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 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT00885105
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected over a period of 8 months. Six months post-vaccination 2
Study: NCT00885105
Study Brief: Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluzone® Vaccine-Primed Group Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. None None 5 112 57 112 View
Influenza Vaccine-Naive Group Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months. None None 1 130 56 130 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sickle cell anaemia with crisis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 7.1 View
Deafness bilateral NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 7.1 View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Pneumonia respiratory syncytial viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 7.1 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 7.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Croup infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View