| 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 | Â | Â | Â | Â | Â | Â |
   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 | Â | Â | Â | Â | Â | Â |
   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 |