Table 2.

Toxicity evaluation at the dose levels 1 and 2 based on NCI toxicity criteria, v2

Number of patients affected (% at dose level 1)Total # of episodes by grade at dose level 1Number of patients affected (% at dose level 2)Total # of episodes by grade at dose level 2Number of patients affected (% at dose level 3)Total # of episodes by grade at dose level 3Number of Patients affected (% at dose Level 4)Total # of episodes by grade at dose level 4
CategoryAdverse reaction1234123412341234
General disorderChills5 (62.5)022604 (66.7)001006 (75)002401 (100)0100
Fever2 (25)55003 (50)63002 (25)04001 (100)1000
Malaise2 (33.3)80001 (12.5)01001 (100)6110
Pain2 (33.3)3201
Back pain0 (0)00000 (0)00003 (37.5)0310
Weight gain1 (100)1000
Blood pressureHypotension1 (12.5)01002 (33.3)04002 (25)03001 (100)1000
Hypertension1 (12.5)01000 (0)00002 (25)4001
CardiacAtrial rhythm1 (12.5)2000
Tachycardia1 (16.7)20001 (12.5)1000
GastrointestinalNausea/vomiting3 (37.5)40002 (33.3)41203 (37.5)41001 (100)0020
Diarrhea1 (16.7)2000
PulmonaryDyspnea0 (0)00000 (0)00001 (12.5)0100
NeurologicalHeadache2 (25)01503 (50)00306 (75)01811 (100)0100
AllergyNasal congestion1 (12.5)1000