1 Leaving the study early: 1. Any reason |
5 |
261 |
Risk Ratio (M‐H, Random, 95% CI) |
0.30 [0.04, 2.33] |
1.1 short term |
4 |
203 |
Risk Ratio (M‐H, Random, 95% CI) |
0.26 [0.01, 4.92] |
1.2 medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
0.40 [0.08, 1.90] |
2 Leaving the study early: 2. Due to adverse events |
2 |
119 |
Risk Ratio (M‐H, Random, 95% CI) |
9.43 [1.22, 73.11] |
2.1 short term |
1 |
61 |
Risk Ratio (M‐H, Random, 95% CI) |
16.47 [0.99, 273.29] |
2.2 medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
5.0 [0.25, 99.82] |
3 Leaving the study early: 3. Due to relapse / worsening or no improvement |
2 |
84 |
Risk Ratio (M‐H, Random, 95% CI) |
0.10 [0.03, 0.42] |
3.1 short term |
2 |
84 |
Risk Ratio (M‐H, Random, 95% CI) |
0.10 [0.03, 0.42] |
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 |
61 |
Risk Ratio (M‐H, Random, 95% CI) |
0.32 [0.13, 0.78] |
5 Mental state: 1. Relapse (clinical diagnosis) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
5.1 short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.14 [0.02, 1.07] |
6 Behaviour: 1a. Wing‐Scale B: social withdrawal ‐ mean change from baseline to endpoint (high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
6.1 short term |
1 |
58 |
Mean Difference (IV, Random, 95% CI) |
0.76 [‐0.51, 2.03] |
7 Behaviour: 1b. Wing‐Scale B: socially embarrassing behaviour ‐ mean change from baseline to endpoint (high = poor) |
1 |
|
Mean Difference (IV, Random, 95% CI) |
Subtotals only |
7.1 short term |
1 |
58 |
Mean Difference (IV, Random, 95% CI) |
0.10 [‐0.54, 0.74] |
8 Adverse events: Movement disorders |
4 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
8.1 akathisia ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
8.2 body rocking ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.16] |
8.3 dystonia ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.07, 15.08] |
8.4 extrapyramidal signs ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
1.75 [0.59, 5.21] |
8.5 facial mask ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
5.0 [0.25, 98.96] |
8.6 oculogyric crisis ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.16] |
8.7 parkinsonism ‐ short term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
7.0 [0.38, 129.74] |
8.8 posture and gait ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
5.0 [0.25, 98.96] |
8.9 rigidity ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
1.33 [0.33, 5.33] |
8.10 tremor ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
1.5 [0.27, 8.19] |
8.11 tremor ‐ medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.15, 6.63] |
8.12 use of antiparkinsonian drugs ‐ short term |
1 |
36 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 69.09] |
9 Other adverse events: 1. Anticholinergic |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
9.1 blurred vision ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
9.2 dry mouth ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.07, 15.08] |
9.3 dry mouth ‐ medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
1.5 [0.27, 8.32] |
9.4 nasal congestion ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
3.0 [0.13, 70.16] |
10 Other adverse events: 2. Arousal |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
10.1 agitation ‐ medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
0.8 [0.24, 2.68] |
10.2 drowsiness ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.17 [0.02, 1.28] |
10.3 drowsiness ‐ medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.86] |
10.4 excitement ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.38 [0.18, 0.79] |
10.5 insomnia ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.56 [0.31, 1.01] |
10.6 insomnia ‐ medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
11 Other adverse events: 3. At least one |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
11.1 short term |
2 |
94 |
Risk Ratio (M‐H, Random, 95% CI) |
1.5 [0.47, 4.76] |
12 Other adverse events: 4. Cardiovascular |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
12.1 ECG abnormalities ‐ short term |
1 |
36 |
Risk Ratio (M‐H, Random, 95% CI) |
2.0 [0.42, 9.58] |
12.2 faintness, dizziness, weakness ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.15, 6.53] |
12.3 faintness, dizziness, weakness ‐ medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
1.0 [0.22, 4.55] |
12.4 hypotension ‐ medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
5.0 [0.25, 99.82] |
12.5 tachycardia ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.80] |
13 Other adverse events: 5. Central nervous system |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
13.1 headache ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.75 [0.19, 3.00] |
14 Other adverse events: 6. Endocrine |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
14.1 lactation ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.0 [0.0, 0.0] |
15 Other adverse events: 7. Gastrointestinal |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
15.1 constipation ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.8 [0.24, 2.62] |
15.2 diarrhoea ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.80] |
15.3 nausea or vomiting ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.6 [0.16, 2.23] |
15.4 nausea or vomiting ‐ medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
5.0 [0.25, 99.82] |
16 Other adverse events: 8. Haematology ‐ abnormal laboratory results |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
16.1 short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
1.5 [0.48, 4.65] |
17 Other adverse events: 9. Skin |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
17.1 dermatitis ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.80] |
17.2 oedema ‐ medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.01, 7.86] |
18 Other adverse events: 10. Others |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
18.1 salivation increased ‐ short term |
1 |
48 |
Risk Ratio (M‐H, Random, 95% CI) |
2.0 [0.19, 20.61] |
18.2 tenseness ‐ medium term |
1 |
58 |
Risk Ratio (M‐H, Random, 95% CI) |
0.5 [0.05, 5.21] |