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This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the previous study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 0.5 mg | Experimental | Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 0.5 mg | Drug | Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ocular Adverse Events in the Study Eye | Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. | Up to 24 months |
| Number of Participants With Non-ocular Adverse Events | Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity. | Baseline (Day 0 of extension study), Months 6, 12, 18, and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Lai, M.D. | Genentech, Inc. | Study Director |
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This is an open label multi-center extension study for participants who completed FVF4165g BRAVO (NCT00486018) or FVF4166g CRUISE (NCT0048583). Cohort 2 consists of enrolled participants with macular edema secondary to retinal vein occlusion (RVO).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab (Sham BRAVO) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study. |
| FG001 | Ranibizumab (0.3 mg BRAVO) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO. |
| FG002 | Ranibizumab (0.5 mg BRAVO) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO. |
| FG003 | Ranibizumab (Sham CRUISE) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study. |
| FG004 | Ranibizumab (0.3 mg CRUISE) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE. |
| FG005 | Ranibizumab (0.5 mg CRUISE) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab (Sham BRAVO) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Ocular Adverse Events in the Study Eye | Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. | Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study. | Posted | Number | participants | Up to 24 months |
|
Up to 24 months
Safety Population included all participants who received at least one dose of study drug in one of the initial studies or this extension study. These analyses include only those adverse events that occurred during this extension study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranibizumab (Sham) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE and received Ranibizumab during the 6 month observation period of the initial study or this extension study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CATARACT | Eye disorders | MedDRA (13.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Genentech | Genentech | ctg-post-d@gene.com |
Not provided
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center. | Baseline (Day 0 of extension study), Months 6 and 12 |
| Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24. Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836). | Baseline (Day 0 of extension study), Months 12 and 24 |
| Death |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Sponsor decision |
|
| Subject non-compliance |
|
| Condition mandated other intervention |
|
| BG001 | Ranibizumab (0.3 mg BRAVO) | In this extension study participant received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO. |
| BG002 | Ranibizumab (0.5 mg BRAVO) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO. |
| BG003 | Ranibizumab (Sham CRUISE) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study. |
| BG004 | Ranibizumab (0.3 mg CRUISE) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE. |
| BG005 | Ranibizumab (0.5 mg CRUISE) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE. |
| BG006 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Ranibizumab (0.3 mg BRAVO) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO. |
| OG002 | Ranibizumab (0.5 mg BRAVO) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO. |
| OG003 | Ranibizumab (Sham CRUISE) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study. |
| OG004 | Ranibizumab (0.3 mg CRUISE) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE. |
| OG005 | Ranibizumab (0.5 mg CRUISE) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE. |
|
|
| Primary | Number of Participants With Non-ocular Adverse Events | Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section. | Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study. | Posted | Number | participants | Up to 24 months |
|
|
|
| Secondary | Change From Baseline in the Best Corrected Visual Acuity (BCVA) | Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity. | Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n". | Posted | Mean | Standard Deviation | letters | Baseline (Day 0 of extension study), Months 6, 12, 18, and 24 |
|
|
|
| Secondary | Change From Baseline in Central Foveal Thickness at Month 6 and Month 12 | Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center. | Enrolled participants for whom data was available for analyses at the given time-point as indicated by "n" in the categories. Observed data were used with no imputation. | Posted | Mean | Standard Deviation | µm | Baseline (Day 0 of extension study), Months 6 and 12 |
|
|
|
| Secondary | Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) | NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24. Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836). | Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n". | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 0 of extension study), Months 12 and 24 |
|
|
|
| 32 |
| 189 |
| 146 |
| 189 |
| EG001 | Ranibizumab (0.3 mg) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE. | 49 | 210 | 179 | 210 |
| EG002 | Ranibizumab (0.5 mg) | In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE. | 46 | 203 | 172 | 203 |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| COR PULMONALE | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| SINUS ARRHYTHMIA | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| AMAUROSIS FUGAX | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| CATARACT | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| CYSTOID MACULAR OEDEMA | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| MACULAR ISCHAEMIA | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| MACULAR OEDEMA | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| MACULOPATHY | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| OPTIC ISCHAEMIC NEUROPATHY | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| RETINAL VEIN OCCLUSION | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| VISUAL ACUITY REDUCED TRANSIENTLY | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| VITREOUS HAEMORRHAGE | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| GASTROINTESTINAL INFLAMMATION | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| DEATH | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
|
| CHOLECYSTITIS CHRONIC | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
|
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA (13.1) | Systematic Assessment |
|
| ARTHRITIS BACTERIAL | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| BACTERIAL SEPSIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| ENDOPHTHALMITIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| PAROTITIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| URINARY TRACT INFECTION PSEUDOMONAL | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| DRUG TOXICITY | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
|
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
|
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
|
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
|
| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| SYNOVIAL CYST | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| ADENOCARCINOMA PANCREAS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| METASTATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| PANCREATIC CARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| T-CELL PROLYMPHOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| AUTONOMIC NERVOUS SYSTEM IMBALANCE | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| PRESYNCOPE | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA (13.1) | Systematic Assessment |
|
| TESTICULAR PAIN | Reproductive system and breast disorders | MedDRA (13.1) | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| AORTIC STENOSIS | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| ARTERIOSCLEROSIS | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| LABILE HYPERTENSION | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| CONJUNCTIVAL HAEMORRHAGE | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| CYSTOID MACULAR OEDEMA | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| EYE PAIN | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| MACULAR OEDEMA | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| MACULOPATHY | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| RETINAL DEPIGMENTATION | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| RETINAL EXUDATES | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| RETINAL HAEMORRHAGE | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| RETINAL VASCULAR DISORDER | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| VITREOUS DETACHMENT | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
Not provided
Not provided
| D013927 |
| Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Serious non-ocular adverse event |
|
| Non-ocular adverse event led to discontinuation |
|
| Death |
|
| Month 12 (n=66,66,73,58,69,50) |
|
| Month 18 (n=23,26,32,31,26,22) |
|
| Month 24 (n=0,2,0,0,1,0) |
|
| Month 12 (n=62,65,72,56,69,51) |
|
| Month 24 (n=0,2,0,0,1,0) |
|