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 @ 4:06 AM
Ignite Modification Date: 2025-12-26 @ 3:03 AM
NCT ID: NCT02764320
Description: None
Frequency Threshold: 1
Time Frame: Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Study: NCT02764320
Study Brief: The MOTS (Medication Overuse Treatment Strategy) Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Discontinuation Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) Discontinuation of Overused Medication: Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy 0 None 7 361 20 361 View
Preventive Therapy Only Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s) Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s) 1 None 7 359 16 359 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cecal Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache Worsened SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Joint Range of Motion Decrease Cervical Spine SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left Ventricular Systolic Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Surgical Procedure - Spine SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Thromboembolic Event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Weight Gain SYSTEMATIC_ASSESSMENT Investigations None View
Headache Worsened SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View