54%) 
Cerebrovascular disorder  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Hepatic encephalopathy  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Hypertensive encephalopathy  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Hypoaesthesia  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Myelopathy  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Status epilepticus  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Transient ischaemic attack  1  1/126 (0.79%)  1/126 (0.79%)  1/118 (0.85%) 
Psychiatric disorders       
Confusional state  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Renal and urinary disorders       
Haematuria  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Nephrotic syndrome  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Renal failure  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Renal impairment  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Renal mass  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Urinary retention  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Uterine prolapse  1  1/126 (0.79%)  1/126 (0.79%)  1/118 (0.85%) 
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Acute respiratory failure  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Asthma  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Dyspnoea  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Pulmonary embolism  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Skin and subcutaneous tissue disorders       
Diabetic foot  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Skin ulcer  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Vascular disorders       
Arterial occlusive disease  1  0/126 (0.00%)  1/126 (0.79%)  1/118 (0.85%) 
Arteriosclerosis  1  1/126 (0.79%)  0/126 (0.00%)  1/118 (0.85%) 
Diabetic macroangiopathy  1  0/126 (0.00%)  1/126 (0.79%)  0/118 (0.00%) 
Diabetic vascular disorder  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Haematoma  1  1/126 (0.79%)  0/126 (0.00%)  0/118 (0.00%) 
Hypertension  1  1/126 (0.79%)  1/126 (0.79%)  0/118 (0.00%) 
Hypotension  1  1/126 (0.79%)  0/126 (0.00%)  1/118 (0.85%) 
Peripheral ischaemia  1  0/126 (0.00%)  0/126 (0.00%)  1/118 (0.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.5%
TE Ranibizumab 0.5 mg and Laser TE Ranibizumab 0.5 mg Alone PRN Ranibizumab 0.5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   98/126 (77.78%)   101/126 (80.16%)   78/118 (66.10%) 
Blood and lymphatic system disorders       
Anaemia  1  4/126 (3.17%)  5/126 (3.97%)  4/118 (3.39%) 
Iron deficiency anaemia  1  0/126 (0.00%)  0/126 (0.00%)  2/118 (1.69%) 
Cardiac disorders       
Cardiovascular insufficiency  1  0/126 (0.00%)  0/126 (0.00%)  2/118 (1.69%) 
Ear and labyrinth disorders       
Vertigo  1  1/126 (0.79%)  1/126 (0.79%)  4/118 (3.39%) 
Eye disorders       
Blepharitis (Study eye)  1  2/126 (1.59%)  1/126 (0.79%)  0/118 (0.00%) 
Blindness transient (Study eye)  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Cataract (Fellow eye)  1  3/126 (2.38%)  4/126 (3.17%)  2/118 (1.69%) 
Cataract (Study eye)  1  5/126 (3.97%)  7/126 (5.56%)  7/118 (5.93%) 
Cataract (Treated non-study eye)  1  2/126 (1.59%)  3/126 (2.38%)  1/118 (0.85%) 
Cataract subcapsular (Study eye)  1  1/126 (0.79%)  2/126 (1.59%)  0/118 (0.00%) 
Conjunctival haemorrhage (Study eye)  1  5/126 (3.97%)  11/126 (8.73%)  6/118 (5.08%) 
Conjunctival haemorrhage (Treated non-study eye)  1  2/126 (1.59%)  2/126 (1.59%)  1/118 (0.85%) 
Conjunctivitis (Study eye)  1  6/126 (4.76%)  2/126 (1.59%)  0/118 (0.00%) 
Corneal disorder (Study eye)  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Diabetic retinal oedema (Fellow eye)  1  1/126 (0.79%)  2/126 (1.59%)  3/118 (2.54%) 
Diabetic retinal oedema (Study eye)  1  4/126 (3.17%)  2/126 (1.59%)  1/118 (0.85%) 
Diabetic retinal oedema (Treated non-study eye)  1  1/126 (0.79%)  0/126 (0.00%)  3/118 (2.54%) 
Diabetic retinopathy (Fellow eye)  1  2/126 (1.59%)  1/126 (0.79%)  3/118 (2.54%) 
Dry eye (Fellow eye)  1  3/126 (2.38%)  0/126 (0.00%)  3/118 (2.54%) 
Dry eye (Study eye)  1  6/126 (4.76%)  3/126 (2.38%)  4/118 (3.39%) 
Dry eye (Treated non-study eye)  1  2/126 (1.59%)  1/126 (0.79%)  1/118 (0.85%) 
Eye haemorrhage (Treated non-study eye)  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Eye irritation (Study eye)  1  2/126 (1.59%)  4/126 (3.17%)  2/118 (1.69%) 
Eye pain (Fellow eye)  1  2/126 (1.59%)  0/126 (0.00%)  2/118 (1.69%) 
Eye pain (Study eye)  1  8/126 (6.35%)  7/126 (5.56%)  3/118 (2.54%) 
Eye pain (Treated non-study eye)  1  1/126 (0.79%)  0/126 (0.00%)  2/118 (1.69%) 
Eye pruritus (Fellow eye)  1  1/126 (0.79%)  0/126 (0.00%)  3/118 (2.54%) 
Eye pruritus (Study eye)  1  2/126 (1.59%)  2/126 (1.59%)  2/118 (1.69%) 
Eye pruritus (Treated non-study eye)  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Eyelid oedema (Fellow eye)  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Eyelid oedema (Study eye)  1  0/126 (0.00%)  2/126 (1.59%)  2/118 (1.69%) 
Foreign body sensation in eyes (Study eye)  1  0/126 (0.00%)  2/126 (1.59%)  1/118 (0.85%) 
Glaucoma (Study eye)  1  3/126 (2.38%)  1/126 (0.79%)  1/118 (0.85%) 
Keratitis (Study eye)  1  1/126 (0.79%)  3/126 (2.38%)  0/118 (0.00%) 
Lacrimation increased (Study eye)  1  1/126 (0.79%)  4/126 (3.17%)  0/118 (0.00%) 
Macular fibrosis (Fellow eye)  1  2/126 (1.59%)  0/126 (0.00%)  1/118 (0.85%) 
Macular fibrosis (Study eye)  1  3/126 (2.38%)  0/126 (0.00%)  0/118 (0.00%) 
Macular fibrosis (Treated non-study eye)  1  3/126 (2.38%)  1/126 (0.79%)  2/118 (1.69%) 
Macular oedema (Fellow eye)  1  3/126 (2.38%)  6/126 (4.76%)  3/118 (2.54%) 
Macular oedema (Study eye)  1  2/126 (1.59%)  3/126 (2.38%)  2/118 (1.69%) 
Macular oedema (Treated non-study eye)  1  1/126 (0.79%)  3/126 (2.38%)  0/118 (0.00%) 
Ocular hyperaemia (Study eye)  1  2/126 (1.59%)  1/126 (0.79%)  1/118 (0.85%) 
Ocular hypertension (Fellow eye)  1  3/126 (2.38%)  1/126 (0.79%)  2/118 (1.69%) 
Ocular hypertension (Study eye)  1  7/126 (5.56%)  2/126 (1.59%)  3/118 (2.54%) 
Posterior capsule opacification (Fellow eye)  1  1/126 (0.79%)  0/126 (0.00%)  2/118 (1.69%) 
Punctate keratitis (Study eye)  1  2/126 (1.59%)  0/126 (0.00%)  2/118 (1.69%) 
Retinal exudates (Fellow eye)  1  1/126 (0.79%)  0/126 (0.00%)  2/118 (1.69%) 
Retinal exudates (Study eye)  1  0/126 (0.00%)  2/126 (1.59%)  2/118 (1.69%) 
Retinal haemorrhage (Study eye)  1  2/126 (1.59%)  3/126 (2.38%)  0/118 (0.00%) 
Retinal haemorrhage (Treated non-study eye)  1  2/126 (1.59%)  1/126 (0.79%)  0/118 (0.00%) 
Retinal neovascularisation (Fellow eye)  1  1/126 (0.79%)  4/126 (3.17%)  3/118 (2.54%) 
Retinal vascular disorder (Study eye)  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Retinal vascular disorder (Treated non-study eye)  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Visual acuity reduced (Study eye)  1  1/126 (0.79%)  2/126 (1.59%)  2/118 (1.69%) 
Visual impairment (Study eye)  1  0/126 (0.00%)  0/126 (0.00%)  2/118 (1.69%) 
Vitreous floaters (Study eye)  1  0/126 (0.00%)  1/126 (0.79%)  4/118 (3.39%) 
Vitreous haemorrhage (Fellow eye)  1  2/126 (1.59%)  4/126 (3.17%)  1/118 (0.85%) 
Vitreous haemorrhage (Study eye)  1  8/126 (6.35%)  2/126 (1.59%)  0/118 (0.00%) 
Gastrointestinal disorders       
Abdominal pain upper  1  2/126 (1.59%)  1/126 (0.79%)  0/118 (0.00%) 
Constipation  1  3/126 (2.38%)  1/126 (0.79%)  0/118 (0.00%) 
Diarrhoea  1  4/126 (3.17%)  4/126 (3.17%)  7/118 (5.93%) 
Gastritis  1  0/126 (0.00%)  0/126 (0.00%)  2/118 (1.69%) 
Nausea  1  1/126 (0.79%)  2/126 (1.59%)  3/118 (2.54%) 
Vomiting  1  3/126 (2.38%)  4/126 (3.17%)  3/118 (2.54%) 
General disorders       
Fatigue  1  0/126 (0.00%)  0/126 (0.00%)  2/118 (1.69%) 
General physical health deterioration  1  2/126 (1.59%)  1/126 (0.79%)  1/118 (0.85%) 
Influenza like illness  1  3/126 (2.38%)  0/126 (0.00%)  1/118 (0.85%) 
Malaise  1  0/126 (0.00%)  1/126 (0.79%)  2/118 (1.69%) 
Oedema peripheral  1  7/126 (5.56%)  5/126 (3.97%)  3/118 (2.54%) 
Pain  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Pyrexia  1  0/126 (0.00%)  3/126 (2.38%)  3/118 (2.54%) 
Immune system disorders       
Hypersensitivity  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Infections and infestations       
Bronchitis  1  11/126 (8.73%)  1/126 (0.79%)  5/118 (4.24%) 
Bronchitis viral  1  0/126 (0.00%)  2/126 (1.59%)  1/118 (0.85%) 
Cellulitis  1  0/126 (0.00%)  5/126 (3.97%)  1/118 (0.85%) 
Conjunctivitis viral (Study eye)  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Cystitis  1  2/126 (1.59%)  2/126 (1.59%)  6/118 (5.08%) 
Ear infection  1  1/126 (0.79%)  1/126 (0.79%)  3/118 (2.54%) 
Gastroenteritis  1  2/126 (1.59%)  2/126 (1.59%)  1/118 (0.85%) 
Gastroenteritis viral  1  2/126 (1.59%)  2/126 (1.59%)  0/118 (0.00%) 
Herpes zoster  1  0/126 (0.00%)  3/126 (2.38%)  1/118 (0.85%) 
Hordeolum (Study eye)  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Influenza  1  9/126 (7.14%)  10/126 (7.94%)  8/118 (6.78%) 
Laryngitis  1  0/126 (0.00%)  1/126 (0.79%)  2/118 (1.69%) 
Localised infection  1  2/126 (1.59%)  1/126 (0.79%)  1/118 (0.85%) 
Lower respiratory tract infection  1  3/126 (2.38%)  3/126 (2.38%)  3/118 (2.54%) 
Nasopharyngitis  1  11/126 (8.73%)  10/126 (7.94%)  8/118 (6.78%) 
Paronychia  1  0/126 (0.00%)  2/126 (1.59%)  0/118 (0.00%) 
Pneumonia  1  3/126 (2.38%)  0/126 (0.00%)  0/118 (0.00%) 
Respiratory tract infection  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Sinusitis  1  0/126 (0.00%)  3/126 (2.38%)  1/118 (0.85%) 
Skin infection  1  0/126 (0.00%)  3/126 (2.38%)  0/118 (0.00%) 
Tooth abscess  1  0/126 (0.00%)  2/126 (1.59%)  2/118 (1.69%) 
Tooth infection  1  2/126 (1.59%)  1/126 (0.79%)  2/118 (1.69%) 
Upper respiratory tract infection  1  3/126 (2.38%)  5/126 (3.97%)  4/118 (3.39%) 
Urinary tract infection  1  9/126 (7.14%)  10/126 (7.94%)  5/118 (4.24%) 
Viral infection  1  0/126 (0.00%)  2/126 (1.59%)  1/118 (0.85%) 
Injury, poisoning and procedural complications       
Contusion  1  1/126 (0.79%)  1/126 (0.79%)  2/118 (1.69%) 
Fall  1  2/126 (1.59%)  1/126 (0.79%)  1/118 (0.85%) 
Laceration  1  2/126 (1.59%)  1/126 (0.79%)  1/118 (0.85%) 
Ligament sprain  1  0/126 (0.00%)  3/126 (2.38%)  0/118 (0.00%) 
Limb injury  1  0/126 (0.00%)  2/126 (1.59%)  1/118 (0.85%) 
Muscle rupture  1  0/126 (0.00%)  2/126 (1.59%)  2/118 (1.69%) 
Investigations       
Alanine aminotransferase increased  1  2/126 (1.59%)  1/126 (0.79%)  1/118 (0.85%) 
Aspartate aminotransferase increased  1  1/126 (0.79%)  1/126 (0.79%)  2/118 (1.69%) 
Blood alkaline phosphatase increased  1  1/126 (0.79%)  0/126 (0.00%)  4/118 (3.39%) 
Blood bilirubin increased  1  0/126 (0.00%)  2/126 (1.59%)  1/118 (0.85%) 
Blood creatinine increased  1  2/126 (1.59%)  4/126 (3.17%)  0/118 (0.00%) 
Blood glucose increased  1  2/126 (1.59%)  3/126 (2.38%)  3/118 (2.54%) 
Blood lactate dehydrogenase increased  1  1/126 (0.79%)  4/126 (3.17%)  3/118 (2.54%) 
Blood potassium increased  1  3/126 (2.38%)  4/126 (3.17%)  2/118 (1.69%) 
Blood urea increased  1  3/126 (2.38%)  4/126 (3.17%)  2/118 (1.69%) 
Blood uric acid increased  1  3/126 (2.38%)  2/126 (1.59%)  1/118 (0.85%) 
Blood urine present  1  2/126 (1.59%)  3/126 (2.38%)  4/118 (3.39%) 
Gamma-glutamyltransferase increased  1  3/126 (2.38%)  6/126 (4.76%)  4/118 (3.39%) 
Glycosylated haemoglobin increased  1  0/126 (0.00%)  2/126 (1.59%)  2/118 (1.69%) 
Haematocrit decreased  1  1/126 (0.79%)  2/126 (1.59%)  0/118 (0.00%) 
Haemoglobin decreased  1  1/126 (0.79%)  4/126 (3.17%)  1/118 (0.85%) 
Intraocular pressure increased (Fellow eye)  1  2/126 (1.59%)  2/126 (1.59%)  1/118 (0.85%) 
Intraocular pressure increased (Study eye)  1  2/126 (1.59%)  7/126 (5.56%)  5/118 (4.24%) 
Platelet count decreased  1  1/126 (0.79%)  1/126 (0.79%)  3/118 (2.54%) 
Protein total increased  1  1/126 (0.79%)  1/126 (0.79%)  2/118 (1.69%) 
Red blood cell count decreased  1  1/126 (0.79%)  2/126 (1.59%)  0/118 (0.00%) 
White blood cell count increased  1  1/126 (0.79%)  2/126 (1.59%)  1/118 (0.85%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  5/126 (3.97%)  3/126 (2.38%)  4/118 (3.39%) 
Diabetes mellitus inadequate control  1  3/126 (2.38%)  4/126 (3.17%)  4/118 (3.39%) 
Gout  1  1/126 (0.79%)  1/126 (0.79%)  3/118 (2.54%) 
Hypercholesterolaemia  1  2/126 (1.59%)  3/126 (2.38%)  3/118 (2.54%) 
Hyperglycaemia  1  6/126 (4.76%)  1/126 (0.79%)  2/118 (1.69%) 
Hyperkalaemia  1  2/126 (1.59%)  0/126 (0.00%)  2/118 (1.69%) 
Hypoglycaemia  1  5/126 (3.97%)  4/126 (3.17%)  1/118 (0.85%) 
Ketosis  1  0/126 (0.00%)  1/126 (0.79%)  2/118 (1.69%) 
Vitamin D deficiency  1  1/126 (0.79%)  0/126 (0.00%)  2/118 (1.69%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/126 (0.79%)  4/126 (3.17%)  0/118 (0.00%) 
Arthritis  1  4/126 (3.17%)  4/126 (3.17%)  0/118 (0.00%) 
Back pain  1  8/126 (6.35%)  10/126 (7.94%)  3/118 (2.54%) 
Myalgia  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Neck pain  1  3/126 (2.38%)  1/126 (0.79%)  0/118 (0.00%) 
Osteoarthritis  1  1/126 (0.79%)  2/126 (1.59%)  1/118 (0.85%) 
Osteoporosis  1  0/126 (0.00%)  1/126 (0.79%)  4/118 (3.39%) 
Pain in extremity  1  3/126 (2.38%)  2/126 (1.59%)  3/118 (2.54%) 
Tendonitis  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer  1  0/126 (0.00%)  0/126 (0.00%)  2/118 (1.69%) 
Nervous system disorders       
Diabetic neuropathy  1  2/126 (1.59%)  1/126 (0.79%)  0/118 (0.00%) 
Dizziness  1  4/126 (3.17%)  2/126 (1.59%)  2/118 (1.69%) 
Headache  1  4/126 (3.17%)  1/126 (0.79%)  4/118 (3.39%) 
Hypoglycaemic coma  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Loss of consciousness  1  0/126 (0.00%)  0/126 (0.00%)  2/118 (1.69%) 
Neuralgia  1  0/126 (0.00%)  0/126 (0.00%)  2/118 (1.69%) 
Sciatica  1  2/126 (1.59%)  1/126 (0.79%)  2/118 (1.69%) 
Syncope  1  0/126 (0.00%)  0/126 (0.00%)  2/118 (1.69%) 
Psychiatric disorders       
Depression  1  1/126 (0.79%)  2/126 (1.59%)  3/118 (2.54%) 
Insomnia  1  4/126 (3.17%)  0/126 (0.00%)  1/118 (0.85%) 
Renal and urinary disorders       
Renal failure  1  2/126 (1.59%)  2/126 (1.59%)  1/118 (0.85%) 
Renal impairment  1  2/126 (1.59%)  1/126 (0.79%)  1/118 (0.85%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/126 (0.79%)  0/126 (0.00%)  2/118 (1.69%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Cough  1  5/126 (3.97%)  4/126 (3.17%)  4/118 (3.39%) 
Dyspnoea  1  2/126 (1.59%)  2/126 (1.59%)  2/118 (1.69%) 
Epistaxis  1  2/126 (1.59%)  0/126 (0.00%)  0/118 (0.00%) 
Skin and subcutaneous tissue disorders       
Diabetic foot  1  0/126 (0.00%)  3/126 (2.38%)  0/118 (0.00%) 
Eczema  1  1/126 (0.79%)  1/126 (0.79%)  2/118 (1.69%) 
Rash  1  2/126 (1.59%)  1/126 (0.79%)  0/118 (0.00%) 
Vascular disorders       
Hypertension  1  19/126 (15.08%)  17/126 (13.49%)  8/118 (6.78%) 
Hypotension  1  1/126 (0.79%)  2/126 (1.59%)  0/118 (0.00%) 
Venous insufficiency  1  2/126 (1.59%)  1/126 (0.79%)  1/118 (0.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 16.0
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 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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01171976    
Other Study ID Numbers: CRFB002D2304
2010-019795-74 ( EudraCT Number )
First Submitted: July 27, 2010
First Posted: July 29, 2010
Results First Submitted: March 31, 2014
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014