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: 2025-12-24 @ 1:17 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT04331795
Description: None
Frequency Threshold: 0
Time Frame: 28 days
Study: NCT04331795
Study Brief: Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours. Second dose is provisioned if: 1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND 2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L 2 None 0 12 9 12 View
Group B Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours. Second dose is provisioned if: 1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND 2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L 3 None 0 20 17 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
QTC prolangulation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Type II NSTEMO SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Emisis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoschezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thick secretions SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Poor appetite SYSTEMATIC_ASSESSMENT General disorders None View
H. Pylori infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acinetobacter PNA SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
ALT elevation SYSTEMATIC_ASSESSMENT Investigations None View
AST elevation SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine elevation SYSTEMATIC_ASSESSMENT Investigations None View
BUN elevation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bilirubin elevation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Starvation ketosis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Transaminitis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right arm contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone mineral disease SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Multifocal subacute stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Worsening altered mental status SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
healthcare-associated pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aspiration event pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right soleal deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View