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 @ 10:37 PM
Ignite Modification Date: 2025-12-25 @ 8:09 PM
NCT ID: NCT02594735
Description: None
Frequency Threshold: 0
Time Frame: week 0 to week 24
Study: NCT02594735
Study Brief: Abatacept in Juvenile Dermatomyositis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open Label Abatacept A patient's participation in this open label non-randomized trial will last approximately 24 weeks (Screening visit and 5 intervention visits) with possible extension to 48 weeks. At screening, participants will have a physical exam, muscle strength assessment, blood and urine collection, and chest x-ray; they will also be asked to complete several questionnaires. All participants will receive each week subcutaneous injection of Abatacept. During intervention phase of the trial, muscle strength testing, physical exam, disease activity measurements, blood and urine collection, and muscle MRI will be performed. Participants will also be asked to complete several questionnaires. Participants will be also monitored closely for for serious drug related side effects. Abatacept: Study participation will consist of a screening visit and 5 protocol visits over six months (week 0, week 6, week 12, week 18, and week 24) for each subject, and phone follow-up (week 2, week 4, week 8, week 10, week 14, week 16, week 20, and week 22). At Visit 1, which will be treatment initiation, eligible subjects will be instructed on the use and side effects of subcutaneous abatacept and will be started on the study drug (abatacept 125 mg SQ weekly for subjects with body weight ≥ 50 KG or abatacept 87.5mg SQ for subjects with body weight \< 50 KG). 0 None 4 10 6 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening of interstitial lung disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Compression fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Calcinosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lipoatrophy, focal NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Febrile episodes NON_SYSTEMATIC_ASSESSMENT General disorders None View
Skin-infection NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
E. coli diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Right knee contracture worsening NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View