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: 2025-12-26 @ 12:16 PM
Ignite Modification Date: 2025-12-26 @ 12:16 PM
NCT ID: NCT00004500
Description: AEs followed until resolution or stable condition
Frequency Threshold: 5
Time Frame: 28 Days
Study: NCT00004500
Study Brief: Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
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 Lucinactant via bronchoaveolar lavage None None 23 38 36 38 View
Standard Care Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization None None 14 31 25 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bradycardia NOS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiomyopathy NOS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Acid-base balance disorder mixed SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Feeding Disorder NOS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Food intolerance NOS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Renal impariment NOS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal infarct SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Bronchopulmonary dysplasia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Meconium aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax NOS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary Haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure (exc neonatal) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypertension NOS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension NOS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Intraventricular haemorrhage NOS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pulmonary hypertension NOS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NOS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocyptopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Bradycardia NOS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiomegaly NOS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pulmonary edema NOS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia NOS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tricuspid valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Patent ductus arteriosus SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Drug withdrawn syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema NOS SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Jaundice NOS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Pneumonia NOS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis NOS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Feeding disorder NOS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycemia NOS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypertonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypotonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal impairment NOS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Atlectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchopulmonary dysplasia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax NOS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure (exc neonatal) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Procedural site reaction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Hypertension NOS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension NOS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pulmonary hypertension NOS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View