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 @ 2:50 PM
Ignite Modification Date: 2025-12-25 @ 1:17 PM
NCT ID: NCT02539459
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT02539459
Study Brief: Sporadic Angiomyolipomas (AMLs) Growth Kinetics While on Everolimus
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 (Everolimus) Patients will take 10 mg (1 tablet) of everolimus each day for 4 months Everolimus: 10 mg tablets 0 None 3 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
flank pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
pneumonitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
heart palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Maculopapular rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Leukocyte decrease NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pruritis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Xerostomia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lymphocyte decrease NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolism + nutrional disorders - other NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT General disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Skin + subcutaneous tissue disorders - other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
limb edema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
UTI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Elevated creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neutrophil decrease NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nervous system disorders - other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pneumonitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
acneiform rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
involuntary movements NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
oral mucositis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alanine aminotransferase increase NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Aspartate aminotransferase increase NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View