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: 2025-12-25 @ 1:45 AM
Ignite Modification Date: 2025-12-26 @ 12:03 AM
NCT ID: NCT04120194
Description: Serious Adverse Events
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT04120194
Study Brief: Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NanoFlu NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season. 8 None 136 1333 0 1333 View
Fluzone Quadrivalent Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season. 8 None 125 1319 0 1319 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood loss anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus node dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colonic fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulum intestinal haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Duodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterocutaneous fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterovesical fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal prolapse SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Complication associated with device SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Ischaemic hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthritis infective SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infected skin ulcer SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pelvic abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Postoperative abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Renal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Streptococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cartilage injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incisional hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Multiple fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Periprosthetic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pulmonary contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic haemothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Benign ovarian tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Endometrial cancer stage I SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Follicular thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hormone receptor positive breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Leiomyosarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung carcinoma cell type unspecified stage IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal cell carcinoma recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Carotid artery disease SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intracranial aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient global amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostatomegaly SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Accelerated hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Arterial spasm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertensive urgency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):