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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:54 AM
NCT ID: NCT01778634
Description: None
Frequency Threshold: 0
Time Frame: 3 years 6 months
Study: NCT01778634
Study Brief: Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm 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
Placebo (5% Dextrose) Placebo Placebo: D5W 10 ml/kg every 24 h x 3 days 6 None 39 61 51 61 View
Azithromycin Azithromycin intravenous (2 mg/ml) 20 mg/kg every 24h x 3 days Azithromycin: Azithromycin intravenous 20 mg/kg every 24 h x 3 days 5 None 44 60 51 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Patent Ductus Arteriosus SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Necrotizing enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileal stricture SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Retinopathy of prematurity SYSTEMATIC_ASSESSMENT Eye disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
White blood cell count >40,000 cells/mm3 SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood Urea Nitrogen > 60 mg/dL SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypochloremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
IV site reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric residual >50% volume of feed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loose stools SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abnormal liver function test SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
conjugated hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Elevated serum creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolic alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated Blood Urea Nitrogen SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View