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: 2025-12-26 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
NCT ID: NCT05096312
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT05096312
Study Brief: Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zinc Gluconate Group interventions: Zinc gluconate (200g/capsule) one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days. Zinc gluconate: oral zinc gluconate 200mg Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \[Epiduo\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening 0 None 0 11 1 11 View
Placebo Group interventions: Placebo capsule, one capsule once in the morning after breakfast for 60 days. Adapalene 0.3% + benzoyl peroxide 2.5% gel to be applied once at night for 60 days. Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel \[Epiduo\]: Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening Placebo: contains cornstarch 0 None 0 12 0 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View