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: 2025-12-25 @ 12:21 AM
Ignite Modification Date: 2025-12-25 @ 10:24 PM
NCT ID: NCT01086358
Description: Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
Frequency Threshold: 0
Time Frame: Approximately 6 months
Study: NCT01086358
Study Brief: Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Prescribed Triptan Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%. 0 None 0 45 18 45 View
Treximet Arm Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Treximet for migraine treatment: Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%. 0 None 0 45 15 45 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lightheadedness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Other View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders Other View
Chest Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders Other View
Giddiness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Other View
Apraxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Other View
Bladder pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders Other View
Muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Other View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders Other View
Xerostomia NON_SYSTEMATIC_ASSESSMENT General disorders Other View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Other View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Other View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Other View