1 Global state: 1. Relapse (any reason) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
1.1 long term |
1 |
63 |
Risk Ratio (M‐H, Random, 95% CI) |
2.13 [0.84, 5.43] |
2 Global state: 2. Needing use of benzodiazepine or sedative drugs |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
2.1 long term |
1 |
369 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.68, 1.47] |
3 Service utilisation: 1. Hospitalisation |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
3.1 long term |
1 |
369 |
Risk Ratio (M‐H, Random, 95% CI) |
0.87 [0.68, 1.10] |
4 Service utilisation: 2. Outpatient care ‐ number of outpatient visits (skewed data) |
|
|
Other data |
No numeric data |
4.1 long term |
|
|
Other data |
No numeric data |
5 Not receiving allocated study medication |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
5.1 long term |
1 |
382 |
Risk Ratio (M‐H, Random, 95% CI) |
0.29 [0.06, 1.37] |
6 Leaving the study early: 1. Any reason |
2 |
467 |
Risk Ratio (M‐H, Random, 95% CI) |
1.24 [0.98, 1.57] |
6.1 long term |
2 |
467 |
Risk Ratio (M‐H, Random, 95% CI) |
1.24 [0.98, 1.57] |
7 Leaving the study early: 2. Specific |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
7.1 insufficient response ‐ long term |
1 |
382 |
Risk Ratio (M‐H, Random, 95% CI) |
0.61 [0.15, 2.50] |
7.2 withdrawn consent ‐ long term |
1 |
382 |
Risk Ratio (M‐H, Random, 95% CI) |
1.41 [0.86, 2.31] |
8 Adverse events: 1. General: a. Death |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
8.1 long term |
1 |
382 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.14, 7.10] |
9 Adverse events: 2. Specific |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
9.1 anxiety ‐ long term |
1 |
85 |
Risk Ratio (M‐H, Random, 95% CI) |
1.40 [0.42, 4.60] |
9.2 diabetes mellitus ‐ long term |
1 |
369 |
Risk Ratio (M‐H, Random, 95% CI) |
1.70 [0.73, 3.96] |
9.3 dizziness ‐ long term |
1 |
85 |
Risk Ratio (M‐H, Random, 95% CI) |
1.49 [0.53, 4.19] |
9.4 fatigue/somnolence ‐ long term |
1 |
85 |
Risk Ratio (M‐H, Random, 95% CI) |
2.05 [0.78, 5.40] |
9.5 gastrointestinal ‐ long term |
1 |
369 |
Risk Ratio (M‐H, Random, 95% CI) |
1.10 [0.95, 1.28] |
9.6 general disorders and administration site conditions ‐ long term |
1 |
369 |
Risk Ratio (M‐H, Random, 95% CI) |
1.31 [1.02, 1.69] |
9.7 headache ‐ long term |
1 |
85 |
Risk Ratio (M‐H, Random, 95% CI) |
2.80 [1.12, 7.00] |
9.8 insomnia ‐ long term |
1 |
85 |
Risk Ratio (M‐H, Random, 95% CI) |
1.73 [0.77, 3.91] |
9.9 nausea/ vomiting ‐ long term |
1 |
85 |
Risk Ratio (M‐H, Random, 95% CI) |
1.86 [0.50, 6.97] |
9.10 prolactin related ‐ long term |
1 |
85 |
Risk Ratio (M‐H, Random, 95% CI) |
10.27 [0.59, 180.05] |
9.11 weight increase ‐ long term |
1 |
85 |
Risk Ratio (M‐H, Random, 95% CI) |
1.33 [0.56, 3.17] |
10 Adverse events: Nervous system disorders (inc. EPS) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
10.1 long term |
1 |
369 |
Risk Ratio (M‐H, Random, 95% CI) |
1.34 [1.13, 1.58] |