Table 2 Patient incidence of motesanib-related adverse events
|
Motesanib + Gemcitabine + Erlotinib (100 mg QD) |
Motesanib + Erlotinib (150 mg QD) | |||||
|---|---|---|---|---|---|---|
| Patient Incidence |
Motesanib 50 mg QD (n = 7) |
Motesanib 100 mg QD (n = 8) |
Motesanib 125 mg QD (n = 10) |
Motesanib 75 mg BID (n = 9) |
Motesanib 100 mg QD (n = 7) |
Motesanib 125 mg QD (n = 7) |
| Any adverse event, n | 3 | 8 | 9 | 7 | 7 | 6 |
| Adverse events of grade 3, na | 0 | 3 | 6 | 3 | 3 | 4 |
| Diarrhea | 0 | 1 | 1 | 0 | 2 | 1 |
| Nausea | 0 | 0 | 3 | 1 | 0 | 0 |
| Vomiting | 0 | 1 | 2 | 0 | 0 | 0 |
| Fatigue | 0 | 1 | 0 | 0 | 0 | 2 |
| Tumor necrosis | 0 | 0 | 0 | 1 | 1 | 0 |
| Deep vein | ||||||
| thrombosis | 0 | 0 | 2 | 0 | 0 | 0 |
| Abnormal liver | ||||||
| function test | 0 | 1 | 0 | 0 | 0 | 1 |
| Neutropenia | 0 | 1 | 0 | 0 | 1 | 0 |
| Adverse events of grade 4, n | ||||||
| Pulmonary | 1 | 0 | 2 | 1 | 0 | 0 |
| embolism | 0 | 0 | 2 | 0 | 0 | 0 |
| Febrile neutropenia | 1 | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 0 | 0 | 0 | 1 | 0 | 0 |
| Adverse events of interest and highest (worst) grade, n | ||||||
| Hypertension | 0 | 0 | 0 | 2 | 1 | 2 |
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 1 |
| Thrombophlebitis (all grade 3) | 0 | 0 | 1 | 0 | 0 | 0 |
| Gallbladder toxicity | 0 | 0 | 2b | 0 | 1c | 0 |
| Grade 3 | 0 | 0 | 1 | 0 | 0 | 0 |
| Hemorrhagic events | 0 | 0 | 1d | 0 | 1e | 0 |
| Grade 3 | 0 | 0 | 1 | 0 | 0 | 0 |
| Cardiac toxicity (all grade 3) | 0 | 1f | 0 | 0 | 0 | 0 |
