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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

Categories

  • Blinding
  • Cardiovascular Therapeutic Area
  • Data Collection Procedures
  • Diabetes Therapeutic Area
  • General Therapeutic Area
  • Golden KRIs
  • IMP supply chain
  • Medical Device Therapeutic Area
  • Oncology Therapeutic Area
  • Operational Complexity
  • Organizational Experience
  • Safety
  • Strategic KRIs
  • Study Complexity
  • Study Endpoints
  • Subject Population
  • Technology
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