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 @ 4:56 PM
Ignite Modification Date: 2025-12-25 @ 2:38 PM
NCT ID: NCT02427750
Description: All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22. Solicited AEs were collected systematically and the unsolicited AEs were collected non-systemically.
Frequency Threshold: 5
Time Frame: Throughout the study, up to 22 days.
Study: NCT02427750
Study Brief: A Study to Evaluate Safety and Immunogenicity of Trivalent Influenza Vaccine, Formulation 2015 Southern Hemisphere, When Administered to Healthy Adult Subjects.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TIV (≥ 61 Years) Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere. None None 0 63 33 63 View
Total None None None 0 126 60 126 View
TIV (18 to ≤ 60 Years) Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere. None None 0 63 27 63 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
INJECTION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
INJECTION SITE ERYTHEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
INJECTION SITE INDURATION SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.0) View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View