| 1 Repeated need for rapid tranquillisation: needing additional injection |
2 |
473 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.78 [0.62, 0.99] |
| 2 Specific behaviour: 1a. Agitation ‐ PANSS‐EC response up to 2 hours (at least 40% change on PANSS‐EC from baseline) |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.07 [0.92, 1.26] |
| 3 Specific behaviour: 1b. Agitation ‐ average scores ‐ up to 2 hours |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 3.1 change score (ACES, low=agitated, high=sedated) |
2 |
470 |
Mean Difference (IV, Fixed, 95% CI) |
0.12 [‐0.30, 0.55] |
| 3.2 change score (CABS, high=worse) |
2 |
470 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.55 [‐2.10, 1.01] |
| 3.3 change score (PANSS‐EC, high=worse) |
1 |
357 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.48 [‐2.12, 1.16] |
| 3.4 change score (PANSS‐EC, high=worse, schizophrenia subgroup) |
1 |
257 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.26 [‐1.48, 0.96] |
| 3.5 change score (PANSS‐EC, high=worse, non‐sedated patients subgroup based on ACES) |
1 |
316 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.33 [‐1.42, 0.76] |
| 3.6 change score (PANSS‐EC, high=worse, non‐sedated patients subgroup based on AEs) |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.34 [‐1.40, 0.72] |
| 4 Global outcome: 1. Need for benzodiazepine |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.26 [0.74, 2.16] |
| 5 Global outcome: 2. Average scores ‐ up to 2 hours |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 5.1 change score (CGI‐S, high=worse) |
2 |
470 |
Mean Difference (IV, Fixed, 95% CI) |
0.07 [‐0.22, 0.36] |
| 5.2 endpoint score (CGI‐I, high=worse) |
2 |
470 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.02 [‐0.23, 0.19] |
| 5.3 change score (CGI‐I, high=worse, schizophrenia subgroup) |
1 |
257 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.02 [‐0.30, 0.26] |
| 6 Mental state: 1. Average scores ‐ up to 2 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 6.1 change score at 2 hours (BPRS positive sub‐scale, high=worse) |
1 |
103 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.23 [‐1.28, 0.82] |
| 6.2 change score at 2 hours (BPRS total, high=worse) |
1 |
102 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.03 [‐5.76, 1.70] |
| 7 Adverse effects: 1a. General |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 7.1 one or more drug related adverse effects during 24 hours |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.18 [0.95, 1.46] |
| 7.2 increased severity of adverse effects after 2nd injection |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.34 [1.03, 1.74] |
| 7.3 overall adverse events during 72 hours |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.33 [1.04, 1.70] |
| 8 Adverse effects: 1b. General ‐ serious |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 8.1 any |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.57 [0.18, 1.81] |
| 8.2 tonic clonic seizure |
1 |
117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.32 [0.01, 7.62] |
| 8.3 death |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 9 Adverse effects: 2a. Specific ‐ arousal level |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 9.1 insomnia ‐ between 0‐1 days (IM phase) (only reported if occurred in ≥5%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.08 [1.01, 4.27] |
| 9.2 insomnia ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.82 [0.47, 1.44] |
| 9.3 "over" sedated |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.66 [0.93, 2.95] |
| 9.4 somnolence ‐ between 0‐1 days |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.71 [0.25, 2.00] |
| 9.5 somnolence ‐ between 0‐1 days (IM phase) (only reported if occurred in ≥5%) |
1 |
117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.22 [0.60, 8.16] |
| 9.6 somnolence ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.84 [0.30, 27.02] |
| 10 Adverse effects: 2b. Specific ‐ cardiac |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 10.1 dizziness ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%) |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.69 [0.33, 1.48] |
| 10.2 sinus tachycardia ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%) |
1 |
117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
6.66 [0.35, 126.06] |
| 10.3 tachycardia ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%) |
1 |
117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.24 [0.03, 2.06] |
| 11 Adverse effects: 2c. Specific ‐ gastrointestinal |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 11.1 dyspepsia ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
10.41 [1.36, 79.76] |
| 11.2 diarrhoea ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.95 [0.28, 3.21] |
| 11.3 nausea ‐ between 0‐1 days (IM phase) (only reported if occurred in ≥5%) |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.18 [0.05, 0.60] |
| 11.4 nausea ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.14 [0.02, 1.09] |
| 11.5 vomiting ‐ between 0‐1 days (IM phase) (only reported if occurred in ≥5%) |
1 |
117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.48 [0.04, 5.10] |
| 11.6 vomiting ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.38 [0.07, 1.92] |
| 12 Adverse effects: 2d. Specific ‐ movement disorder |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 12.1 akathisia ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%) |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.85 [0.94, 8.61] |
| 12.2 akathisia ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.21 [0.58, 8.40] |
| 12.3 dystonia ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%) |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
6.63 [1.52, 28.86] |
| 12.4 EPS ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
9.46 [1.22, 73.13] |
| 12.5 EPS ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
7.09 [1.65, 30.58] |
| 12.6 Use of antiparkinson drugs ‐ between 3 ‐ 7 days (oral phase) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
4.94 [2.50, 9.78] |
| 12.7 dystonia |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.84 [0.12, 69.22] |
| 13 Adverse effects: 2e. Specific ‐ miscellaneous |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 13.1 agitation ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%) |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.22 [0.46, 3.22] |
| 13.2 agitation ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.09 [0.68, 1.74] |
| 13.3 anxiety ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.30 [0.54, 3.16] |
| 13.4 headache ‐ between 0 ‐1 day (IM phase) (only reported if occurred in ≥5%) |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.85 [0.45, 1.59] |
| 13.5 headache ‐ between 3 ‐ 7 days (oral phase) (only reported if occurred in ≥ 2%) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.57, 1.97] |
| 13.6 pain at injection site |
1 |
117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.32 [0.01, 7.62] |
| 13.7 pain (1st injection) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.32 [0.06, 1.54] |
| 13.8 pain (2nd injection) |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.34 [1.03, 1.74] |
| 14 Leaving the study early: 1. For specific reasons |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 14.1 any |
2 |
480 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.07 [0.86, 4.98] |
| 14.2 lack of efficacy |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.84 [0.12, 69.22] |
| 14.3 adverse effects |
2 |
480 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.97 [0.17, 5.59] |
| 14.4 withdrew |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.42 [0.24, 8.39] |
| 14.5 consent |
2 |
480 |
Risk Ratio (M‐H, Fixed, 95% CI) |
6.0 [0.74, 48.34] |
| 14.6 other |
2 |
480 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.36 [0.27, 6.75] |
