TABLE 7.

Summary of treatment-related AEs (NCI CTCAE Grades) in single ascending dose cohorts.

Cohorts	25 mg (N = 6), n (%)		50 mg (N = 6), n (%)		100 mg (N = 6), n (%)		150 mg (N = 6), n (%)		200 mg (N = 6), n (%)		250 mg (N = 6), n (%)		300 mg (N = 6), n (%)		400 mg (N = 6), n (%)		Placebo (N = 16), n (%)
Item	Grade 1–2	Grade 3	Grade 1–2	Grade 3	Grade 1–2	Grade 3	Grade 1–2	Grade 3	Grade 1–2	Grade 3	Grade 1–2	Grade 3	Grade 1–2	Grade 3	Grade 1–2	Grade 3	Grade 1–2	Grade 3
Headache	0	0	0	0	0	0	0	0	0	0	1 (16.7)	0	4 (66.7)	0	0	0	0	0
Urine erythrocyte positive	0	0	0	0	0	0	3 (50.0)	0	1 (16.7)	0	0	0	0	0	0	0	1 (6.3)	0
Urine leukocyte positive	0	0	0	0	0	0	2 (33.3)	0	0	0	0	0	0	0	0	0	1 (6.3)	0
Fever	0	0	0	0	0	0	0	0	0	0	1 (16.7)	0	1 (16.7)	0	0	0	0	0
Elevated serum creatinine	1 (16.7)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hematuria	0	0	0	0	1 (16.7)	0	0	0	0	0	0	0	0	0	0	0	0	0
Lymphocytopenia	0	0	0	0	0	0	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0
Neutrophilic granulocytosis	0	0	0	0	0	0	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0
Fecal leukocytosis	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0	0	0	0	0	0	0
Urinary sediment positive	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0	0	0	0	0	1 (6.3)	0
Positive fecal occult blood	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0	0	0	0	0	0	0
Dizziness	0	0	0	0	0	0	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0
Upper abdominal pain	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0	0	0	0	0	0	0
Mucous stool	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0	0	0	0	0	0	0
Nausea	0	0	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0	0	0	0	0
Anemia	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1 (16.7)	0	0	0
Varicella	0	0	0	0	0	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0	0
Hyperglycemia	0	0	0	0	0	0	1 (16.7)	0	0	0	0	0	0	0	0	0	0	0
Supraventricular arrhythmia	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2 (12.5)	0

Note: No treatment-related Grade 4–5 AEs observed in all single ascending dose cohorts.

AE, adverse event; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.