State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia)

Grade 3 atrial tachycardia with onset in cycle 6 (2013-02-26); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-02-27.

Grade 4 thrombocytopenia with onset in cycle 3 (2012-12-25); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-01-05.

Grade 4 febrile neutropenia with onset in cycle 2 (2012-12-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-08; action: dose reduced.

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-074, 2013-05-11)

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-045, 2013-01-27)

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-060, 2013-01-23)

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-046, 2012-11-12)

PROHIBITED CONCOMITANT THERAPY: Other systemic anticancer therapy started while on study treatment (subject P2B-021, 2012-09-28)

DOSING WITH INADEQUATE COUNTS: Study drug given with ANC <1,500/mm3 or platelets <100,000/mm3 on Day 1 (retreatment criteria not met) (subject P2B-008, 2012-06-07)