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 @ 4:36 AM
Ignite Modification Date: 2025-12-26 @ 3:38 AM
NCT ID: NCT01073618
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 1
Time Frame: Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment.
Study: NCT01073618
Study Brief: Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vfend Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD. None None 239 692 94 692 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA13.1 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA13.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA13.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA13.1 View
Thrombotic microangiopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA13.1 View
Thrombotic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA13.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA13.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA13.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA13.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA13.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA13.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA13.1 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA13.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA13.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA13.1 View
Neutropenic colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA13.1 View
Brain death SYSTEMATIC_ASSESSMENT General disorders MedDRA13.1 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA13.1 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA13.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA13.1 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA13.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA13.1 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA13.1 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA13.1 View
Hepatorenal failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA13.1 View
Hepatosplenomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA13.1 View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA13.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA13.1 View
Acute graft versus host disease in intestine SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA13.1 View
Acute graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA13.1 View
Graft versus host disease SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA13.1 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Brain abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Enterococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Liver abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Pneumonia primary atypical SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA13.1 View
Collapse of lung SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA13.1 View
Acoustic stimulation tests SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Blood creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Cytomegalovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA13.1 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA13.1 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA13.1 View
Acute lymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Hypopharyngeal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Leukaemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Leukaemic infiltration SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Multiple myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA13.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA13.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA13.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA13.1 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA13.1 View
Intracranial pressure increased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA13.1 View
Paraplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA13.1 View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA13.1 View
Cystitis haemorrhagic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA13.1 View
Nephropathy toxic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA13.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA13.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA13.1 View
Renal failure chronic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA13.1 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA13.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Bronchopulmonary dysplasia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Hydropneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA13.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA13.1 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA13.1 View
Euthyroid sick syndrome SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Enterococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Chemical peritonitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Mental impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Pulmonary alveolar haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA13.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA13.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA13.1 View