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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT00729469
Description: None
Frequency Threshold: 3
Time Frame: 16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information
Study: NCT00729469
Study Brief: Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Subjects on Placebo Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. None None 7 456 102 456 View
Subjects on Ospemifene 60 mg/Day Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed. None None 6 463 153 463 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Autoimmune Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.1 View
Hypoparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Peridiverticular Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Lumbar Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Lung Adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Intracranial Aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Bipolar Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Bladder Prolapse SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Vulvovaginal Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Vulvovaginal Mycotic Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Vaginal Discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.1 View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View