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. Author manuscript; available in PMC: 2020 Sep 26.
Published in final edited form as: Invest New Drugs. 2018 Jan 15;36(5):836–847. doi: 10.1007/s10637-018-0560-6

Table 3.

Treatment emergent adverse events by dose level

0.15 mg/kg
(n = 2)		 0.3 mg/kg
(n = 2)		 0.6 mg/kg
(n = 4)		 1.2 mg/kg
(n = 4)		 2.4 mg/kg
(n = 4)		 3.6 mg/kg
(n = 6)		 4.2 mg/kg
(n = 1)		 4.8 mg/kg
(n = 8)
Gr 1/2 Gr 3/4 Gr 1/2 Gr 3/4 Gr 1/2 Gr 3/4 Gr 1/2 Gr 3/4 Gr 1/2 Gr 3/4 Gr 1/2 Gr 3/4 Gr 1/2 Gr 3/4 Gr 1/2 Gr 3/4
All Causality
 Fatigue 0 0 0 0 3 0 1 0 1 0 3 1 0 0 3 1
 Constipation 0 0 0 0 2 0 1 0 2 0 1 0 0 0 5 0
 Nausea 0 0 0 0 2 0 0 0 2 0 3 0 0 0 3 0
 Chills 0 0 1 0 0 0 0 0 1 0 3 0 0 0 4 0
 Infusion Reactions 0 0 0 0 0 0 1 0 1 0 4 0 0 0 1 1
 Neutropenia 0 0 0 0 0 0 0 0 0 1 0 2 0 0 1 4
 Rash 0 0 0 0 0 0 0 0 2 0 1 1 0 0 1 3
 Decreased Appetite 0 0 1 0 3 0 0 0 1 0 1 0 0 0 1 0
 Arthralgia 0 0 0 0 2 0 1 0 0 0 2 0 0 0 2 0
 Mucosal Inflammation 0 0 0 0 0 0 0 0 0 0 1 1 1 0 1 2
 Diarrhea 0 0 0 0 2 0 0 0 2 0 2 0 0 0 0 0
 Pruritus 0 0 0 0 0 0 0 0 2 0 1 1 0 0 2 0
Treatment Related
 Fatigue 0 0 0 0 1 0 1 0 0 0 3 1 0 0 2 0
 Constipation 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0
 Nausea 0 0 0 0 2 0 0 0 1 0 3 0 0 0 3 0
 Chills 0 0 1 0 0 0 0 0 1 0 1 0 0 0 2 0
 Infusion Reactions 0 0 0 0 0 0 1 0 1 0 4 0 1 0 1 1
 Neutropenia 0 0 0 0 0 0 0 0 0 1 0 2 0 0 1 4
 Rash 0 0 0 0 0 0 0 0 2 0 1 1 0 0 1 3
 Decreased Appetite 0 0 1 0 2 0 0 0 0 0 1 0 0 0 1 0
 Arthralgia 0 0 0 0 0 0 0 0 0 0 2 0 0 0 2 0
 Mucosal Inflammation 0 0 0 0 0 0 0 0 0 0 1 1 1 0 0 2
 Diarrhea 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0
 Pruritus 0 0 0 0 0 0 0 0 1 0 1 1 0 0 1 0