- 29-11-20 - 1 Formulier, 15 Itemgroepen, 57 Data-elementen, 1 Taal

Itemgroepen: Administrative, Adverse Events, Adverse Events/ Serious Adverse Events - Section 1, Adverse Events/ Serious Adverse Events - Section 2 (Seriousness), Adverse Events/ Serious Adverse Events - Section 3 (Demography Data), Adverse Events/ Serious Adverse Events - Section 4, Adverse Events/ Serious Adverse Events - Section 5, Adverse Events/ Serious Adverse Events - Section 6 (Medical Conditions), Adverse Events/ Serious Adverse Events - Section 7 (Other RELEVANT Risk Factors) , Adverse Events/ Serious Adverse Events - Section 8 (RELEVANT Concomitant Medications) , Adverse Events/ Serious Adverse Events - Section 9 (Details of Investigational Product(s)) , Adverse Events/ Serious Adverse Events - Section 10 (Details of RELEVANT ASSESSMENTS) , Adverse Events/ Serious Adverse Events - Section 11 (Narrative Remarks), Prior and Concomitant Medications/Non-drug Therapies , Prior and Concomitant Medications/Non-drug Therapies

• Concomitant Medication
• Diabetes Mellitus, Type 2
• Adverse event
• Clinical Trial
• Simvastatin