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: 2025-12-26 @ 11:09 AM
Ignite Modification Date: 2025-12-26 @ 11:09 AM
NCT ID: NCT03692312
Description: A participant assigned to placebo was found to have some tideglusib levels (due to inadvertent exposure between siblings in opposing arms), and was therefore, included in the safety analysis and full analysis sets for tideglusib.
Frequency Threshold: 5
Time Frame: Consent to end of study, up to 28 weeks
Study: NCT03692312
Study Brief: Efficacy and Safety of Tideglusib in Congenital Myotonic Dystrophy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tideglusib Weight adjusted tideglusib, orally, once daily Tideglusib for oral suspension, weight-adjusted at 400 mg for 2 weeks, then up-titrated to a weight-adjusted 600 mg for 2 weeks, after which 1000 mg was administered for the remainder of the treatment period, once daily 0 None 1 28 20 28 View
Placebo Matching placebo, orally, once daily Placebo: Matching placebo formulation 0 None 0 25 19 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Scoliosis Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngytitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vaccination site pain SYSTEMATIC_ASSESSMENT General disorders None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View