Table 3.
Dose (mg/m2) |
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---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total (N = 41) |
||||||||||||||||||||||||||
1 (n = 3) |
2 (n = 3) |
2H* (n = 2) |
3.3 (n =3) |
5 (n = 6) |
7 (n = 8) |
9† (n = 10) |
12 (n = 6) | Any | ||||||||||||||||||
Adverse Event | All | Gr 3 | All | Gr 3 | All | Gr 3 | All | Gr 3 | All | Gr 3 | All | Gr 3 | All | Gr 3–4 | All | Gr 3–4 | No. | % | ||||||||
Hematologic/Coagulation | ||||||||||||||||||||||||||
Neutropenia | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 5 | 2 | 3 | 3 | 10 | 24 | ||||||||||||
Anemia | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 1 | 1 | 5 | 12 | ||||||||||||
aPTT prolonged | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 3 | 7 | |||||||||||||
Leukopenia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 3 | 7 | |||||||||||||
Gastrointestinal toxicity | ||||||||||||||||||||||||||
Nausea | 1 | 0 | 2 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 3 | 0 | 8 | 0 | 3 | 0 | 21 | 51 | ||||||||
Diarrhea | 3 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 6 | 0 | 5 | 1 | 3 | 0 | 19 | 46 | ||||||||||
Vomiting | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 9 | 22 | |||||||||||
Constipation | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 6 | 15 | ||||||||||||
Dyspepsia | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 7 | ||||||||||||||
Abdominal pain | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 5 | |||||||||||||||
OtheNonhematologic toxicity | ||||||||||||||||||||||||||
Fatigue | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 3 | 0 | 6 | 2 | 3 | 0 | 17 | 41 | ||||||||
Alopecia | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 0 | 6 | 0 | 2 | 0 | 12 | 29 | ||||||||||||
Anorexia | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 2 | 0 | 1 | 0 | 8 | 20 | ||||||||||
Dysgeusia | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 3 | 7 | |||||||||||||
Dehydration | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 5 | ||||||||||||||
Dizziness | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 5 | ||||||||||||||
Hypokalemia | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 5 | ||||||||||||||
Hypomagnesemia | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 5 | |||||||||||||||
Peripheral neuropathy | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 2 | 5 | ||||||||||||||
Skin hyperpigmentation | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 2 | 5 |
Abbreviation: aPTT, activated partial thromboplastin time; Gr, grade.
Note: Two patients (one in the 9-mg/m2 and one in the 12-mg/m2 cohort) had grade 4 neutropenia; all other patients had grade 3 events.
Patients with homozygous (*28/*28) UGT1A1 genotype.