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 @ 9:36 PM
Ignite Modification Date: 2025-12-25 @ 7:19 PM
NCT ID: NCT05027932
Description: None
Frequency Threshold: 5
Time Frame: 7 months
Study: NCT05027932
Study Brief: Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine
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 15 participants receiving IM BPL1357 and IN Placebo 0 None 0 15 15 15 View
Group B 15 participants receiving IN BPL1357 and IM Placebo 0 None 0 15 15 15 View
Group C 15 participants receiving IM and IN placebo 0 None 0 15 15 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory rate SYSTEMATIC_ASSESSMENT Investigations None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
CPK increased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Rhinorrhea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hoarseness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal cramps NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
WBC decreased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eye discomfort NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Feverish NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
WBC increased SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rhinovirus infection NON_SYSTEMATIC_ASSESSMENT Investigations None View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shoulder pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anterior cruciate ligament tear NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BUN increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Cotton wool spots NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dental implant user NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diaphoresis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Difficulty thinking NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Injection site ecchymosis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site itching NON_SYSTEMATIC_ASSESSMENT General disorders None View
Itchy throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Loss of smell NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Low back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Meniscus tear of knee NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Menstrual irregularity NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle soreness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle strain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness lower limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Numbness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Puncture wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Scar NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Smell alteration NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Systolic hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Taste alteration NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tendinitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Uric acid high NON_SYSTEMATIC_ASSESSMENT Investigations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Venipuncture site bruise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View