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 @ 4:54 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT01241318
Description: Umbilical cord was observed by the field data collector at every visit (day 1, 4, 10, 28 post-partum). Adverse events were defined as ocular exposure to chlorhexidine, local skin irritation, accidental ingestion, contact dermatitis, or anaphylaxis.
Frequency Threshold: 0
Time Frame: Adverse event data were collected during the 1 month follow up period past delivery.
Study: NCT01241318
Study Brief: Zambia Chlorhexidine Application Trial
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 Cord Care Mothers located in health facility catchment areas assigned to this arm will apply chlorhexidine to their infants daily until three days after the cord completely separates. Chlorhexidine gluconate (4%): Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body. 282 None 0 18510 9 18510 View
Dry Cord Care Mothers in health facility catchment areas assigned to this arm will use dry cord care - keeping their babies' umbilical stumps clean and dry - as per normal routine standard of care and in accordance with Zambia Ministry of Health policy. Dry cord care: Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump. 263 None 0 19346 0 19346 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chlorhexidine-related adverse events SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chlorhexidine ocular exposure NON_SYSTEMATIC_ASSESSMENT Eye disorders None View