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 @ 6:36 PM
Ignite Modification Date: 2025-12-25 @ 4:06 PM
NCT ID: NCT00389857
Description: None
Frequency Threshold: 5.0
Time Frame: Adverse events data were collected from the day of vaccination for 14 days post-vaccination (Influenza vaccine-primed) and for 42 days post-vaccination (Influenza vaccine-naive) participants.
Study: NCT00389857
Study Brief: Trial to Collect Safety Data and Sera for Immunogenicity Testing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Influenza Vaccine-Naive Group Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively. None None 0 14 9 14 View
Influenza Vaccine-Primed Group Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0. None None 0 17 7 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Injection site redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Vomiting NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Crying SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Teething NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View