Table 2.

Treatment emergent adverse events (TEAE)

Adverse event, N (%)NC-6004 135 mg/m2 All Grade (N = 9)NC-6004 135 mg/m2 Grade 3-4 (N = 9)Overall all grade (N = 22)Overall grade 3–4 (N = 22)
Total TEAEs51677139183
At least one TEAE9 (100)8 (89)22 (100)18 (82)
Leukopenia9 (100)7 (78)21 (95)15 (68)
Thrombocytopenia9 (100)4 (44)21 (95)13 (59)
Neutropenia8 (89)6 (67)18 (82)12 (55)
Lymphopenia5 (56)4 (44)12 (55)10 (45)
Anemia6 (67)3 (33)16 (73)6 (27)
Fatigue6 (67)2 (22)12 (55)4 (18)
Hypomagnesemia9 (100)1 (11)22 (100)3 (14)
Hyponatremia5 (56)1 (11)12 (55)3 (14)
Decreased appetite5 (56)1 (11)9 (41)2 (9)
Dehydration1 (11)04 (18)2 (9)
Hyperglycemia2 (22)1 (11)8 (36)2 (9)
Hypokalemia5 (56)014 (64)2 (9)
Nausea9 (100)016 (73)2 (9)
Prolonged APTT1 (11)02 (9)1 (5)
Increased GGT4 (44)1 (11)13 (59)1 (5)
Increased AST6 (67)018 (82)1 (5)
Increased ALT4 (44)013 (59)1 (5)
Weight loss1 (11)04 (18)1 (5)
Abdominal distension001 (5)1 (5)
Abdominal pain1 (11)1 (11)2 (9)1 (5)
Diarrhea3 (33)09 (41)1 (5)
Dysphagia001 (5)1 (5)
Vomiting4 (44)09 (41)1 (5)
General edema001 (5)1 (5)
Pneumonia1 (11)1 (11)1 (5)1 (5)
Dyspnea1 (11)03 (14)1 (5)
Dose-limiting toxicities (DLT)
NC-6004 doseDLTNC-6004 action taken
150 mg/m2Grade 4 ThrombocytopeniaDose reduced
150 mg/m2Grade 4 ThrombocytopeniaDose reduced
150 mg/m2Grade 4 ThrombocytopeniaDose reduced
150 mg/m2Grade 3 VomitingDrug discontinued
165 mg/m2Grade 3 NauseaNone
180 mg/m2Grade 4 Febrile neutropeniaDose reduced