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 @ 9:40 PM
Ignite Modification Date: 2025-12-25 @ 7:22 PM
NCT ID: NCT00344032
Description: Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort
Frequency Threshold: 5
Time Frame: None
Study: NCT00344032
Study Brief: Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women
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 Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months). None None 2 176 153 176 View
Placebo Subjects who received 3 doses of Placebo (at 0, 1, 6 months). None None 4 178 132 178 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aborption spontaneous NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchogenic cyst NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lymph node tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache 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
Fever (above 37.5 degree Celsius) SYSTEMATIC_ASSESSMENT General disorders None View
Gastro-intestinal symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia SYSTEMATIC_ASSESSMENT General disorders None View