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:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
NCT ID:
NCT00486018
Description:
Investigators assessed the occurrence of AE/SAEs at all study visits. Summaries are for the safety-evaluable population and include events regardless of relation to study drug or location (e.g. non-study eye events are included). For each AE/SAE, the number of patients experiencing the event, not the number of occurrences of the event, is reported.
Frequency Threshold:
5
Time Frame:
6 months
Study:
NCT00486018
Study Brief:
A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sham Injection | Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections. | None | None | 6 | 131 | 115 | 131 | View |
| Ranibizumab Injection 0.3 mg | Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. | None | None | 14 | 134 | 125 | 134 | View |
| Ranibizumab Injection 0.5 mg | Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. | None | None | 14 | 130 | 115 | 130 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Angina Unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (12.0) | View |
| Gaze Palsy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Visual Acuity Reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Retinal Neovascularization | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Retinal Tear | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Macular Edema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Small Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Intra-Abdominal Hematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Rectal Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Intestinal Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (12.0) | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Corneal Abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Pelvic Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Diabetes Mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Gastric Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | View |
| Thalamus Hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Retinal Ischemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Retinal Vein Occlusion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Retinal Detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Colonic Polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Endophthalmitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Lobar Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Post Procedural Hemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Cerebral Hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myodesopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Retinal Depigmentation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Conjunctival Hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Eye Irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Eye Pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Foreign Body Sensation in Eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Maculopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Ocular Hyperemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Ocular Vascular Disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Retinal Exudates | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Retinal Hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Retinal Vascular Disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Vitreous Detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (12.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Intraocular Pressure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (12.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |