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 @ 2:56 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT03311659
Description: Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Frequency Threshold: 0
Time Frame: Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31).
Study: NCT03311659
Study Brief: Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian 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
dTpa Group Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1. 0 None 1 447 52 447 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site lymphadenopathy SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Vaccination site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Vaccination site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Arthritis reactive SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View