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 @ 2:14 AM
Ignite Modification Date: 2025-12-26 @ 12:43 AM
NCT ID: NCT00027560
Description: None
Frequency Threshold: 5
Time Frame: Weekly during the first 3 months post transplant, every 6 weeks during months 3-6 and then 3 month intervals for 1 year post transplant
Study: NCT00027560
Study Brief: Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction. None None 3 50 43 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection with grade 3/4 neut SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Infection w.out neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Constitut symp, other SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
SGOT (AST) SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Bilirubin increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Stomatitis/BMT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Transfusion (PLT/BMT) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (2.0) View
SGPT (ALT) SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View