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 @ 1:47 PM
Ignite Modification Date:
2025-12-25 @ 12:41 PM
NCT ID:
NCT00379795
Description:
Safety Population includes all participants who received at least one dose of study drug in one of the initial studies or this extension study. As per the protocol participants who did not receive study drug were excluded from the analyses.
Only adverse events that occurred during this extension study are reported.
Frequency Threshold:
5
Time Frame:
The summary includes adverse events that occurred from enrollment in this extension study through 36 months (+/- 7 days).
Study:
NCT00379795
Study Brief:
An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization Secondary to AMD or Macular Edema Secondary to RVO
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 Treated Initial Mono | In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g. | None | None | 213 | 526 | 491 | 526 | View |
| Ranibizumab Treated PDT XO | In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study. | None | None | 24 | 74 | 71 | 74 | View |
| Ranibizumab Treated Initial + PDT | In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g. | None | None | 26 | 74 | 70 | 74 | View |
| Ranibizumab Treated Sham XO | In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g or this extension study. | None | None | 43 | 116 | 110 | 116 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| CORONARY ARTERY OCCLUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| ISCHAEMIC CARDIOMYOPATHY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| PALPITATIONS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| SICK SINUS SYNDROME | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| VENTRICULAR TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (12.0) | View |
| HYPOPARATHYROIDISM | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (12.0) | View |
| MACULAR DEGENERATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| CHOROIDAL NEOVASCULARISATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| VISUAL ACUITY REDUCED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| RETINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| VITREOUS HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| MACULAR OEDEMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| OPTIC ISCHAEMIC NEUROPATHY | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| POSTERIOR CAPSULE OPACIFICATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| RETINAL DEGENERATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| ANGLE CLOSURE GLAUCOMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| PAPILLOEDEMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| RETINAL ARTERY OCCLUSION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| RETINAL PIGMENT EPITHELIAL TEAR | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| SUBRETINAL FIBROSIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| UVEITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| VITRITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| ABDOMINAL COMPARTMENT SYNDROME | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| COLITIS ISCHAEMIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| COLONIC OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| COLONIC STENOSIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| DIVERTICULUM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| DUODENAL ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| ILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| INTESTINAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| INTESTINAL PERFORATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| PHARYNGOESOPHAGEAL DIVERTICULUM | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| RECTAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| VARICES OESOPHAGEAL | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| GRANULOMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| HERNIA OBSTRUCTIVE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| IDIOSYNCRATIC DRUG REACTION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| BILE DUCT STONE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| CHOLECYSTITIS CHRONIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| LOBAR PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| DEVICE RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| OSTEOMYELITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| CLOSTRIDIUM DIFFICILE COLITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| INTERVERTEBRAL DISCITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| KERATITIS HERPETIC | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| KLEBSIELLA BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| PYELONEPHRITIS ACUTE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| SEPTIC SHOCK | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| STAPHYLOCOCCAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| VIRAL MYOCARDITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| PELVIC FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| FEMORAL NECK FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| PATELLA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| PUBIC RAMI FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| ANKLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| ARTERIAL INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| DEVICE FAILURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| HEAD INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| MEDICATION ERROR | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| MULTIPLE FRACTURES | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| POST PROCEDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| RIB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| SPINAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| STRESS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| THERAPEUTIC AGENT TOXICITY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| INTRAOCULAR PRESSURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| FAILURE TO THRIVE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| HYPERKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| SPINAL COLUMN STENOSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| LUMBAR SPINAL STENOSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| RHEUMATOID ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| SACROILIITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| SYNOVITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| LUNG NEOPLASM MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| COLON CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| RENAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| BREAST CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| NON-HODGKIN'S LYMPHOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| PANCREATIC CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| PROSTATE CANCER METASTATIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| ACUTE MYELOID LEUKAEMIA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| BLADDER CANCER RECURRENT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| BRAIN NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| BREAST CANCER METASTATIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| COLON ADENOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| ENDOMETRIAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| GASTROINTESTINAL TRACT ADENOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| LUNG ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| LYMPHOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| MALIGNANT MELANOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| OVARIAN EPITHELIAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| PANCREATIC NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| SARCOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| SMALL CELL LUNG CANCER STAGE UNSPECIFIED | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| SQUAMOUS CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| CAROTID ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| ISCHAEMIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| SUBARACHNOID HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| APHASIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| BRAIN MASS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| BRAIN STEM INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| CAROTID ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| CEREBELLAR HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| CEREBRAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| COMPLEX REGIONAL PAIN SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| CONVULSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| DEMENTIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| DEMENTIA ALZHEIMER'S TYPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| ISCHAEMIC CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| SPONDYLITIC MYELOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| THROMBOTIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| BIPOLAR DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| MENTAL STATUS CHANGES | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| RENAL ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| RENAL DISORDER | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| URINARY RETENTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| URINARY TRACT OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| BENIGN PROSTATIC HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (12.0) | View |
| PELVIC PROLAPSE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (12.0) | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| PULMONARY FIBROSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| EMPHYSEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| AORTIC ANEURYSM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| AORTIC STENOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| PERIPHERAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| PERIPHERAL VASCULAR DISORDER | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| ANEURYSM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| AORTIC ANEURYSM RUPTURE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| AORTIC DISSECTION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| INTERMITTENT CLAUDICATION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| COAGULOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| HAEMOLYTIC ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| ANGINA PECTORIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| CARDIO-RESPIRATORY ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| BRADYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| ACUTE CORONARY SYNDROME | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| ANGINA UNSTABLE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| ARRHYTHMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| MACULAR DEGENERATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| RETINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| CONJUNCTIVAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| CHOROIDAL NEOVASCULARISATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| MACULAR OEDEMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| EYE PAIN | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| MYODESOPSIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| VISUAL ACUITY REDUCED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| DETACHMENT OF RETINAL PIGMENT EPITHELIUM | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| MACULOPATHY | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| EYE IRRITATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| POSTERIOR CAPSULE OPACIFICATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| FOREIGN BODY SENSATION IN EYES | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| BLEPHARITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| EYE PRURITUS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| RETINAL DISORDER | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| RETINAL DEGENERATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| PHOTOPSIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| EAR INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| INTRAOCULAR PRESSURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| BENIGN PROSTATIC HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (12.0) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| SUBMACULAR FLUID | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |