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 @ 10:23 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT00807235
Description: None
Frequency Threshold: 0
Time Frame: 28 days
Study: NCT00807235
Study Brief: Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature 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
Lucinactant - 3 Hour Interval Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours None None 5 11 11 11 View
Lucinactant - 1 Hour Interval Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour None None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis neonatal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Neonatal apnoeic attack SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Neonatal respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Neonatal respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary hypertension NOS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia neonatal SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Bradycardia NOS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Patent ductus arteriosus SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oedema NOS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hyperglycaemia NOS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Nasal passage irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Neonatal respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Intraventricular haemorrhage neonatal SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Gastro-oesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Jaundice neonatal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Abscess NOS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NOS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis neonatal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Acidosis NOS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia neonatal SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Metabolic acidosis NOS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Feeding problem in newborn SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Agitation neonatal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Bronchopulmonary dysplasia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypercapnia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Neonatal apnoeic attach SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Neonatal respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Neonatal hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pulmonary hypertension NOS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View