| 1 Specific behaviour: 1a. Agitation ‐ clinically important change (PANSS‐ EC reduction ≥ 40% from baseline) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 1.1 up to 2 hours |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.77 [0.60, 0.99] |
| 2 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. up to 2 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 2.1 change score (ACES, low=agitated, high=sedated) |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
0.58 [0.10, 1.06] |
| 2.2 change score (PANSS‐EC, high=worse) |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
3.30 [1.25, 5.35] |
| 3 Global state: 1. Average scores ‐ i. up to 2 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 3.1 change score (CGI‐S, high=worse) |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
0.58 [0.01, 1.15] |
| 4 Adverse effects: 1a. General |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 4.1 one or more drug related adverse events during 24 hours |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.75 [0.45, 1.24] |
| 5 Adverse effects: 1b. General ‐ serious |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 5.1 rated as serious |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 6 Adverse effects: 2a. Specific ‐ arousal |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 6.1 somnolence during 24 hours |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.25 [0.08, 0.82] |
| 7 Adverse effects: 2b. Specific ‐ cardiovascular |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 7.1 systolic blood pressure change up to 2 hours |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
2.85 [‐6.77, 12.47] |
| 7.2 diastolic blood pressure change up to 2 hours |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.05 [‐8.09, 5.99] |
| 7.3 pulse rate change up to 2 hours |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.67 [‐6.80, 5.46] |
| 7.4 systolic blood pressure change up to 24 hours |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
3.37 [‐5.43, 12.17] |
| 7.5 diastolic blood pressure change up to 24 hours |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.30 [‐8.55, 5.95] |
| 7.6 pulse rate change up to 24 hours |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
‐6.05 [‐13.43, 1.33] |
| 8 Adverse effects: 2c. Specific ‐ movement disorders ‐ i. dichotomous |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 8.1 akathisia up to 24 hours |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 8.2 dystonia up to 24 hours |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 8.3 rigidity up to 24 hours |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.33 [0.32, 5.58] |
| 8.4 tremor up to 24 hours |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.5 [0.26, 8.50] |
| 9 Adverse effects: 2d. Specific ‐ movement disorders ‐ ii. average scores |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 9.1 SAS change score up to 2 hours (high=worse) |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.05 [‐0.26, 0.16] |
| 9.2 SAS change score up to 24 hours (high=worse) |
1 |
80 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.03 [‐0.29, 0.23] |
| 10 Adverse effects: 2e. Specific ‐ miscellaneous |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 10.1 headache during 24 hours |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.0 [0.19, 21.18] |
| 10.2 pain at injection site during 24 hours |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.67 [0.76, 9.33] |
| 10.3 nausea during 24 hours |
1 |
80 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.0 [0.13, 71.51] |
| 11 Leaving the study early |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
