1 Leaving the study early: 1. Any reason |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
1.1 short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.40 [0.59, 3.34] |
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 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.61 [0.15, 2.49] |
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 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
2.38 [0.63, 8.94] |
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 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.15 [0.88, 1.49] |
5 Adverse events: Movement disorders |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
5.1 akathisia ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.84 [0.49, 1.44] |
5.2 ataxia ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.34 [0.04, 3.21] |
5.3 dyskinesia ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.57 [0.20, 1.63] |
5.4 parkinsonism ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.98 [0.60, 1.59] |
5.5 use of antiparkinsonian drugs ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.88 [0.69, 1.13] |
6 Other adverse events: 1. Anticholinergic |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
6.1 blurred vision ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.41 [0.08, 2.05] |
6.2 dry mouth ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.68 [0.25, 1.84] |
7 Other adverse events: 2. Arousal |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
7.1 insomnia ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.16 [0.83, 1.63] |
7.2 need of additional benzodiazepines ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.09 [0.81, 1.46] |
7.3 sleepiness/sedation ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.47, 2.24] |
8 Other adverse events: 3. At least one |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
8.1 short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.92 [0.78, 1.07] |
9 Other adverse events: 4. Cardiovascular |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
9.1 angina pectoris ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.68 [0.20, 2.34] |
9.2 palpitations ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.34 [0.07, 1.64] |
10 Other adverse events: 5. Central nervous system |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
10.1 disturbance of consciousness ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
10.2 headache ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
2.55 [0.83, 7.86] |
10.3 paraesthesia ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
4.08 [0.46, 35.88] |
10.4 vertigo ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.45, 2.34] |
11 Other adverse events: 6. Gastrointestinal |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
11.1 constipation ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.25 [0.54, 2.87] |
11.2 icterus ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
11.3 loss of appetite ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.76 [0.89, 3.50] |
11.4 nausea and vomiting ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
2.30 [1.05, 5.03] |
12 Other adverse events: 7. Skin |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
12.1 pruritus ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.15, 7.10] |
12.2 rash ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.15, 7.10] |
13 Other adverse events: 8. Genitourinary |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
13.1 diminished sexual desire |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.06, 16.09] |
13.2 micturition disturbances ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.51 [0.10, 2.72] |
14 Other adverse events: 9. Others |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
14.1 cramps ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
14.2 sweating ‐ short term |
1 |
192 |
Risk Ratio (M‐H, Random, 95% CI) |
0.17 [0.02, 1.39] |