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 @ 5:10 PM
Ignite Modification Date:
2025-12-25 @ 2:47 PM
NCT ID:
NCT00284050
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00284050
Study Brief:
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement
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 0.3 mg | Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections. | None | None | 9 | 51 | 37 | 51 | View |
| Ranibizumab 0.5 mg | Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections. | None | None | 9 | 51 | 43 | 51 | View |
| Sham Injection | Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections. | None | None | 9 | 49 | 32 | 49 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Endophthalmitis (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Retinal artery occlusion (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Retinal detachment (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Retinal ischaemia (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Vitreous haemorrhage (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Pitting oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Diabetic gangrene | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Infected epidermal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Allergic transfusion reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cataract (Fellow 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 |
| Conjunctivitis (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Corneal disorder (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 |
| Eyelid oedema (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 oedema (Fellow eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Ocular hyperaemia (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Retinal disorder (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Retinal exudates (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Retinal haemorrhage (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Visual acuity reduced (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Visual disturbance (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Vitreous floaters (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 |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Intraocular pressure increased (Fellow eye) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Intraocular pressure increased (Study eye) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |