Safety
- Extended Hospital Stay compared to expectation (Complications)
- High Percentage of Early Subject Deaths
- High Percentage of Subject Death
- High Percentage of Subjects with Angina Pectoris Attacks
- High Percentage of Subjects with Hyperglycaemic events
- High Percentage of Subjects with Hypoglycaemic events
- High Percentage of Subjects with NYHA stage deterioration
- Overreporting of Reported (S)AEs
- Underreporting of Reported (S)AEs