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 @ 11:58 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT04380961
Description: The All Subjects Treated analysis set consisted of all participants who received the study drug. The number of participants at risk in placebo arm in follow-up phase were 59 participants, however, the data for 2 participants in placebo arms were not collected due to pandemic situation, and were excluded from the analysis. Therefore, here number of participants at risk are 57 participants.
Frequency Threshold: 5
Time Frame: Treatment phase: Weeks 0-4; Follow-up phase: Weeks 4-16
Study: NCT04380961
Study Brief: A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (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
Sirukumab + Standard of Care (SOC): Treatment Phase Hospitalized participants with confirmed coronavirus disease-2019 (COVID-19) received intravenous (IV) single dose infusion of sirukumab (5 milligrams per kilogram \[mg/kg\]) on Day 1 along with SOC treatment per the discretion of the Investigator. 18 None 35 139 24 139 View
Sirukumab + SOC: Follow-up Phase Hospitalized participants with confirmed COVID-19 received IV single dose infusion of sirukumab 5 mg/kg on Day 1 along with SOC treatment per the discretion of the Investigator. 4 None 7 118 1 118 View
Placebo + SOC: Treatment Phase Hospitalized participants with confirmed COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator. 13 None 22 70 16 70 View
Placebo + SOC: Follow-up Phase Hospitalized participants with confirmed COVID-19 disease received IV single dose infusion of placebo on Day 1 along with SOC treatment per the discretion of the Investigator. 3 None 3 57 1 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Left Ventricular Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 22.1 View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 22.1 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 22.1 View
Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 22.1 View
Cardio-Respiratory Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 22.1 View
Cardiogenic Shock NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 22.1 View
Myocardial Ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 22.1 View
Supraventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 22.1 View
Gastrointestinal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 22.1 View
Lower Gastrointestinal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 22.1 View
Mallory-Weiss Syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 22.1 View
Mouth Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 22.1 View
Retroperitoneal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 22.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Septic Shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Staphylococcal Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Streptococcal Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Viral Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 22.1 View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 22.1 View
Glomerular Filtration Rate Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 22.1 View
Hepatic Enzyme Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 22.1 View
Transaminases Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 22.1 View
Acute Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.1 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.1 View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.1 View
Pneumomediastinum NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.1 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.1 View
Pneumothorax Spontaneous NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.1 View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 22.1 View
Blood Loss Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 22.1 View
Disseminated Intravascular Coagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 22.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 22.1 View
Multiple Organ Dysfunction Syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22.1 View
Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Bacterial Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Covid-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Covid-19 Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Enterobacter Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Enterococcal Bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Hiv Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Klebsiella Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.1 View
Urine Analysis Abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 22.1 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 22.1 View
Cerebrovascular Accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.1 View
Embolic Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.1 View
Haemorrhage Intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.1 View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 22.1 View
Oliguria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 22.1 View
Renal Impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 22.1 View
Acute Respiratory Distress Syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.1 View
Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.1 View
Subcutaneous Emphysema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 22.1 View
Haemodialysis NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA Version 22.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 22.1 View
Orthostatic Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 22.1 View
Shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 22.1 View
Troponin Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 22.1 View
Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 22.1 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 22.1 View
Transaminases Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 22.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 22.1 View