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 @ 9:42 PM
Ignite Modification Date: 2025-12-25 @ 7:23 PM
NCT ID: NCT02672332
Description: Adverse events were collected for all subjects who were randomized and received at least one dose of study medication. Two subjects who were randomized to the Vehicle group received SB204 and per the definition of the Safety Population in the Statistical Analysis Plan, these subjects were analyzed in the SB204 group. Therefore, 654 subjects were in the SB204 group and 652 subjects were in the Vehicle group for analyses of all cause mortality, adverse events and serious adverse events.
Frequency Threshold: 1
Time Frame: Adverse events were collected after the subject signed the informed consent and completed any study assessment until the end of the final study visit, approximately 12 weeks for most subjects.
Study: NCT02672332
Study Brief: P3 Study in Acne Comparing Once Daily SB204 and Vehicle
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SB204 4% SB204 4% topically once daily 0 None 0 654 66 654 View
Vehicle Gel Vehicle Gel (placebo comparator) topically once daily 1 None 4 652 10 652 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Bulimia nervosa SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Application site dryness SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View