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 @ 2:50 AM
Ignite Modification Date: 2025-12-26 @ 1:31 AM
NCT ID: NCT03138733
Description: All AEs were defined as treatment-emergent AEs (TEAEs), i.e., occurring from the start of first dosing up to and including the scheduled PTE visit, and were considered for the analysis purpose.
Frequency Threshold: 5
Time Frame: All AEs occurring from the start of first dosing up to and including the scheduled PTE visit on Day 70 (± 5 days) were collected.
Study: NCT03138733
Study Brief: Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ceftobiprole Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril) Ceftobiprole: Ceftobiprole 500 mg as a 2 h infusion 17 None 36 191 61 191 View
Daptomycin Daptomycin 6 mg/kg, with or without aztreonam Daptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam 18 None 45 198 45 198 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wound healing normal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrial thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Intracardiac mass SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Hypocoagulable state SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Generalised tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hypoglycaemic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Eosinophilic pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Eosinophilic pneumonia acute SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Intra-abdominal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Oesophageal varices haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Pancreatic haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Pancreatitis necrotising SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Retroperitoneal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Renal haematoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Cutaneous vasculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Pemphigoid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Candida sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Endocarditis staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Escherichia bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Lung abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Mediastinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Muscle abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Psoas abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Purulent pericarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Septic necrosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Skin bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Superinfection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Kidney rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Chloroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Leg amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Extremity necrosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Haematoma infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Intervertebral discitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Arteriovenous fistula thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Haemodialysis complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View