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 @ 5:05 PM
Ignite Modification Date:
2025-12-25 @ 2:44 PM
NCT ID:
NCT01027650
Description:
Adverse events (AEs) and serious adverse events (SAEs) are reported by treatment group assigned during Stage 1 and Stage 2. The Safety Population consisted of all patients who received the study treatment, and was used to assess AEs and SAEs.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01027650
Study Brief:
Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (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 |
|---|---|---|---|---|---|---|---|---|
| Stage 2 Arm 2 | AGN208397 intravitreal injection 450 ug on Day 1. | None | None | 4 | 26 | 26 | 26 | View |
| Stage 2 Arm 3 | AGN208397 intravitreal injection 300 ug on Day 1. | None | None | 2 | 25 | 25 | 25 | View |
| Stage 2 Arm 4 | Dexamethasone 700 ug intravitreal implant on Day 1. | None | None | 3 | 24 | 24 | 24 | View |
| Stage 1 Cohort 4 | AGN208397 intravitreal injection 900 ug on Day 1. | None | None | 1 | 6 | 6 | 6 | View |
| Stage 1 Cohort 3 | AGN208397 intravitreal injection 600 ug on Day 1. | None | None | 0 | 6 | 6 | 6 | View |
| Stage 1 Cohort 2 | AGN208397 intravitreal injection 300 ug on Day 1. | None | None | 1 | 6 | 6 | 6 | View |
| Stage 1 Cohort 1 | AGN208397 intravitreal injection 75 ug on Day 1. | None | None | 0 | 3 | 3 | 3 | View |
| Stage 2 Arm 1 | AGN208397 intravitreal injection 600 ug on Day 1. | None | None | 4 | 25 | 25 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ankle Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 15.1 | View |
| Gastric Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Benign Prostatic Hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.1 | View |
| Exostosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Facet Joint Syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Pseudoendophthalmitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Atrioventricular Block Second Degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.1 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Myocardial Ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Vasculitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Glioblastoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Basal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood Glucose Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Protein Urine Present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Eye Pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 15.1 | View |
| Macular Fibrosis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Ocular Hypertension | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Cystoid Macular Oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Eye Pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Medication Residue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Intraocular Pressure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Conjunctival Haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Retinal Haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Blood Urea Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Vitreous Floaters | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 15.1 | View |
| Arteriosclerotic Retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Eye Swelling | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Glioblastoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Mean Cell Haemoglobin Concentration Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Upper Respiratory Tract Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Upper Respiratory Tract Infection Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Vulvovaginal Pruritus | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.1 | View |
| Visual Acuity Reduced | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Vitreous Detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Cataract subcapsular | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Foreign Body Sensation in Eyes | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Macular Oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Photophobia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| White Blood Cells Urine Positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.1 | View |
| Blood Bilirubin Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Blood Pressure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Conjunctival Hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Conjunctival Oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Dermatitis Contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Eye Naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Facial Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Gamma-Glutamyltransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 15.1 | View |
| Iris Adhesions | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Iris Neovascularisation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 15.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Optic Nerve Infarction | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Polydipsia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 15.1 | View |
| Posterior Capsule Opacification | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Retinal Aneurysm | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Retinal Neovascularisation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Seasonal Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 15.1 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 15.1 | View |
| Vitreous Opacities | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Weight Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Vision Blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Animal bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 15.1 | View |
| Basal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Blood Triglycerides Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Diabetic Retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Dry Eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Macular Cyst | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Macular Degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Nitrite Urine Present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Retinal Exudates | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Suicidal Ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 15.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 15.1 | View |
| Urine Leukocyte Esterase Positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Benign Prostatic Hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 15.1 | View |
| Blepharal Papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | View |
| Cataract Nuclear | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Localised Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Pterygium | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Retinal pigment epitheliopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Retinal Vein Occlusion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 15.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 15.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Exostosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 15.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Blood Cholesterol Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 15.1 | View |
| Optic Disc Haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Vulvovaginal Mycotic Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 15.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | View |
| Anterior Chamber Cell | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Anterior Chamber Angle Neovascularisation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Anterior Chamber Flare | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Anterior Chamber Inflammation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |
| Lenticular Opacities | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 15.1 | View |