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 @ 7:51 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT01846104
Description: None
Frequency Threshold: 5
Time Frame: 9 months
Study: NCT01846104
Study Brief: Booster Dose (50 µg) of Recombinant Ricin Toxin Vaccine (RVEc™) in Previously Vaccinated Healthy Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
50-μg Booster Dose RVEc Subjects will be receive one 50-μg dose of RVEc 50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination. None None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Migrain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Temporo-mandibular joint syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hyper-natraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Blood creatine phosphor-kinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Vessel puncture site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Blood urea increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View