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 @ 6:45 PM
Ignite Modification Date: 2025-12-25 @ 4:16 PM
NCT ID: NCT04412057
Description: None
Frequency Threshold: 5
Time Frame: All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Study: NCT04412057
Study Brief: Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CERC-002 CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg. 4 None 8 40 10 40 View
Placebo Placebo: Administered once subcutaneously 9 None 12 42 6 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ventricular Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 23.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.0 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Pneumomediastinum NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 23.0 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Pulseless electrical activity NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Adverse event NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 23.0 View
COVID-19 pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 23.0 View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 23.0 View
Hepatic Enzyme Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 23.0 View