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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT02366312
Description: None
Frequency Threshold: 0
Time Frame: Up to three years
Study: NCT02366312
Study Brief: A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NBCCS-associated KCOT Nevoid Basal Cell Carcinoma Syndrome (NBCCS)-associated Keratocystic Odontogenic Tumor (KCOT) Group 0 None 0 1 1 1 View
Sporadic KCOT Sporadic Keratocystic Odontogenic Tumor (KCOT) Group 0 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
High grade Newuorendocrine Carcinoma of head/neck SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Earache SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT General disorders None View
Cramping NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
spasm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Spasm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hair loss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Facial numbness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Leg Cramp NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest Discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cold symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
GI upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Loss of taste NON_SYSTEMATIC_ASSESSMENT General disorders None View
Toes cramping NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Loose stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
lower extremity pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right facial pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left sided muscle ache NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sacral injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasopharyn lesion NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
bilateral lower extremities swelling NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View