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 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:29 AM
NCT ID: NCT01231620
Description: Safety population was used to assess adverse events.
Frequency Threshold: 5
Time Frame: From the start of study drug until follow-up (up to 42 days).
Study: NCT01231620
Study Brief: A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intravenous (IV) Zanamivir 300mg Twice Daily 300mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily 15 None 38 201 17 201 View
Intravenous (IV) Zanamivir 600mg Twice Daily 600mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily 15 None 33 209 26 209 View
Oral Oseltamivir 75mg Twice Daily 75mg oral oseltamivir twice daily plus intravenous placebo zanamivir twice daily 11 None 38 205 24 205 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Distributive shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Mechanical ventilation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 18.0 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Anti-neutrophil cytoplasmic antibody SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Delirium febrile SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Endotracheal intubation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Tracheostomy malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
ECG signs of ventricular hypertrophy SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Chronic obstructive pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Intraventricular haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Neuromyopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
IgA nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Gouty arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia necrotising SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Vestibular neuronitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Disseminated intravascular SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Respiratory disorderv SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View