Table 2 Adverse events (worst grade; ≥ 2pts) possibly, probably or definitely related to the study regimen (N = 30)
Type | Any Grade | Grade 3 | Grade 4 | |||
|---|---|---|---|---|---|---|
No. patients | % | No. Pts. | % | No. Pts. | % | |
Skin | ||||||
Pruritus | 19 | 63 | 2 | 7 | 0 | 0 |
Rash maculopapular | 14 | 47 | 6 | 20 | 0 | 0 |
Gastrointestinal | ||||||
Diarrhea/Colitis | 15 | 50 | 3 | 10 | 0 | 0 |
Nausea | 16 | 53 | 1 | 3 | 0 | 0 |
Vomiting | 9 | 30 | 1 | 3 | 0 | 0 |
Hepatic | ||||||
ALT | 22 | 73 | 6 | 20 | 0 | 0 |
AST | 28 | 93 | 5 | 17 | 1 | 3 |
Endocrine | ||||||
Hypothyroidism | 8 | 27 | 0 | 0 | 0 | 0 |
Hyperthyroidism | 3 | 10 | 0 | 0 | 0 | 0 |
Adrenal insufficiency | 10 | 33 | 3 | 10 | 0 | 0 |
Hypophysitis | 2 | 7 | 2 | 7 | 0 | 0 |
Lipase increased | 9 | 30 | 3 | 10 | 0 | 0 |
Hematologic | ||||||
Neutropenia | 21 | 70 | 2 | 7 | 0 | 0 |
Thrombocytopenia | 20 | 67 | 0 | 0 | 0 | 0 |
Other | ||||||
Fever | 17 | 57 | 0 | 0 | 0 | 0 |
Fatigue | 27 | 90 | 16 | 53 | 0 | 0 |
CPK increased | 19 | 63 | 2 | 7 | 0 | 0 |
Creatinine increased | 6 | 20 | 2 | 7 | 0 | 0 |