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
| 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 |
| 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 |
| 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 |