- Patients who have been treated with most recent chemotherapy or investigational drugs ≤21 days or 5 half-lives (whichever is longer) for enrolment, and/or who have National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) v4.03 Grade 1 treatment-related side effect, with the exceptions of alopecia, should not be enrolled. For further details, please refer to the following link: http://evs.nci.nih.gov/ftp1/CTCAE/About.html.