| 7.1 Proportion of participants with non‐serious adverse events |
35 |
5342 |
Risk Ratio (IV, Random, 95% CI) |
1.23 [1.11, 1.37] |
| 7.2 Subgroup analysis: proportion of participants with non‐serious adverse events according to dose |
32 |
4718 |
Risk Ratio (IV, Random, 95% CI) |
1.24 [1.12, 1.37] |
| 7.2.1 Low dose |
3 |
289 |
Risk Ratio (IV, Random, 95% CI) |
1.02 [0.97, 1.07] |
| 7.2.2 High dose |
22 |
3365 |
Risk Ratio (IV, Random, 95% CI) |
1.23 [1.14, 1.32] |
| 7.2.3 Unknown dose |
8 |
1064 |
Risk Ratio (IV, Random, 95% CI) |
1.37 [0.93, 2.02] |
| 7.3 Nervous system (including psychiatry) |
37 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 7.3.1 Affective |
4 |
456 |
Risk Ratio (IV, Random, 95% CI) |
2.39 [0.48, 11.96] |
| 7.3.2 Aggression |
3 |
503 |
Risk Ratio (IV, Random, 95% CI) |
1.23 [0.30, 5.08] |
| 7.3.3 Apathy |
1 |
59 |
Risk Ratio (IV, Random, 95% CI) |
0.80 [0.19, 3.33] |
| 7.3.4 Confusion or confusional state |
3 |
823 |
Risk Ratio (IV, Random, 95% CI) |
0.75 [0.17, 3.24] |
| 7.3.5 Depression |
1 |
59 |
Risk Ratio (IV, Random, 95% CI) |
0.83 [0.22, 3.10] |
| 7.3.6 Dizziness |
11 |
2149 |
Risk Ratio (IV, Random, 95% CI) |
1.77 [0.95, 3.30] |
| 7.3.7 Drowsiness |
4 |
811 |
Risk Ratio (IV, Random, 95% CI) |
1.27 [0.82, 1.98] |
| 7.3.8 Emotional lability |
5 |
624 |
Risk Ratio (IV, Random, 95% CI) |
1.24 [0.54, 2.85] |
| 7.3.9 Fatigue |
14 |
2228 |
Risk Ratio (IV, Random, 95% CI) |
0.67 [0.44, 1.02] |
| 7.3.10 Headache |
32 |
5041 |
Risk Ratio (IV, Random, 95% CI) |
1.33 [1.04, 1.70] |
| 7.3.11 Irritability |
20 |
3290 |
Risk Ratio (IV, Random, 95% CI) |
1.05 [0.82, 1.34] |
| 7.3.12 Nervousness |
2 |
362 |
Risk Ratio (IV, Random, 95% CI) |
2.52 [0.82, 7.76] |
| 7.3.13 Pain |
1 |
132 |
Risk Ratio (IV, Random, 95% CI) |
1.91 [0.21, 17.60] |
| 7.3.14 Picking at skin or fingers, nail biting, lip or cheek chewing |
5 |
686 |
Risk Ratio (IV, Random, 95% CI) |
0.97 [0.60, 1.57] |
| 7.3.15 Sad, tearful or depressed |
7 |
1015 |
Risk Ratio (IV, Random, 95% CI) |
1.47 [0.95, 2.28] |
| 7.3.16 Thirst |
2 |
179 |
Risk Ratio (IV, Random, 95% CI) |
3.00 [0.13, 71.82] |
| 7.3.17 Dull, tired, listless |
1 |
110 |
Risk Ratio (IV, Random, 95% CI) |
1.70 [0.51, 5.68] |
| 7.3.18 Tics or nervous movements |
12 |
1556 |
Risk Ratio (IV, Random, 95% CI) |
0.77 [0.27, 2.22] |
| 7.3.19 Worried or anxious |
3 |
596 |
Risk Ratio (IV, Random, 95% CI) |
1.37 [0.84, 2.25] |
| 7.3.20 Feeling jittery |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.52 [0.05, 5.56] |
| 7.3.21 Malaise |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.3.22 Dysgeusia |
2 |
171 |
Risk Ratio (IV, Random, 95% CI) |
0.79 [0.19, 3.30] |
| 7.3.23 Lethargy |
2 |
224 |
Risk Ratio (IV, Random, 95% CI) |
0.69 [0.40, 1.17] |
| 7.3.24 Aphonia |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.3.25 Psychomotor hyperactivity |
3 |
522 |
Risk Ratio (IV, Random, 95% CI) |
3.67 [0.61, 22.01] |
| 7.3.26 Syncope |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.3.27 Tremor |
3 |
231 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.3.28 Social withdrawal |
1 |
110 |
Risk Ratio (IV, Random, 95% CI) |
2.56 [0.24, 26.71] |
| 7.3.29 Sedation |
1 |
138 |
Risk Ratio (IV, Random, 95% CI) |
1.30 [0.66, 2.53] |
| 7.3.30 Mood swings |
2 |
247 |
Risk Ratio (IV, Random, 95% CI) |
2.53 [0.94, 6.82] |
| 7.3.31 Anger |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.3.32 Anxiety |
2 |
180 |
Risk Ratio (IV, Random, 95% CI) |
0.64 [0.08, 5.08] |
| 7.3.33 Change in sustained attention |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.3.34 Emotional poverty |
2 |
175 |
Risk Ratio (IV, Random, 95% CI) |
3.47 [0.37, 32.68] |
| 7.3.35 Trichotillomania |
1 |
85 |
Risk Ratio (IV, Random, 95% CI) |
2.80 [0.12, 66.85] |
| 7.3.36 Stuttering |
1 |
94 |
Risk Ratio (IV, Random, 95% CI) |
0.33 [0.01, 7.98] |
| 7.3.37 Emotional disorder |
2 |
174 |
Risk Ratio (IV, Random, 95% CI) |
0.42 [0.02, 10.16] |
| 7.3.38 Negativism |
2 |
174 |
Risk Ratio (IV, Random, 95% CI) |
3.83 [0.16, 91.41] |
| 7.3.39 Migraine |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.3.40 Tension |
1 |
60 |
Risk Ratio (IV, Random, 95% CI) |
23.00 [1.42, 373.44] |
| 7.4 Digestive system |
34 |
22299 |
Risk Ratio (IV, Random, 95% CI) |
1.81 [1.54, 2.14] |
| 7.4.1 Change in appetite |
1 |
94 |
Risk Ratio (IV, Random, 95% CI) |
0.78 [0.32, 1.92] |
| 7.4.2 Decreased appetite |
30 |
5127 |
Risk Ratio (IV, Random, 95% CI) |
3.35 [2.49, 4.50] |
| 7.4.3 Increased appetite |
2 |
265 |
Risk Ratio (IV, Random, 95% CI) |
0.15 [0.02, 1.34] |
| 7.4.4 Change in weight |
1 |
94 |
Risk Ratio (IV, Random, 95% CI) |
0.40 [0.08, 1.96] |
| 7.4.5 Increased weight |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.4.6 Decreased weight |
11 |
2001 |
Risk Ratio (IV, Random, 95% CI) |
5.44 [2.47, 11.98] |
| 7.4.7 Dyspepsia |
5 |
390 |
Risk Ratio (IV, Random, 95% CI) |
0.71 [0.16, 3.19] |
| 7.4.8 Upper abdominal pain |
10 |
1745 |
Risk Ratio (IV, Random, 95% CI) |
1.25 [0.79, 1.96] |
| 7.4.9 Stomachache (abdominal pain) |
18 |
3069 |
Risk Ratio (IV, Random, 95% CI) |
1.19 [0.94, 1.50] |
| 7.4.10 Vomiting |
20 |
3105 |
Risk Ratio (IV, Random, 95% CI) |
1.26 [0.85, 1.86] |
| 7.4.11 Constipation |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.4.12 Oral pain |
2 |
171 |
Risk Ratio (IV, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.4.13 Retching |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.4.14 Diarrhoea |
8 |
1088 |
Risk Ratio (IV, Random, 95% CI) |
0.83 [0.35, 1.94] |
| 7.4.15 Dry mouth |
4 |
1057 |
Risk Ratio (IV, Random, 95% CI) |
3.79 [1.26, 11.39] |
| 7.4.16 Nausea |
19 |
3484 |
Risk Ratio (IV, Random, 95% CI) |
1.40 [1.00, 1.95] |
| 7.4.17 Flatulence |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.4.18 Gastritis |
1 |
89 |
Risk Ratio (IV, Random, 95% CI) |
3.83 [0.16, 91.40] |
| 7.4.19 Gastrointestinal concerns (unspecified) |
1 |
94 |
Risk Ratio (IV, Random, 95% CI) |
1.00 [0.06, 15.52] |
| 7.4.20 Polydipsia |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.5 Cardiovascular system |
12 |
3047 |
Risk Ratio (IV, Random, 95% CI) |
1.41 [0.81, 2.46] |
| 7.5.1 ECG: prolonged QT‐interval |
2 |
466 |
Risk Ratio (IV, Random, 95% CI) |
0.81 [0.13, 5.00] |
| 7.5.2 ECG: tachycardia |
5 |
686 |
Risk Ratio (IV, Random, 95% CI) |
0.66 [0.20, 2.22] |
| 7.5.3 Increased diastolic blood pressure |
1 |
119 |
Risk Ratio (IV, Random, 95% CI) |
1.07 [0.43, 2.68] |
| 7.5.4 Increased systolic blood pressure |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.5.5 Increased heart rate |
2 |
422 |
Risk Ratio (IV, Random, 95% CI) |
4.99 [0.86, 28.85] |
| 7.5.6 Supraventricular extrasystoles |
1 |
17 |
Risk Ratio (IV, Random, 95% CI) |
3.00 [0.11, 84.55] |
| 7.5.7 Ventricular arrhythmia |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.5.8 Epistaxis |
3 |
303 |
Risk Ratio (IV, Random, 95% CI) |
1.71 [0.29, 10.07] |
| 7.5.9 Increased blood pressure |
2 |
414 |
Risk Ratio (IV, Random, 95% CI) |
2.72 [0.00, 7037727483218459000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000.00] |
| 7.5.10 Orthostatic hypotension |
1 |
329 |
Risk Ratio (IV, Random, 95% CI) |
2.72 [0.00, 7037727483218459000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000.00] |
| 7.5.11 Palpitations |
1 |
60 |
Risk Ratio (IV, Random, 95% CI) |
11.00 [0.64, 190.54] |
| 7.5.12 Pallor |
1 |
60 |
Risk Ratio (IV, Random, 95% CI) |
23.00 [1.42, 373.44] |
| 7.6 Respiratory system |
13 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 7.6.1 Pharyngolaryngeal pain |
1 |
303 |
Risk Ratio (IV, Random, 95% CI) |
1.12 [0.59, 2.13] |
| 7.6.2 Upper respiratory tract infection |
3 |
421 |
Risk Ratio (IV, Random, 95% CI) |
1.14 [0.56, 2.34] |
| 7.6.3 Bronchitis |
1 |
85 |
Risk Ratio (IV, Random, 95% CI) |
0.31 [0.01, 7.43] |
| 7.6.4 Oropharyngeal pain |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
7.33 [0.39, 137.67] |
| 7.6.5 Rhinorrhoea |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
5.23 [0.26, 105.88] |
| 7.6.6 Allergic bronchitis |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.6.7 Sneezing |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.6.8 Nasal congestion |
3 |
565 |
Risk Ratio (IV, Random, 95% CI) |
1.24 [0.62, 2.48] |
| 7.6.9 Cough |
9 |
1656 |
Risk Ratio (IV, Random, 95% CI) |
1.31 [0.62, 2.78] |
| 7.6.10 Shortness of breath |
2 |
179 |
Risk Ratio (IV, Random, 95% CI) |
3.00 [0.13, 71.82] |
| 7.7 Urinary system |
1 |
178 |
Risk Ratio (M‐H, Random, 95% CI) |
3.83 [0.41, 36.08] |
| 7.7.1 Pollakiuria |
1 |
89 |
Risk Ratio (M‐H, Random, 95% CI) |
3.83 [0.16, 91.40] |
| 7.7.2 Urinary incontinence |
1 |
89 |
Risk Ratio (M‐H, Random, 95% CI) |
3.83 [0.16, 91.40] |
| 7.8 Skeletal and muscular systems (including pain) |
7 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 7.8.1 Arthralgia |
2 |
388 |
Risk Ratio (IV, Random, 95% CI) |
0.67 [0.24, 1.84] |
| 7.8.2 Asthenia |
1 |
177 |
Risk Ratio (IV, Random, 95% CI) |
0.21 [0.01, 4.25] |
| 7.8.3 Back pain |
3 |
474 |
Risk Ratio (IV, Random, 95% CI) |
0.77 [0.38, 1.57] |
| 7.8.4 Myalgia |
3 |
474 |
Risk Ratio (IV, Random, 95% CI) |
0.55 [0.22, 1.35] |
| 7.8.5 Toothache |
1 |
303 |
Risk Ratio (IV, Random, 95% CI) |
1.01 [0.43, 2.35] |
| 7.8.6 Ligament strain |
1 |
85 |
Risk Ratio (IV, Random, 95% CI) |
0.31 [0.01, 7.43] |
| 7.8.7 Muscle strain |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.8.8 Fractures |
1 |
94 |
Risk Ratio (IV, Random, 95% CI) |
3.00 [0.13, 71.82] |
| 7.8.9 Muscle cramps |
1 |
94 |
Risk Ratio (IV, Random, 95% CI) |
3.00 [0.13, 71.82] |
| 7.8.10 Pain in extremity |
1 |
89 |
Risk Ratio (IV, Random, 95% CI) |
0.26 [0.01, 5.16] |
| 7.8.11 Pain |
1 |
132 |
Risk Ratio (IV, Random, 95% CI) |
1.87 [0.22, 16.19] |
| 7.9 Immune system (including infections) |
17 |
|
Risk Ratio (IV, Random, 95% CI) |
Subtotals only |
| 7.9.1 Gastroenteritis |
5 |
606 |
Risk Ratio (IV, Random, 95% CI) |
2.41 [0.66, 8.78] |
| 7.9.2 Influenza |
4 |
709 |
Risk Ratio (IV, Random, 95% CI) |
0.55 [0.23, 1.30] |
| 7.9.3 Nasopharyngitis |
10 |
1623 |
Risk Ratio (IV, Random, 95% CI) |
1.14 [0.76, 1.70] |
| 7.9.4 Otitis media |
3 |
271 |
Risk Ratio (IV, Random, 95% CI) |
0.99 [0.15, 6.61] |
| 7.9.5 Pharyngitis |
5 |
614 |
Risk Ratio (IV, Random, 95% CI) |
2.02 [0.55, 7.35] |
| 7.9.6 Pyrexia |
5 |
678 |
Risk Ratio (IV, Random, 95% CI) |
0.68 [0.12, 3.81] |
| 7.9.7 Rhinitis |
1 |
132 |
Risk Ratio (IV, Random, 95% CI) |
1.28 [0.43, 3.79] |
| 7.9.8 Upper respiratory tract infection ‐ not otherwise specified (NOS) |
12 |
1929 |
Risk Ratio (IV, Random, 95% CI) |
0.95 [0.65, 1.39] |
| 7.9.9 Viral infection NOS |
5 |
1029 |
Risk Ratio (IV, Random, 95% CI) |
0.97 [0.44, 2.14] |
| 7.9.10 Seasonal allergy |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.9.11 Streptococcal impetigo |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.9.12 Sinusitis |
1 |
89 |
Risk Ratio (IV, Random, 95% CI) |
0.42 [0.02, 10.16] |
| 7.9.13 Cellulitis |
1 |
89 |
Risk Ratio (IV, Random, 95% CI) |
0.42 [0.02, 10.16] |
| 7.9.14 Pleurisy |
1 |
275 |
Risk Ratio (IV, Random, 95% CI) |
1.49 [0.06, 36.27] |
| 7.10 Integumentary system |
7 |
1455 |
Risk Ratio (M‐H, Random, 95% CI) |
0.76 [0.37, 1.58] |
| 7.10.1 Purple spots |
1 |
94 |
Risk Ratio (M‐H, Random, 95% CI) |
3.00 [0.13, 71.82] |
| 7.10.2 Skin disorder (rash) |
5 |
460 |
Risk Ratio (M‐H, Random, 95% CI) |
0.76 [0.12, 4.96] |
| 7.10.3 Skin laceration |
3 |
474 |
Risk Ratio (M‐H, Random, 95% CI) |
0.47 [0.18, 1.22] |
| 7.10.4 Burns second degree |
1 |
85 |
Risk Ratio (M‐H, Random, 95% CI) |
2.80 [0.12, 66.85] |
| 7.10.5 Burns first degree |
1 |
86 |
Risk Ratio (M‐H, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.10.6 Subcutaneous haematoma |
1 |
86 |
Risk Ratio (M‐H, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.10.7 Periorbital haematoma |
1 |
0 |
Risk Ratio (M‐H, Random, 95% CI) |
Not estimable |
| 7.10.8 Rash maculo‐papular |
1 |
0 |
Risk Ratio (M‐H, Random, 95% CI) |
Not estimable |
| 7.11 Sleep variability |
29 |
7308 |
Risk Ratio (IV, Random, 95% CI) |
1.57 [1.23, 2.02] |
| 7.11.1 Somnolence |
6 |
757 |
Risk Ratio (IV, Random, 95% CI) |
0.87 [0.52, 1.46] |
| 7.11.2 Trouble sleeping or sleep problems |
15 |
2620 |
Risk Ratio (IV, Random, 95% CI) |
1.62 [1.18, 2.21] |
| 7.11.3 Insomnia |
15 |
2315 |
Risk Ratio (IV, Random, 95% CI) |
1.90 [1.12, 3.22] |
| 7.11.4 Initial insomnia |
5 |
917 |
Risk Ratio (IV, Random, 95% CI) |
2.25 [0.89, 5.71] |
| 7.11.5 Middle insomnia |
2 |
171 |
Risk Ratio (IV, Random, 95% CI) |
1.05 [0.07, 16.22] |
| 7.11.6 Sleep disorder |
2 |
528 |
Risk Ratio (IV, Random, 95% CI) |
0.67 [0.22, 2.10] |
| 7.12 Sleep variability continuous outcomes |
2 |
943 |
Mean Difference (IV, Fixed, 95% CI) |
0.03 [‐0.01, 0.06] |
| 7.12.1 Sleep efficiency after treatment discontinuation (percentage) |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
5.42 [0.21, 10.63] |
| 7.12.2 Sleep onset latency (min) |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
‐20.16 [‐45.74, 5.42] |
| 7.12.3 Total sleep time (min) |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
30.82 [‐7.73, 69.37] |
| 7.12.4 Total in‐bed time (min) |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.07 [‐33.82, 29.68] |
| 7.12.5 Wake after sleep onset (min) |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
‐7.89 [‐22.87, 7.09] |
| 7.12.6 Number of wake bouts |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.66 [‐8.38, 7.06] |
| 7.12.7 Mean wake bout time (min) |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.17 [‐0.47, 0.13] |
| 7.12.8 Interdaily stability |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
0.03 [‐0.06, 0.12] |
| 7.12.9 Interdaily variability |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
0.03 [‐0.01, 0.07] |
| 7.12.10 Amount of activity during the 5 hours with the lowest activity |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.46 [‐1.62, 0.70] |
| 7.12.11 Amount of activity during the 10 hours with the highest activity |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.59 [‐3.57, 2.39] |
| 7.12.12 Amplitude of sleep‐wake rhythm |
1 |
48 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.12 [‐2.87, 2.63] |
| 7.12.13 Pittsburgh Sleep Quality Index (PSQI) |
1 |
367 |
Mean Difference (IV, Fixed, 95% CI) |
0.10 [‐0.83, 1.03] |
| 7.13 Vital signs |
14 |
6407 |
Mean Difference (IV, Random, 95% CI) |
2.12 [1.26, 2.98] |
| 7.13.1 Diastolic blood pressure (mmHg) |
13 |
2032 |
Mean Difference (IV, Random, 95% CI) |
1.90 [0.68, 3.11] |
| 7.13.2 Systolic blood pressure (mmHg) |
13 |
2032 |
Mean Difference (IV, Random, 95% CI) |
0.85 [‐0.20, 1.89] |
| 7.13.3 Pulse or heart rate (bpm) |
13 |
2205 |
Mean Difference (IV, Random, 95% CI) |
3.86 [2.09, 5.63] |
| 7.13.4 ECG: changes in QTcB |
1 |
138 |
Mean Difference (IV, Random, 95% CI) |
‐1.70 [‐7.94, 4.54] |
| 7.14 Physical parameters |
7 |
2425 |
Std. Mean Difference (IV, Random, 95% CI) |
‐0.97 [‐1.24, ‐0.70] |
| 7.14.1 Height |
1 |
215 |
Std. Mean Difference (IV, Random, 95% CI) |
‐0.06 [‐0.35, 0.22] |
| 7.14.2 Weight |
7 |
1400 |
Std. Mean Difference (IV, Random, 95% CI) |
‐1.13 [‐1.40, ‐0.85] |
| 7.14.3 BMI |
3 |
810 |
Std. Mean Difference (IV, Random, 95% CI) |
‐1.00 [‐1.26, ‐0.73] |
| 7.15 Other (including drug toxicity) |
9 |
4145 |
Risk Ratio (IV, Random, 95% CI) |
1.13 [0.74, 1.72] |
| 7.15.1 Accidental injury |
3 |
656 |
Risk Ratio (IV, Random, 95% CI) |
0.99 [0.48, 2.07] |
| 7.15.2 Excoriation |
2 |
389 |
Risk Ratio (IV, Random, 95% CI) |
3.22 [1.20, 8.64] |
| 7.15.3 Overdose |
1 |
221 |
Risk Ratio (IV, Random, 95% CI) |
2.97 [0.12, 72.20] |
| 7.15.4 Arthropod‐bite |
2 |
171 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.15.5 Contusion |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.12 [0.01, 2.10] |
| 7.15.6 Wound |
2 |
171 |
Risk Ratio (IV, Random, 95% CI) |
0.73 [0.06, 9.22] |
| 7.15.7 Tinnitus |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
5.23 [0.26, 105.89] |
| 7.15.8 Dry eye |
2 |
171 |
Risk Ratio (IV, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.15.9 Excessive eye blinking |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.15.10 Occular hyperaemia |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.15.11 Visual impairment |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.15.12 Red eyes |
1 |
94 |
Risk Ratio (IV, Random, 95% CI) |
0.33 [0.01, 7.98] |
| 7.15.13 Conjunctival abrasion |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.15.14 Radius fracture |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.15.15 Snake bite |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
3.14 [0.13, 74.98] |
| 7.15.16 Enuresis |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.15.17 Night sweats |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.15.18 Abnormal liver function test |
1 |
85 |
Risk Ratio (IV, Random, 95% CI) |
0.31 [0.01, 7.43] |
| 7.15.19 Alopecia |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.15.20 Nail injury |
1 |
86 |
Risk Ratio (IV, Random, 95% CI) |
0.35 [0.01, 8.33] |
| 7.15.21 Itching |
2 |
179 |
Risk Ratio (IV, Random, 95% CI) |
5.00 [0.25, 101.43] |
| 7.15.22 Ear pain |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.15.23 Corneal injury |
1 |
89 |
Risk Ratio (IV, Random, 95% CI) |
0.42 [0.02, 10.16] |
| 7.15.24 Wrist fracture |
1 |
329 |
Risk Ratio (IV, Random, 95% CI) |
1.51 [0.06, 36.85] |
| 7.15.25 Dysmennorhea |
1 |
329 |
Risk Ratio (IV, Random, 95% CI) |
1.51 [0.06, 36.85] |
| 7.15.26 Myopia |
1 |
0 |
Risk Ratio (IV, Random, 95% CI) |
Not estimable |
| 7.15.27 Other AEs unspecified |
1 |
60 |
Risk Ratio (IV, Random, 95% CI) |
0.40 [0.08, 1.90] |
