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 @ 5:20 PM
Ignite Modification Date: 2025-12-25 @ 2:56 PM
NCT ID: NCT01529450
Description: Participants with evaluable data are included for Adverse Events
Frequency Threshold: 5
Time Frame: None
Study: NCT01529450
Study Brief: Pilot LDE225 in Locally Advanced or Metastatic BCC + Previously Tx Non-LDE225 Smoothened Inhibitors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Refractory Group Patients previously treated with non-LDE225 Smo inhibitor who were refractory. LDE225: 800-mg (4 200-mg capsules/day) capsule None None 0 3 3 3 View
Resistance Developed Group Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease. LDE225: 800-mg (4 200-mg capsules/day) capsule None None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Altered mental status NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.3) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.3) View
ear canal stenosis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.3) View
ear drainage SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.3) View
hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.3) View
appetite decrease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.3) View
dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.3) View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.3) View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.3) View
vomit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.3) View
weight loss SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.3) View
ecchymosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.3) View
laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.3) View
elevated creatine kinase SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.3) View
hip fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.3) View
restless arms and legs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.3) View
rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.3) View
neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.3) View
altered mental status SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.3) View
migraine SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.3) View
somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.3) View
agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.3) View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.3) View
taste disturbance SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.3) View
candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.3) View
muscle cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.3) View