Table 2.
Event –n (%) (patients) | 60 mg SC (single dose) (n = 6) | 180 mg SC (single dose) (n = 6) | 180 mg Q4W (3 doses) (n = 6) | Total (n = 18) |
---|---|---|---|---|
All AE | 6 (100) | 6 (100) | 6 (100) | 6 (100) |
Serious AE | 0 (0) | 2 (33) † | 0 (0) | 2 (11) |
Treatment‐related AE | 3 (50) | 3 (50) | 3 (50) | 9 (50) |
Serious treatment‐related AE | 0 (0) | 1 (16.7) ‡ | 0 (0) | 1 (5.6) |
Deaths on study | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Adverse events occurring in 2 or more patients | ||||
Fatigue | 2 (33) | 1 (17) | 2 (33) | 5 (28) |
Anorexia | 2 (33) | 1 (17) | 1 (17) | 4 (22) |
Headache | 2 (33) | 0 (0) | 2 (33) | 4 (22) |
Malaise | 1 (17) | 3 (50) | 0 (0) | 4 (22) |
Nausea | 1 (17) | 2 (33) | 1 (17) | 4 (22) |
Arthralgia | 2 (33) | 0 (0) | 1 (17) | 3 (17) |
Constipation | 1 (17) | 1 (17) | 1 (17) | 3 (17) |
Diarrhea | 2 (33) | 0 (0) | 1 (17) | 3 (17) |
Metastases to bone | 1 (17) | 1 (17) | 1 (17) | 3 (17) |
Edema | 1 (17) | 1 (17) | 1 (17) | 3 (17) |
Shoulder pain | 1 (17) | 1 (17) | 1 (17) | 3 (17) |
Stomatitis | 2 (33) | 1 (17) | 0 (0) | 3 (17) |
Alopecia | 2 (33) | 0 (0) | 0 (0) | 2 (11) |
Chest pain | 1 (17) | 1 (17) | 0 (0) | 2 (11) |
Hot flush | 0 (0) | 1 (17) | 1 (17) | 2 (11) |
Hypoesthesia | 0 (0) | 0 (0) | 2 (33) | 2 (11) |
Hypocalcemia | 1 (17) | 1 (17) | 0 (0) | 2 (11) |
Insomnia | 0 (0) | 2 (33) | 0 (0) | 2 (11) |
Metastases to liver | 0 (0) | 1 (17) | 1 (17) | 2 (11) |
Nasopharyngitis | 1 (17) | 1 (17) | 0 (0) | 2 (11) |
Neutrophil count decreased | 2 (33) | 0 (0) | 0 (0) | 2 (11) |
Pain in extremity | 1 (17) | 1 (17) | 0 (0) | 2 (11) |
White blood cell count decreased | 2 (33) | 0 (0) | 0 (0) | 2 (11) |
Includes 1 patient with grade 4 myositis and 1 patient with grade 3 febrile neutropenia.
Includes 1 patient with grade 4 myositis.
AE, adverse events; SC, subcutaneous.