Safety
deaths, organ failure, Toxicities
ADVERSE EVENTS
For the safety analysis the ITT-cohort comprised of sixty patients–10 from the phase I and 50 from the phase II parts, who all received at least one cycle of study treatment. Altogether no episodes of severe organ failure or treatment related deaths were documented in the study.Within the dose escalation phase I, in total 272 possibly or probably related to treatment adverse events (AE’s) were calculated per cycle and patient and classified according to the NCI-CTCAE 4.0 (Table Toxicities of interest within the cohorts of the phase I and phase II trialIn total 856 AE’s were identified during the phase II part of the study per cycle and patient as possibly or probably related to study treatment, where 53% (