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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT01108094
Description: All patients treated with itraconazole were monitored for adverse events ≥ Grade 2. Only adverse events (AEs) grade 2 or greater were collected and reported.
Frequency Threshold: 5
Time Frame: 2.3 months (average)
Study: NCT01108094
Study Brief: Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A1 - Itraconazole 400 mg +/- Prior Vismodegib Oral itraconazole 400 mg as 200 mg twice daily, for 1 month. 0 None 1 12 1 12 View
Cohort A2 - Itraconazole 400 mg (Prior Vismodegib) Oral itraconazole 400 mg as 200 mg twice daily, for 1 month. 0 None 0 3 0 3 View
Cohort B - Itraconazole 200 mg (Vismodegib-naïve) Oral itraconazole 200 mg as 100 mg twice daily, for up to 3 months treatment. All Cohort B participants were vismodegib-naïve. 0 None 0 4 0 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Grade 2 Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View