State Health Centre Oncology Department (Budapest, Hungary)

Grade 3 pleurisy with onset in cycle 1 (2013-05-19); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-05-29; action: drug interrupted.

Grade 4 febrile neutropenia with onset in cycle 3 (2013-02-11); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-02-20; action: dose reduced.

Grade 4 febrile neutropenia with onset in cycle 1 (2013-02-11); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-02-17; action: dose reduced.

Grade 3 anaemia with onset in cycle 3 (2013-02-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-03-08; action: drug interrupted.

Grade 3 gastroenteritis with onset in cycle 4 (2013-01-16); serious (hospitalization); assessed as related to study drug (possible); resolved 2013-01-20; action: drug interrupted.

Grade 2 oral herpes with onset in cycle 1 (2012-08-25); serious (hospitalization); assessed as related to study drug (possible); resolved 2012-09-02.

Grade 3 cellulitis with onset in cycle 1 (2012-07-30); serious (hospitalization); assessed as related to study drug (possible); resolved 2012-08-11; action: drug interrupted.

Grade 3 leukocytosis with onset in cycle 2 (2012-07-22); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-07-27; action: dose reduced.

CARDIAC ASSESSMENT NOT DONE: Protocol-required ECHO/MUGA after cycle 2 or 4 not performed (subject P2B-119, 2013-06-27)

CARDIAC ASSESSMENT NOT DONE: Protocol-required ECHO/MUGA after cycle 2 or 4 not performed (subject P2B-113, 2013-06-25)

PROHIBITED CONCOMITANT THERAPY: Other systemic anticancer therapy started while on study treatment (subject P2B-088, 2013-05-11)

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-072, 2013-05-07)

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-095, 2013-04-13)

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-040, 2013-02-27)

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-070, 2013-02-26)

TUMOUR ASSESSMENT OUT OF WINDOW: CT/MRI tumour assessment performed outside the +/-7-day window of the 6-weekly schedule (subject P2B-055, 2013-01-27)

VISIT OUT OF WINDOW: Cycle Day 1 visit outside the +/-3-day window without a documented toxicity delay (subject P2B-038, 2012-12-13)

IP STORAGE TEMPERATURE EXCURSION: Investigational product stored outside 2-8 C for <24 h; quarantined and released by sponsor (site-level, 2012-11-20)

2026-10-13