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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT01375205
Description: None
Frequency Threshold: 3
Time Frame: From the time informed consent is signed through the 24 month study follow-up telephone call.
Study: NCT01375205
Study Brief: Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cetaphil Restoraderm Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. Cetaphil Restoraderm: Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser. 0 None 2 54 30 54 View
Standard of Care Subjects will apply Johnson\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\&Johnson cleanser. Standard of Care: Subjects will apply Johnson\&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson\&Johnson cleanser. 0 None 0 46 21 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
RSV and Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Idiopathic Intracranial Hypertension SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Baby Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Viral exanthems SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Heat rash/miliaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Candidiasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diaper dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seborrheic Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bacterial Skin Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Unspecified Transient Rashes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash to Vaccination/Drug Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Irritant Contact Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticarial Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View