Table 1.

Adverse events of special interest (n = 22)

Adverse event	n (% of patients)
	Any grade	Grade 3 or 4
Acneform rasha	22 (100)	2 (9.1)
Diarrhea	17 (77.3)	1 (4.5)
Hypomagnesemiab	10 (58.8)	2 (11.8)
Infusion reactionc	3 (13.6)	0

^aAcneform rash was a composite of the Medical Dictionary for Regulatory Activities version 10 preferred terms: rash, rash pustular, rash erythematous, dermatitis acneform, dermatitis exfoliative, rash papular, rash pruritic, rash generalized, rash macular, rash maculopapular, acne, acne pustular, skin desquamation, and dry skin.

^bIncidence of hypomagnesemia in 17 patients who had serum magnesium measured.

^cInfusion reaction was a composite of the following preferred terms: infusion reaction, infusion-related reaction, hypersensitivity, anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction. In addition, the terms dyspnea, pyrexia, and chills were grouped under infusion reaction when their onset occurred on the first day of study treatment.