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 @ 1:29 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT03961295
Description: At each visit the investigator had to assess any occurrence of adverse events. Participants may report adverse events occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 0
Time Frame: Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than Day 127
Study: NCT03961295
Study Brief: A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A: Vedolizumab SC PFS Vedolizumab 108 mg, injection, subcutaneously using a PFS, once on Day 1. 0 None 1 12 9 12 View
Group B: Vedolizumab SC Investigational Device Vedolizumab 108 mg, injection, subcutaneously using an investigational device, once on Day 1. 0 None 0 12 6 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Injection site paraesthesia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Epididymitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View