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 @ 4:07 AM
Ignite Modification Date: 2025-12-26 @ 3:04 AM
NCT ID: NCT02019420
Description: All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
Frequency Threshold: 5
Time Frame: Up to 32 days
Study: NCT02019420
Study Brief: Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tedizolid Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia. 101 None 129 357 176 357 View
Linezolid Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia. 103 None 149 361 175 361 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiovascular insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Pyloric stenosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 21.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Glossoptosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Meningitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia acinetobacter SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Toxic shock syndrome SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Brain herniation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Endotracheal intubation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Gastrointestinal stoma complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Splenic rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Tracheostomy malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Propofol infusion syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Cerebellopontine angle tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Chronic myelomonocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Amyotrophic lateral sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Autonomic nervous system imbalance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Benign enlargement of the subarachnoid spaces SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Brain hypoxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Brain injury SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cerebral vasoconstriction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Cholinergic syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Generalised tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hypoxic-ischaemic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Intracranial pressure increased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Intraventricular haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Myasthenia gravis crisis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Ruptured cerebral aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Stroke in evolution SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Laryngospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Organising pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pharyngeal haematoma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pleural thickening SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary alveolar haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Respiratory tract haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Penile ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Extremity necrosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Haemodynamic instability SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Neurogenic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Oesophageal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Pancreatic necrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Pneumatosis intestinalis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Brain death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Acute hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Acinetobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Brain abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
CNS ventriculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Endotoxaemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Endotoxic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Enterobacter pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Fungaemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Intervertebral discitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Pulseless electrical activity SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Intra-abdominal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Mallory-Weiss syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View