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 AE	15 (100)	3 (100)	3 (100)	3 (100)	3 (100)	3 (100)
Any SAE	3 (20.0)	0	0	1 (33.3)	1 (33.3)	1 (33.3)
Fatigue	5 (33.3)	2 (66.7)	0 (0.0)	1 (33.3)	1 (33.3)	1 (33.3)
Nausea	4 (26.7)	1 (33.3)	1 (33.3)	0 (0.0)	1 (33.3)	1 (33.3)
Vomiting	4 (26.7)	2 (66.7)	1 (33.3)	0 (0.0)	1 (33.3)	0 (0.0)
Blood creatine phosphokinase increased	3 (20.0)	0 (0.0)	1 (33.3)	1 (33.3)	0 (0.0)	1 (33.3)
Blood creatinine increased	3 (20.0)	0 (0.0)	0 (0.0)	1 (33.3)	1 (33.3)	1 (33.3)
Cough	3 (20.0)	1 (33.3)	1 (33.3)	1 (33.3)	0 (0.0)	0 (0.0)
Decreased appetite	3 (20.0)	1 (33.3)	0 (0.0)	1 (33.3)	0 (0.0)	1 (33.3)
Diarrhea	3 (20.0)	0 (0.0)	1 (33.3)	0 (0.0)	2 (66.7)	0 (0.0)
Lipase increased	3 (20.0)	0 (0.0)	1 (33.3)	0 (0.0)	2 (66.7)	0 (0.0)
Abdominal distension	2 (13.3)	0 (0.0)	0 (0.0)	1 (33.3)	1 (33.3)	0 (0.0)
Abdominal pain	2 (13.3)	0 (0.0)	0 (0.0)	1 (33.3)	1 (33.3)	0 (0.0)
Alanine aminotransferase increased	2 (13.3)	0 (0.0)	0 (0.0)	1 (33.3)	0 (0.0)	1 (33.3)
Amylase increased	2 (13.3)	0 (0.0)	0 (0.0)	1 (33.3)	1 (33.3)	0 (0.0)
Anemia of malignant disease	2 (13.3)	0 (0.0)	0 (0.0)	1 (33.3)	1 (33.3)	0 (0.0)
Aspartate aminotransferase increased	2 (13.3)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (66.7)
Blood alkaline phosphatase increased	2 (13.3)	0 (0.0)	0 (0.0)	0 (0.0)	1 (33.3)	1 (33.3)
Dehydration	2 (13.3)	0 (0.0)	1 (33.3)	0 (0.0)	1 (33.3)	0 (0.0)
Dyspepsia	2 (13.3)	2 (66.7)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Dysphagia	2 (13.3)	1 (33.3)	0 (0.0)	1 (33.3)	0 (0.0)	0 (0.0)
Gamma-glutamyl transferase increased	2 (13.3)	0 (0.0)	0 (0.0)	0 (0.0)	1 (33.3)	1 (33.3)
Hypercalcemia	2 (13.3)	0 (0.0)	1 (33.3)	1 (33.3)	0 (0.0)	0 (0.0)
Lymphocyte count decreased	2 (13.3)	0 (0.0)	1 (33.3)	0 (0.0)	0 (0.0)	1 (33.3)
Palmar-plantar erythrodysesthesia syndrome	2 (13.3)	1 (33.3)	0 (0.0)	1 (33.3)	0 (0.0)	0 (0.0)
Platelet count decreased	2 (13.3)	0 (0.0)	1 (33.3)	0 (0.0)	0 (0.0)	1 (33.3)
Fever	2 (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 pain	2 (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.