| 5.1 Proportions of participants with serious adverse events (SAE) |
26 |
3673 |
Risk Ratio (IV, Random, 95% CI) |
0.80 [0.39, 1.67] |
| 5.2 Nervous system (including psychiatry) |
12 |
4199 |
Risk Ratio (IV, Random, 95% CI) |
0.70 [0.29, 1.71] |
| 5.2.1 Aggression |
1 |
303 |
Risk Ratio (IV, Random, 95% CI) |
0.50 [0.05, 5.49] |
| 5.2.2 Concussion |
1 |
303 |
Risk Ratio (IV, Random, 95% CI) |
0.34 [0.01, 8.17] |
| 5.2.3 Loss of consciousness |
1 |
221 |
Risk Ratio (IV, Random, 95% CI) |
0.33 [0.01, 8.02] |
| 5.2.4 Psychosis |
4 |
919 |
Risk Ratio (IV, Random, 95% CI) |
0.81 [0.13, 5.12] |
| 5.2.5 Syncope |
3 |
741 |
Risk Ratio (IV, Random, 95% CI) |
1.39 [0.23, 8.47] |
| 5.2.6 Suicidal ideation |
6 |
1032 |
Risk Ratio (IV, Random, 95% CI) |
1.63 [0.07, 38.55] |
| 5.2.7 Suicidal behaviour |
2 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 5.2.8 Oppositional behaviour/negativism |
1 |
217 |
Risk Ratio (IV, Random, 95% CI) |
0.17 [0.01, 4.04] |
| 5.2.9 Adjustment disorder |
1 |
230 |
Risk Ratio (IV, Random, 95% CI) |
0.78 [0.03, 18.91] |
| 5.3 Digestive system |
2 |
414 |
Risk Ratio (IV, Random, 95% CI) |
2.11 [0.22, 20.04] |
| 5.3.1 Appendicitis |
2 |
414 |
Risk Ratio (IV, Random, 95% CI) |
2.11 [0.22, 20.04] |
| 5.4 Cardiovascular systems |
2 |
280 |
Risk Ratio (IV, Random, 95% CI) |
1.02 [0.11, 9.65] |
| 5.4.1 Haematoma |
1 |
221 |
Risk Ratio (IV, Random, 95% CI) |
0.33 [0.01, 8.02] |
| 5.4.2 Tachycardia |
1 |
59 |
Risk Ratio (IV, Random, 95% CI) |
3.10 [0.13, 73.14] |
| 5.5 Respiratory systems |
1 |
606 |
Risk Ratio (IV, Random, 95% CI) |
1.01 [0.11, 9.62] |
| 5.5.1 Bronchitis |
1 |
303 |
Risk Ratio (IV, Random, 95% CI) |
0.34 [0.01, 8.17] |
| 5.5.2 Asthma |
1 |
303 |
Risk Ratio (IV, Random, 95% CI) |
3.02 [0.12, 73.54] |
| 5.6 Urinary system |
2 |
578 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.14 [0.23, 19.81] |
| 5.6.1 Renal cyst |
1 |
275 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.49 [0.06, 36.27] |
| 5.6.2 Kidney infection |
1 |
303 |
Risk Ratio (M‐H, Fixed, 95% CI) |
3.02 [0.12, 73.54] |
| 5.7 Skeletal and muscular system (including pain) |
1 |
221 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 8.02] |
| 5.7.1 Clavical fracture |
1 |
221 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.33 [0.01, 8.02] |
| 5.8 Immune system (including infections) |
1 |
303 |
Risk Ratio (IV, Random, 95% CI) |
3.02 [0.12, 73.54] |
| 5.8.1 Cyst rupture |
1 |
303 |
Risk Ratio (IV, Random, 95% CI) |
3.02 [0.12, 73.54] |
| 5.9 Other |
2 |
524 |
Risk Ratio (IV, Random, 95% CI) |
1.00 [0.10, 9.55] |
| 5.9.1 Drug toxicity |
1 |
303 |
Risk Ratio (IV, Random, 95% CI) |
0.34 [0.01, 8.17] |
| 5.9.2 Overdose |
1 |
221 |
Risk Ratio (IV, Random, 95% CI) |
2.97 [0.12, 72.20] |
