1 Leaving the study early: 1. Any reason |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
1.1 long term |
2 |
657 |
Risk Ratio (M‐H, Random, 95% CI) |
1.16 [1.05, 1.29] |
2 Leaving the study early: 2. Due to adverse events |
2 |
643 |
Risk Ratio (M‐H, Random, 95% CI) |
0.85 [0.59, 1.21] |
2.1 long term |
2 |
643 |
Risk Ratio (M‐H, Random, 95% CI) |
0.85 [0.59, 1.21] |
3 Leaving the study early: 3. Due to relapse / worsening or no improvement |
2 |
643 |
Risk Ratio (M‐H, Random, 95% CI) |
1.24 [0.47, 3.29] |
3.1 long term |
2 |
643 |
Risk Ratio (M‐H, Random, 95% CI) |
1.24 [0.47, 3.29] |
4 Mental state: 1a. State ‐ BPRS end score (high = poor, skewed data) |
|
|
Other data |
No numeric data |
4.1 long term |
|
|
Other data |
No numeric data |
5 Mental state: 1b. State ‐ PANSS total endpoint score (high = poor, skewed data) |
|
|
Other data |
No numeric data |
5.1 long term |
|
|
Other data |
No numeric data |
6 Mental state: 1c. State ‐ PANSS: mean endpoint score from baseline (high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
6.1 total ‐ short term |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
4.21 [2.17, 6.25] |
6.2 positive ‐ short term |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
8.23 [7.26, 9.20] |
6.3 negative ‐ short term |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
1.58 [0.64, 2.52] |
6.4 general psychopathology ‐ short term |
1 |
60 |
Mean Difference (IV, Random, 95% CI) |
‐0.39 [‐0.79, 0.01] |
7 Mental state: 1d. State ‐ less than 25% PANSS reduction ('no effect') |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
7.1 short term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
2.0 [0.40, 10.11] |
8 Adverse events: Movement disorders |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
8.1 akathisia ‐ long term |
2 |
591 |
Risk Ratio (M‐H, Random, 95% CI) |
1.33 [0.68, 2.60] |
8.2 EPS ‐ long term |
1 |
539 |
Risk Ratio (M‐H, Random, 95% CI) |
0.79 [0.42, 1.49] |
8.3 tardive dyskinesia ‐ long term |
1 |
473 |
Risk Ratio (M‐H, Random, 95% CI) |
1.28 [0.83, 1.95] |
8.4 use of antiparkinsonian drugs ‐ long term |
1 |
46 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.34, 26.76] |
9 Other adverse events: 1. Anticholinergic |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
9.1 increased salivation ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.87] |
10 Other adverse events: 2. Arousal |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
10.1 agitation ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.33, 27.23] |
10.2 anxiety ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
1.25 [0.37, 4.21] |
10.3 insomnia ‐ long term |
2 |
657 |
Risk Ratio (M‐H, Random, 95% CI) |
2.34 [0.62, 8.89] |
10.4 sleepiness/ sedation ‐ long term |
1 |
597 |
Risk Ratio (M‐H, Random, 95% CI) |
0.92 [0.71, 1.18] |
11 Other adverse events: 3. Cardiovascular |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
11.1 bradycardia ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
11.2 faintness, dizziness, weakness ‐ long term |
1 |
597 |
Risk Ratio (M‐H, Random, 95% CI) |
1.20 [0.75, 1.95] |
11.3 hypotension ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.87] |
12 Other adverse events: 4. Central nervous system |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
12.1 headache ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.71 [0.25, 2.00] |
12.2 hypertonia ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
13 Other adverse events: 5. Gastrointestinal |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
13.1 gastroenteritis ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
13.2 weight gain ‐ long term |
1 |
550 |
Risk Ratio (M‐H, Random, 95% CI) |
0.40 [0.27, 0.58] |
14 Other adverse events: 6. Skin |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
14.1 cellulitis ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.87] |
14.2 eczema ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
14.3 fungal dermatitis ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.87] |
14.4 rash ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.07, 15.26] |
15 Other adverse events: 7. Genitourinary |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
15.1 diminished sexual desire ‐ long term |
1 |
597 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.69, 1.19] |
15.2 galactorrhea/ gynaecomastia ‐ long term |
1 |
597 |
Risk Ratio (M‐H, Random, 95% CI) |
0.74 [0.22, 2.49] |
16 Other adverse events: 8. Others |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
16.1 allergic reaction ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.87] |
16.2 back pain ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.83] |
16.3 incontinence nocturia ‐ long term |
1 |
597 |
Risk Ratio (M‐H, Random, 95% CI) |
0.43 [0.17, 1.07] |
16.4 suicide attempt ‐ long term |
1 |
597 |
Risk Ratio (M‐H, Random, 95% CI) |
0.64 [0.06, 7.06] |
16.5 urinary hesitancy, dry mouth, constipation ‐ long term |
1 |
597 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.69, 1.25] |
17 Other adverse events: 9. any serious adverse event |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
17.1 long term |
1 |
597 |
Risk Ratio (M‐H, Random, 95% CI) |
1.17 [0.72, 1.88] |
18 Other adverse events: 10. lab data |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
18.1 anemia ‐ long term |
1 |
60 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.07, 15.26] |
19 Other adverse events: 11a. lab data |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
19.1 mean weight change (lb) ‐ long term |
1 |
597 |
Mean Difference (IV, Random, 95% CI) |
‐11.4 [‐14.19, ‐8.61] |
19.2 change in blood glucose ‐ long term |
1 |
597 |
Mean Difference (IV, Random, 95% CI) |
‐9.8 [‐16.54, ‐3.06] |
19.3 change in glycosylated haemoglobin ‐ long term |
1 |
597 |
Mean Difference (IV, Random, 95% CI) |
‐0.31 [‐0.52, ‐0.10] |
19.4 change in cholesterol ‐ long term |
1 |
597 |
Mean Difference (IV, Random, 95% CI) |
‐9.2 [‐15.30, ‐3.10] |
19.5 change in triglycerides ‐ long term |
1 |
597 |
Mean Difference (IV, Random, 95% CI) |
‐34.60 [‐62.51, ‐6.69] |
19.6 change in prolactin ‐ long term |
1 |
597 |
Mean Difference (IV, Random, 95% CI) |
6.5 [2.42, 10.58] |
20 Other adverse events: 11b. lab data (skewed) |
|
|
Other data |
No numeric data |
20.1 weight change |
|
|
Other data |
No numeric data |