Table 2.

Drug-related AEs occurring in more than 3% of patients

Dose, mg/d patients treatedb	5 (n = 2)		10 (n = 1)		20 (n = 1)		40 (n = 1)		80 (n = 1)		150 (n = 3)		300 (n = 5)		600 (n = 6)		900a (n =25)		1,300 (n =9)
NCI-CTCAE grade	1–2	3–4	1–2	3–4	1–2	3–4	1–2	3–4	1–2	3–4	1–2	3–4	1–2	3–4	1–2	3–4	1–2	3–4	1–2	3–4
Blood/bone marrow
Thrombocytopenia															1		1
Anemia																			2
Hemoglobin															1		1
Gastrointestinal
Nausea													1		2		9	1	3
Diarrhea	1												1		1		6		3
Vomiting													1		1		6		2
Dysgeusia									1						2		4		3
Constipation													2				2		1
Oral mucosal exfoliation	1								1		1		2				1		1
Abdominal distention															1		1		1
Dry mouth																	2		1
Stomatitis/oral mucosal blistering											1						1		1
Abdominal pain															1		1
Constitutional symptoms
Fatigue											1				1		12		3	2
Anorexia/decreased appetite													1		1		7	1	4
Weight loss																	2		2
Myalgia															1		1		2
Headache																	1		1
Night sweats/hot flash											1				1		1
Metabolic/laboratory
Elevated AST															1		8		3
Elevated ALT															1		7	1	1	2
Hypomagnesemia																	3		1
Other
Rash/psoriasis/pruritus													1				4
Muscle spasm									1						1		4		2

NOTE: Drug-related is defined as possibly, probably, or definitely related to bardoxolone methyl. Abbreviation: NCI-CTCAE, National Cancer Institute-Common Terminology Criteria for Adverse Events.

^aA total of 900 mg/d is the recommended phase II dose for bardoxolone methyl administered orally once a day for 21 consecutive days during a 28-day treatment cycle.

^bNumber of patients treated at each dose level is greater than the total number of patients enrolled due to dose adjustments during the study.