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 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:19 PM
NCT ID: NCT04090658
Description: None
Frequency Threshold: 0
Time Frame: Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Study: NCT04090658
Study Brief: A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RSV_PreF3_AS01B Group Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably. 0 None 0 20 19 20 View
Placebo Group Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably. 0 None 1 20 10 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Ulna fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View