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 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT02858908
Description: SAEs were collected from the time of informed consent. Non-serious AEs were collected from the time of single-blind dosing. Any non-serious medical occurrences occurring between Screening (visit 1) and Run in (visit 2) were recorded as Medical/Surgical History. Any non-serious signs and symptoms occurring between Screening (visit 1) and Run in (visit 2) were recorded and classified as baseline signs and symptoms.
Frequency Threshold: 0
Time Frame: Consent to end of study, up to 14 weeks
Study: NCT02858908
Study Brief: Study of Tideglusib in Adolescent and Adult Patients With 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
Cohort 1 1000 mg tideglusib 0 None 0 8 8 8 View
Cohort 2 400 mg tideglusib 0 None 0 8 6 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervous system cyst SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Post-tussive vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysmenorrhea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Axillary mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View