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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT00568334
Description: None
Frequency Threshold: 5
Time Frame: Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
Study: NCT00568334
Study Brief: Study of Two Formulations of GSK Biologicals' Varicella 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
Varilrix HSA-Free Group Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). 0 None 2 122 103 122 View
Varilrix Group Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). 0 None 5 122 100 122 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Breath holding SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Mastoiditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain (Dose 1) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Redness (Dose 1) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Swelling (Dose 1) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pain (Dose 2) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Redness (Dose 2) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Swelling (Dose 2) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fever (Dose 1) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fever (Dose 2) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Bronchitis (Dose 1) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral infection (Dose 1) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Rhinitis (Dose 1) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchitis (Dose 2) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral infection (Dose 2) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Rhinitis (Dose 2) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View