Table 2. Adverse events and end-of-cycle 1 dose-limiting toxicities.
Dosage by grade |
|
||||||
---|---|---|---|---|---|---|---|
|
2.5 mg Daily (n=6) |
5 mg Daily (n=11) |
10 mg Daily (n=3) |
All (n=20) |
|||
Adverse eventsb | 1/2 | 3/4 | 1/2 | 3/4 | 1/2 | 3/4 | Any grade |
Haematologic toxicities | |||||||
Anaemia | 5 | 0 | 10 | 1 | 3 | 0 | 19 |
Neutropenia | 3 | 1 | 3 | 6 | 1 | 2 | 16 |
Thrombocytopenia | 2 | 0 | 3 | 1 | 2 | 2 | 12 |
Febrile neutropenia | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
Leukopenia |
4 |
1 |
4 |
4 |
2 |
0 |
15 |
Nonhaematologic toxicities | |||||||
Anorexia | 2 | 0 | 3 | 0 | 1 | 0 | 6 |
Vomiting | 0 | 0 | 2 | 0 | 0 | 0 | 1 |
Stomatitis | 2 | 0 | 5 | 0 | 1 | 0 | 8 |
Diarrhoea | 0 | 0 | 2 | 0 | 1 | 0 | 3 |
Neuropathy | 1 | 0 | 3 | 1 | 2 | 0 | 7 |
Pain | 2 | 0 | 6 | 0 | 2 | 0 | 10 |
AST increased | 1 | 0 | 4 | 0 | 1 | 0 | 6 |
ALT increased | 1 | 0 | 5 | 0 | 0 | 0 | 6 |
Hyperglycemia | 6 | 0 | 9 | 0 | 2 | 1 | 18 |
Hypertriglycemia | 3 | 0 | 2 | 0 | 2 | 0 | 7 |
Itching | 0 | 0 | 2 | 0 | 2 | 0 | 4 |
Pneumonitis |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
Dose-limiting toxicity, cycle 1 | |||||||
Thrombocytopenia | 0 | 0 | 0 | 1a | 0 | 1 | 2 |
Fever with grade 4 neutropenia | 0 | 0 | 0 | 1a | 0 | 0 | 1 |
Hyperglycemia | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
Abbreviations: ALT=alanine aminotranferease; AST=aspartate aminotransferase.
Two dose-limiting toxicities in the same person.
A patient with multiple occurrence of an adverse event was counted only once in the adverse event category. A patient with multiple severity ratings for an adverse event was only included under the maximum rating.