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 @ 2:05 AM
Ignite Modification Date: 2025-12-26 @ 12:30 AM
NCT ID: NCT01831960
Description: Any treatment emergent AEs ongoing at the end of the treatment period (Day 14) were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
Frequency Threshold: 0
Time Frame: 14 Days
Study: NCT01831960
Study Brief: An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cortexolone 17α-Propionate (Cohort 2) Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours. 0 None 0 22 3 22 View
Cortexolone 17α-Propionate (Cohort 1) Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours. 0 None 0 20 5 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Application site folliculitis SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
ACTH stimulation test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View