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: 2025-12-24 @ 10:03 PM
Ignite Modification Date: 2025-12-25 @ 7:39 PM
NCT ID: NCT00427635
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00427635
Study Brief: Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Esomeprazole Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. None None 0 6 6 6 View
Placebo Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. None None 3 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bradycardia Neonatal SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cyanosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Inappropriate Device Signal Detection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Infantile Apnoeic Attack SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia Neonatal SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Cyanosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Deafness Neurosensory SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Retinopathy Of Prematurity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Neonatal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Urinary Tract Infection Neonatal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Oxygen Saturation Decreased SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View