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 @ 6:54 PM
Ignite Modification Date: 2025-12-25 @ 4:27 PM
NCT ID: NCT00605657
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00605657
Study Brief: Valproic Acid (Depakote[Registered Trademark]) to Treat Autoimmune Lymphoproliferative Syndrome (ALPS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Valproic Acid valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL. None None 1 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pneumomediastinum NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders No source vocabulary View
low serum IgG SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders No source vocabulary View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fever SYSTEMATIC_ASSESSMENT General disorders No source vocabulary View
decreased platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
decreased hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
decreased neutrophil count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT General disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
rhinorrhea SYSTEMATIC_ASSESSMENT General disorders None View
elevated AST SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
elevated ALT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pruritis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
elevated alkaline phosphatase SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View