Table 3.

Summary of adverse events in the safety set.

	Olanzapine group (n = 175)		Placebo group (n = 174)		P valuea
	Grade 1–2	Grade 3–4	Grade 1–2	Grade 3–4
All adverse events	111 (63%)	10 (6%)	126 (72%)	10 (6%)	0.15
Common adverse eventsb
Treatment-related
Insomnia	2 (1%)	0	10 (6%)	0	0.020
Constipation	35 (20%)	0	31 (18%)	0	0.68
Hiccups	14 (8%)	0	13 (7%)	0	1.00
Dry mouth	10 (6%)	0	2 (1%)	0	0.035
Somnolence	1 (0·6%)	0	2 (1%)	0	0.62
Dizziness	15 (9%)	0	14 (8%)	0	1.00
Appetite loss	25 (14%)	0	32 (18%)	0	0.31
Hematological
Leukopenia	17 (10%)	2 (1%)	18 (10%)	2 (1%)	0.95
Neutropenia	14 (8%)	1 (0.6%)	15 (7%)	2 (1%)	0.83
Anemia	25 (14%)	0	28 (16%)	0	0.66
Thrombocytopenia	11 (6%)	2 (1%)	10 (6%)	0	0.54
Nonhematological
Fatigue	25 (14%)	0	27 (16%)	0	0.77
Nephrotoxicity	6 (3%)	0	4 (2%)	0	0.75
Hepatoxicity	12 (7%)	1 (0.6%)	10 (6%)	1 (0.6%)	0.91
Diarrhea	9 (5%)	1 (0.6%)	10 (6%)	3 (2%)	0.62
Hyponatremia	7 (4%)	2 (1%)	4 (2%)	1 (0.6%)	0.59
Hypokalemia	4 (2%)	1 (0.6%)	5 (3%)	1 (0.6%)	0.88
Hypoalbuminemia	6 (3%)	0	4 (2%)	0	0.75
Alopecia	9 (5%)	0	10 (6%)	0	0.82
Myalgia	5 (3%)	0	4 (2%)	0	1.00
Pruritus	3 (2%)	0	2 (1%)	0	1.00

Abbreviation: n, number of patients.

Bold values indicate statistical significance (P < 0.05).

^aP values were calculated with the Fisher's exact test or the chi-square test.

^bAdverse events with incidence rate ≥1% in at least one treatment arm.