Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:57 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT02040532
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected using the SAFTEE-SI self-report questionnaire at each visit
Study: NCT02040532
Study Brief: Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open-label Gabapentin Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks. Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks. None None 0 26 11 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sweating SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Feeling tired/fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Feeling drowsy during the day SYSTEMATIC_ASSESSMENT General disorders None View
Problems falling asleep SYSTEMATIC_ASSESSMENT General disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Stomach/abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gas SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tension SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased interest in sex SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Waking up too early SYSTEMATIC_ASSESSMENT General disorders None View
Coughing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aches, pains in muscles, bones or joints SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Mild rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View