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 @ 3:57 AM
Ignite Modification Date: 2025-12-26 @ 2:49 AM
NCT ID: NCT01389102
Description: Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT01389102
Study Brief: Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
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 Transdermal Three 90 μL Sprays Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator None None 0 75 13 75 View
Placebo Transdermal Two 90 μL Sprays Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator None None 0 76 18 76 View
Placebo Transdermal One 90 μL Spray Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator None None 1 77 12 77 View
Estradiol Transdermal Three 90 μL Sprays Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator None None 3 76 21 76 View
Estradiol Transdermal Two 90 μL Sprays Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator None None 1 74 29 74 View
Estradiol Transdermal One 90 μL Spray Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator None None 3 76 21 76 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (7.1) View
Uterine Prolapse NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (7.1) View
Impaired Gastric Emptying NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (7.1) View
Spinal Column Stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (7.1) View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (7.1) View
Chronic Obstructive Airways Disease Excerbated NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (7.1) View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (7.1) View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (7.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (7.1) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (7.1) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (7.1) View
Breast Tenderness NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (7.1) View
Nipple Pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (7.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (7.1) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (7.1) View