Table 2

Type, grade and frequency of adverse events regardless of attribution across the two arms of the study

Grade 1 (%)Grade 2 (%)Grade 3 (%)Grade 4 (%)
Arm A (n=9)
Alkaline phosphatase increased22
Alanine/aspartate aminotransaminases increased2211
Amylase increased561122
Anemia1111
Anorexia11
Chest wall pain11
Cardiac chest pain11
Constipation11
Cough2211
Diarrhea11
Dry skin22
Dyspnea113311
Ear pain11
Fatigue66
Hyperglycemia33
Hypermagnesemia11
Hypoalbuminemia11
Hypobilirubinemia11
Hypokalemia11
Hyponatremia22
Hypotension11
Lipase increased1122
Nausea1111
Pain in extremity2222
Weight loss22
Arm B (n=9)
Alanine/aspartate aminotransferases increased2222
Anemia22
Anorexia22
Aspartate aminotransferases increased22
Back pain11
Constipation11
Cough22
Diarrhea33
Dyspnea11
Fatigue56
Hypoalbuminemia11
Hypokalemia11
Hyponatremia22
Hyperglycemia33
Hyponatremia22
Insomnia22
Nasal congestion11
Nausea22
Pain4411
Platelet count decreased33
Pruritus11
Rash22
Sinus tachycardia22
Weight loss11
White cell count decreased11