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 @ 11:39 PM
Ignite Modification Date: 2025-12-25 @ 9:29 PM
NCT ID: NCT05005351
Description: None
Frequency Threshold: 2
Time Frame: 12 weeks
Study: NCT05005351
Study Brief: "SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Digital Acceptance and Commitment Therapy (ACT) Arm Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual. 0 None 0 39 7 39 View
Digital Symptom Tracker Arm Digital Symptom Tracker: Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual. 0 None 0 28 3 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis in Face SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post COVID-19 Vaccination Syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Broken Foot SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Worsening Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Exacerbation of Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Exacerbation of Fibromyalgia Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left Side Rib Contusions SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View