| 1 Leaving the study early: 1. Any reason |
24 |
4067 |
Risk Ratio (M‐H, Random, 95% CI) |
1.10 [0.92, 1.31] |
| 1.1 short term |
21 |
2500 |
Risk Ratio (M‐H, Random, 95% CI) |
1.09 [0.83, 1.42] |
| 1.2 medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
1.92 [0.86, 4.25] |
| 1.3 long term |
2 |
1520 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.94, 1.09] |
| 2 Leaving the study early: 2. Due to adverse events |
12 |
3214 |
Risk Ratio (M‐H, Random, 95% CI) |
1.11 [0.82, 1.52] |
| 2.1 short term |
9 |
1661 |
Risk Ratio (M‐H, Random, 95% CI) |
1.13 [0.70, 1.83] |
| 2.2 medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
2.88 [0.12, 67.29] |
| 2.3 long term |
2 |
1506 |
Risk Ratio (M‐H, Random, 95% CI) |
1.07 [0.79, 1.47] |
| 3 Leaving the study early: 3. Due to relapse / worsening or no improvement |
10 |
2532 |
Risk Ratio (M‐H, Random, 95% CI) |
1.10 [0.90, 1.35] |
| 3.1 short term |
7 |
979 |
Risk Ratio (M‐H, Random, 95% CI) |
1.26 [0.78, 2.03] |
| 3.2 medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
1.15 [0.41, 3.25] |
| 3.3 long term |
2 |
1506 |
Risk Ratio (M‐H, Random, 95% CI) |
1.07 [0.85, 1.34] |
| 4 Global state: 1. Change over time ‐ no better or deterioration (ITT) |
17 |
1850 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.92, 1.17] |
| 4.1 short term |
16 |
1803 |
Risk Ratio (M‐H, Random, 95% CI) |
1.03 [0.90, 1.17] |
| 4.2 medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
1.20 [0.73, 1.97] |
| 5 Global state: 2. Average endpoint score (CGI‐S, high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 5.1 short term |
1 |
294 |
Mean Difference (IV, Random, 95% CI) |
‐0.20 [‐0.56, 0.16] |
| 6 Mental state: 2a. State ‐ BPRS score reduction ('no effect') |
4 |
383 |
Risk Ratio (M‐H, Random, 95% CI) |
1.24 [0.61, 2.52] |
| 6.1 less than 20% reduction ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
0.81 [0.61, 1.08] |
| 6.2 less than 25% reduction ‐ short term |
2 |
129 |
Risk Ratio (M‐H, Random, 95% CI) |
1.38 [0.46, 4.12] |
| 6.3 less than 30% reduction ‐ short term |
1 |
147 |
Risk Ratio (M‐H, Random, 95% CI) |
3.44 [0.86, 13.79] |
| 7 Mental state: 2b. State ‐ BPRS total score (high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 7.1 short term |
1 |
64 |
Mean Difference (IV, Random, 95% CI) |
1.10 [‐1.26, 3.46] |
| 8 Mental state: 2c. State ‐ BPRS end score (high = poor, skewed data) |
|
|
Other data |
No numeric data |
| 8.1 medium term |
|
|
Other data |
No numeric data |
| 9 Mental state: 2c. State ‐ BPRS end score (high = poor, skewed data) |
|
|
Other data |
No numeric data |
| 9.1 long term |
|
|
Other data |
No numeric data |
| 10 Mental state: 2d. State ‐ PANSS score reduction ('no effect') |
3 |
231 |
Risk Ratio (M‐H, Random, 95% CI) |
0.90 [0.67, 1.20] |
| 10.1 less than 20% reduction ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
0.86 [0.64, 1.15] |
| 10.2 less than 25% reduction ‐ short term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
2.0 [0.40, 10.11] |
| 10.3 less than 40% reduction ‐ short term |
1 |
64 |
Risk Ratio (M‐H, Random, 95% CI) |
1.7 [0.30, 9.50] |
| 11 Mental state: 2e. State ‐ PANSS: mean change/ endpoint from baseline (high = poor) |
3 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
| 11.1 total ‐ short term |
3 |
232 |
Mean Difference (IV, Random, 95% CI) |
3.65 [1.86, 5.43] |
| 11.2 positive ‐ short term |
2 |
125 |
Mean Difference (IV, Random, 95% CI) |
4.45 [‐1.00, 11.90] |
| 11.3 negative ‐ short term |
2 |
125 |
Mean Difference (IV, Random, 95% CI) |
1.20 [0.07, 2.33] |
| 11.4 general psychopathology ‐ short term |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
‐0.39 [‐0.79, 0.01] |
| 12 Mental state: 2f. State ‐ PANSS total change score (high = poor, skewed data) |
|
|
Other data |
No numeric data |
| 12.1 short term |
|
|
Other data |
No numeric data |
| 13 Mental state: 2g. State ‐ PANSS total endpoint score (high = poor, skewed data) |
|
|
Other data |
No numeric data |
| 13.1 long term |
|
|
Other data |
No numeric data |
| 14 Behaviour: 1. Behaviour subscale of the Psychiatric Rating Scale: no better or worse |
3 |
244 |
Risk Ratio (M‐H, Random, 95% CI) |
1.03 [0.86, 1.23] |
| 15 Adverse events: Extrapyramidal and movement disorders |
22 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 15.1 akathisia ‐ short term |
11 |
1736 |
Risk Ratio (M‐H, Random, 95% CI) |
1.12 [0.79, 1.58] |
| 15.2 akathisia ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
2.88 [0.64, 12.82] |
| 15.3 akathisia ‐ long term |
2 |
1346 |
Risk Ratio (M‐H, Random, 95% CI) |
1.10 [0.65, 1.85] |
| 15.4 akinesia ‐ short term |
2 |
475 |
Risk Ratio (M‐H, Random, 95% CI) |
0.44 [0.11, 1.70] |
| 15.5 ataxia ‐ short term |
4 |
514 |
Risk Ratio (M‐H, Random, 95% CI) |
0.77 [0.25, 2.41] |
| 15.6 dyskinesia ‐ short term |
8 |
1282 |
Risk Ratio (M‐H, Random, 95% CI) |
0.63 [0.39, 1.04] |
| 15.7 dyskinesia ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
0.48 [0.05, 4.93] |
| 15.8 dystonia ‐ short term |
4 |
416 |
Risk Ratio (M‐H, Random, 95% CI) |
1.36 [0.23, 8.16] |
| 15.9 extrapyramidal signs ‐ short term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
0.90 [0.62, 1.31] |
| 15.10 EPS ‐ short term |
3 |
429 |
Risk Ratio (M‐H, Random, 95% CI) |
2.23 [0.88, 5.67] |
| 15.11 EPS ‐ long term |
1 |
1281 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.58, 1.73] |
| 15.12 hyperkinesia ‐ short term |
2 |
135 |
Risk Ratio (M‐H, Random, 95% CI) |
2.64 [0.88, 7.91] |
| 15.13 myotony ‐ short term |
1 |
147 |
Risk Ratio (M‐H, Random, 95% CI) |
2.06 [0.92, 4.62] |
| 15.14 parkinsonism ‐ short term |
7 |
1254 |
Risk Ratio (M‐H, Random, 95% CI) |
1.10 [0.89, 1.35] |
| 15.15 rigidity ‐ short term |
4 |
210 |
Risk Ratio (M‐H, Random, 95% CI) |
1.81 [0.38, 8.64] |
| 15.16 rigidity ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
0.64 [0.12, 3.48] |
| 15.17 tardive dyskinesia ‐ long term |
1 |
1073 |
Risk Ratio (M‐H, Random, 95% CI) |
1.23 [0.89, 1.70] |
| 15.18 tremor ‐ short term |
4 |
329 |
Risk Ratio (M‐H, Random, 95% CI) |
1.79 [0.73, 4.39] |
| 15.19 tremor ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
1.34 [0.50, 3.63] |
| 15.20 use of antiparkinsonian drugs ‐ short term |
8 |
996 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.83, 1.30] |
| 15.21 use of antiparkinsonian drugs ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
0.14 [0.01, 2.52] |
| 15.22 use of antiparkinsonian drugs ‐ long term |
1 |
46 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.34, 26.76] |
| 16 Adverse events: Movement disorders ‐ TESS total score (high = poor, skewed data) |
|
|
Other data |
No numeric data |
| 16.1 short term |
|
|
Other data |
No numeric data |
| 17 Other adverse events: 1. Anticholinergic |
12 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 17.1 blurred vision ‐ short term |
8 |
1028 |
Risk Ratio (M‐H, Random, 95% CI) |
0.80 [0.40, 1.61] |
| 17.2 dry mouth ‐ short term |
9 |
1017 |
Risk Ratio (M‐H, Random, 95% CI) |
1.43 [0.82, 2.47] |
| 17.3 dry mouth ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
1.92 [0.19, 19.73] |
| 17.4 increased salivation ‐ short term |
2 |
211 |
Risk Ratio (M‐H, Random, 95% CI) |
0.42 [0.00, 35.79] |
| 17.5 increased salivation ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.87] |
| 17.6 nasal congestion ‐ short term |
1 |
80 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 71.51] |
| 18 Other adverse events: 2. Arousal |
19 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 18.1 agitation ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
1.05 [0.63, 1.77] |
| 18.2 agitation ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.33, 27.23] |
| 18.3 anxiety ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
1.19 [0.63, 2.24] |
| 18.4 anxiety ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
1.25 [0.37, 4.21] |
| 18.5 depression ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
1.34 [0.76, 2.35] |
| 18.6 drowsiness ‐ short term |
5 |
442 |
Risk Ratio (M‐H, Random, 95% CI) |
0.88 [0.53, 1.44] |
| 18.7 emotional indifference ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
1.06 [0.58, 1.94] |
| 18.8 excitation ‐ short term |
4 |
463 |
Risk Ratio (M‐H, Random, 95% CI) |
2.59 [0.57, 11.84] |
| 18.9 excitation ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
1.28 [0.32, 5.10] |
| 18.10 increased dream activity ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
1.51 [0.62, 3.67] |
| 18.11 insomnia ‐ short term |
11 |
1422 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.86, 1.18] |
| 18.12 insomnia ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
0.24 [0.03, 1.99] |
| 18.13 insomnia ‐ long term |
2 |
1520 |
Risk Ratio (M‐H, Random, 95% CI) |
2.15 [0.41, 11.29] |
| 18.14 need of additional benzodiazepines ‐ short term |
5 |
448 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.74, 1.16] |
| 18.15 need of additional benzodiazepines ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
1.60 [0.43, 5.93] |
| 18.16 need of additional benzodiazepines ‐ long term |
1 |
46 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.76, 1.09] |
| 18.17 restlessness ‐ short term |
1 |
147 |
Risk Ratio (M‐H, Random, 95% CI) |
3.75 [1.96, 7.18] |
| 18.18 sleepiness/sedation ‐ short term |
7 |
991 |
Risk Ratio (M‐H, Random, 95% CI) |
1.19 [0.87, 1.62] |
| 18.19 sleepiness/ sedation ‐ long term |
1 |
1460 |
Risk Ratio (M‐H, Random, 95% CI) |
0.98 [0.79, 1.21] |
| 18.20 somnolence ‐ short term |
1 |
147 |
Risk Ratio (M‐H, Random, 95% CI) |
0.36 [0.13, 0.98] |
| 18.21 tension ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.63, 1.50] |
| 19 Other adverse events: 3. At least one |
9 |
974 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.95, 1.09] |
| 19.1 short term |
9 |
974 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.95, 1.09] |
| 20 Other adverse events: 4. Cardiovascular |
13 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 20.1 angina pectoris ‐ short term |
2 |
391 |
Risk Ratio (M‐H, Random, 95% CI) |
0.57 [0.26, 1.26] |
| 20.2 bradycardia ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
| 20.3 dizziness ‐ short term |
1 |
147 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.59, 1.40] |
| 20.4 faintness, dizziness, weakness ‐ short term |
7 |
930 |
Risk Ratio (M‐H, Random, 95% CI) |
1.27 [0.82, 1.96] |
| 20.5 faintness, dizziness, weakness ‐ long term |
1 |
1460 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.70, 1.50] |
| 20.6 orthostatic hypotension ‐ short term |
1 |
64 |
Risk Ratio (M‐H, Random, 95% CI) |
0.17 [0.02, 1.31] |
| 20.7 hypotension ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.87] |
| 20.8 lassitude ‐ short term |
2 |
305 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.68, 1.45] |
| 20.9 palpitations ‐ short term |
2 |
391 |
Risk Ratio (M‐H, Random, 95% CI) |
0.22 [0.07, 0.73] |
| 20.10 tachycardia ‐ short term |
4 |
413 |
Risk Ratio (M‐H, Random, 95% CI) |
0.54 [0.21, 1.39] |
| 21 Other adverse events: 5. Central nervous system |
11 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 21.1 confusion ‐ short term |
1 |
198 |
Risk Ratio (M‐H, Random, 95% CI) |
0.67 [0.11, 3.90] |
| 21.2 difficulty in concentration ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
1.06 [0.71, 1.58] |
| 21.3 disturbance of consciousness ‐ short term |
4 |
648 |
Risk Ratio (M‐H, Random, 95% CI) |
0.84 [0.10, 6.78] |
| 21.4 dysarticulation ‐ short term |
1 |
198 |
Risk Ratio (M‐H, Random, 95% CI) |
0.83 [0.38, 1.84] |
| 21.5 electroencephalogram (increase) ‐ short term |
1 |
25 |
Risk Ratio (M‐H, Random, 95% CI) |
0.57 [0.09, 3.64] |
| 21.6 headache ‐ short term |
9 |
1304 |
Risk Ratio (M‐H, Random, 95% CI) |
0.72 [0.50, 1.03] |
| 21.7 headache ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.71 [0.25, 2.00] |
| 21.8 hypertonia ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
| 21.9 paraesthesia ‐ short term |
6 |
726 |
Risk Ratio (M‐H, Random, 95% CI) |
1.37 [0.57, 3.26] |
| 21.10 seizure ‐ short term |
1 |
198 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
| 21.11 vertigo ‐ short term |
2 |
364 |
Risk Ratio (M‐H, Random, 95% CI) |
0.87 [0.44, 1.74] |
| 22 Other adverse events: 6. Endocrine |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 22.1 amenorrhoea (women only) ‐ short term |
1 |
30 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 68.26] |
| 22.2 amenorrhoea ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
0.32 [0.04, 2.85] |
| 22.3 gynaecomastia ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
0.15 [0.01, 2.85] |
| 22.4 lactation ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
0.21 [0.01, 4.30] |
| 22.5 lactation ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
0.19 [0.01, 3.80] |
| 22.6 menorrhagia (women only) ‐ short term |
1 |
30 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 68.26] |
| 23 Other adverse events: 7. Gastrointestinal |
13 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 23.1 constipation ‐ short term |
9 |
1017 |
Risk Ratio (M‐H, Random, 95% CI) |
0.71 [0.40, 1.28] |
| 23.2 diarrhoea ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
0.15 [0.01, 2.85] |
| 23.3 diarrhoea ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.22, 4.56] |
| 23.4 dyspepsia ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.59 [0.27, 1.30] |
| 23.5 gastroenteritis ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
| 23.6 icterus ‐ short term |
3 |
450 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.96] |
| 23.7 loss of appetite ‐ short term |
6 |
699 |
Risk Ratio (M‐H, Random, 95% CI) |
0.96 [0.69, 1.33] |
| 23.8 nausea and vomiting ‐ short term |
7 |
806 |
Risk Ratio (M‐H, Random, 95% CI) |
1.12 [0.75, 1.67] |
| 23.9 nausea and vomiting ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
0.32 [0.04, 2.85] |
| 23.10 nausea and vomiting ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.07, 15.26] |
| 23.11 weight loss ‐ short term |
2 |
171 |
Risk Ratio (M‐H, Random, 95% CI) |
3.03 [0.75, 12.20] |
| 23.12 weight gain ‐ short term |
3 |
235 |
Risk Ratio (M‐H, Random, 95% CI) |
1.53 [0.29, 8.10] |
| 23.13 weight gain ‐ long term |
1 |
1316 |
Risk Ratio (M‐H, Random, 95% CI) |
0.66 [0.46, 0.95] |
| 24 Other adverse events: 8. Skin |
8 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 24.1 cellulitis ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.87] |
| 24.2 eczema ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
| 24.3 fungal dermatitis ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.87] |
| 24.4 oedema |
1 |
105 |
Risk Ratio (M‐H, Random, 95% CI) |
3.17 [0.13, 76.16] |
| 24.5 pruritus ‐ short term |
3 |
498 |
Risk Ratio (M‐H, Random, 95% CI) |
0.77 [0.31, 1.93] |
| 24.6 rash ‐ short term |
7 |
806 |
Risk Ratio (M‐H, Random, 95% CI) |
0.90 [0.37, 2.17] |
| 24.7 rash ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.07, 15.26] |
| 24.8 sweating ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
0.66 [0.23, 1.89] |
| 25 Other adverse events: 9. Genitourinary |
7 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 25.1 diminished sexual desire |
4 |
1958 |
Risk Ratio (M‐H, Random, 95% CI) |
1.03 [0.82, 1.30] |
| 25.2 ejaculatory dysfunction (men only) ‐ short term |
1 |
77 |
Risk Ratio (M‐H, Random, 95% CI) |
0.18 [0.02, 1.43] |
| 25.3 erectile dysfunction (men only) ‐ short term |
1 |
77 |
Risk Ratio (M‐H, Random, 95% CI) |
0.90 [0.30, 2.70] |
| 25.4 galactorrhoea ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
0.15 [0.01, 2.85] |
| 25.5 galactorrhoea/ gynaecomastia ‐ long term |
1 |
1460 |
Risk Ratio (M‐H, Random, 95% CI) |
0.56 [0.20, 1.56] |
| 25.6 increased sexual desire ‐ short term |
2 |
212 |
Risk Ratio (M‐H, Random, 95% CI) |
1.06 [0.22, 5.01] |
| 25.7 micturition disturbances ‐ short term |
5 |
635 |
Risk Ratio (M‐H, Random, 95% CI) |
0.59 [0.22, 1.63] |
| 25.8 orgastic dysfunction ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
5.28 [0.26, 107.51] |
| 26 Other adverse events: 10. Others |
11 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 26.1 abdominal pain ‐ medium term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
0.14 [0.01, 2.52] |
| 26.2 allergic reaction ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.87] |
| 26.3 back pain ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
| 26.4 cramps ‐ short term |
3 |
450 |
Risk Ratio (M‐H, Random, 95% CI) |
0.47 [0.05, 4.46] |
| 26.5 failing memory ‐ short term |
1 |
107 |
Risk Ratio (M‐H, Random, 95% CI) |
1.27 [0.60, 2.68] |
| 26.6 muscle pain ‐ short term |
1 |
80 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 71.51] |
| 26.7 sweating ‐ short term |
6 |
726 |
Risk Ratio (M‐H, Random, 95% CI) |
0.73 [0.39, 1.37] |
| 26.8 incontinence nocturia ‐ long term |
1 |
1460 |
Risk Ratio (M‐H, Random, 95% CI) |
0.41 [0.18, 0.92] |
| 26.9 urinary hesitancy, dry mouth, constipation ‐ long term |
1 |
1460 |
Risk Ratio (M‐H, Random, 95% CI) |
0.86 [0.67, 1.10] |
| 26.10 suicide attempt ‐ long term |
1 |
1460 |
Risk Ratio (M‐H, Random, 95% CI) |
0.77 [0.09, 6.33] |
| 26.11 psychosis ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.63 [0.29, 1.40] |
| 27 Other adverse events: 11. Lab data |
7 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 27.1 abnormal EKG/ ECG ‐ short term |
2 |
211 |
Risk Ratio (M‐H, Random, 95% CI) |
2.44 [0.62, 9.59] |
| 27.2 abnormal liver function ‐ short term |
1 |
64 |
Risk Ratio (M‐H, Random, 95% CI) |
4.0 [0.92, 17.40] |
| 27.3 anemia ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.07, 15.26] |
| 27.4 decrease in white blood cell count and haemoglobin level ‐ short term |
1 |
64 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.07, 15.30] |
| 27.5 ECG – atrial extrasystole & flattening of T‐wave in V6 ‐ short term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
6.72 [0.37, 123.33] |
| 27.6 ECG abnormality (1st degree atrioventricular block) |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
15.82 [2.12, 118.27] |
| 27.7 high white blood cell count ‐ short term |
1 |
147 |
Risk Ratio (M‐H, Random, 95% CI) |
1.03 [0.10, 11.09] |
| 27.8 increase in white blood cell count and haemoglobin level ‐ short term |
1 |
64 |
Risk Ratio (M‐H, Random, 95% CI) |
0.5 [0.10, 2.54] |
| 27.9 liver function (GPT+) ‐ short term |
1 |
147 |
Risk Ratio (M‐H, Random, 95% CI) |
0.69 [0.23, 2.02] |
| 27.10 low white blood cell count ‐ short term |
1 |
147 |
Risk Ratio (M‐H, Random, 95% CI) |
0.17 [0.02, 1.28] |
| 27.11 prolactin: clinically significant high levels |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
12.66 [6.06, 26.45] |
| 27.12 prolonged QTc interval (≥450 msec and ≥10% increase from baseline) ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
| 27.13 rise in alkaline phosphate and GOT levels ‐ short term |
1 |
64 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 71.00] |
| 27.14 slight T‐wave changes on EKG ‐ short term |
1 |
50 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.15, 6.55] |
| 27.15 ventricular extrasystole ‐ short term |
1 |
47 |
Risk Ratio (M‐H, Random, 95% CI) |
0.32 [0.01, 7.48] |
| 28 Other adverse events: 11a. Lab data (skew) |
|
|
Other data |
No numeric data |
| 28.1 weight change |
|
|
Other data |
No numeric data |
| 29 Other adverse events: 12. Any serious adverse event |
2 |
1760 |
Risk Ratio (M‐H, Random, 95% CI) |
0.98 [0.68, 1.41] |
| 29.1 short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.79 [0.49, 1.28] |
| 29.2 long term |
1 |
1460 |
Risk Ratio (M‐H, Random, 95% CI) |
1.15 [0.78, 1.69] |
