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 @ 2:04 PM
Ignite Modification Date: 2025-12-25 @ 12:48 PM
NCT ID: NCT00092495
Description: Adverse events were collected from subjects with follow-up.
Frequency Threshold: 5
Time Frame: None
Study: NCT00092495
Study Brief: Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
40% Formulation Subjects in this group received a 40% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6. None None 2 509 426 509 View
60% Formulation Subjects in this group received a 60% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6. None None 1 500 431 500 View
100% Formulation Subjects in this group received a 100% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6. None None 4 1498 1276 1498 View
20% Formulation Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6. None None 5 496 434 496 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Tachycardia foetal SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Cephalo-pelvic disproportion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 11.1 View
Failed trial of labour SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 11.1 View
Hyperemesis gravidarum SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 11.1 View
Premature rupture of membranes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 11.1 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.1 View
Anorexia nervosa SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View