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Table 2 Patient incidence of motesanib-related adverse events

From: Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study

  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
  1. BID = twice daily; QD = once daily
  2. aFor motesanib-related adverse events only those grade 3 events are listed that occurred in ≥ 2 patients.
  3. bCholecystitis (n = 1; grade 3) and gallbladder enlargement (n = 1; grade 1)
  4. cGallbladder enlargement (grade 2)
  5. dSubdural hematoma
  6. eEpistaxis (grade 1)
  7. fCongestive heart failure and pulmonary edema