1 Leaving the study early: 1. Any reason |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
1.1 short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.74 [0.50, 1.11] |
2 Leaving the study early: 2. Due to adverse events |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
2.1 short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.53 [0.27, 1.05] |
3 Leaving the study early: 3. Due to relapse / worsening or no improvement |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
3.1 short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.84 [0.34, 2.08] |
4 Global state: 1. Change over time ‐ no better or deterioration (ITT) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
4.1 short term |
1 |
294 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.89, 1.17] |
5 Global state: 2. Average endpoint score (CGI‐S) |
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') |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
6.1 less than 25% reduction ‐ short term |
1 |
65 |
Risk Ratio (M‐H, Random, 95% CI) |
1.45 [0.26, 8.14] |
7 Mental state: 2b. State ‐ PANSS: mean endpoint from baseline (high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
7.1 total ‐ short term |
1 |
65 |
Mean Difference (IV, Random, 95% CI) |
1.38 [‐2.66, 5.42] |
7.2 positive ‐ short term |
1 |
65 |
Mean Difference (IV, Random, 95% CI) |
0.63 [‐0.80, 2.06] |
7.3 negative ‐ short term |
1 |
65 |
Mean Difference (IV, Random, 95% CI) |
0.33 [‐1.46, 2.12] |
8 Mental state: 2c. State ‐ PANSS total change score (high = poor, skewed data) |
|
|
Other data |
No numeric data |
8.1 short term |
|
|
Other data |
No numeric data |
9 Adverse events: Movement disorders |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
9.1 akathisia ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
2.29 [0.89, 5.85] |
9.2 EPS ‐ short term |
2 |
365 |
Risk Ratio (M‐H, Random, 95% CI) |
1.65 [0.70, 3.88] |
9.3 use of antiparkinsonian drugs ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
1.56 [1.01, 2.41] |
10 Adverse events: Movement disorders ‐ TESS total score (high = poor, skewed data) |
|
|
Other data |
No numeric data |
10.1 short term |
|
|
Other data |
No numeric data |
11 Other adverse events: 1. Arousal |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
11.1 agitation ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
1.05 [0.63, 1.77] |
11.2 anxiety ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
1.19 [0.63, 2.24] |
11.3 insomnia ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.86 [0.56, 1.31] |
11.4 sleepiness/sedation ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
2.64 [0.85, 8.22] |
12 Other adverse events: 2. Cardiovascular |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
12.1 faintness, dizziness, weakness ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
5.27 [1.18, 23.66] |
13 Other adverse events: 3. Central nervous system |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
13.1 headache ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.55 [0.29, 1.03] |
14 Other adverse events: 4. Gastrointestinal |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
14.1 dyspepsia ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.59 [0.27, 1.30] |
15 Other adverse events: 5. lab data |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
15.1 ECG abnormality (1st degree atrioventricular block) |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
15.82 [2.12, 118.27] |
15.2 prolactin: clinically significant high levels |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
12.66 [6.06, 26.45] |
15.3 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] |
16 Other adverse events: 6. any serious adverse event |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
16.1 short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.79 [0.49, 1.28] |
16.2 psychosis ‐ short term |
1 |
300 |
Risk Ratio (M‐H, Random, 95% CI) |
0.63 [0.29, 1.40] |