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Table 5 Treatment-emergent adverse events preferred term by decreasing frequency ≥ 2% of patients or statistically significant comparison level ITT patients in the overall population

From: A double-blind, placebo-controlled comparator study of LY2140023 monohydrate in patients with schizophrenia

      

p-value

Preferred term

PBO N = 295 n (%)

LY40 N = 292 n (%)

LY80 N = 280 n (%)

RIS N = 142 n (%)

Total N = 1009 n (%)

Overall

LY40 vs. PBO

LY80 vs. PBO

RIS vs. PBO

Patients with > = 1 TEAE

177 (60.0)

159 (54.5)

176 (62.9)

82 (57.7)

594 (58.9)

0.220

0.183

0.494

0.678

Headache

27 (9.2)

20 (6.8)

21 (7.5)

11 (7.7)

79 (7.8)

0.770

0.362

0.547

0.719

Schizophrenia

23 (7.8)

14 (4.8)

16 (5.7)

5 (3.5)

58 (5.7)

0.284

0.174

0.407

0.098

Nausea

14 (4.7)

22 (7.5)

16 (5.7)

5 (3.5)

57 (5.6)

0.338

0.172

0.708

0.627

Insomnia

21 (7.1)

10 (3.4)

15 (5.4)

10 (7.0)

56 (5.6)

0.188

0.064

0.396

>.999

Blood CK increased

15 (5.1)

12 (4.1)

17 (6.1)

4 (2.8)

48 (4.8)

0.485

0.694

0.717

0.327

Anxiety

9 (3.1)

11 (3.8)

12 (4.3)

5 (3.5)

37 (3.7)

0.887

0.657

0.508

0.778

Vomiting

6 (2.0)

11 (3.8)

13 (4.6)

5 (3.5)

35 (3.5)

0.350

0.229

0.102

0.347

Dyspepsia

5 (1.7)

7 (2.4)

11 (3.9)

8 (5.6)

31 (3.1)

0.105

0.575

0.130

0.033*

Constipation

8 (2.7)

7 (2.4)

7 (2.5)

5 (3.5)

27 (2.7)

0.900

>.999

>.999

0.765

Psychotic disorder

7 (2.4)

6 (2.1)

10 (3.6)

2 (1.4)

25 (2.5)

0.594

>.999

0.465

0.724

Agitation

3 (1.0)

8 (2.7)

10 (3.6)

1 (0.7)

22 (2.2)

0.102

0.141

0.050*

>.999

Weight increased

2 (0.7)

4 (1.4)

1 (0.4)

5 (3.5)

12 (1.2)

0.049*

0.449

>.999

0.039*

Restlessness

5 (1.7)

1 (0.3)

0 (0.0)

4 (2.8)

10 (1.0)

0.008*

0.216

0.062

0.481

Extrapyramidal disorder

3 (1.0)

0 (0.0)

6 (2.1)

0 (0.0)

9 (0.9)

0.029*

0.249

0.329

0.554

Dysmenorrhoea

0 (0.0

5 (5.2)

0 (0.0)

1 (1.8)

6 (1.7)

0.006*

0.019*

 

0.325

Sinusitis

0 (0.0)

5 (1.7)

0 (0.0)

1 (0.7)

6 (0.6)

0.013*

0.030*

 

0.325

Asthenia

2 (0.7)

0 (0.0)

0 (0.0)

4 (2.8)

6 (0.6)

0.002*

0.499

0.499

0.091

Fatigue

1 (0.3)

0 (0.0)

1 (0.4)

3 (2.1)

5 (0.5)

0.031*

>.999

>.999

0.103

Hyperhidrosis

0 (0.0)

0 (0.0)

1 (0.4)

2 (1.4)

3 (0.3)

0.019*

 

0.487

0.105

  1. Abbreviations: CK creatine phosphokinase, ITT intent-to-treat, N/n number of patients, TEAE treatment-emergent adverse event.
  2. Groups: PBO = placebo; LY40 = LY2140023 monohydrate 40 mg; LY80 = LY2140023 monohydrate 80 mg; RIS = risperidone.
  3. Note: p-values are calculated from Fisher's exact test; * indicates nominal 2-sided p-value < = 0.05.
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BMC Psychiatry

ISSN: 1471-244X

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