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 @ 12:00 PM
Ignite Modification Date: 2025-12-25 @ 11:57 AM
NCT ID: NCT00426361
Description: For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
Frequency Threshold: 5
Time Frame: During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
Study: NCT00426361
Study Brief: Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cervarix + Boostrix Polio Group Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0. None None 4 255 245 255 View
Cervarix Group Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6. None None 3 248 232 248 View
Boostrix Polio → Cervarix Group Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7. None None 3 248 242 248 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Imminent abortion NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (Unspecified) View
Muscle rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Ovarian cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (Unspecified) View
Scoliosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Tonsillitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Ovarian cyst ruptured NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (Unspecified) View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Redness SYSTEMATIC_ASSESSMENT General disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever (above 37.5 degree Celsius) SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT General disorders None View
Urticaria SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Myalgia SYSTEMATIC_ASSESSMENT General disorders None View