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 @ 1:27 AM

Ignite Modification Date: 2025-12-25 @ 11:38 PM

NCT ID: NCT01073293

Description: Adverse events were collected for all participants who received at least one dose of V503 and Repevax™

Frequency Threshold: 5

Time Frame: Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs

Study: NCT01073293

Study Brief: A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Non-concomitant Vaccination	V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1	None	None	7	527	505	527	View
Concomitant Vaccination	V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Day 1	None	None	9	525	509	525	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Forearm fracture	None	Injury, poisoning and procedural complications	None	View
Non-cardiac chest pain	None	General disorders	None	View
Appendiceal abscess	None	Infections and infestations	None	View
Appendicitis	None	Infections and infestations	None	View
Dengue fever	None	Infections and infestations	None	View
Pyelonephritis	None	Infections and infestations	None	View
Pyelonephritis acute	None	Infections and infestations	None	View
Viral pharyngitis	None	Infections and infestations	None	View
Road traffic accident	None	Injury, poisoning and procedural complications	None	View
Thermal burn	None	Injury, poisoning and procedural complications	None	View
Fibromyalgia	None	Musculoskeletal and connective tissue disorders	None	View
Syncope	None	Nervous system disorders	None	View
Eating disorder	None	Psychiatric disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Abdominal pain upper	None	Gastrointestinal disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Injection-site erythema	None	General disorders	None	View
Injection-site pain	None	General disorders	None	View
Injection-site pruritus	None	General disorders	None	View
Upper respiratory tract infection	None	Infections and infestations	None	View
Headache	None	Nervous system disorders	None	View
Oropharyngeal pain	None	Respiratory, thoracic and mediastinal disorders	None	View
Injection-site swelling	None	General disorders	None	View
Pyrexia	None	General disorders	None	View
Nasopharyngitis	None	Infections and infestations	None	View