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 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:40 PM
NCT ID:
NCT01309451
Description:
None
Frequency Threshold:
3
Time Frame:
1 year
Study:
NCT01309451
Study Brief:
Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Bevacizumab Alone Group | bevacizumab 1.25mg intravitreally | None | None | 2 | 9 | 9 | 9 | View |
| Combined Group | bevacizumab 1.25mg intravitreally plus Ozurdex THIS GROUP ALSO INCLUDES PARTICIPANTS WHO HAD BOTH EYES IN THE STUDY (they received bevacizumab alone in one eye and bavacizumab + Ozurdex in the other. | None | None | 8 | 21 | 21 | 21 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| acute renal insufficiency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| generalized weakness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| worsening of hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| congestive heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| contusion left arm | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| otitis media | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| epiretinal membrane | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| esophageal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| infection of toe | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| iritis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| knee pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| posterior capsule opacification | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| heel discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| worsening of cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| worsening of coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| worsening of diabetes mellitus | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (10.0) | View |
| headaches | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| renal insufficiency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| blepharitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| osteophyte right foot | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| canaliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| corneal abrasion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| corneal precipatates | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| cough | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| cyst lower eyelid | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| decreased ability to concentrate | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| decreased visual acuity | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| degenerative joint disease | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| dry eye syndrome | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| esophageal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| fallen arch left foot | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| vitreous floater | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| peripheral edema | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| fracture ribs | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| adhesive capsulitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| suspected glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| hordeolum lower eyelid | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (10.0) | View |
| increased intraocular pressure | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| loss of blood sugar control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| low back bain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| low tension glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| macular scar | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| magnesium deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| nail fungus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| neovascularization of retina | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| peripheral vascular insufficiency | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| poison ivy | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| laceration right leg | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| sleep apnea | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| ankle sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| subconjunctival hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| tear film insufficiency | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| foot ulcer | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| upper respiratory infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (10.0) | View |
| visual disturbance | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| vitreous hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| worsening of hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| worsening of peripheral vascular disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| worsening of posterior capsule opacification | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| worsening of vitreoretinal traction | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| worsening of vitreous hemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |