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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT05200403
Description: None
Frequency Threshold: 0
Time Frame: 3 weeks
Study: NCT05200403
Study Brief: Improvement In Scratch Behavior And Sleep In Patients With 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
Caregiver Caregivers of Child Participants; caregivers did not receive treatment with crisaborole or vehicle. 0 None 0 36 0 36 View
Crisaborole 2% Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks. Crisaborole 2%: The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks. Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment. Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires. 0 None 0 21 1 21 View
Vehicle Arm Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks. Vehicle treatment: The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment). Accelerometry device for children: Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment. Accelerometry device for adult caregivers: Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires. 0 None 0 15 0 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Overall Study SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View