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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT02925403
Description: None
Frequency Threshold: 0
Time Frame: Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit.
Study: NCT02925403
Study Brief: A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, With Matrix-M1 Adjuvant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 2 Saline injection on days 0, 28, and 56. Saline 0 None 0 5 5 5 View
Group 1 10μg R21/Matrix-M1 on days 0, 28, and 56. R21/Matrix-M1 0 None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Epigastralgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ocular hyperhemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Epididymitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Furuncle SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Teeth decay SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropaenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropaenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropaenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epigastralgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Furuncle SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Elevated ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Elevated ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Elevated ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View