Table 2.
Treatment emergent adverse events (all causalities)
Adverse event | Any grade, n (%) | Grade 3, n (%) | Grade 4, n (%) |
CP-870,893 0.05 mg/kg (n = 5) | |||
Abdominal pain | 4 (80) | 1 (20) | 0 |
Back pain | 2 (40) | 0 | 0 |
Chills | 4 (80) | 0 | 0 |
Constipation | 1 (20) | 1 (20) | 0 |
Dehydration | 1 (20) | 1 (20) | 0 |
CP-870,893 0.1 mg/kg (n = 3) | |||
Arthralgias | 2 (67) | 0 | 0 |
Autoimmune disorder | 1 (33) | 1 (33) | 0 |
Dyspnea | 2 (67) | 0 | 0 |
Eye lid ptosis | 1 (33) | 1 (33) | 0 |
Musculoskeletal pain | 2 (67) | 0 | 0 |
Nausea | 2 (67) | 0 | 0 |
Non-cardiac chest pain | 1 (33) | 1 (33) | 0 |
CP-870,893 0.2 mg/kg (n = 13) | |||
Abdominal distention | 2 (15) | 0 | 0 |
Abdominal pain | 2 (15) | 1 (8) | 0 |
Arthralgias | 3 (23) | 0 | 0 |
AST increase | 2 (15) | 1 (8) | 0 |
Bronchitis | 2 (15) | 0 | 0 |
Chills | 3 (23) | 0 | 0 |
Confusion | 1 (8) | 1 (8) | 0 |
Constipation | 3 (23) | 0 | 0 |
Cough | 4 (31) | 0 | 0 |
Cytokine release syndrome | 11 (85) | 2 (16)* | 0 |
Dehydration | 2 (15) | 0 | 0 |
Diarrhea | 3 (23) | 0 | 0 |
Dizziness | 3 (23) | 0 | 0 |
Dyspnea | 2 (15) | 1 (8) | 0 |
Fatigue | 7 (54) | 1 (8) | 0 |
Flushing | 2 (15) | 0 | 0 |
Headache | 5 (39) | 0 | 0 |
Hemoptysis | 2 (15) | 0 | 0 |
Hypophosphatemia | 1 (8) | 1 (8) | 0 |
Lethargy | 1 (8) | 1 (8) | 0 |
Lymphedema | 1 (8) | 1 (8) | 0 |
Musculoskeletal chest pain | 2 (15) | 1 (8) | 0 |
Nausea | 5 (38) | 0 | 0 |
Pleuritic pain | 2 (15) | 0 | 0 |
Pneumonia | 1 (8) | 1 (8) | 0 |
Pulmonary embolism | 1 (8) | 0 | 1 (8) |
Vomiting | 3 (23) | 0 | 0 |
CP-870,893 0.25 mg/kg (n = 6) | |||
Alk Phos increase | 3 (50) | 1 (17) | 0 |
ALT increase | 3 (50) | 0 | 0 |
AST increase | 4 (67) | 0 | 0 |
Anemia | 2 (33) | 0 | 0 |
Arthralgias | 2 (33) | 0 | 0 |
Back pain | 3 (50) | 1 (17) | 0 |
Constipation | 3 (50) | 0 | 0 |
Cytokine release syndrome | 4 (67) | 1 (17)* | 0 |
Dizziness | 2 (33) | 0 | 0 |
Dyspnea | 2 (33) | 0 | 0 |
Fatigue | 2 (33) | 0 | 0 |
Headache | 2 (33) | 0 | 0 |
LDH increase | 1 (17) | 1 (17) | 0 |
Muscle weakness | 2 (33) | 1 (17) | 0 |
Pyrexia | 2 (33) | 0 | 0 |
Upper respiratory tract infection | 2 (33) | 0 | 0 |
Urticaria | 1 (17) | 1 (17)* | 0 |
Events listed if present in ≥ 2 for toxicities grade 1 and 2, or in ≥ 1 if grades 3 or 4 toxicity, *dose-limiting toxicity (DLT).