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 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:06 AM
NCT ID: NCT00825305
Description: Subjects were instructed to report on a daily basis any adverse events and record them on a diary card.
Frequency Threshold: 5
Time Frame: Any unsolicited adverse events were collected for 7 days after each vaccination, all serious adverse events were collected throughout the whole study period (beyond individual study participation, from 12 Nov 2008 to 12 Jan 2009).
Study: NCT00825305
Study Brief: Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Abbreviated Zagreb (2-1-1) Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21. None None 0 549 52 549 View
Conventional Essen(1-1-1-1-1) Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively. None None 1 275 26 275 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Injury of soft tissue in the leg and shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View