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 @ 2:38 PM
Ignite Modification Date: 2025-12-26 @ 2:38 PM
NCT ID: NCT00189306
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Study: NCT00189306
Study Brief: Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aldara Aldara (imiquimod) cream 5% None None 23 169 130 169 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Embolism pulmonary SYSTEMATIC_ASSESSMENT Vascular disorders WHOART View
Non-hodgkins lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHOART View
Excision BCC R forehead SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHOART View
Pulmonary carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHOART View
Bleeding post colonoscopy SYSTEMATIC_ASSESSMENT Surgical and medical procedures WHOART View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Vascular disorders WHOART View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders WHOART View
Cholecyctitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WHOART View
Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHOART View
Breast neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHOART View
Colon carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHOART View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHOART View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT General disorders WHOART View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders WHOART View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders WHOART View
Bladder carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHOART View
Prostatic disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders WHOART View
Acute renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders WHOART View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders WHOART View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHOART View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders WHOART View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders WHOART View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) WHOART View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders WHOART View
Chest pain SYSTEMATIC_ASSESSMENT General disorders WHOART View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHOART View
Chronic renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders WHOART View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WHOART View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders WHOART View
Pain SYSTEMATIC_ASSESSMENT General disorders WHOART View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHOART View