Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT00687804
Description: Safety Population included all randomized treated participants. Participants are grouped according to the treatment actually received in the Core Study.
Frequency Threshold: 5
Time Frame: None
Study: NCT00687804
Study Brief: A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ranibizumab 0.5 mg Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met: Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits. Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes. In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy. None None 41 115 79 115 View
Ranibizumab 0.5 mg + Laser Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met: Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits. Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes. In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy None None 43 120 83 120 View
Laser With Ranibizumab in Extension Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met: Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits. Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes. In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy. None None 28 59 50 59 View
Laser Without Ranibizumab in Extension Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met: Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits. Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes. In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy. None None 7 51 31 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hypochromic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Spleen disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Splenic infarction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Conjunctival haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Corneal oedema (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diabetic retinal oedema (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lenticular opacities (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous adhesions (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous haemorrhage (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colonic polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal necrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hernial eventration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Polyserositis SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Biliary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gas gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Mediastinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia cytomegaloviral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Systemic candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Back injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Eye injury (Fellow eye) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Eye injury (Study eye) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Eyelid injury (Study eye) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Meniscus lesion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Open wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Periorbital haematoma (Study eye) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Spinal cord injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood calcium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Body temperature decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetic foot SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Hepatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant neoplasm of ampulla of Vater SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Multiple myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Urethral neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral artery embolism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Embolic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Acute prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Bladder prolapse SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Calculus urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure chronic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal septum deviation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary haematoma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute febrile neutrophilic dermatosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin hypertrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Arterial thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Varicose vein SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Spinocerebellar ataxia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Cataract (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract subcapsular (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Blepharitis (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival hyperaemia (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctivitis (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diabetic retinal oedema (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diabetic retinal oedema (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diabetic retinopathy (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diabetic retinopathy (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye discharge (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye haemorrhage (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye irritation (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pain (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pruritus (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Foreign body sensation in eyes (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Macular fibrosis (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Punctate keratitis (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal aneurysm (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal exudates (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal exudates (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal haemorrhage (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vision blurred (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual acuity reduced (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual acuity reduced (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Intraocular pressure increased (Fellow eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View