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 @ 7:01 PM
Ignite Modification Date: 2025-12-25 @ 4:35 PM
NCT ID: NCT00822757
Description: None
Frequency Threshold: 1
Time Frame: All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Study: NCT00822757
Study Brief: Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
V710 (60 mcg) Lyophilized V710 (60 mcg)single dose at baseline. None None 0 41 15 41 View
Placebo Saline placebo single dose at baseline. None None 0 10 3 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View