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 @ 2:12 AM
Ignite Modification Date: 2025-12-26 @ 12:40 AM
NCT ID: NCT02242760
Description: None
Frequency Threshold: 4
Time Frame: Adverse events (AEs) were collected from the time the subject signed the Informed Consent Form until the final study visit; an average of 12 weeks. Treatment emergent adverse events were those with an onset on or after the date of the first application of study medication. Adverse events noted prior to the first study drug administration that worsened after Baseline were also reported as AEs.
Study: NCT02242760
Study Brief: P2 Multi-center Study of SB204 Gel in the Treatment of 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
Vehicle Gel QD Vehicle Gel: Applied topically once daily 0 None 0 26 1 26 View
Vehicle Gel BID Vehicle Gel: Applied topically twice daily 0 None 0 29 4 29 View
SB204 2% BID SB204 2%: Applied topically twice daily 0 None 0 53 4 53 View
SB204 4% QD SB204 4%: Applied topically once daily 0 None 1 52 5 52 View
SB204 4% BID SB204 4%: Applied topically twice daily 0 None 0 51 3 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site dryness SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View