1 Leaving the study early: 1. Any reason |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
1.1 short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.35, 2.83] |
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 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
4.0 [0.47, 34.20] |
3 Global state: 1. Change over time ‐ no better or deterioration (ITT) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
3.1 short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
1.05 [0.68, 1.64] |
4 Behaviour: 1. Behaviour subscale of the Psychiatric Rating Scale: no better or worse |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.88 [0.61, 1.26] |
5 Adverse events: Movement disorders |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
5.1 akathisia ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
1.25 [0.36, 4.31] |
5.2 ataxia ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
5.3 dyskinesia ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.2 [0.02, 1.63] |
5.4 parkinsonism ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.8 [0.35, 1.81] |
6 Other adverse events: 1. Anticholinergic |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
6.1 blurred vision ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.2 [0.01, 4.04] |
6.2 dry mouth ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
2.0 [0.19, 21.16] |
7 Other adverse events: 2. Arousal |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
7.1 insomnia ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.64 [0.28, 1.47] |
7.2 sleepiness/sedation ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.5 [0.10, 2.57] |
8 Other adverse events: 3. At least one |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
8.1 short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.96 [0.70, 1.33] |
9 Other adverse events: 4. Central nervous system |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
9.1 disturbance of consciousness ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
9.2 headache ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.06, 15.43] |
9.3 paraesthesia ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
9.4 vertigo ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.94] |
10 Other adverse events: 5. Gastrointestinal |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
10.1 constipation ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.94] |
10.2 icterus ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
10.3 loss of appetite ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.6 [0.15, 2.34] |
10.4 nausea and vomiting ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
1.5 [0.27, 8.49] |
11 Other adverse events: 6. Skin |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
11.1 rash ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.06, 15.43] |
12 Other adverse events: 7. Genitourinary |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
12.1 micturition disturbances ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.94] |
13 Other adverse events: 8. Others |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
13.1 cramps ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
13.2 sweating ‐ short term |
1 |
78 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |