Table 2 Adverse events. All adverse events at least possibly attributed to study treatment are shown. Numbers represent the number of patients per arm experience a particular event at any point during the treatment period, with the highest grade reported for any single individual. Adverse event grade is according to NCI CTCAE v.3
Grade 1 | Grade 2 | Grade 3–5 | ||||
|---|---|---|---|---|---|---|
Arm 1 | Arm 2 | Arm 1 | Arm 2 | Arm 1 | Arm 2 | |
General / Constitutional | ||||||
Chills | 3 (33%) | 1 (11%) | 1 (11%) | |||
Fatigue | 2 (22%) | 2 (22%) | 1 (11%) | |||
Fever | 1 (11%) | 1 (11%) | ||||
Malaise | 1 (11%) | |||||
Pain | 2 (22%) | |||||
Headache | 3 (33%) | |||||
Injection site reaction | 6 (67%) | |||||
Gastrointestinal | ||||||
Nausea | 3 (33%) | 3 (33%) | ||||
Diarrhea | 1 (11%) | |||||
Vascular | ||||||
Hypertension | 1 (11%) | |||||
Hot flashes | 1 (11%) | |||||
Hematologic | ||||||
Anemia | 1 (11%) | |||||
Metabolism | ||||||
Anorexia | 1 (11%) | |||||
Musculoskeletal | ||||||
Arthralgia | 1 (11%) | |||||
Back pain | 1 (11%) | |||||
Myalgia | 1 (11%) | |||||
Pain in extremity | 1 (11%) | |||||