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: 2025-12-24 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT02554656
Description: The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Frequency Threshold: 2
Time Frame: 16 weeks at maximum
Study: NCT02554656
Study Brief: Vfend Special Investigation For Pediatric - Observational
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 (Voriconazole) Participants who received VFEND as indicated in the approved local product document were observed for a period of 16 weeks at maximum. The dosage can be adjusted as per physician's discretion. 6 None 11 86 41 86 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cytomegalovirus viraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pulmonary mycosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Cytokine storm NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 21.0 View
Haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Obliterative bronchiolitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Venoocclusive liver disease NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Drug-induced liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Multiple organ dysfunction syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Photophobia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Liver disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View