1 Repeated need for tranquillisation |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
1.1 needing additional injections during 24 hours |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.28 [1.00, 1.63] |
1.2 needing 1 additional injection during 24 hours |
1 |
117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.34 [0.66, 2.70] |
1.3 needing 2 additional injections during 24 hours |
1 |
117 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.37 [0.77, 7.26] |
2 Specific behaviour: 1a. Agitation ‐ clinically important change (PANSS‐ EC reduction ≥ 40% from baseline) |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
2.1 up to 2 hours |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.94 [0.80, 1.11] |
3 Specific behaviour: 1b. Agitation ‐ average scores ‐ i. up to 2 hours |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
3.1 change score (ABS, high=worse) |
2 |
473 |
Mean Difference (IV, Fixed, 95% CI) |
0.55 [‐1.00, 2.10] |
3.2 change score (ACES, low=agitated, high=sedated) |
2 |
473 |
Mean Difference (IV, Fixed, 95% CI) |
0.12 [‐0.30, 0.55] |
3.3 change score (PANSS‐EC, high=worse) |
1 |
357 |
Mean Difference (IV, Fixed, 95% CI) |
0.48 [‐1.16, 2.12] |
3.4 change score (PANSS‐EC, high=worse, schizophrenia subgroup) |
2 |
336 |
Mean Difference (IV, Fixed, 95% CI) |
0.07 [‐0.99, 1.13] |
3.5 change score (PANSS‐EC, high=worse, non‐sedated patients subgroup based on ACES) |
2 |
422 |
Mean Difference (IV, Fixed, 95% CI) |
0.12 [‐0.82, 1.06] |
3.6 change score (PANSS‐EC, high=worse, non‐sedated patients subgroup based on AEs) |
2 |
448 |
Mean Difference (IV, Fixed, 95% CI) |
0.26 [‐0.68, 1.19] |
4 Global state: 1. Various |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
4.1 non‐responders to the first injection |
1 |
360 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.18 [0.78, 1.79] |
4.2 need for benzodiazepine up to 24 hours |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.79 [0.46, 1.35] |
5 Global outcome: 2. Average scores ‐ i. up to 2 hours |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
5.1 endpoint score (CGI‐I, high=worse) |
2 |
473 |
Mean Difference (IV, Fixed, 95% CI) |
0.02 [‐0.19, 0.23] |
5.2 endpoint score (CGI‐I, high=worse, schizophrenia subgroup |
1 |
79 |
Mean Difference (IV, Fixed, 95% CI) |
0.02 [‐0.44, 0.48] |
5.3 change score (CGI‐S, high=worse) |
2 |
473 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.07 [‐0.36, 0.22] |
6 Mental state: 1. Average scores ‐ i. up to 2 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
6.1 change score up to 2 hours (BPRS total, high=worse) |
1 |
102 |
Mean Difference (IV, Fixed, 95% CI) |
2.03 [‐1.70, 5.76] |
6.2 change score up to 2 hours (BPRS positive subscale, high=worse) |
1 |
103 |
Mean Difference (IV, Fixed, 95% CI) |
0.23 [‐0.82, 1.28] |
7 Adverse effects: 1a. General |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
7.1 one or more drug related adverse events during 24 hours |
1 |
113 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.91 [0.61, 1.35] |
7.2 onset or increased severity of adverse effects after 2nd injection |
1 |
358 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.74 [0.57, 0.96] |
8 Adverse effects: 1b. General ‐ serious |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
8.1 death |
1 |
358 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
8.2 rated as serious |
2 |
471 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.73 [0.54, 5.52] |
8.3 tonic clonic seizure |
1 |
113 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.05 [0.13, 73.38] |
9 Adverse effects: 2a. Specific ‐ arousal |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
9.1 insomnia during 24 hours |
1 |
358 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.48 [0.23, 0.97] |
9.2 "over" sedated during 24 hours |
1 |
358 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.60 [0.34, 1.07] |
9.3 somnolence during 24 hours |
2 |
471 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.81 [0.41, 1.58] |
10 Adverse effects: 2b. Specific ‐ cardiovascular |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
10.1 dizziness during 24 hours |
2 |
471 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.41 [0.66, 3.01] |
10.2 sinus tachycardia during 24 hours |
1 |
113 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.15 [0.01, 2.75] |
10.3 tachycardia during 24 hours |
1 |
113 |
Risk Ratio (M‐H, Fixed, 95% CI) |
4.07 [0.47, 35.31] |
11 Adverse effects: 2c. Specific ‐ movement disorders |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
11.1 akathisia during 24 hours |
1 |
113 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.51 [0.13, 1.94] |
11.2 dystonia during 24 hours |
1 |
113 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.25 [0.03, 2.21] |
11.3 EPS during 24 hours |
2 |
471 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.29 [0.12, 0.70] |
12 Adverse effects: 2d. Specific ‐ miscellaneous |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
12.1 agitation during 24 hours |
2 |
471 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.42, 2.58] |
12.2 headache during 24 hours |
2 |
471 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.16 [0.62, 2.18] |
12.3 pain at injection site |
2 |
471 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.12 [0.75, 12.91] |
12.4 nausea during 24 hours |
2 |
471 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.52 [1.63, 18.70] |
12.5 vomiting during 24 hours |
1 |
113 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.04 [0.19, 21.82] |
13 Leaving the study early |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
13.1 any reason |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.49 [0.20, 1.18] |
13.2 lack of efficacy |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.05 [0.15, 7.43] |
13.3 withdrew consent |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.35 [0.10, 1.28] |
13.4 adverse effects |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.18, 6.04] |
13.5 other |
2 |
477 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.75 [0.15, 3.78] |