1 Leaving study early: 1. Any reason |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
1.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.13 [0.84, 1.52] |
1.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.96 [0.71, 1.32] |
1.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.68, 1.28] |
1.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.81 [0.63, 1.05] |
2 Leaving study early: 2. Any adverse event |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
2.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
17.70 [1.03, 303.37] |
2.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
18.70 [1.10, 317.94] |
2.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
12.70 [0.72, 223.04] |
2.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.28 [0.83, 1.97] |
3 Leaving study early: 3. Abnormal blood chemistry values |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
3.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.24, 103.22] |
4 Leaving study early: 4. Due to leukopenia |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
4.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.24, 103.22] |
5 Leaving study early: 5. Due to prolonged QT intervals |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
5.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.0 [0.18, 21.81] |
6 Leaving study early: 6. insufficient treatment response |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
6.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.27 [0.72, 2.25] |
6.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.26 [0.71, 2.21] |
6.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.03 [0.57, 1.87] |
6.4 Sertindole 24mg |
1 |
242 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.07 [0.58, 1.95] |
7 Leaving study early: 7. patient's decision |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
7.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.55, 1.99] |
7.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.68 [0.33, 1.40] |
7.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.79 [0.40, 1.58] |
7.4 Sertindole 24mg |
1 |
242 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.67 [0.32, 1.41] |
8 Leaving study early: 8. non‐compliance |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
8.4 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.15 [0.04, 0.67] |
9 Mental state: 1. Improvement in PANSS=30% |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
9.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.72 [0.56, 0.93] |
9.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.97 [0.79, 1.20] |
9.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.87 [0.70, 1.09] |
9.4 Sertindole 24mg |
1 |
242 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.91 [0.73, 1.14] |
10 Mental state: 2. Improvement in PANSS=40% |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
10.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.66 [0.48, 0.92] |
10.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.97 [0.74, 1.27] |
10.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.96 [0.73, 1.26] |
10.4 Sertindole 24mg |
1 |
242 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.71, 1.24] |
11 Mental state: 3. Improvement in PANSS=50% |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
11.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.61 [0.40, 0.93] |
11.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.05 [0.75, 1.47] |
11.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.82 [0.57, 1.18] |
11.4 Sertindole 24mg |
1 |
242 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.87 [0.60, 1.26] |
12 Extrapyramidal adverse effects: 1. General ‐ extrapyramidal syndrome |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
12.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.09 [0.01, 0.66] |
12.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.11, 0.99] |
12.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.24 [0.07, 0.84] |
12.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.59 [0.43, 0.80] |
13 Extrapyramidal adverse effects: 2. Akathisia |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
13.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.17 [0.06, 0.46] |
13.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.08 [0.02, 0.33] |
13.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.31 [0.15, 0.67] |
13.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.47 [0.31, 0.71] |
14 Extrapyramidal adverse effects: 3. Dystonia |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
14.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.06 [0.00, 1.05] |
14.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.06 [0.00, 0.99] |
14.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.37 [0.10, 1.35] |
14.4 Sertindole 24mg |
1 |
242 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.27 [0.06, 1.23] |
15 Extrapyramidal adverse effects: 4. Hypertonia |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
15.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.40 [0.15, 1.09] |
15.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.45 [0.18, 1.16] |
15.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.68 [0.30, 1.52] |
15.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.45 [0.26, 0.76] |
16 Extrapyramidal adverse effects: 5. Hypokinesia |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
16.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.15 [0.01, 2.85] |
16.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.66 [0.11, 3.86] |
16.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.65 [0.11, 3.83] |
16.4 Sertindole 24mg |
1 |
242 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.14 [0.55, 8.35] |
17 Extrapyramidal adverse effects: 6. Tremor |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
17.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.30 [0.12, 0.71] |
17.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.19 [0.07, 0.53] |
17.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.23 [0.09, 0.60] |
17.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.36 [0.22, 0.60] |
18 Other adverse effects: 1. Any event |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
18.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.74 [0.62, 0.88] |
18.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.85 [0.73, 0.98] |
18.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.82 [0.70, 0.96] |
18.4 Sertindole 24mg |
1 |
242 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.87 [0.75, 1.00] |
19 Other adverse effects: 2. Cardiovascular ‐ postural hypotension |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
19.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.35, 3.14] |
19.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.48 [0.54, 4.03] |
19.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.79 [0.68, 4.69] |
19.4 Sertindole 24mg |
1 |
242 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.67 [1.07, 6.65] |
20 Other adverse effects: 3. Cardiovascular ‐ QTc interval=500msec |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
20.1 Sertindole 16mg |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
20.2 Sertindole 24mg |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
21 Other adverse effects: 4. Cardiovascular ‐ QT intervals exceeding 500msec |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
21.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.12, 73.02] |
22 Other adverse effects: 5. Cardiovascular ‐ QTc intervals of at least 500msec |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
22.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
23.0 [1.37, 386.58] |
23 Other adverse effects: 6. Gastrointestinal ‐ dyspepsia |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
23.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.06 [0.00, 1.05] |
23.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.06 [0.00, 0.99] |
23.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.37 [0.10, 1.35] |
23.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.57 [0.30, 1.07] |
24 Other adverse effects: 7. Gastrointestinal ‐ nausea |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
24.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.0 [0.54, 1.84] |
25 Other adverse effects: 8. Gastrointestinal ‐ vomiting |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
25.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.69 [0.33, 1.43] |
26 Other adverse effects: 9. Sleep related ‐ somnolence |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
26.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.09 [0.01, 0.66] |
26.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.49 [0.19, 1.27] |
26.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.41 [0.15, 1.12] |
26.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.64 [0.43, 0.95] |
27 Other adverse effects: 10. Sleep related ‐ insomnia |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
27.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.92 [0.66, 1.28] |
28 Other adverse effects: 11. Accidental injury |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
28.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.6 [0.27, 1.33] |
29 Other adverse effects: 12. Asthenia |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
29.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.43 [0.16, 1.19] |
29.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.57 [0.23, 1.41] |
29.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.81 [0.36, 1.82] |
29.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.91 [0.55, 1.51] |
30 Other adverse effects: 13. Coughing |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
30.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.0 [0.51, 1.97] |
31 Other adverse effects: 14. Dizziness |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
31.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.43, 2.53] |
31.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.66 [0.24, 1.79] |
31.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.41 [0.63, 3.18] |
31.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.96 [0.61, 1.50] |
32 Other adverse effects: 15. Dry mouth |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
32.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.83 [0.94, 3.56] |
33 Other adverse effects: 16. Headache |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
33.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.11 [0.58, 2.15] |
33.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.05 [0.54, 2.03] |
33.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.24 [0.66, 2.32] |
33.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.23 [0.90, 1.68] |
34 Other adverse effects: 17. Infection |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
34.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.61, 1.45] |
35 Other adverse effects: 18. Myalgia |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
35.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.91 [0.53, 1.57] |
36 Other adverse effects: 19. Overdose |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
36.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.47 [0.21, 1.05] |
37 Other adverse effects: 20. Psychosis |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
37.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.65 [0.31, 1.33] |
38 Other adverse effects: 21. Rhinitis |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
38.1 Sertindole 8mg |
1 |
245 |
Risk Ratio (M‐H, Fixed, 95% CI) |
4.17 [0.47, 36.75] |
38.2 Sertindole 16mg |
1 |
252 |
Risk Ratio (M‐H, Fixed, 95% CI) |
10.83 [1.42, 82.61] |
38.3 Sertindole 20mg |
1 |
253 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.91 [0.44, 34.47] |
38.4 Sertindole 24mg |
2 |
524 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.09 [1.39, 3.13] |
39 Other adverse effects: 22. Weight gain |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
39.1 Sertindole 24mg |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
40 Service utilisation: 1. Requiring psychiatric hospitalisation |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
40.1 Sertindole 24mg |
1 |
282 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.17 [0.04, 0.73] |