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 @ 4:55 PM
Ignite Modification Date: 2025-12-25 @ 2:38 PM
NCT ID: NCT00450450
Description: Group 2 enrollment total is 14, patient 774353 enrolled on study, but was not randomized and didn't contribute any data. Group 2 AE total is 13.
Frequency Threshold: 0
Time Frame: None
Study: NCT00450450
Study Brief: Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control BM Arm Conventional bone marrow transplant (BM) None None 1 13 8 13 View
Experimental G-BM Arm G-CSF (filgrastim) stimulated bone marrow (G-BM) None None 0 13 7 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Pneumothorax None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders None View
Anemia None Blood and lymphatic system disorders None View
Anorexia None Metabolism and nutrition disorders None View
Autoimmune disorder None Immune system disorders None View
Bladder infection None Infections and infestations None View
Blood bilirubin increased None Investigations None View
Death NOS None General disorders None View
Edema face None General disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Hematuria None Renal and urinary disorders None View
Hepatobiliary disorders - Other, specify None Hepatobiliary disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Infections and infestations - Other, specify None Infections and infestations None View
Lung infection None Infections and infestations None View
Lymphocyte count decreased None Investigations None View
Mucositis oral None Gastrointestinal disorders None View
Multi-organ failure None General disorders None View
Nausea None Gastrointestinal disorders None View
Neutrophil count decreased None Investigations None View
Oral pain None Gastrointestinal disorders None View
Peripheral nerve infection None Infections and infestations None View
Pharyngitis None Infections and infestations None View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders None View
Platelet count decreased None Investigations None View
Rectal mucositis None Gastrointestinal disorders None View
Renal and urinary disorders - Other, specify None Renal and urinary disorders None View
Skin infection None Infections and infestations None View
White blood cell decreased None Investigations None View