Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 6:50 PM
Ignite Modification Date: 2025-12-25 @ 4:22 PM
NCT ID: NCT01609257
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: 2
Time Frame: Serious Adverse Events: 393 Days. Non-Serious Unsolicited Events Post Vaccination: Initial vaccination until 28 days after second vaccination
Study: NCT01609257
Study Brief: Norovirus Bivalent-Vaccine Efficacy Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28. None None 0 65 7 65 View
Norovirus Bivalent VLP Vaccine Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28. None None 0 67 10 67 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View