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 @ 7:50 PM
Ignite Modification Date: 2025-12-25 @ 5:26 PM
NCT ID: NCT00634504
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00634504
Study Brief: Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A (High-dose Methotrexate, Leucovorin, and Glucarpidase) High-dose methotrexate, leucovorin, and glucarpidase glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose None None 3 11 7 11 View
B (High-dose Methotrexate and Leucovorin Without Glucarpidase) High-dose methotrexate and leucovorin without glucarpidase high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours None None 0 9 0 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
hemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
ALT increased SYSTEMATIC_ASSESSMENT Investigations None View
AST increased SYSTEMATIC_ASSESSMENT Investigations None View
serum creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypomagnesmia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders None View
pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hypoesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View