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 @ 12:31 PM
Ignite Modification Date: 2025-12-25 @ 12:09 PM
NCT ID: NCT00951561
Description: No Serious Adverse Events were deemed to be related to the VIPON.
Frequency Threshold: 0
Time Frame: None
Study: NCT00951561
Study Brief: A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Participants Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals. None None 2 102 48 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dental abscess NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dental infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dental pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lymphedema NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Mountain sickness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peridontal surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Poison ivy reaction NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rectal bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Achilles tendon pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ankle pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Labial biopsy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Root canal NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shoulder pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sinus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stomach flu NON_SYSTEMATIC_ASSESSMENT General disorders None View
Stomach pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Strep throat NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sunburn NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swollen bruised right eye NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tick bite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Twisted back NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal yeast infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Generalized body aches NON_SYSTEMATIC_ASSESSMENT General disorders None View
Giardia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Insect bite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Back ache NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cold NON_SYSTEMATIC_ASSESSMENT General disorders None View
Colposcopy NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cramps NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cryptosporidiosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Daytime hypersomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Elevated blood pressure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View