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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:34 AM
NCT ID: NCT02332902
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02332902
Study Brief: Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention This is a single arm intervention using Everolimus. Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL. 0 None 0 22 22 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Upper Respiratory Infection/Cough/Sinus Infection/Pneumonia/Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal (GI) Upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Folliculitis/Impetigo/Rash/Itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decreased Per Oral Intake/Weight loss NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tooth Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Erythema Nodosum NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vaginitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrush NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bladder Leakage NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pheochromocytoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ingrown Toenail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nose Bleed NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Left Side Numbness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Biopsy Infection NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Foggy Hearing NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ammenorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Ovarian Cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View