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: 2025-12-25 @ 5:06 AM
Ignite Modification Date: 2025-12-26 @ 4:10 AM
NCT ID: NCT01489527
Description: None
Frequency Threshold: 0
Time Frame: 1 year, 6 months
Study: NCT01489527
Study Brief: Preparedness Study - HPV Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gardasil Vaccine Administration Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle. None None 0 202 59 202 View
Placebo Administration Placebo injected intramuscularly into the deltoid or thigh muscle. None None 0 200 62 200 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Anal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal disorders - Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Immune system disorders - Other SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Pelvic infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Vulval infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Injury, poisoning and procedural complications - Other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neoplasms benign, malignant and unspecified - Other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (4.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Reproductive system and breast disorders - Other SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Vaginal hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Vaginal inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sinus disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin and subcutaneous tissue disorders - Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Surgical and medical procedures - Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Dyspareunia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (4.0) View