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 @ 11:19 PM
Ignite Modification Date: 2025-12-25 @ 9:00 PM
NCT ID: NCT01874756
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected over the 8 week time period that subjects were enrolled in the study.
Study: NCT01874756
Study Brief: The Efficacy and Safety of a Selective Estrogen Receptor Beta Agonist (LY500307) for Negative Symptoms and Cognitive Impairment Associated With Schizophrenia
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 placebo 6 pills of inactive drug Placebo: 6 placebo capsules daily for 8 weeks 0 None 1 29 4 29 View
LY500307 25mg LY500307 25mg LY500307 25mg: LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks 0 None 0 10 1 10 View
LY500307 75mg LY500307 75mg LY500307 75mg: LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks 0 None 0 29 3 29 View
LY500307 150mg LY500307 150mg LY500307 150mg: LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks 0 None 1 25 7 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hematemesis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Erectile Dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Psychotic Exacerbation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View