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 @ 2:20 PM
Ignite Modification Date: 2025-12-25 @ 12:56 PM
NCT ID: NCT01092195
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT01092195
Study Brief: Gardasil Vaccination in Post Stem Cell Transplant Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Transplant With Immunosuppression Subjects post stem cell transplant with chronic GVHD requiring systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months. 0 None 0 23 23 23 View
Transplant With no Immunosuppression Subjects post stem cell transplant on no systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months. 0 None 0 21 18 21 View
Healthy Volunteer Healthy normal female volunteers. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months. 0 None 0 20 20 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Erythema SYSTEMATIC_ASSESSMENT General disorders None View
Pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View