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 @ 11:55 PM
Ignite Modification Date: 2025-12-25 @ 9:51 PM
NCT ID: NCT00573651
Description: In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Frequency Threshold: 0
Time Frame: Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit.
Study: NCT00573651
Study Brief: Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aggregate of All Three Arms. All girls enrolled in the study 9-26 data were analyzed together as the original 72 subjects planned was not large enough to have statistically significant results once it became apparent that outcomes would need to be not only analyzed by subgroup but also by age 9-15 and 16-26. 0 None 1 43 21 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions NCI View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
bruise SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
syncope vaso-vagal SYSTEMATIC_ASSESSMENT Vascular disorders None View
dry socket following extraction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
otalgia SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injection site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
insomnia SYSTEMATIC_ASSESSMENT General disorders None View
musculoskeletal pain due to MVA injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
warts, plantar SYSTEMATIC_ASSESSMENT Infections and infestations None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Achiness SYSTEMATIC_ASSESSMENT Infections and infestations None View
nausea or diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
lightheadedness SYSTEMATIC_ASSESSMENT Vascular disorders None View
fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
strep throat SYSTEMATIC_ASSESSMENT Infections and infestations None View
flare SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View