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 @ 3:01 AM
Ignite Modification Date: 2025-12-26 @ 1:41 AM
NCT ID: NCT00922233
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00922233
Study Brief: Pericoital Oral Contraception With Levonorgestrel
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Levonorgestrel Arm Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex. None None 0 72 28 72 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
irritability SYSTEMATIC_ASSESSMENT General disorders None View
hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
chlamydial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
tonsilitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
urinary tract infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
vaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
cervical dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
decereased libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
dermititis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
seborrhea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View