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] |