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 @ 2:22 PM
Ignite Modification Date: 2025-12-25 @ 12:58 PM
NCT ID: NCT03260595
Description: None
Frequency Threshold: 0
Time Frame: Baseline up to Day 29 for Cohort 1 and Day 36 for Cohort 2
Study: NCT03260595
Study Brief: A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis
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 2: Vehicle Vehicle matched to Crisaborole ointment 2% was applied topically to the treatable %BSA (defined as percent of a participant's total BSA that AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. 0 None 0 2 2 2 View
Cohort 1: Crisaborole Ointment 2% and Vehicle Crisaborole ointment 2% and matching vehicle was applied topically to 2 randomly assigned, adjacent sites on the skin area field at infrascapular area of the back respectively within each healthy participant under occlusive patch condition on Day 1. Ointment and vehicle were remained under occlusion for 48 hours. Target sites were identified at Baseline (Day 1) by investigator. 0 None 0 20 0 20 View
Cohort 2: Crisaborole Ointment 2% Crisaborole ointment 2% was applied topically to the treatable percent body surface area (%BSA: defined as percent of a participant's total BSA that is AD-involved and is not on the scalp or in designated venous access areas) of participants with AD twice daily from Days 2 to 7 and once only on Days 1 and 8. Treatable %BSA was calculated at Baseline (Day 1) by investigator. 0 None 0 10 9 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eyelid oedema NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v20.1 View
Application site coldness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.1 View
Application site irritation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.1 View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.1 View
Application site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v20.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v20.1 View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v20.1 View