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 @ 2:00 PM
Ignite Modification Date: 2025-12-25 @ 12:46 PM
NCT ID: NCT00637195
Description: None
Frequency Threshold: 5
Time Frame: From Month 0 up to Month 13.
Study: NCT00637195
Study Brief: Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Engerix™ Group Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12). None None 2 76 73 76 View
Cervarix™ & Engerix™ Group Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12). None None 2 76 76 76 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion spontaneous complete NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 10.0 View
Graves-Basedow's disease NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
Endometriosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Type 1 diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain at injection site SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Redness at injection site SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Swelling at injection site SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Arthralgia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Gastrointestinal symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Myalgia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Temperature SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Dysmenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.0 View