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 @ 5:56 PM
Ignite Modification Date: 2025-12-25 @ 3:20 PM
NCT ID: NCT05212168
Description: Safety Population: consisted of all participants who received any study vaccination (active or placebo). This population was summarized according to the actual vaccination received.
Frequency Threshold: 5
Time Frame: Up to approximately 16 months
Study: NCT05212168
Study Brief: Norovirus Challenge 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
VXA-G1.1-NN Healthy participants received a single dose of VXA-G1.1-NN oral vaccine tablet. Approximately 29 days post-vaccination, participants began the Challenge Phase Day 1. During this phase, participants were isolated, exposed to the NV GI.1 Norwalk challenge strain, and monitored for signs and symptoms of AGE until discharge. Asymptomatic participants were discharged on Day 3 of the Challenge Phase and continued with a series of outpatient visits and telephone follow-ups. Symptomatic participants could remain in isolation for up to an additional 3 days. 0 None 0 86 55 86 View
Placebo Healthy participants received a single dose of matching placebo. Approximately 29 days post-vaccination, participants began the Challenge Phase Day 1. During this phase, participants were isolated, exposed to the NV GI.1 Norwalk challenge strain, and monitored for signs and symptoms of AGE until discharge. Asymptomatic participants were discharged on Day 3 of the Challenge Phase and continued with a series of outpatient visits and telephone follow-ups. Symptomatic participants could remain in isolation for up to an additional 3 days. 0 None 1 79 47 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (Unspecified) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View