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 @ 11:15 PM
Ignite Modification Date: 2025-12-25 @ 8:52 PM
NCT ID: NCT00890656
Description: None
Frequency Threshold: 5
Time Frame: 7 years, 7 months
Study: NCT00890656
Study Brief: Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Augmented Hyper-CVAD Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase. None None 33 90 57 90 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenic fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Cardiac other SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Allergic reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Visual loss SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
GI hemmorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (3.0) View
Elevated liver function tests SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View