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 @ 5:18 PM
Ignite Modification Date: 2025-12-25 @ 2:55 PM
NCT ID: NCT01808950
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01808950
Study Brief: Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.06% Resiquimod Gel - A * 60 mg gel * Once daily prior to normal sleeping hours * 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation 0.06% Resiquimod Gel - A None None 0 1 1 1 View
0.06% Resiquimod Gel - B * 100 mg gel * Once daily prior to normal sleeping hours * 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation 0.06% Resiquimod Gel - B None None 1 3 1 3 View
0.06% Resiquimod Gel - C * 100 mg gel * Once daily prior to normal sleeping hours * 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation * The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed 0.06% Resiquimod Gel - C None None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mutlilocular BCC right had Prox. NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nodular BCC arm left NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
superficial BCC submammary NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
exertional dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cornu cutaneum NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View