Adverse Events Module

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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT00250432
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00250432
Study Brief: A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Caspofungin 70/50 mg Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1) None None 46 None 69 None View
Caspofungin 150 mg Caspofungin 150 mg IV daily None None 44 None 70 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Acute Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Atrioventricular Block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Atrioventricular Block Complete NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cardiac Failure Congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cardio-Respiratory Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Electromechanical Disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Gastrointestinal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Gastrointestinal Ulcer Perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Intra-Abdominal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Lower Gastrointestinal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Peritoneal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Brain Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Clostridial Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Enterococcal Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Fungaemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Fungal Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Klebsiella Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Lower Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Meningitis Aseptic NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Pneumonia Staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Pseudomonal Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Septic Shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Stenotrophomonas Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Systemic Candida NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Accidental Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.1 View
Tracheal Obstruction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.1 View
Joint Swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Adenocarcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Chronic Myeloid Leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Colon Cancer Metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Metastases To Lung NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Pituitary Cancer Metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Tumour Necrosis NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Cerebral Haematoma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Myasthenia Gravis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Partial Seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Oliguria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Renal Failure Acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Acute Pulmonary Oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Acute Respiratory Distress Syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Acute Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Hypercapnia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Lung Infiltration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pneumonia Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pulmonary Oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Respiratory Arrest NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Respiratory Disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Haemodynamic Instability NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Peripheral Vascular Disorder NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Shock Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Venous Thrombosis Limb NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Non-Cardiac Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Systemic Inflammatory Response Syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Hepatitis Toxic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Jaundice Cholestatic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Abdominal Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Cholecystitis Infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
General Physical Health Deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Multi-Organ Failure NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Ventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Oedema Peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Carbon Dioxide Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Adrenal Insufficiency NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.1 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Gastrointestinal Hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Generalised Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Hypothermia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Injection Site Erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Injection Site Phlebitis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Injection Site Swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Empyema NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Staphylococcal Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Activated Partial Thromboplastin Time Prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Albumin Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Alkaline Phosphatase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Bilirubin Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Calcium Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Calcium Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Chloride Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Creatinine Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Glucose Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Glucose Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Magnesium Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Phosphorus Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Potassium Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Potassium Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Sodium Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Sodium Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Urea Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood Uric Acid Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
White Blood Cell Count Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Confusional State NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Renal Failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Renal Failure Acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Vaginal Discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.1 View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Lung Infiltration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pulmonary Oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Tachypnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Decubitus Ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Jugular Vein Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Venous Thrombosis Limb NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View