Table 3.

Adverse Events Most Severe Level Recorded After Baseline by Treatment (Mean ± SD)

Adverse Event	Total (n = 291)a	LAI-R (n = 143)	Oral Second-Generation Antipsychotics (n = 148)	Test and Significance of Difference
Bruising easily	1.45±0.71	1.43±0.67	1.48±0.75	t = −0.64, P = .52
Rash	1.48±0.74	1.53±0.78	1.44±0.71	t = 1.06, P = .29
Urticaria (hives, itching)	1.66±0.77	1.60±0.69	1.71±0.84	t = −1.20, P = .23
Blurred vision	1.84±0.79	1.76±0.73	1.91±0.83	t = −1.63, P = .10
Sedation/drowsiness	2.43±0.83	2.34±0.87	2.53±0.78	t = −1.90, P = .058
Restlessness	2.45±0.79	2.48±0.76	2.43±0.82	t = 0.47, P = .64
Insomnia	2.37±0.92	2.38±0.89	2.36±0.94	t = 0.18, P = .86
Malaise (weakness, fatigue)	2.18±0.86	2.22±0.85	2.14±0.87	t = 0.75, P = .46
Stiffness	1.99±0.84	2.01±0.82	1.97±0.85	t = 0.49, P = .63
Tremor	1.76±0.76	1.77±0.72	1.75±0.80	t = 0.22, P = .83
Dizziness	1.80±0.81	1.82±0.79	1.78±0.82	t = 0.43, P = .66
Headache	1.94±0.89	1.99±0.88	1.89±0.90	t = 1.04, P = .30
Fever	1.25±0.47	1.27±0.49	1.24±0.46	t = 0.53, P = .60
Sore throat	1.60±0.74	1.64±0.78	1.57±0.69	t = 0.72, P = .47
Dry mouth	2.31±0.93	2.36±0.92	2.25±0.94	t = 1.04, P = .30
Hypersalivation	1.80±0.87	1.76±0.80	1.84±0.94	t = −0.74, P = .46
Enuresis	1.59±0.86	1.63±0.89	1.56±0.83	t = −0.68, P = .50
Constipation	1.69±0.84	1.75±0.86	1.64±0.82	t = 1.08, P = .28
Diarrhea	1.66±0.83	1.65±0.86	1.68±0.81	t = −0.26, P = .80
Anorexia (loss of appetite)	1.77±0.85	1.89±0.86	1.69±0.84	t = 2.00, P = .046
Nausea	1.75±0.81	1.78±0.82	1.72±0.80	t = 0.70, P = .48
Vomiting	1.49±0.74	1.48±0.72	1.51±0.76	t = −0.44, P = .66
Menstrual irregularity (N = 122)	1.58±0.91	1.62±0.96	1.55±0.86	t = 0.41, df = 120, P = .68
Breast tenderness/galactorrhea (N = 290)	1.36±0.65	1.39±0.69	1.32±0.61	t = 0.91, df = 288, P = .36

Note: LAI-R, long-acting injectable risperidone. Only subjects with postbaseline ratings are included.

^a N = 291 (LAI-R: 143, Oral second-generation antipsychotics: 148), all t tests have df = 289 except as noted.