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 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:48 PM
NCT ID: NCT03769194
Description: Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
Frequency Threshold: 5
Time Frame: up to Day 365
Study: NCT03769194
Study Brief: Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 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
VLA15 Low Dose VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate 0 None 0 29 26 29 View
VLA15 Medium Dose VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate 0 None 4 214 203 214 View
VLA15 High Dose VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate 0 None 5 205 202 205 View
Placebo Placebo: Placebo: PBS (Phosphate Buffered Saline) 0 None 3 124 85 124 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neurosyphilis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Biliary colic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Peripheral arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Multiple injuries NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Plasmacytoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View