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 @ 11:34 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT01530256
Description: None
Frequency Threshold: 0
Time Frame: Up to death or termination of study (approximately 139 days).
Study: NCT01530256
Study Brief: Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ALD518 ALD518: 160 mg IV q 4 weeks for 4 doses 2 None 3 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders None View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
International normalized ratio increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cytomegalovirus viraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations None View
Oedema peripheral SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Gastric haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View