Adverse Events Module

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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:23 AM
NCT ID: NCT00367133
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00367133
Study Brief: Intravitreal Triamcinolone Acetonide Versus Laser for 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
Focal/Grid Laser Photocoagulation Standard of care group: conventional treatment consisting of focal/grid photocoagulation. None None 135 330 69 330 View
4 mg Intravitreal Triamcinolone Intravitreal injection of 4mg of triamcinolone acetonide None None 54 254 163 254 View
1mg Intravitreal Triamcinolone Intravitreal injection of 1mg of triamcinolone acetonide None None 69 256 98 256 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Allergy to arthropod bite NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (11.0) View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (11.0) View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Angioplasty NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Arteriosclerosis coronary artery NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Asbestosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Atrioventricular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Bladder transitional cell carcinoma NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Blindness NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.0) View
Blood count abnormal NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (11.0) View
Blood electrolytes decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (11.0) View
Blood glucose abnormal NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (11.0) View
Blood glucose decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (11.0) View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (11.0) View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Bronchitis viral NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Cardio-respiratory arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Carotid artery occlusion NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.0) View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (11.0) View
Cholecystitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (11.0) View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (11.0) View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (11.0) View
Colonoscopy abnormal NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (11.0) View
Colostomy closure NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Coronary arterial stent insertion NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Dementia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.0) View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (11.0) View
Diabetic coma NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (11.0) View
Dialysis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Diverticulum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Endarterectomy NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Epididymitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (11.0) View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Gastric bypass NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Gastrointestinal infection NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Gastrointestinal injury NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Generalised oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Gout NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Heart rate increased NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Heart rate irregular NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Hernia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Hypoxia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Iliac artery stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Impaired gastric emptying NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Intermittent claudication NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Kidney infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Limb operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (11.0) View
Lower gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0) View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Meniscus lesion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Mental disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.0) View
Metatarsal excision NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (11.0) View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Nephropathy toxic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Nephrotic syndrome NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Oesophageal carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (11.0) View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Ovarian cancer NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (11.0) View
Ovarian cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (11.0) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Pelvic fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Post procedural infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (11.0) View
Prostate examination abnormal NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (11.0) View
Pseudomonas infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.0) View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Renal disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Renal failure chronic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Renal transplant NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Renal vessel disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.0) View
Shunt malfunction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Skin bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Skin lesion excision NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (11.0) View
Skin ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (11.0) View
Sleep apnoea syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Spinal compression fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Stent placement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (11.0) View
Surgical vascular shunt NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (11.0) View
Toe amputation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (11.0) View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Urinary tract disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Vascular dementia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.0) View
Vertigo NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Visual acuity reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.0) View
Vitrectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (11.0) View
Volvulus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Wound infection staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Abdominal hernia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (11.0) View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (11.0) View
Compression fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Convulsion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Diabetic complications NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (11.0) View
Diabetic retinopathy NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.0) View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Haemolytic anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (11.0) View
Head injury NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Hyperparathyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (11.0) View
Knee arthroplasty NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Limb injury NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Normochromic normocytic anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (11.0) View
oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Pulse absent NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.0) View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.0) View
Tobacco abuse NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Vitreous floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anterior Chamber Cell NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract Cortical NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract Nuclear NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract Operation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract Subcapsular NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival Hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diabetic Retinopathy NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry Eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye Irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye Pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye Pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Foreign body in the eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Intraocular Pressure increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Maculopathy NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vision Blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual acuity reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual disturbance NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous Detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitrous Hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cardiac Failure Congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Dysonoea NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View