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 @ 12:35 AM
Ignite Modification Date: 2025-12-25 @ 10:43 PM
NCT ID: NCT03278067
Description: Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
Frequency Threshold: 0
Time Frame: AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Study: NCT03278067
Study Brief: Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vaccinated_Fluarix Tetra Group Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017 3 None 25 16433 1514 16433 View
Vaccinated_Non GSK Group Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017 0 None 3 3310 133 3310 View
Vaccinated_Unknown Brand Group Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017 0 None 10 4196 66 4196 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Accidental fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Blood transfusion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Chronic Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fracture of bone SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Frail SYSTEMATIC_ASSESSMENT General disorders None View
Gynaecological SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Infection of Chronic Wound SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Self Harm SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sensitivity Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unknown, non-causal SYSTEMATIC_ASSESSMENT General disorders None View
Viral gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever/pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Local symptoms (i.e. local erythema) SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Coryza SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaphylactic reactions SYSTEMATIC_ASSESSMENT Immune system disorders None View
Facial oedema SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypersensitivity reactions SYSTEMATIC_ASSESSMENT Immune system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle aches / myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bell's palsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure / Febrile convulsions SYSTEMATIC_ASSESSMENT Nervous system disorders None View