Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Any adverse experience occurring at any dose or level of participation that results in any of the following outcomes:

• Results in death,
• Is life-threatening
• Requires inpatient hospitalization or prolongation of existing hospitalization,
• Results in persistent or significant disability/incapacity, or
• Is a congenital anomaly/birth defect.
• An unexpected result of therapy or other intervention that is severe, life threatening, or fatal, corresponding to grades III, IV, or V using NCI/CTC Common Toxicity Criteria.