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: 2025-12-26 @ 10:56 AM
Ignite Modification Date: 2025-12-26 @ 10:56 AM
NCT ID: NCT04331808
Description: Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
Frequency Threshold: 0
Time Frame: Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Study: NCT04331808
Study Brief: CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TOCILIZUMAB -- Severe COVID Population (WHO-CPS =5) Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg) 7 None 20 63 0 0 View
Standard of Care -- Severe COVID Population (WHO-CPS =5) Usual care was provided at the discretion of the clinicians 11 None 29 67 0 0 View
TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5) Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg) 12 None 31 49 0 0 View
Standard of Care -- Critical COVID Population (WHO-CPS >5) Usual care was provided at the discretion of the clinicians 13 None 27 43 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia SYSTEMATIC_ASSESSMENT General disorders None View
Hyperlipasemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic cytolysis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Multiple organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyperkaliemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Arterial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tetraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ischemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypovolemic shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Severe acute pancreatis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperleukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arterial hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Guillain Barré syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Limb ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tracheotomy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Psoas hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):