1 Mental state: no clinically significant response in psychotic symptoms (defined by various scale total score change) ‐ short term (up to 12 weeks) |
7 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
1.1 defined by PANSS<30% decline |
3 |
707 |
Risk Ratio (M‐H, Random, 95% CI) |
0.74 [0.67, 0.83] |
1.2 defined by PANSS/BPRS <20% decline |
6 |
864 |
Risk Ratio (M‐H, Random, 95% CI) |
0.64 [0.52, 0.78] |
2 Leaving the study early ‐ short term (up to 12 weeks) |
12 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
2.1 any reason |
12 |
2261 |
Risk Ratio (M‐H, Random, 95% CI) |
0.69 [0.62, 0.78] |
2.2 due to adverse events |
10 |
2081 |
Risk Ratio (M‐H, Random, 95% CI) |
0.78 [0.59, 1.03] |
2.3 due to lack of efficacy |
11 |
2211 |
Risk Ratio (M‐H, Random, 95% CI) |
0.39 [0.29, 0.51] |
2.4 due to noncompliance |
4 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
1.15 [0.33, 4.05] |
2.5 lost to follow‐up |
6 |
1545 |
Risk Ratio (M‐H, Random, 95% CI) |
0.79 [0.25, 2.56] |
2.6 protocol violation |
4 |
1257 |
Risk Ratio (M‐H, Random, 95% CI) |
0.79 [0.39, 1.62] |
2.7 reported death |
10 |
1532 |
Risk Ratio (M‐H, Random, 95% CI) |
3.07 [0.13, 74.28] |
2.8 withdrawal of consent |
7 |
1589 |
Risk Ratio (M‐H, Random, 95% CI) |
1.12 [0.80, 1.56] |
2.9 other |
3 |
615 |
Risk Ratio (M‐H, Random, 95% CI) |
1.03 [0.68, 1.57] |
3 Global state: 1. average endpoint scores of CGI severity scale (high=poor) ‐ short term (up to 12 weeks) |
3 |
457 |
Mean Difference (IV, Random, 95% CI) |
‐0.81 [‐0.89, ‐0.73] |
4 Global state: 2. no significant clinical improvement CGI ‐ short term (up to 12 weeks) |
4 |
594 |
Risk Ratio (M‐H, Random, 95% CI) |
0.69 [0.57, 0.83] |
5 Global state: 3. needing additional medication ‐ short term (up to 12 weeks) |
6 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
5.1 benzodiazepine |
1 |
42 |
Risk Ratio (M‐H, Random, 95% CI) |
0.96 [0.77, 1.20] |
5.2 benzodiazepine derivatives ‐ Lorazepam |
2 |
228 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.68, 1.27] |
5.3 benzodiazepine derivatives ‐ Nitrazepam |
1 |
184 |
Risk Ratio (M‐H, Random, 95% CI) |
0.51 [0.10, 2.72] |
5.4 benzodiazepine related drugs ‐ Zolpidem |
1 |
184 |
Risk Ratio (M‐H, Random, 95% CI) |
0.81 [0.53, 1.23] |
5.5 sedative/hypnotic |
2 |
230 |
Risk Ratio (M‐H, Random, 95% CI) |
0.86 [0.69, 1.06] |
5.6 antiparkinsonian |
2 |
172 |
Risk Ratio (M‐H, Random, 95% CI) |
1.21 [0.79, 1.86] |
5.7 psychotropics |
1 |
186 |
Risk Ratio (M‐H, Random, 95% CI) |
0.62 [0.45, 0.85] |
6 Mental state: 1. average endpoint scores on various scales on psychotic symptoms (high=poor) ‐ short term (up to 12 weeks) |
3 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
6.1 BPRS total |
2 |
171 |
Mean Difference (IV, Random, 95% CI) |
‐12.69 [‐17.06, ‐8.32] |
6.2 PANSS total |
3 |
457 |
Mean Difference (IV, Random, 95% CI) |
‐17.81 [‐18.17, ‐17.45] |
6.3 PANSS general pathology |
1 |
44 |
Mean Difference (IV, Random, 95% CI) |
‐13.20 [‐20.15, ‐6.25] |
6.4 PANSS negative symptom |
3 |
457 |
Mean Difference (IV, Random, 95% CI) |
‐3.10 [‐3.19, ‐3.01] |
6.5 PANSS positive symptom |
3 |
457 |
Mean Difference (IV, Random, 95% CI) |
‐5.49 [‐6.18, ‐4.80] |
7 Mental state: 2. skewed data ‐ short term (up to 12 weeks) |
|
|
Other data |
No numeric data |
7.1 average endpoint score BPRS total (high=poor) |
|
|
Other data |
No numeric data |
7.2 average change score of CGI‐C (larger decline=good) |
|
|
Other data |
No numeric data |
7.3 average change score of CGI‐SI (larger decline=good) |
|
|
Other data |
No numeric data |
7.4 average change score of HAM‐D‐17 (larger decline=good) |
|
|
Other data |
No numeric data |
7.5 average change score of PANSS total (larger decline=good) |
|
|
Other data |
No numeric data |
7.6 average change score of PANSS negative symptom (larger decline=good) |
|
|
Other data |
No numeric data |
7.7 average change score of PANSS positive symptom (larger decline=good) |
|
|
Other data |
No numeric data |
8 Adverse effects: 1a. extrapyramidal ‐ various effects ‐ short term (up to 12 weeks) |
11 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
8.1 general ‐ any significant EPS |
7 |
1511 |
Risk Ratio (M‐H, Random, 95% CI) |
1.56 [1.13, 2.15] |
8.2 general ‐ no improvement on AIMS score |
1 |
42 |
Risk Ratio (M‐H, Random, 95% CI) |
0.30 [0.15, 0.61] |
8.3 general ‐ no improvement on BAS score |
1 |
226 |
Risk Ratio (M‐H, Random, 95% CI) |
1.14 [1.01, 1.28] |
8.4 general ‐ needing medication for EPS |
2 |
94 |
Risk Ratio (M‐H, Random, 95% CI) |
1.14 [0.78, 1.67] |
8.5 specific ‐ akathisia |
5 |
1204 |
Risk Ratio (M‐H, Random, 95% CI) |
2.58 [1.41, 4.72] |
8.6 specific ‐ bradykinesia |
2 |
485 |
Risk Ratio (M‐H, Random, 95% CI) |
0.87 [0.60, 1.24] |
8.7 specific ‐ dyskinesia |
1 |
303 |
Risk Ratio (M‐H, Random, 95% CI) |
0.32 [0.01, 7.86] |
8.8 specific ‐ dystonia |
3 |
687 |
Risk Ratio (M‐H, Random, 95% CI) |
3.40 [0.26, 44.46] |
8.9 specific ‐ hypertonia |
3 |
505 |
Risk Ratio (M‐H, Random, 95% CI) |
2.98 [1.35, 6.59] |
8.10 specific ‐ parkinsonism |
2 |
485 |
Risk Ratio (M‐H, Random, 95% CI) |
7.64 [1.40, 41.59] |
8.11 specific ‐ tardive dyskinesia |
1 |
303 |
Risk Ratio (M‐H, Random, 95% CI) |
6.77 [0.35, 130.03] |
8.12 specific ‐ tremor |
5 |
1204 |
Risk Ratio (M‐H, Random, 95% CI) |
1.60 [0.89, 2.88] |
9 Adverse effects: 1b. extrapyramidal ‐ AIMS average endpoint score ‐ short term (up to 12 weeks) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
10 Adverse effects: 1c. extrapyramidal ‐ skewed data (various scales) ‐ short term (up to 12 weeks) |
|
|
Other data |
No numeric data |
10.1 average change score of AIMS |
|
|
Other data |
No numeric data |
10.2 average change score of CGI severity dyskinesia |
|
|
Other data |
No numeric data |
10.3 average change score of CGI severity parkinsonism |
|
|
Other data |
No numeric data |
10.4 average change score of ESRS |
|
|
Other data |
No numeric data |
10.5 average change score of ESRS ‐ akathisia |
|
|
Other data |
No numeric data |
10.6 average change score of ESRS ‐ dystonia |
|
|
Other data |
No numeric data |
10.7 average change score of ESRS ‐ dyskinesia |
|
|
Other data |
No numeric data |
10.8 average change score of ESRS ‐ parkinsonism |
|
|
Other data |
No numeric data |
11 Adverse effects: 2. any adverse event ‐ short term (up to 12 weeks) |
9 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
11.1 any adverse event |
7 |
1610 |
Risk Ratio (M‐H, Random, 95% CI) |
1.05 [0.96, 1.15] |
11.2 asthenia |
2 |
639 |
Risk Ratio (M‐H, Random, 95% CI) |
1.93 [0.62, 6.02] |
11.3 back pain |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.38, 2.86] |
11.4 blurred vision |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
4.16 [0.47, 36.59] |
11.5 cogwheel rigidity |
1 |
226 |
Risk Ratio (M‐H, Random, 95% CI) |
5.25 [0.69, 39.88] |
11.6 death |
1 |
182 |
Risk Ratio (M‐H, Random, 95% CI) |
3.13 [0.13, 75.92] |
11.7 dental disorder |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
3.64 [0.78, 17.11] |
11.8 dysmenorrhoea |
2 |
495 |
Risk Ratio (M‐H, Random, 95% CI) |
1.10 [0.04, 30.00] |
11.9 fatigue |
2 |
558 |
Risk Ratio (M‐H, Random, 95% CI) |
2.23 [0.69, 7.22] |
11.10 fever |
1 |
130 |
Risk Ratio (M‐H, Random, 95% CI) |
9.28 [0.51, 168.90] |
11.11 infection |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
0.52 [0.10, 2.78] |
11.12 salivation ‐ increased |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
7.28 [0.38, 139.15] |
11.13 pyrexia |
1 |
182 |
Risk Ratio (M‐H, Random, 95% CI) |
1.19 [0.45, 3.16] |
11.14 pain |
1 |
121 |
Risk Ratio (M‐H, Random, 95% CI) |
1.58 [0.47, 5.31] |
11.15 rash (skin) |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
1.19 [0.45, 3.16] |
11.16 vaginitis |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
1.07 [0.07, 16.32] |
11.17 hyperhidrosis |
1 |
437 |
Risk Ratio (M‐H, Random, 95% CI) |
10.35 [0.50, 214.17] |
12 Adverse effects: 3. cardiovascular ‐ short term (up to 12 weeks) |
4 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
12.1 dizziness ‐ orthostatic |
1 |
44 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 69.87] |
12.2 ECG abnormal |
1 |
182 |
Risk Ratio (M‐H, Random, 95% CI) |
9.40 [0.51, 172.11] |
12.3 heart rate decreased |
1 |
182 |
Risk Ratio (M‐H, Random, 95% CI) |
0.52 [0.05, 5.66] |
12.4 heart rate increased |
1 |
182 |
Risk Ratio (M‐H, Random, 95% CI) |
0.85 [0.37, 1.96] |
12.5 hypotension ‐ postural |
1 |
44 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 69.87] |
12.6 QTc > 450 milliseconds or > 10% increase from baseline |
2 |
380 |
Risk Ratio (M‐H, Random, 95% CI) |
8.46 [1.07, 67.07] |
12.7 tachycardia |
2 |
332 |
Risk Ratio (M‐H, Random, 95% CI) |
12.22 [2.33, 64.10] |
13 Adverse effects: 4. central nervous system ‐ short term (up to 12 weeks) |
10 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
13.1 agitation |
8 |
1388 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.75, 1.17] |
13.2 anxiety |
6 |
1225 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.73, 1.48] |
13.3 dizziness |
5 |
970 |
Risk Ratio (M‐H, Random, 95% CI) |
1.41 [0.65, 3.05] |
13.4 headache |
10 |
1905 |
Risk Ratio (M‐H, Random, 95% CI) |
0.99 [0.81, 1.21] |
13.5 insomnia |
10 |
1905 |
Risk Ratio (M‐H, Random, 95% CI) |
1.16 [0.97, 1.39] |
13.6 sedation |
2 |
517 |
Risk Ratio (M‐H, Random, 95% CI) |
1.84 [0.52, 6.50] |
13.7 somnolence |
6 |
951 |
Risk Ratio (M‐H, Random, 95% CI) |
1.61 [1.06, 2.45] |
13.8 restlessness |
2 |
619 |
Risk Ratio (M‐H, Random, 95% CI) |
1.16 [0.49, 2.74] |
14 Adverse effects: 5. endocrine ‐ serum prolactin increase above reference range (23 ng/ml) ‐ short term (up to 12 weeks) |
2 |
323 |
Risk Ratio (M‐H, Random, 95% CI) |
12.14 [4.38, 33.68] |
15 Adverse effects: 6. gastrointestinal system ‐ short term (up to 12 weeks) |
10 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
15.1 constipation |
8 |
1695 |
Risk Ratio (M‐H, Random, 95% CI) |
1.88 [1.19, 2.96] |
15.2 diarrhoea |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
0.92 [0.37, 2.30] |
15.3 dry mouth |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
2.43 [0.65, 9.12] |
15.4 dyspepsia |
5 |
1058 |
Risk Ratio (M‐H, Random, 95% CI) |
1.24 [0.64, 2.40] |
15.5 nausea |
6 |
1225 |
Risk Ratio (M‐H, Random, 95% CI) |
1.18 [0.75, 1.86] |
15.6 vomiting |
5 |
1181 |
Risk Ratio (M‐H, Random, 95% CI) |
1.16 [0.65, 2.07] |
16 Adverse effects: 7a. metabolic ‐ weight gain ‐ short term (up to 12 weeks) |
6 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
16.1 any gain |
3 |
910 |
Risk Ratio (M‐H, Random, 95% CI) |
3.77 [1.34, 10.63] |
16.2 >7% increase from baseline |
3 |
606 |
Risk Ratio (M‐H, Random, 95% CI) |
3.47 [1.64, 7.33] |
17 Adverse effects: 7b. metabolic ‐ skewed data ‐ average change value on lipid profile ‐ short term (up to 12 weeks) |
|
|
Other data |
No numeric data |
17.1 cholesterol ‐ total |
|
|
Other data |
No numeric data |
17.2 HDL |
|
|
Other data |
No numeric data |
17.3 LDL |
|
|
Other data |
No numeric data |
17.4 triglycerides |
|
|
Other data |
No numeric data |
17.5 VLDL |
|
|
Other data |
No numeric data |
18 Adverse effects: 8. musculoskeletal system ‐ short term (up to 12 weeks) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
18.1 myalgia |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
0.69 [0.12, 4.06] |
18.2 Joint disorder |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
2.60 [0.52, 13.10] |
19 Adverse effects: 9. physiology ‐ short term (up to 12 weeks) |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
19.1 ALT increased |
1 |
182 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.07, 16.45] |
19.2 AST increased |
1 |
182 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
19.3 blood CPK increased |
2 |
619 |
Risk Ratio (M‐H, Random, 95% CI) |
0.67 [0.23, 1.95] |
19.4 blood pressure increased |
1 |
182 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.15, 7.26] |
20 Adverse effects: 10. respiratory system ‐ short term (up to 12 weeks) |
4 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
20.1 upper respiratory infection |
2 |
323 |
Risk Ratio (M‐H, Random, 95% CI) |
2.83 [1.03, 7.74] |
20.2 pharyngitis |
1 |
202 |
Risk Ratio (M‐H, Random, 95% CI) |
0.42 [0.08, 2.10] |
20.3 rhinitis |
2 |
306 |
Risk Ratio (M‐H, Random, 95% CI) |
10.81 [2.58, 45.29] |
20.4 sinusitis |
1 |
437 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.09, 11.36] |