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 @ 2:23 PM
Ignite Modification Date:
2025-12-25 @ 12:59 PM
NCT ID:
NCT02074059
Description:
None
Frequency Threshold:
0
Time Frame:
From enrollment to 36 weeks post-menstrual age (PMA). As infants are enrolled at a gestational age of 29 to 34 weeks PMA, this represents a period of 2 to 7 weeks.
Study:
NCT02074059
Study Brief:
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature 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 |
|---|---|---|---|---|---|---|---|---|
| Aerolized Lucinactant (25 mg/kg) | 25 mg TPL/kg of Lucinactant for inhalation with nCPAP | None | None | 2 | 8 | 8 | 8 | View |
| Aerosolized Lucinactant (50 mg/kg) | 50 mg TPL/kg of Lucinactant for inhalation with nCPAP | None | None | 3 | 8 | 8 | 8 | View |
| Aerosolized Lucinactant (75 mg/kg) | 75 mg TPL/kg of Lucinactant for inhalation with nCPAP | None | None | 2 | 8 | 8 | 8 | View |
| Aerosolized Lucinactant (100 mg/kg) | 100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met | None | None | 3 | 8 | 7 | 8 | View |
| Aerosolized Lucinactant (150 mg/kg) | 150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met | None | None | 3 | 8 | 8 | 8 | View |
| nCPAP Alone | nCPAP therapy alone | None | None | 7 | 40 | 37 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Necrotising Enterocolitis Neonatal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Cadio-respiratory Arrest | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Apnoea Neonatal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pneumomediastinum | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Pulmonary Haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Cardio-respiratory Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Anaemia Neonatal | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Acrochordon | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Alveolar Lung Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Apnoea Neonatal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Atrial Septal Defect | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (16.1) | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Blood Thyroid Stimulating Hormone Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Blood Urea Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Blood Urea Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Bradypnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Bronchopulmonary Dysplasia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | View |
| C-reactive Protein Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Candida Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Cardiac Murmur | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Catheter Site Infection | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Cephalhaematoma | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | View |
| CNS Ventriculitis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Congenital Choroid Plexus Cyst | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| Congenital Naevus | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (16.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Cyst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Dermatitis Diaper | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Enteral Feeding Intolerance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Erythema of Eyelid | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Gastrooesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Hiatus Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Hydrocele | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (16.1) | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypercapnia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Hyperchloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypermagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypernatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hyperphosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypocapnia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Hypochloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypoproteinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Hypothermia Neonatal | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Infantile Spasms | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Infusion Site Extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Infusion Site Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Intraventricular Haemorrhage Neonatal | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | View |
| Jaundice Neonatal | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | View |
| Laryngospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Metabolic Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Mitral Valve Incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Nasal Inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Neonatal Respiratory Distress Syndrome | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | View |
| Neonatal Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Oedema Genital | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (16.1) | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| Oxygen Saturation Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Patent Ductus Arteriosus | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (16.1) | View |
| Pectus Excavatum | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (16.1) | View |
| Pericardial Effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Periorbital Oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.1) | View |
| Persistent Foetal Circulation | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Poor Peripheral Circulation | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| Pulmonary Artery Stenosis Congenital | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (16.1) | View |
| Pulmonary Hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pulmonary Interstitial Emphysema Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pulmonary Oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pulmonary Pneumatocele | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Retinal Anomaly Congenital | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (16.1) | View |
| Right Ventricular Systolic Pressure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Sepsis Neonatal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Supraventricular Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Talipes | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (16.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Transient Tachypnoea of the Newborn | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (16.1) | View |
| Tricuspid Valve Incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Umbilical Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Umbilical Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Ventricular Septal Defect | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (16.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |