Table 2

Adverse events of all grade (safety population)

No. of patients with at least one adverse eventsLevel dose 1Level dose 2Total
N=13N=6N=19
13 (100%)6 (100%)19 (100%)
Fatigue9 (69%)5 (83%)14 (74%)
Diarrhea10 (77%)3 (50%)13 (68%)
Disease-related pain9 (69%)3 (50%)12 (63%)
Fever7 (54%)4 (67%)11 (58%)
Pain8 (62%)2 (33%)10 (53%)
Nausea/vomiting7 (54%)3 (50%)10 (53%)
Anorexia6 (46%)2 (33%)8 (42%)
Constipation4 (31%)3 (50%)7 (37%)
Colitis4 (31%)2 (33%)6 (32%)
Pruritus4 (31%)2 (33%)6 (32%)
Weight loss6 (46%)0 (0%)6 (32%)
Anemia2 (15%)4 (67%)6 (32%)
Edema of limbs4 (31%)1 (17%)5 (26%)
Dyspnea3 (23%)2 (33%)5 (26%)
Skin eruption3 (23%)1 (17%)4 (21%)
Vitiligo4 (31%)0 (0%)4 (21%)
Hypereosinophilia3 (23%)1 (17%)4 (21%)
Alanine/aspartate aminotransferase increased2 (15%)2 (33%)4 (21%)
Cough3 (23%)1 (17%)4 (21%)
Lymphedema3 (23%)1 (17%)4 (21%)