Table 3.
400 mg (n = 6) | 300 mg (n = 18) | All patients (N = 24) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
All grades | G 3/4 | All grades | G 3/4 | All grades | G 3/4 | |||||||
n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | |
Nausea,Vomiting | 6 | 100 | 0 | 0 | 11 | 61 | 0 | 0 | 19 | 79 | 0 | 0 |
Diarrhea | 6 | 100 | 2 | 33 | 11 | 61 | 0 | 0 | 17 | 71 | 2 | 8 |
Mucositis oral | 6 | 100 | 1 | 17 | 11 | 61 | 0 | 0 | 17 | 71 | 1 | 4 |
Liver function tests increased | 1 | 0 | 1 | 0 | 10 | 56 | 1 | 6 | 11 | 46 | 2 | 8 |
Anorexia | 5 | 83 | 0 | 0 | 3 | 17 | 0 | 0 | 8 | 33 | 0 | 0 |
Hyperglycemia | 1 | 17 | 1 | 17 | 7 | 39 | 1 | 6 | 8 | 33 | 2 | 8 |
Dyspepsia | 2 | 33 | 0 | 0 | 3 | 17 | 0 | 0 | 5 | 21 | 0 | 0 |
Stomach or abdominal pain | 2 | 33 | 0 | 0 | 3 | 17 | 0 | 0 | 5 | 21 | 0 | 0 |
Neutropenia | 1 | 17 | 1 | 17 | 4 | 22 | 1 | 6 | 5 | 21 | 2 | 8 |
Anemia | 1 | 17 | 0 | 0 | 3 | 17 | 2 | 11 | 4 | 17 | 2 | 8 |
Fatigue | 2 | 33 | 0 | 0 | 2 | 11 | 0 | 0 | 4 | 17 | 0 | 0 |
Platelet count decreased | 0 | 0 | 0 | 0 | 4 | 22 | 4 | 22 | 4 | 17 | 4 | 17 |
Bloating, Flatulence | 2 | 33 | 0 | 0 | 2 | 11 | 0 | 0 | 4 | 17 | 0 | 0 |
Anal pain | 3 | 50 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 13 | 0 | 0 |
C-peptide increase | 0 | 0 | 0 | 0 | 3 | 17 | 0 | 0 | 3 | 13 | 0 | 0 |
Constipation | 2 | 33 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 8 | 0 | 0 |
Alkaline phosphatase increased | 0 | 0 | 0 | 0 | 2 | 11 | 0 | 0 | 2 | 8 | 0 | 0 |
Lipase increased | 0 | 0 | 0 | 0 | 2 | 11 | 1 | 6 | 2 | 8 | 1 | 4 |
Weight loss | 2 | 33 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 8 | 0 | 0 |
Hypertriglyceridemia | 2 | 33 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 8 | 0 | 0 |
Hoarseness | 2 | 33 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 8 | 0 | 0 |
Colitis | 0 | 0 | 0 | 0 | 1 | 6 | 0 | 0 | 1 | 4 | 0 | 0 |
Gastroenteritis | 0 | 0 | 0 | 0 | 1 | 6 | 1 | 6 | 1 | 4 | 1 | 4 |
Esophagitis | 0 | 0 | 0 | 0 | 1 | 6 | 1 | 6 | 1 | 4 | 1 | 4 |
Erythema multiforme | 1 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 0 |
Skin infection | 1 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 0 |
Nail ridging | 0 | 0 | 0 | 0 | 1 | 6 | 0 | 0 | 1 | 4 | 0 | 0 |
Urea increased | 0 | 0 | 0 | 0 | 1 | 6 | 0 | 0 | 1 | 4 | 0 | 0 |
Serum amylase increased | 0 | 0 | 0 | 0 | 1 | 6 | 1 | 6 | 1 | 4 | 1 | 4 |
Dry skin | 0 | 0 | 0 | 0 | 1 | 6 | 0 | 0 | 1 | 4 | 0 | 0 |
Insomnia | 0 | 0 | 0 | 0 | 1 | 6 | 0 | 0 | 1 | 4 | 0 | 0 |
Muscle cramps | 1 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 0 |
Dizziness | 1 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 0 |
Dysgeusia | 1 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 0 |
Alopecia | 1 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 0 |
Treatment associated adverse events are listed according to frequency. Gastrointestinal AEs like vomiting, diarrhea and oral mucositis were most frequent but only in rare cases with higher grades (3/4). The most frequent AE with higher grade was lowering of thrombocyte count