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 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
NCT ID:
NCT01580020
Description:
The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.
Frequency Threshold:
3
Time Frame:
None
Study:
NCT01580020
Study Brief:
Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With 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 (BRVO) | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | None | None | 2 | 52 | 35 | 52 | View |
| Dexamethasone (BRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required | None | None | 3 | 40 | 28 | 40 | View |
| Ranibizumab (CRVO) | Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally | None | None | 6 | 61 | 45 | 61 | View |
| Dexamethasone (CRVO) | A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required | None | None | 1 | 22 | 16 | 22 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| GLAUCOMA (Fellow eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| GLAUCOMA (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| IRIS NEOVASCULARISATION (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| MACULAR OEDEMA (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| OCULAR ISCHAEMIC SYNDROME (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| RETINAL DETACHMENT (Study 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 |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| SQUAMOUS CELL CARCINOMA OF SKIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | View |
| LUMBAR RADICULOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| SUBSTANCE ABUSE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| PSORIASIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| FACTOR V LEIDEN MUTATION | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic 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 |
| CONJUNCTIVAL IRRITATION (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| CONJUNCTIVITIS ALLERGIC (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 PAIN (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| FOREIGN BODY SENSATION IN EYES (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| GLAUCOMA (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 |
| MACULAR OEDEMA (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| OCULAR DISCOMFORT (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| OCULAR HYPERAEMIA (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| PHOTOPSIA (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| RETINAL EXUDATES (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| RETINAL ISCHAEMIA (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| RETINAL OEDEMA (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| VISION BLURRED (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| VISUAL ACUITY REDUCED (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| VISUAL IMPAIRMENT (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| VITREOUS DETACHMENT (Fellow eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| VITREOUS DETACHMENT (Study eye) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| CHEST DISCOMFORT | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| CONJUNCTIVITIS (Study eye) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| GASTROINTESTINAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| PERIODONTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| MUSCLE STRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| POST PROCEDURAL SWELLING (Study eye) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| INTRAOCULAR PRESSURE DECREASED (Study eye) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| INTRAOCULAR PRESSURE INCREASED (Study eye) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| VITAMIN D DEFICIENCY | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| SJOGREN'S SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| SCIATICA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| TRIGEMINAL NEURALGIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |