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: 2025-12-25 @ 2:40 AM
Ignite Modification Date: 2025-12-26 @ 1:18 AM
NCT ID: NCT01215734
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01215734
Study Brief: Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High-Dose Trivalent Inactivated Influenza Vaccine Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1 None None 11 29 5 29 View
Standard Dose Trivalent Inactivated Flu Vaccine Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine. Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1. None None 7 15 5 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
pericardial effusion None Cardiac disorders None View
Supraventricular tachycardia None Cardiac disorders None View
nausea None Gastrointestinal disorders None View
malaise None General disorders None View
Cholecystitis None Hepatobiliary disorders None View
Alkaline phosphatase increased None Investigations None View
Creatinine increased None Investigations None View
Platelet count decreased None Investigations None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Hypomagnesemia None Metabolism and nutrition disorders None View
Presyncope None Nervous system disorders None View
Transient ischemic attacks None Nervous system disorders None View
Acute kidney injury None Renal and urinary disorders None View
cough None Respiratory, thoracic and mediastinal disorders None View
dyspnea None Respiratory, thoracic and mediastinal disorders None View
hypoxia None Respiratory, thoracic and mediastinal disorders None View
pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Erythema multiforme None Skin and subcutaneous tissue disorders None View
Methicillin-resistant Staphylococcus aureus bacteremia None Infections and infestations None View
rectal abscess None Gastrointestinal disorders None View
diffuse muscle pain None Musculoskeletal and connective tissue disorders None View
fever None General disorders None View
febrile neutropenia None Blood and lymphatic system disorders None View
chest pain, cardiac None Cardiac disorders None View
heart failure None Cardiac disorders None View
palpitations None Cardiac disorders None View
abdominal pain None Gastrointestinal disorders None View
diarrhea None Gastrointestinal disorders None View
vomiting None Gastrointestinal disorders None View
Infections and infestations other None Infections and infestations None View
Laryngitis None Infections and infestations None View
upper respiratory infection None Respiratory, thoracic and mediastinal disorders None View
weight loss None Investigations None View
dehydration None Metabolism and nutrition disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Planned knee replacement surgery None Musculoskeletal and connective tissue disorders None View
Chronic inflammatory demyelinating polyneuropathy None Nervous system disorders None View
respiratory failure None Respiratory, thoracic and mediastinal disorders None View
bonchitis obliterans None Respiratory, thoracic and mediastinal disorders None View
wheezing None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
upper respiratory infection None Respiratory, thoracic and mediastinal disorders None View
investigations, other None Investigations None View
anorexia None Gastrointestinal disorders None View
cough None Respiratory, thoracic and mediastinal disorders None View
dry skin None Skin and subcutaneous tissue disorders None View
edema limbs None General disorders None View
hepatobiliary disorders, other None Hepatobiliary disorders None View
hypokalemia None Metabolism and nutrition disorders None View
mucositits oral None Gastrointestinal disorders None View
nasal congestion None Respiratory, thoracic and mediastinal disorders None View
skin and other subcutaneous disorders-other None Skin and subcutaneous tissue disorders None View
vomiting None Gastrointestinal disorders None View
wheezing None Respiratory, thoracic and mediastinal disorders None View