Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-25 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:56 PM
NCT ID: NCT04355767
Description: None
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT04355767
Study Brief: Convalescent Plasma in Outpatients With 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
Placebo Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion. 1 None 64 254 35 254 View
Convalescent Plasma Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion. 5 None 59 257 51 257 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral diarrhoea SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Oesophagoscopy SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
End stage renal disease, could not get outpatient dialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Iliac artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alcohol poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Coronavirus test positive SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View