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: 2025-12-25 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT02907593
Description: Adverse Event Definition: Any untoward medical occurrence in a patient or clinical investigation in which a subject is given a pharmaceutical product; does not necessarily have a causal relationship with such treatment, or Any unfavorable and unintended sign (including abnormal laboratory findings),symptom, or disease temporally associated with the use of a medicinal (investigational) product; not necessarily related to the product.
Frequency Threshold: 0
Time Frame: Adverse event data was collected through 28 days of life.
Study: NCT02907593
Study Brief: Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.025 mg/kg Budesonide 0.025 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant 0 None 1 8 8 8 View
0.050 mg/kg Budesonide 0.050 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant 0 None 1 8 7 8 View
0.10 mg/kg Budesonide 0.10 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant 3 None 4 9 8 9 View
0.15 mg/kg Budesonide 0.15 mg/kg Budesonide in Calfactant Budesonide in Calfactant: Budesonide in Calfactant 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Severe Respiratory Decompensation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Necrotizing Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiopulmonary arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elevated blood gas SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased urine output SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Intraventricular hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Presumed formula aspiratiom SYSTEMATIC_ASSESSMENT General disorders None View
Reflux into ETT during dosing SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PDA requiring treatment SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary decompensation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Re-intubation during study SYSTEMATIC_ASSESSMENT General disorders None View
Renal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Severe hypotension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Severe respiratory decompensation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Severe pulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Uncontrolled hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View