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 @ 12:34 AM
Ignite Modification Date: 2025-12-25 @ 10:42 PM
NCT ID: NCT04494867
Description: None
Frequency Threshold: 0
Time Frame: Until 30 days post randomization or until hospital discharge
Study: NCT04494867
Study Brief: Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Core Warming Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. 2 None 1 9 9 9 View
Standard of Care Patients who received standard temperature management and treatment Standard of Care: Standard temperature management and treatment 4 None 2 10 9 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
MSSA Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stenotrophomonas maltophilia pneumonia and bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Worsening of bilateral upper/lower extremity weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Endocrine disorders None View
tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
elevated D-dimer SYSTEMATIC_ASSESSMENT Immune system disorders None View
delirium SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
elevated liver function tests SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
adrenal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
E. coli pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pseudomonas aeruginosa pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
tracheobronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
E. coli bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
azotemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
mild respiratory alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
heparin-induced thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
possible herpes stomatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
hyperammonia cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
toxic metabolic encephalopathy SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
low phosphorous level SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
femoral DVT SYSTEMATIC_ASSESSMENT Vascular disorders None View
Klebsiella pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
head tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
tracheobronchomalacia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
elevated PTT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
elevated BUN SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
tinea corpus under pannus SYSTEMATIC_ASSESSMENT Infections and infestations None View
anasarca SYSTEMATIC_ASSESSMENT Vascular disorders None View
epistaxis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
acute encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
elevated CA-125 tumor marker SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
elevated carcino-embyonic antigen SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
acute tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
duodenal ulcers SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
tongue deviation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
premature atrial contractions SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
penile skin yeast infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
elevated procalcitonin SYSTEMATIC_ASSESSMENT Immune system disorders None View
PTH intact SYSTEMATIC_ASSESSMENT Endocrine disorders None View
septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
supraglottic edema SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
dysphagia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
stammering SYSTEMATIC_ASSESSMENT Nervous system disorders None View
stool positive for occult blood SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
toxic vacuoles SYSTEMATIC_ASSESSMENT Immune system disorders None View
elevated troponin SYSTEMATIC_ASSESSMENT Cardiac disorders None View
elevated eosinophils SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leukocytosis SYSTEMATIC_ASSESSMENT Immune system disorders None View
enterobacter penumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
elevated RDW SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
bacterial superinfection SYSTEMATIC_ASSESSMENT Infections and infestations None View
tracheostomy leak SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
tracheostomy wound infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View