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 @ 3:55 AM
Ignite Modification Date: 2025-12-26 @ 2:46 AM
NCT ID: NCT02160002
Description: Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.
Frequency Threshold: 0
Time Frame: Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure.
Study: NCT02160002
Study Brief: Incubator Weaning of Moderately Preterm 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
Lower Weight (1600 Grams) Weaning from an incubator at a lower weight (1600 grams) 0 None 1 187 19 187 View
Higher Weight (1800 Grams) Weaning from an incubator at a higher weight (1800 grams) 0 None 0 179 7 179 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Desaturations SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Moderate cold stress SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Severe cold stress SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Feeding Intolerance SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NEC IIa SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tachycardia with desaturations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increasing heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View