Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania)

Grade 3 neutropenia with onset in cycle 1 (2012-12-11); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-20; action: dose reduced.

Grade 3 stomatitis with onset in cycle 1 (2012-12-04); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-10; action: drug interrupted.

Grade 3 cellulitis with onset in cycle 3 (2012-11-13); serious (hospitalization); assessed as not related to study drug (not related); resolved 2012-11-27.

LABORATORY ASSESSMENT NOT DONE: Pre-dose haematology or chemistry panel not performed within 72 h of Day 1 (subject P2B-034, 2013-01-04)

CARDIAC ASSESSMENT NOT DONE: Protocol-required ECHO/MUGA after cycle 2 or 4 not performed (subject P2B-056, 2012-12-17)

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-056, 2012-12-17)

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-056, 2012-12-16)

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-034, 2012-11-02)