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. 2005 Jul 20;2005(3):CD001715. doi: 10.1002/14651858.CD001715.pub2

Comparison 1. SERTINDOLE versus PLACEBO.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Leaving study early: 1. Due to adverse events 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
1.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.62 [0.11, 3.53]
1.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.31 [0.03, 2.91]
1.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 2.37 [0.67, 8.43]
2 Leaving study early: 2. Due to ineffective treatment 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
2.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.87 [0.48, 1.55]
2.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.88 [0.49, 1.58]
2.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.61 [0.32, 1.18]
3 Global improvement: 1. CGI total scores (high = poor) 1   Mean Difference (IV, Fixed, 95% CI) Totals not selected
3.1 Sertindole 8mg 1   Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
3.2 Sertindole 12mg 1   Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
3.3 Sertindole 20mg 1   Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
4 Global improvement: 2. very much improved (CGI) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
4.1 Sertindole 20mg/day 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 7.11 [0.92, 54.81]
5 Mental state: 1. BPRS total scores (high = poor) 1   Mean Difference (IV, Fixed, 95% CI) Totals not selected
5.1 Sertindole 8mg 1   Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
5.2 Sertindole 12mg 1   Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
5.3 Sertindole 20mg 1   Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
6 Mental State: 2. PANSS total scores (high = poor). 1   Mean Difference (IV, Fixed, 95% CI) Totals not selected
6.1 Sertindole 8mg 1   Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
6.2 Sertindole 12mg 1   Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
6.3 Sertindole 20mg 1   Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
7 Extrapyramidal adverse effects: 1. EPS symptoms 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
7.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.26 [0.06, 1.21]
7.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.94 [0.36, 2.48]
7.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.38 [0.10, 1.39]
8 Extrapyramidal adverse effects: 2. Use of EPS medication 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
8.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.69 [0.16, 2.94]
8.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.71 [0.17, 2.99]
8.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.10 [0.01, 1.79]
9 Extrapyramidal adverse effects: 3. Akathisia ‐ Barnes Akathisia scores (data skewed, high=poor)     Other data No numeric data
9.1 Sertindole 8mg     Other data No numeric data
9.2 Sertindole 12mg     Other data No numeric data
9.3 Sertindole 20mg     Other data No numeric data
10 Extrapyramidal adverse effects: 4. General ‐ Simpson‐Angus scale scores (data skewed, high=poor).     Other data No numeric data
10.1 Sertindole 8mg     Other data No numeric data
10.2 Sertindole 12mg     Other data No numeric data
10.3 Sertindole 20mg     Other data No numeric data
11 Extrapyramidal adverse effects: 5. Tardive dyskinesia ‐ AIMS scores (data skewed, high=poor)     Other data No numeric data
11.1 Sertindole 8mg     Other data No numeric data
11.2 Sertindole 12mg     Other data No numeric data
11.3 Sertindole 20mg     Other data No numeric data
12 Extrapyramidal adverse effects: 6. Akathisia 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
12.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 2.77 [0.12, 66.49]
12.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
12.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
13 Extrapyramidal adverse effects: 7. Cogwheel rigidity 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
13.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.18 [0.01, 3.76]
13.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.19 [0.01, 3.83]
13.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.18 [0.01, 3.62]
14 Extrapyramidal adverse effects: 8. Hypertonia 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
14.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 4.62 [0.23, 93.91]
14.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 4.71 [0.23, 95.70]
14.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
15 Extrapyramidal adverse effects: 9. Tremor 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
15.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 1.85 [0.17, 19.71]
15.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.94 [0.06, 14.63]
15.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.30 [0.01, 7.12]
16 Other adverse effects: 1. Cardiovascular ‐ hypotension (postural) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
16.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 3.69 [0.43, 31.89]
16.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 2.82 [0.30, 26.22]
16.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 3.56 [0.41, 30.72]
17 Other adverse effects: 2. Cardiovascular ‐ peripheral oedema 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
17.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 6.47 [0.34, 122.13]
17.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 2.83 [0.12, 67.76]
17.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 4.45 [0.22, 90.54]
18 Other adverse effects: 4. Gastrointestinal ‐ constipation 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
18.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 2.15 [0.59, 7.86]
18.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 1.25 [0.30, 5.32]
18.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 1.78 [0.47, 6.72]
19 Other adverse effects: 3. Gastrointestinal ‐ dyspepsia 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
19.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.92 [0.32, 2.67]
19.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.47 [0.12, 1.78]
19.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.74 [0.24, 2.27]
20 Other adverse effects: 4. Sleep related ‐ insomnia 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
20.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.54 [0.23, 1.25]
20.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.94 [0.47, 1.89]
20.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.67 [0.31, 1.44]
21 Other adverse effects: 5. Sleep related ‐ somnolence 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
21.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 1.38 [0.24, 7.93]
21.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 2.35 [0.48, 11.56]
21.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 2.67 [0.56, 12.59]
22 Other adverse effects: 6. Dizziness 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
22.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.92 [0.24, 3.49]
22.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.47 [0.09, 2.45]
22.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 1.33 [0.40, 4.44]
23 Other adverse effects: 7. Dry mouth 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
23.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 1.85 [0.17, 19.71]
23.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.94 [0.06, 14.63]
23.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 3.56 [0.41, 30.72]
24 Other adverse effects: 8. Fever 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
24.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 12.02 [0.70, 207.80]
24.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 4.71 [0.23, 95.70]
24.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
25 Other adverse effects: 9. Headache 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
25.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 1.21 [0.66, 2.21]
25.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.94 [0.49, 1.82]
25.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.96 [0.50, 1.83]
26 Other adverse effects: 10. Increased salivation 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
26.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.31 [0.01, 7.39]
26.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.94 [0.06, 14.63]
26.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.30 [0.01, 7.12]
27 Other adverse effects: 11. Infection 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
27.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.92 [0.32, 2.67]
27.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 0.16 [0.02, 1.26]
27.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 1.33 [0.51, 3.47]
28 Other adverse effects: 12. Myalgia 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
28.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 0.62 [0.18, 2.05]
28.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 1.41 [0.54, 3.67]
28.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 0.44 [0.12, 1.68]
29 Other adverse effects: 13. Rhinitis 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
29.1 Sertindole 8mg 1 100 Risk Ratio (M‐H, Fixed, 95% CI) 1.66 [0.60, 4.61]
29.2 Sertindole 12mg 1 99 Risk Ratio (M‐H, Fixed, 95% CI) 1.32 [0.45, 3.87]
29.3 Sertindole 20mg 1 102 Risk Ratio (M‐H, Fixed, 95% CI) 2.49 [0.97, 6.40]