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 @ 9:43 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT00485732
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00485732
Study Brief: A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years
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 Group Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule. None None 2 149 144 149 View
Placebo Group Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule. None None 1 76 70 76 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ovarian cyst ruptured NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pelvic inflammatory disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratoy tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dysmenorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Injection site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders None 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
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT General disorders None View
Urticaria SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View