Please select the outcome measures that correspond to the clinical trial below.
Title: A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia
Brief Summary: This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.


Options:
A: Percentage of Women With Serious Adverse Events (5 years open-label extension period); Invasive Breast Cancer Incidence (Breast Cancer-Free Survival) (Over randomization period of study (median follow-up 35 months))
B: Incidence of hip fxs; Incidence of new vertebral fxs
C: Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years))
D: N/A

Answer: C