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. Author manuscript; available in PMC: 2021 Jul 12.
Published in final edited form as: Clin Cancer Res. 2021 Jan 20;27(7):1882–1892. doi: 10.1158/1078-0432.CCR-20-3946

Table 2. Dose limiting toxicities (DLT) observed within the dose escalation phase by treatment cohort.

Cohort Patient DLT criteria met (and associated details)
1 (n=4) 61 Other clinically significant grade 3 or above toxicity except nausea or vomiting (grade 3 pulmonary embolism)
51 Grade 4 neutropenia ≥ 7 days duration
52 Grade 3-4 neutropenia associated with a temperature ≥38.5°C
2 (n=8) 41 Grade 3-4 neutropenia associated with a temperature ≥38.5°C
3 (n=5) 54 Grade 3-4 neutropenia associated with a temperature ≥38.5°C Grade 4 thrombocytopenia ≥ 7 days duration Greater than 14 days of delay in commencing a second cycle of treatment due to drug toxicity
80 Grade 4 thrombocytopenia ≥ 7 days duration Grade 4 neutropenia ≥ 7 days duration Other clinically significant grade 3 or above toxicity except nausea or vomiting (grade 3 dental infection)
63 Other clinically significant grade 3 or above toxicity except nausea or vomiting (grade 3 diarrhoea and grade 3 hypokalaemia)