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 @ 4:57 PM
Ignite Modification Date: 2025-12-25 @ 2:39 PM
NCT ID: NCT01090050
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01090050
Study Brief: Treximet in the Treatment of Chronic Migraine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sumatriptan/Naproxen Sodium In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue. None None 1 16 9 16 View
Naproxen Sodium In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue. None None 1 12 6 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Menorragia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Common Cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Elevated Blood Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Enhanced Smell SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Flu SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fluid in Ears SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea with Fatty Foods SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Numb Feeling in Head SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain Behind Eyes SYSTEMATIC_ASSESSMENT General disorders None View
Right Ankle Sprain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right Leg Ulcer SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus Burning Sensation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus Discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sore Throat SYSTEMATIC_ASSESSMENT General disorders None View
Stomach Burn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Strep Throat SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Worsening Stress SYSTEMATIC_ASSESSMENT Psychiatric disorders None View