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Table 3 Frequency of TEAEs Occurring at ≥5% or Any Statistically Significant Events

From: Impact of race on efficacy and safety during treatment with olanzapine in schizophrenia, schizophreniform or schizoaffective disorder

Event Term

White

N = 600

N (%)

Black

N = 369

N (%)

Total

N = 969

N (%)

p-value *

P = value **

Somnolence

88 (14.7)

52 (14.1)

140 (14.4)

0.851

0.792

Headache

76 (12.7)

62 (16.8)

138 (14.2)

0.088

0.057

Weight Increased

72 (12.0)

62 (16.8)

134 (13.8)

0.044

0.031

Insomnia

64 (10.7)

26 (7.0)

90 (9.3)

0.068

0.050

Anxiety

61 (10.2)

23 (6.2)

84 (8.7)

0.035

0.216

Dry Mouth

57 (9.5)

33 (8.9)

90 (9.3)

0.820

0.785

Nausea

47 (7.8)

27 (7.3)

74 (7.6)

0.804

0.858

Sedation

47 (7.8)

22 (6.0)

69 (7.1)

0.305

0.223

Increased Appetite

41 (6.8)

32 (8.7)

73 (7.5)

0.317

0.542

Depression

40 (6.7)

19 (5.1)

59 (6.1)

0.407

0.369

Fatigue

38 (6.3)

19 (5.1)

57 (5.9)

0.485

0.205

Neopharyngitits

36 (6.0)

15 (4.1)

51 (5.3)

0.236

0.165

Vomiting

35 (5.8)

13 (3.5)

48 (5.0)

0.127

0.154

Dizziness

32 (5.3)

20 (5.4)

52 (5.4)

1.000

0.791

Akathesia

31 (5.2)

11 (3.0)

42 (4.3)

0.143

0.230

Diarrhoea

31 (5.2)

24 (6.5)

55 (5.7)

0.394

0.375

Tremor

31 (5.2)

7 (1.9)

38 (3.9)

0.010

0.019

Disturbance in Attention

13 (2.2)

1 (0.3)

14 (1.4)

0.023

0.028

Irritability

12 (2.0)

0 (0.0)

12 (1.2)

0.005

0.012

Chills

8 (1.3)

0 (0.0)

8 (0.8)

0.027

0.032

Initial Insomnia

7 (1.2)

0 (0.0)

7 (0.7)

0.049

0.046

Migraine

1 (0.2)

4 (1.1)

5 (0.5)

0.073

0.033

Cyst

0 (0.0)

3 (0.8)

3 (0.3)

0.055

0.022

Left Ventricular Hypertrophy

0 (0.0)

2 (0.5)

2 (0.2)

0.145

0.017

Leukopenia

0 (0.0)

2 (0.5)

2 (0.2)

0.145

0.006

  1. *Fisher Exact Test; **CMH Test adjusted for protocol
  2. Abbreviation: N = number of randomized patients who have taken at least 1 dose of study drug and have a post-baseline visit; TEAEs = treatment-emergent adverse events