INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records. If submitting by fax, use an original form for maximum clarity in transmission and fax to 919-416-4990. Use NCI CTCAE v4.0 or most current version with MedDRA codes posted at http://www.calgb.org to grade each adverse event. Grade = -1 if category not evaluated. Grade = 0 if category evaluated but event not reported. AE is defined as adverse event. TREATMENT ATTRIBUTION CODES: 1 = unrelated, 2 = unlikely, 3 = possible, 4 = probable, 5 = definite