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 @ 12:38 AM
Ignite Modification Date: 2025-12-25 @ 10:48 PM
NCT ID: NCT02326467
Description: All subjects were monitored for adverse events including skin reactions, anemia and significant changes to baseline lab values.
Frequency Threshold: 0
Time Frame: The adverse event data collection period for enrolled subjects were collected up to a maximum of 40 days.
Study: NCT02326467
Study Brief: Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chlorhexidine Gluconate Bath All subjects received a bath twice a week with 2% CHG bathing cloths. The baths were followed by blood sampling for CHG levels prior to initiation of baths and every Friday for the duration of study participation. The study team monitored the infant's skin for evidence of untoward lesions prior to the first bath and every 12 hours during the course of the study. CHG blood levels were monitored for associated adverse events and accumulation. Chlorhexidine gluconate: Bi-weekly chlorhexidine baths 0 None 0 9 2 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View