1 Tranquillisation or asleep ‐ not asleep up to 24 hours |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
4.31 [0.54, 34.48] |
2 Specific behaviour: 2. Aggression ‐ various measures |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
2.1 no overall improvement |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.1 [0.69, 1.76] |
3 Global outcome: 1. General ‐ no change ‐ i. over 24 hours |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
3.1 up to 48 hours (CGI‐I, high=worse) |
1 |
56 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.14, 6.15] |
3.2 up to 72 hours (CGI‐I, high=worse) |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.39 [0.04, 3.49] |
3.3 at endpoint (CGI‐I, high=worse) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.40 [0.12, 1.32] |
4 Global outcome: 2a. Specific ‐ not sedated ‐ i. by 30 minutes |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
4.1 at 30 minutes |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.29 [0.65, 2.54] |
5 Global outcome: 2b. Specific ‐ not sedated ‐ ii. up to 2 hours |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
5.1 at 1 hour |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.5 [0.86, 14.18] |
5.2 at 2 hours |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
7.0 [0.98, 50.16] |
6 Mental state: 1. Average scores |
1 |
52 |
Mean Difference (IV, Fixed, 95% CI) |
6.10 [4.48, 7.72] |
6.1 endpoint score (BPRS, high=worse) |
1 |
52 |
Mean Difference (IV, Fixed, 95% CI) |
6.10 [4.48, 7.72] |
7 Adverse effects: 1. General |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
7.1 one or more drug related adverse effect |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.8 [0.44, 1.45] |
8 Adverse effects: 2a. Specific ‐ anticholinergic |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
8.1 constipation ‐ between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.32 [0.01, 7.26] |
8.2 salivation ‐ too little ‐ between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.83 [0.33, 24.66] |
8.3 salivation ‐ too little ‐ between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.22, 4.05] |
8.4 salivation ‐ too much ‐ between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.33, 2.69] |
8.5 salivation ‐ too much ‐ between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.43 [0.04, 4.48] |
8.6 salivation ‐ too much ‐ between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.05 [0.57, 1.93] |
8.7 polyuria ‐ between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.84 [0.12, 65.34] |
8.8 sweating ‐ between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.15, 5.97] |
8.9 sweating ‐ between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.84 [0.12, 65.34] |
9 Adverse effects: 2b. Specific ‐ arousal level |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
9.1 asleep ‐ by 12 hours |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.86 [0.72, 1.04] |
9.2 drowsiness ‐ between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.89 [0.70, 1.12] |
9.3 drowsiness ‐ between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
33.16 [2.15, 511.57] |
9.4 drowsiness during 72 hours |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.75 [0.20, 2.79] |
9.5 insomnia ‐ between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.32 [0.01, 7.26] |
9.6 insomnia ‐ between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
6.63 [0.37, 119.59] |
10 Adverse effects: 2c. Specific ‐ cardiovascular |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
10.1 blood pressure ‐ increased ‐ between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.17 [0.01, 3.45] |
10.2 dizziness ‐ between 3‐28 days |
2 |
65 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.38 [0.09, 1.52] |
10.3 dyspnoea ‐ between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.84 [0.12, 65.34] |
10.4 palpitations during 72 hours |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 7.58] |
10.5 pulse rate ‐ increased ‐ between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.29 [0.01, 6.79] |
11 Adverse effects: 2d. Specific ‐ movement disorders |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
11.1 akathisia between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.57 [0.16, 2.02] |
11.2 akathisia between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.65 [0.26, 1.61] |
11.3 akathisia between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.18 [0.62, 2.27] |
11.4 dysarthria between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.14 [0.01, 2.44] |
11.5 dyskinesia between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.29 [0.01, 6.79] |
11.6 dystonia between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.06, 13.93] |
11.7 dystonia between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.65 [0.26, 1.61] |
11.8 involuntary movement between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.32 [0.01, 7.26] |
11.9 motor retardation between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.06, 13.93] |
11.10 muscle spasms between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.26 [0.33, 4.82] |
11.11 oculogyric crisis between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.6 [0.11, 61.11] |
11.12 rigidity between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.88 [0.65, 1.19] |
11.13 rigidity between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.86 [0.13, 5.68] |
11.14 rigidity during between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.13 [0.93, 1.38] |
11.15 tremor between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.42, 2.13] |
11.16 tremor during between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.12 [0.71, 1.76] |
11.17 tremor between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.6 [0.11, 61.11] |
11.18 use of antiparkinson medication |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.83 [0.66, 12.16] |
11.19 dystonia during 72 hours |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.0 [0.26, 96.13] |
11.20 extrapyramidal effects ‐ use of antiparkinson drugs during 72 hours |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.6 [0.17, 2.07] |
11.21 EPS during 72 hours |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
7.0 [0.98, 50.16] |
11.22 thick tongue ‐ between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.29 [0.01, 6.79] |
12 Adverse effects: 2e. Specific ‐ miscellaneous |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
12.1 allergy ‐ itch ‐ between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.84 [0.12, 65.34] |
12.2 allergy ‐ tissue reaction at injection site ‐ between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
12.3 nervousness ‐ between 0‐10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.29 [0.01, 6.79] |
12.4 pain ‐ during 24 hours |
1 |
30 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.67 [0.13, 3.44] |
12.5 pain ‐ headache ‐ between 0‐3 days (IM phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.32 [0.01, 7.26] |
12.6 pain ‐ myalgia ‐ between 3‐28 days (Oral phase) |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.84 [0.12, 65.34] |
13 Leaving the study early: 1. For general reasons |
2 |
|
Risk Ratio (M‐H, Fixed, 90% CI) |
Subtotals only |
13.1 by 72 hours |
1 |
35 |
Risk Ratio (M‐H, Fixed, 90% CI) |
0.63 [0.21, 1.85] |
13.2 by 10 days |
1 |
54 |
Risk Ratio (M‐H, Fixed, 90% CI) |
1.18 [0.67, 2.07] |
13.3 by endpoint |
1 |
35 |
Risk Ratio (M‐H, Fixed, 90% CI) |
0.94 [0.42, 2.13] |
14 Leaving the study early: 2. Specific reasons |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
14.1 adverse effects by 72 hours |
1 |
35 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.84 [0.12, 65.34] |