Table 2

TEAE occurring in two or more patients at any grade and SAE occurring in one or more patients (safety analysis set)

AE, n (%)Total
(N=15)
100 mg two times per day (n=3)200 mg two times per day (n=3)400 mg two times per day (n=3)600 mg two times per day (n=3)800 mg two times per day (n=3)
Any AE15 (100)3 (100)3 (100)3 (100)3 (100)3 (100)
Any SAE3 (20.0)001 (33.3)1 (33.3)1 (33.3)
Fatigue5 (33.3)2 (66.7)0 (0.0)1 (33.3)1 (33.3)1 (33.3)
Nausea4 (26.7)1 (33.3)1 (33.3)0 (0.0)1 (33.3)1 (33.3)
Vomiting4 (26.7)2 (66.7)1 (33.3)0 (0.0)1 (33.3)0 (0.0)
Blood creatine phosphokinase increased3 (20.0)0 (0.0)1 (33.3)1 (33.3)0 (0.0)1 (33.3)
Blood creatinine increased3 (20.0)0 (0.0)0 (0.0)1 (33.3)1 (33.3)1 (33.3)
Cough3 (20.0)1 (33.3)1 (33.3)1 (33.3)0 (0.0)0 (0.0)
Decreased appetite3 (20.0)1 (33.3)0 (0.0)1 (33.3)0 (0.0)1 (33.3)
Diarrhea3 (20.0)0 (0.0)1 (33.3)0 (0.0)2 (66.7)0 (0.0)
Lipase increased3 (20.0)0 (0.0)1 (33.3)0 (0.0)2 (66.7)0 (0.0)
Abdominal distension2 (13.3)0 (0.0)0 (0.0)1 (33.3)1 (33.3)0 (0.0)
Abdominal pain2 (13.3)0 (0.0)0 (0.0)1 (33.3)1 (33.3)0 (0.0)
Alanine aminotransferase increased2 (13.3)0 (0.0)0 (0.0)1 (33.3)0 (0.0)1 (33.3)
Amylase increased2 (13.3)0 (0.0)0 (0.0)1 (33.3)1 (33.3)0 (0.0)
Anemia of malignant disease2 (13.3)0 (0.0)0 (0.0)1 (33.3)1 (33.3)0 (0.0)
Aspartate aminotransferase increased2 (13.3)0 (0.0)0 (0.0)0 (0.0)0 (0.0)2 (66.7)
Blood alkaline phosphatase increased2 (13.3)0 (0.0)0 (0.0)0 (0.0)1 (33.3)1 (33.3)
Dehydration2 (13.3)0 (0.0)1 (33.3)0 (0.0)1 (33.3)0 (0.0)
Dyspepsia2 (13.3)2 (66.7)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Dysphagia2 (13.3)1 (33.3)0 (0.0)1 (33.3)0 (0.0)0 (0.0)
Gamma-glutamyl transferase increased2 (13.3)0 (0.0)0 (0.0)0 (0.0)1 (33.3)1 (33.3)
Hypercalcemia2 (13.3)0 (0.0)1 (33.3)1 (33.3)0 (0.0)0 (0.0)
Lymphocyte count decreased2 (13.3)0 (0.0)1 (33.3)0 (0.0)0 (0.0)1 (33.3)
Palmar-plantar erythrodysesthesia syndrome2 (13.3)1 (33.3)0 (0.0)1 (33.3)0 (0.0)0 (0.0)
Platelet count decreased2 (13.3)0 (0.0)1 (33.3)0 (0.0)0 (0.0)1 (33.3)
Fever2 (13.3)0 (0.0)1 (33.3)0 (0.0)0 (0.0)1 (33.3)
Maculopapular rash*2 (13.3)1 (33.3)0 (0.0)1 (33.3)0 (0.0)0 (0.0)
Tumor pain2 (13.3)0 (0.0)0 (0.0)1 (33.3)1 (33.3)0 (0.0)
  • All TEAEs were grade 3 or lower. Grade 3 TEAEs were experienced by a total of 6 patients within the 400, 600, and 800 mg M4112 two times per day cohorts.

  • *MedDRA preferred term: rash maculopapular.

  • AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; TEAE, treatment-emergent adverse event.