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 @ 5:49 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT04412668
Description: Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
Frequency Threshold: 0
Time Frame: Baseline up to Day 60
Study: NCT04412668
Study Brief: Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Efzofitimod 1 mg/kg Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1. 2 None 5 10 8 10 View
Efzofitimod 3 mg/kg Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1. 0 None 0 12 7 12 View
Placebo Participants received placebo matched to efzofitimod IV infusion on Day 1. 0 None 0 10 7 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.0 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumomediastinum NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pneumomediastinum NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Nasal dryness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary fibrosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Pulmonary hypertension NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.0 View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood chloride decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood potassium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood sodium decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Carbon dioxide increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Haemoglobin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Hepatitis B virus test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
N-terminal prohormone brain natriuretic peptide increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Platelet count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Prothrombin time ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Hypoaesthesia oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Genital candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Hypercoagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Fluid retention NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.0 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.0 View