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A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR) (HARBOR)

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ClinicalTrials.gov Identifier: NCT00891735
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : January 18, 2013
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Age-related Macular Degeneration
Intervention Drug: Ranibizumab
Enrollment 1097
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Hide Arm/Group Description Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months. Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months. Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally. Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Period Title: Overall Study
Started 275 274 275 273
Completed 258 258 263 258
Not Completed 17 16 12 15
Reason Not Completed
Adverse Event             2             0             2             0
Death             8             5             4             5
Lost to Follow-up             2             2             2             2
Physician's decision to withdraw patient             1             0             0             0
Patient's decision to withdraw             4             9             4             8
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN]) Total
Hide Arm/Group Description Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months. Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months. Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally. Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally. Total of all reporting groups
Overall Number of Baseline Participants 275 274 275 273 1097
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 275 participants 274 participants 275 participants 273 participants 1097 participants
78.8  (8.4) 79.3  (8.3) 78.5  (8.3) 78.3  (8.3) 78.7  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 274 participants 275 participants 273 participants 1097 participants
Female
162
  58.9%
170
  62.0%
163
  59.3%
156
  57.1%
651
  59.3%
Male
113
  41.1%
104
  38.0%
112
  40.7%
117
  42.9%
446
  40.7%
1.Primary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
Hide Description BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.
Time Frame Baseline to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Hide Arm/Group Description:
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Overall Number of Participants Analyzed 275 274 275 273
Mean (Standard Deviation)
Unit of Measure: Letters
10.1  (13.3) 9.2  (14.6) 8.2  (13.3) 8.6  (13.8)
2.Secondary Outcome
Title Number of Ranibizumab Injections up to But Not Including Month 12
Hide Description [Not Specified]
Time Frame Baseline to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients. Observed data were used with no imputation.
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Hide Arm/Group Description:
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Overall Number of Participants Analyzed 274 274 275 272
Mean (Standard Deviation)
Unit of Measure: Injections
11.3  (1.8) 11.2  (2.1) 7.7  (2.7) 6.9  (2.4)
3.Secondary Outcome
Title Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12
Hide Description BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Time Frame Baseline to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Hide Arm/Group Description:
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Overall Number of Participants Analyzed 275 274 275 273
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
34.5
(28.9 to 40.2)
36.1
(30.4 to 41.8)
30.2
(24.8 to 35.6)
33.0
(27.4 to 38.5)
4.Secondary Outcome
Title Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12
Hide Description VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Hide Arm/Group Description:
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Overall Number of Participants Analyzed 275 274 275 273
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
52.4
(46.5 to 58.3)
50.0
(44.1 to 55.9)
46.2
(40.3 to 52.1)
43.6
(37.7 to 49.5)
5.Secondary Outcome
Title Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12
Hide Description The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness < 270 µm.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Hide Arm/Group Description:
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Overall Number of Participants Analyzed 275 274 275 273
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
5.1
(2.5 to 7.7)
5.8
(3.1 to 8.6)
2.9
(0.9 to 4.9)
4.8
(2.2 to 7.3)
6.Secondary Outcome
Title Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Hide Description Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT).
Time Frame Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Hide Arm/Group Description:
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Overall Number of Participants Analyzed 275 274 275 273
Mean (Standard Deviation)
Unit of Measure: µm
Day 7 -104.9  (130.3) -84.9  (111.3) -103.5  (141.3) -100.6  (123.4)
Month 1 -141.5  (137.5) -128.6  (133.3) -132.6  (148.2) -146.0  (144.3)
Month 2 -152.5  (142.4) -140.3  (131.1) -142.9  (141.6) -156.9  (145.0)
Month 3 -157.0  (143.8) -147.9  (134.3) -154.5  (147.9) -164.9  (144.5)
Month 4 -164.0  (146.6) -151.8  (143.3) -142.7  (153.6) -159.7  (148.8)
Month 6 -162.0  (150.0) -149.2  (144.0) -147.5  (151.9) -159.1  (149.6)
Month 9 -164.5  (151.8) -153.1  (144.8) -153.5  (147.1) -157.8  (155.6)
Month 12 -172.0  (150.5) -163.3  (142.6) -161.2  (152.3) -172.4  (148.6)
7.Secondary Outcome
Title Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Hide Description Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT).
Time Frame Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Hide Arm/Group Description:
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Overall Number of Participants Analyzed 275 274 275 273
Mean (Standard Deviation)
Unit of Measure: mm^3
Day 7 -0.79  (0.80) -0.80  (0.76) -0.72  (0.87) -0.81  (0.76)
Month 1 -1.26  (1.06) -1.30  (1.15) -1.16  (1.03) -1.38  (1.18)
Month 2 -1.34  (1.17) -1.49  (1.31) -1.30  (1.13) -1.47  (1.25)
Month 3 -1.42  (1.25) -1.51  (1.32) -1.43  (1.33) -1.55  (1.28)
Month 4 -1.42  (1.22) -1.56  (1.31) -1.31  (1.24) -1.48  (1.27)
Month 6 -1.47  (1.25) -1.61  (1.34) -1.35  (1.33) -1.48  (1.36)
Month 9 -1.55  (1.41) -1.67  (1.34) -1.35  (1.31) -1.48  (1.33)
Month 12 -1.54  (1.31) -1.66  (1.37) -1.41  (1.36) -1.49  (1.35)
8.Secondary Outcome
Title Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12
Hide Description The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm^2.
Time Frame Baseline to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Hide Arm/Group Description:
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Overall Number of Participants Analyzed 275 274 275 273
Mean (Standard Deviation)
Unit of Measure: Disc area units
Change in the total area of CNV -2.14  (2.40) -2.42  (2.38) -1.74  (2.22) -1.98  (2.39)
Change in the total area of CNV leakage -2.35  (2.39) -2.63  (2.34) -2.01  (2.28) -2.22  (2.48)
Time Frame Adverse events were recorded from Baseline (first treatment day) through Month 12.
Adverse Event Reporting Description Safety population: All patients who received at least 1 study treatment. Adverse events reported here include ocular adverse events in the study eye and fellow eye, as well as non-ocular adverse events.
 
Arm/Group Title Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Hide Arm/Group Description Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months. Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months. Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally. Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
All-Cause Mortality
Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/274 (24.09%)   54/274 (19.71%)   57/275 (20.73%)   54/272 (19.85%) 
Blood and lymphatic system disorders         
Anaemia  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Hypocoagulable state  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Cardiac disorders         
Acute myocardial infarction  1  1/274 (0.36%)  1/274 (0.36%)  0/275 (0.00%)  1/272 (0.37%) 
Angina pectoris  1  1/274 (0.36%)  1/274 (0.36%)  1/275 (0.36%)  1/272 (0.37%) 
Angina unstable  1  2/274 (0.73%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Arrhythmia  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Arteriosclerosis coronary artery  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Atrial fibrillation  1  2/274 (0.73%)  1/274 (0.36%)  4/275 (1.45%)  4/272 (1.47%) 
Atrioventricular block complete  1  0/274 (0.00%)  1/274 (0.36%)  1/275 (0.36%)  0/272 (0.00%) 
Cardiac arrest  1  3/274 (1.09%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Cardiac failure congestive  1  6/274 (2.19%)  1/274 (0.36%)  2/275 (0.73%)  2/272 (0.74%) 
Coronary artery disease  1  0/274 (0.00%)  0/274 (0.00%)  2/275 (0.73%)  2/272 (0.74%) 
Mitral valve incompetence  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Myocardial infarction  1  5/274 (1.82%)  1/274 (0.36%)  0/275 (0.00%)  3/272 (1.10%) 
Pericardial effusion  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Sick sinus syndrome  1  0/274 (0.00%)  1/274 (0.36%)  1/275 (0.36%)  1/272 (0.37%) 
Sinus arrest  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Tachyarrhythmia  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Ventricular fibrillation  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Ventricular tachycardia  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Ear and labyrinth disorders         
Vertigo  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Eye disorders         
Age-related macular degeneration  1 [1]  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Corneal oedema  1 [2]  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Iridocyclitis  1 [2]  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Macular degeneration  1 [2]  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Macular hole  1 [1]  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Retinal artery occlusion  1 [2]  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Retinal haemorrhage  1 [2]  0/274 (0.00%)  1/274 (0.36%)  1/275 (0.36%)  1/272 (0.37%) 
Retinal tear  1 [2]  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Retinal vein occlusion  1 [2]  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Visual acuity reduced  1 [2]  0/274 (0.00%)  3/274 (1.09%)  2/275 (0.73%)  0/272 (0.00%) 
Vitreous floaters  1 [2]  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Visual acuity reduced  1 [1]  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Gastrointestinal disorders         
Abdominal adhesions  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Abdominal pain  1  1/274 (0.36%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Colitis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Diarrhoea  1  0/274 (0.00%)  1/274 (0.36%)  1/275 (0.36%)  0/272 (0.00%) 
Gastric antral vascular ectasia  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Gastric ulcer haemorrhage  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Gastritis  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Gastrointestinal haemorrhage  1  2/274 (0.73%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Haematochezia  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  2/272 (0.74%) 
Ileus  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Inguinal hernia  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Intestinal obstruction  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  1/272 (0.37%) 
Large intestinal harmorrhage  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Pancreatic mass  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Small intestinal obstruction  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
General disorders         
Asthenia  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Chest pain  1  2/274 (0.73%)  0/274 (0.00%)  2/275 (0.73%)  0/272 (0.00%) 
Death  1  2/274 (0.73%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Device dislocation  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Device failure  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Medical device complication  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Non-cardiac chest pain  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Oedema peripheral  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Pain  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Ulcer haemorrhage  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Hepatobiliary disorders         
Bile duct stone  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Cholangitis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Cholecystitis acute  1  1/274 (0.36%)  0/274 (0.00%)  1/275 (0.36%)  1/272 (0.37%) 
Cholelithiasis  1  2/274 (0.73%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Gallbladder pain  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Infections and infestations         
Appendicitis perforated  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Bacterial sepsis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Brain abscess  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Breast infection  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Bronchitis  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Cellulitis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Clostridium difficile colitis  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Diverticulitis  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Empyema  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Endocarditis bacterial  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Endophthalmitis  1 [2]  2/274 (0.73%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Lobar pneumonia  1  0/274 (0.00%)  1/274 (0.36%)  1/275 (0.36%)  1/272 (0.37%) 
Lung abscess  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Pneumonia  1  5/274 (1.82%)  5/274 (1.82%)  6/275 (2.18%)  3/272 (1.10%) 
Pyelonephritis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Sepsis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  1/272 (0.37%) 
Septic shock  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Urinary tract infection  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Endophthalmitis  1 [1]  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  2/272 (0.74%) 
Cystitis radiation  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Facial bones fracture  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Fall  1  1/274 (0.36%)  2/274 (0.73%)  1/275 (0.36%)  3/272 (1.10%) 
Hip fracture  1  1/274 (0.36%)  1/274 (0.36%)  3/275 (1.09%)  3/272 (1.10%) 
Joint dislocation  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  1/272 (0.37%) 
Joint sprain  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Overdose  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Pelvic fracture  1  0/274 (0.00%)  0/274 (0.00%)  2/275 (0.73%)  0/272 (0.00%) 
Post procedural complication  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Post procedural heamatoma  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Procedural hypertension  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Road traffic accident  1  1/274 (0.36%)  1/274 (0.36%)  1/275 (0.36%)  0/272 (0.00%) 
Splenic injury  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Splenic rupture  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Thoracic vertebral fracture  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Upper limb fracture  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Wrist fracture  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Investigations         
Blood creatinine increased  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Haemoglobin decreased  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Urine output decreased  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  3/274 (1.09%)  1/274 (0.36%)  1/275 (0.36%)  0/272 (0.00%) 
Hyperkalaemia  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Hyponatraemia  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Hypovolaemia  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/274 (0.00%)  2/274 (0.73%)  0/275 (0.00%)  1/272 (0.37%) 
Arthritis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  2/272 (0.74%) 
Back pain  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Bone pain  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Foot deformity  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Intervertebral disc degeneration  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Lumbar spinal stenosis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Osteoarthritis  1  0/274 (0.00%)  0/274 (0.00%)  3/275 (1.09%)  0/272 (0.00%) 
Osteonecrosis  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Spinal column stenosis  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Spondylolisthesis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bladder cancer  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Breast cancer  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Bronchial carcinoma  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Colon adenoma  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Endometrial cancer  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Gallbladder cancer  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Hepatic neoplasm malignant  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Lipoma  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Lung adenocarcinoma recurrent  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Lung cancer metastatic  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Lung carcinoma cell type unspecified recurrent  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Lung neoplasm malignant  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Metastases to lung  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Non-Hodgkin's lymphoma  1  1/274 (0.36%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Non-Hodgkin's lymphoma recurrent  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Oesophageal carcinoma  1  1/274 (0.36%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Pancreatic carcinoma  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Renal cell carcinoma  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Skin cancer  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Small cell carcinoma  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Small cell lung cancer metastatic  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Small cell lung cancer stage unspecified  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Splenic marginal zone lymphoma  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Tumour ulceration  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Nervous system disorders         
Carotid artery stenosis  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  2/272 (0.74%) 
Cerebrovascular accident  1  2/274 (0.73%)  1/274 (0.36%)  2/275 (0.73%)  2/272 (0.74%) 
Cervicobrachial syndrome  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Convulsion  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Dementia  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Embolic stroke  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Hypoaesthesia  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Hypoxic-ischaemic encephalopathy  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Ischaemic stroke  1  0/274 (0.00%)  1/274 (0.36%)  1/275 (0.36%)  0/272 (0.00%) 
Loss of consciousness  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Nerve compression  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Paraparesis  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Presyncope  1  1/274 (0.36%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Syncope  1  2/274 (0.73%)  2/274 (0.73%)  1/275 (0.36%)  1/272 (0.37%) 
Transient ischaemic attack  1  0/274 (0.00%)  1/274 (0.36%)  1/275 (0.36%)  0/272 (0.00%) 
Psychiatric disorders         
Anxiety  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Depression  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Hallucination  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Mental status changes  1  0/274 (0.00%)  1/274 (0.36%)  1/275 (0.36%)  0/272 (0.00%) 
Somatic delusion  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Renal and urinary disorders         
Cystitis haemorrhagic  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Nephrolithiasis  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Renal artery stenosis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Renal failure  1  1/274 (0.36%)  1/274 (0.36%)  2/275 (0.73%)  2/272 (0.74%) 
Renal failure chronic  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Renal impairment  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Reproductive system and breast disorders         
Uterine haemorrhage  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Uterovaginal prolapse  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute pulmonary oedema  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Acute respiratory failure  1  1/274 (0.36%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Asthma  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Bronchospasm  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Chronic obstructive pulmonary disease  1  2/274 (0.73%)  0/274 (0.00%)  1/275 (0.36%)  4/272 (1.47%) 
Dyspnoea  1  1/274 (0.36%)  1/274 (0.36%)  0/275 (0.00%)  1/272 (0.37%) 
Idiopathic pulmonary fibrosis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Nasal polyps  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Pleural effusion  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Pneumonitis  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Pneumothorax  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Pulmonary embolism  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Respiratory arrest  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Respiratory failure  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Surgical and medical procedures         
Thrombosis prophylaxis  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Vascular disorders         
Aortic aneurysm  1  1/274 (0.36%)  1/274 (0.36%)  2/275 (0.73%)  1/272 (0.37%) 
Deep vein thrombosis  1  0/274 (0.00%)  1/274 (0.36%)  1/275 (0.36%)  0/272 (0.00%) 
Haemorrhage  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Hypertension  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  1/272 (0.37%) 
Hypertensive crisis  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Peripheral arterial occlusive disease  1  0/274 (0.00%)  0/274 (0.00%)  0/275 (0.00%)  1/272 (0.37%) 
Peripheral embolism  1  0/274 (0.00%)  0/274 (0.00%)  1/275 (0.36%)  0/272 (0.00%) 
Shock haemorrhagic  1  0/274 (0.00%)  1/274 (0.36%)  0/275 (0.00%)  0/272 (0.00%) 
Thrombophlebitis  1  1/274 (0.36%)  0/274 (0.00%)  0/275 (0.00%)  0/272 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
[1]
Fellow eye
[2]
Study eye
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ranibizumab 0.5 mg Monthly Ranibizumab 2.0 mg Monthly Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   240/274 (87.59%)   243/274 (88.69%)   250/275 (90.91%)   239/272 (87.87%) 
Eye disorders         
Age-related macular degeneration  1 [1]  8/274 (2.92%)  15/274 (5.47%)  15/275 (5.45%)  13/272 (4.78%) 
Conjunctival haemorrhage  1 [2]  63/274 (22.99%)  51/274 (18.61%)  48/275 (17.45%)  41/272 (15.07%) 
Detachment of retinal pigment epithelium  1 [2]  4/274 (1.46%)  4/274 (1.46%)  17/275 (6.18%)  11/272 (4.04%) 
Eye pain  1 [2]  15/274 (5.47%)  25/274 (9.12%)  16/275 (5.82%)  23/272 (8.46%) 
Macular degeneration  1 [2]  12/274 (4.38%)  8/274 (2.92%)  18/275 (6.55%)  15/272 (5.51%) 
Retinal haemorrhage  1 [2]  6/274 (2.19%)  7/274 (2.55%)  14/275 (5.09%)  12/272 (4.41%) 
Vitreous detachment  1 [2]  22/274 (8.03%)  21/274 (7.66%)  16/275 (5.82%)  27/272 (9.93%) 
Vitreous floaters  1 [2]  26/274 (9.49%)  15/274 (5.47%)  11/275 (4.00%)  17/272 (6.25%) 
Macular degeneration  1 [1]  14/274 (5.11%)  12/274 (4.38%)  11/275 (4.00%)  14/272 (5.15%) 
Retinal haemorrhage  1 [1]  12/274 (4.38%)  15/274 (5.47%)  6/275 (2.18%)  12/272 (4.41%) 
Vitreous detachment  1 [1]  20/274 (7.30%)  24/274 (8.76%)  17/275 (6.18%)  13/272 (4.78%) 
Infections and infestations         
Nasopharyngitis  1  17/274 (6.20%)  10/274 (3.65%)  17/275 (6.18%)  23/272 (8.46%) 
Sinusitis  1  12/274 (4.38%)  7/274 (2.55%)  27/275 (9.82%)  8/272 (2.94%) 
Urinary tract infection  1  15/274 (5.47%)  14/274 (5.11%)  17/275 (6.18%)  16/272 (5.88%) 
Injury, poisoning and procedural complications         
Fall  1  14/274 (5.11%)  12/274 (4.38%)  8/275 (2.91%)  21/272 (7.72%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  5/274 (1.82%)  10/274 (3.65%)  6/275 (2.18%)  14/272 (5.15%) 
Vascular disorders         
Hypertension  1  14/274 (5.11%)  20/274 (7.30%)  21/275 (7.64%)  15/272 (5.51%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
[1]
Fellow eye
[2]
Study eye
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800-821-8590
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00891735     History of Changes
Other Study ID Numbers: FVF4579g
GX01511 ( Other Identifier: Hoffmann-La Roche )
First Submitted: April 29, 2009
First Posted: May 1, 2009
Results First Submitted: September 18, 2012
Results First Posted: January 18, 2013
Last Update Posted: January 18, 2013