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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:29 AM
NCT ID: NCT04937920
Description: AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.
Frequency Threshold: 0
Time Frame: Day 14 (Visit 6) from the baseline Day 1 (Visit 1)
Study: NCT04937920
Study Brief: A Trial to Evaluate the Safety and Antimicrobial Efficacy of DBI-002 Probiotic in Adults With Tinea Versicolor
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 3EXT Aqueous Gel High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 4 0 4 View
Cohort 3EXT Probiotic Gel High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 4 0 4 View
Cohort 1 Probiotic Gel Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 6 0 6 View
Cohort 1 Aqueous Gel Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 6 0 6 View
Cohort 2 Probiotic Gel Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 6 0 6 View
Cohort 2 Aqueous Gel Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 6 0 6 View
Cohort 3 Aqueous Gel High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 6 0 6 View
Cohort 3 Probiotic Gel High dose 10\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 6 0 6 View
Cohort 1EXT Aqueous Gel Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 4 0 4 View
Cohort 1EXT Probiotic Gel Low dose 10\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 4 1 4 View
Cohort 2EXT Aqueous Gel Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 4 0 4 View
Cohort 2EXT Probiotic Gel Medium dose 10\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Single treatment dose OR Once-daily application for 5 consecutive days 0 None 0 4 0 4 View
Cohort 4 Aqueous Vehicle gel vs. aqueous (CMC) gel Once-daily application for 5 consecutive days 0 None 0 4 0 4 View
Cohort 4 Probiotic Vehicle gel vs. aqueous (CMC) gel Once-daily application for 5 consecutive days 0 None 0 4 0 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View