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 @ 2:39 PM
Ignite Modification Date: 2025-12-25 @ 1:10 PM
NCT ID: NCT05299359
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: Main Part: Day 1 up to 366 and Extension Part: Day 1 up to Day 366 (Participants who participated in the Main Part and the Extension Part, total participation duration was approximately 17 months)
Study: NCT05299359
Study Brief: A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Main Part: TAK-019 Participants received a first single booster vaccination of TAK-019 0.5 milliliter (mL), intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Main Part. 0 None 0 150 123 150 View
Extension Part: TAK-019 Participants received a second booster vaccination of TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm at Day 1 of Extension Part. 0 None 4 129 107 129 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Cerebral thrombosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Tenderness SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View