Adverse Events Module

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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 @ 3:43 PM
Ignite Modification Date: 2025-12-25 @ 1:51 PM
NCT ID: NCT00540592
Description: For the systematically assessed other (non-serious) adverse events,the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Frequency Threshold: 5
Time Frame: Serious adverse events were assessed from day 0 to day 20 and day 21 to day 179. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
Study: NCT00540592
Study Brief: Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Influenza Vaccine GSK576389A Formulation 1 Group Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A. None None 18 204 107 204 View
Influenza Vaccine GSK576389A Formulation 3 Group Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A. None None 5 202 150 202 View
Influenza Vaccine GSK576389A Formulation 4 Group Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A. None None 8 202 121 202 View
Influenza Vaccine GSK576389A Formulation 5 Group Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A. None None 9 199 138 199 View
Influenza Vaccine GSK576389A Formulation 6 Group Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A. None None 10 198 158 198 View
Influenza Vaccine GSK576389A Formulation 8 Group Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A. None None 19 199 155 199 View
Fluarix Elderly Group Subjects aged ≥65 years received one dose of Fluarix vaccine. None None 15 200 74 200 View
Fluarix Young Group Subjects aged 18-40 years received one dose of Fluarix vaccine. None None 3 203 133 203 View
Influenza Vaccine GSK576389A Formulation 2 Group Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A. None None 9 202 129 202 View
Influenza Vaccine GSK576389A Formulation 7 Group Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A. None None 16 198 134 198 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bile duct stone NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bladder cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Facial bones fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gastric ulcer haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Goitre NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ischaemic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Multiple myeloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pancreatic neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Post procedural infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peripheral arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Left ventricular failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Uterine cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Wrist fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Abdominal adhesions NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrioventricular block first degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Benign salivary gland neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Bifascicular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Biliary colic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bleeding varicose vein NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cervical vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cholecystitis chronic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Chronic myeloid leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chronic myelomonocytic leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Clavicle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Emphysema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gangrene NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis norovirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Herpes Zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertensive cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypovolaemic shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Incisional hernia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Jaw fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Metastases to central nervous system NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Multiple fractures NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nasal septum deviation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neuritis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Osteoporotic fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Panic attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pelvic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Postmenopausal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Prostate cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostatic adenoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Reversible ischaemic neurological deficit NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sick sinus syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Staphylococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope vasovagal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thyroid neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ulcerative keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Varicose vein NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vestibular disorder NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vestibular neuronitis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Shivering SYSTEMATIC_ASSESSMENT General disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Redness SYSTEMATIC_ASSESSMENT General disorders None View