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 @ 12:03 AM
Ignite Modification Date: 2025-12-25 @ 10:01 PM
NCT ID: NCT01585558
Description: None
Frequency Threshold: 5
Time Frame: 40 weeks
Study: NCT01585558
Study Brief: Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks None None 1 49 11 49 View
Ospemifene 30 mg (Dose 1) Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks None None 2 62 9 62 View
Ospemifene 60 mg (Dose 2) Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks None None 5 69 21 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.1 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.1 View
Encephalitis Herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Meningitis Candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.1 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.1 View
Breast Cancer In Situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 9.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.1 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.1 View
Breast Prosthesis Implantation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 9.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.1 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9.1 View
Pharyngolaryngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.1 View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9.1 View