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 @ 11:07 PM
Ignite Modification Date: 2025-12-25 @ 8:39 PM
NCT ID: NCT00361569
Description: Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.
Frequency Threshold: 3
Time Frame: Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks).
Study: NCT00361569
Study Brief: A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DR-2041a Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter None None 1 150 34 150 View
Placebo-a 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter None None 1 155 18 155 View
DR-2041b Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter None None 1 161 36 161 View
Placebo-b 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter None None 3 156 33 156 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic Sinusitus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
Cardiac Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (9.0) View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (9.0) View
Hodgkin's Disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (9.0) View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (9.0) View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (9.0) View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (9.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (9.0) View
Genital Pruritus Female SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (9.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (9.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (9.0) View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
Vulvovaginal Mycotic Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View