Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:36 AM
Ignite Modification Date: 2025-12-26 @ 1:13 AM
NCT ID: NCT03767634
Description: None
Frequency Threshold: 0
Time Frame: Project A: Adverse event data was not collected in this epidemiological study Project B: Adverse event data collected from birth until discharge home from hospital, assessed up to 1 year of age
Study: NCT03767634
Study Brief: Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Neonatal Population (Project A) Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England and Wales). 5725 None 0 62145 0 62145 View
No PN Use (Project B) All neonates born between 30 and 33 weeks postmenstrual age in England and Wales and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who did not receive any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days. 163 None 0 8146 0 8146 View
PN Use (Project B) All neonates born between 30 and 33 weeks postmenstrual age in England and Wales and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who received any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days. Parenteral nutrition: Parenteral nutrition is the administration of an intravenous solution containing amino acids (with or without lipids) to provide nutritional support. 90 None 0 8146 0 8146 View
Serious Events(If Any):
Other Events(If Any):