Table 4.

Summary of all Adverse Events on Study (n = 46)

	Total (n=46)
	G1&2	G3	G4	G5
General disorder
Decreased appetite	19 (41.3%)	0	0	0
Fatigue	26 (56.5%)	7 (15.2%)	0	0
Peripheral edema	0	1 (2.2%)	0	0
Hematologic disorder
Anemia	0	1 (2.2%)	0	0
Febrile neutropenia	0	0	1 (2.2%)	0
Leukopenia	0	2 (4.3%)	0	0
Neutropenia	0	1 (2.2%)	2 (4.3%)	0
Cardiac disorders
Angina pectoris	0	1 (2.2%)	0	0
Cardiac failure	0	1 (2.2%)	0	0
Electrocardiogram abnormalities	0	2 (4.3%)	0	0
Hypertension	0	2 (4.3%)	0	0
Hypotension	0	0	1 (2.2%)	0
Troponin increased	0	1 (2.2%)	0	0
Ophthalmic disorders
Blurry vision	0	1 (2.2%)	0	0
Cataracts	0	2 (4.3%)	0	0
Gastrointestinal disorders
Abdominal pain	0	1 (2.2%)	0	0
Constipation	16 (34.8%)	2 (4.3%)	0	0
Diarrhea	13 (28.3%)	2 (4.3%)	0	0
Enterovesical fistula	0	1 (2.2%)	0	0
Gastrointestinal hemorrhage	0	1 (2.2%)	0	0
Increased transaminases	0	1 (2.2%)	0	0
Nausea	14 (30.4%)	1 (2.2%)	0	0
Small bowel obstruction	0	1 (2.2%)	0	0
Infectious disorders
Miscellaneous infections	0	2 (4.3%)	0	0
Sepsis	0	0	0	1 (2.2%)
Metabolic disorder
Hyperglycemia	0	3 (6.5%)	1 (2.2%)	0
Hyponatremia	0	0	1 (2.2%)	0
Hypophosphatemia	0	1 (2.2%)	0	0
Inappropriate antidiuretic hormone secretion	0	1 (2.2%)	1 (2.2%)	0
Nervous System disorder
Motor	0	1 (2.2%)	1 (2.2%)	0
Sensory	14 (30.4%)	2 (4.3%)	0	0
Renal disorder
Acute renal failure	0	0	2 (4.3%)	0
Pulmonary disorder
Dyspnea	14 (30.4%)	1 (2.2%)	0	0
Hypoxia	0	1 (2.2%)	0	0
Pulmonary embolism	0	0	1 (2.2%)	0
Miscellaneous
Depression	0	1 (2.2%)	0	0
Maculopapular rash	0	1 (2.2%)	0	0
Multi-organ failure	0	0	0	2 (4.3%)
Musculoskeletal pain	0	4 (8.7%)	0	0

Subjects with AEs in multiple severity ratings are counted once under the maximum severity.

The table summarizes grade 1 and grade 2 AEs occurring in > 20% of subjects and all grade 3 or higher AEs.