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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT04377620
Description: All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
Frequency Threshold: 5
Time Frame: Up to approximately 2 months.
Study: NCT04377620
Study Brief: Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ruxolitinib 15 mg BID Ruxolitinib 15 mg BID 42 None 23 77 35 77 View
Ruxolitinib 5 mg BID Ruxolitinib 5 mg BID 48 None 21 87 46 87 View
Placebo Placebo 36 None 11 45 21 45 View
Total Total 124 None 55 209 102 209 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Aspergillus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA 22 View
Duodenal ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Endotracheal intubation complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22 View
Fungaemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22 View
Hepatic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22 View
Pulseless electrical activity SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Streptococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Strongyloidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Torsade de pointes SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22 View