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. 2020 Oct 19;9(10):1011. doi: 10.3390/antiox9101011

Table 3.

Subgroup analyses for the risk of treatment-emergent AEs, stratified by smoking habit, cardiovascular disease, presence of diabetes, pregnancy, neurological disorders, rheumatic affections, age, and severe renal impairment at baseline.

AEs Smoking Habit Cardiovascular Disease Diabetes Pregnancy Neurological Disorders Rheumatic Affections Children and/or Adolescents Severe Renal Impairment
Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No
Gastrointestinal AEs Number of reported AEs (active arm/placebo arm) -/- 4/2 2/0 97/88 137/77 17/14 3/2 180/97 144/76 -/- 5/2 4/3 3/2 180/97 -/- 94/81
Odd ratio - 1.192 2.734 1.103 1.267 1.155 1.531 1.313 1.295 - 2.841 1.433 1.705 1.309 - 1.158
95% CI (lower limit; upper limit) - 0.265; 5.361 0.273; 27.383 0.781; 1.558 0.879; 1.827 0.540; 2.468 0.245; 9.574 0.966; 1.784 0.897; 1.869 - 0.500; 16.138 0.300; 6.833 0.260; 11.156 0.964; 1.779 - 0.811;
1.653
Z-value - 0.229 0.856 0.556 1.268 0.371 0.456 1.740 1.382 - 1.178 0.451 0.556 1.724 - 0.809
I2 (%) - 0 0 0 50 0 0 0 48 - 0 0 0 0 - 0
P-value - 0.819 0.392 0.578 0.205 0.711 0.649 0.082 0.167 - 0.239 0.652 0.578 0.085 - 0.418
Neurological AEs Number of reported AEs (active arm/placebo arm) -/- 6/2 1/0 19/18 10/0 18/14 -/- 50/23 25/9 -/- 8/6 0/1 -/- 50/23 -/- 22/16
Odd ratio - 1.024 3.078 1.153 2.368 1.268 - 1.526 1.718 - 1.474 0.315 - 1.526 - 3.078
95% CI (lower limit; upper limit) - 0.236; 4.442 0.122; 77.905 0.544; 2.442 0.884; 2.634 0.552; 2.914 - 0.884; 2.634 0.742; 3.977 - 0.432; 5.027 0.012; 7.999 - 0.884; 2.634 - 0.122;
77.905
Z-value - 0.032 0.682 0.371 1.517 0.560 - 1.517 1.264 - 0.619 −0.700 - 1.517 - 0.682
I2 (%) - 0 0 0 0 0 - 0 0 - 0 0 - 0 - 0
P-value - 0.974 0.495 0.711 0.129 0.575 - 0.129 0.206 - 0.536 0.484 - 0.129 - 0.495
Psychiatric AEs Number of reported AEs (active arm/placebo arm) -/- 2/0 -/- 30/25 26/25 4/0 -/- 30/25 26/25 -/- -/- 2/0 -/- 30/25 -/- 28/25
Odd ratio - 5.145 - 1.131 1.014 5.071 - 1.131 1.014 - - 5.145 - 1.131 - 1.073
95% CI (lower limit; upper limit) - 0.238; 111.087 - 0.644;
1.986		 0.566;
1.817		 0.582;
44.174		 - 0.644;
1.986		 0.566;
1.817		 - - 0.238; 111.087 - 0.644; 1.986 - 0.605; 1.903
Z-value - 1.045 - 0.429 0.048 1.470 - 0.429 0.048 - - 1.045 - 0.429 - 0.242
I2 (%) - 0 - 0 0 0 - 0 0 - - 0 - 0 - 0
P-value - 0.296 - 0.668 0.962 0.142 - 0.668 0.962 - - 0.296 - 0.668 - 0.809
Musculoskeletal AEs Number of reported AEs (active arm/placebo arm) -/- 1/0 -/- 3/5 -/- 3/4 -/- 5/5 4/4 -/- 0/1 1/0 -/- 5/5 -/- 3/5
Odd ratio - 3.000 - 0.625 - 0.738 - 0.761 0.683 - 0.321 3.000 - 0.761 - 0.625
95% CI (lower limit; upper limit) - 0.118;
76.161		 - 0.147;
2.661		 - 0.146;
3.723		 - 0.220;
2.635		 0.156;
2.997		 - 0.013;
8.241		 0.118;
76.161		 - 0.220;
2.635		 - 0.147; 2.661
Z-value - 0.666 - −0.636 - −0.368 - −0.431 −0.505 - −0.686 0.666 - −0.431 - −0.636
I2 (%) - 0 - 0 - 0 - 0 0 - 0 0 - 0 - 0
P-value - 0.506 - 0.525 - 0.713 - 0.666 0.614 - 0.493 0.506 - 0.666 - 0.525
Skin AEs Number of reported AEs (active arm/placebo arm) -/- 21/4 -/- 92/94 83/90 14/6 -/- 139/103 83/91 1/0 -/- -/- -/- 139/103 2/0 104/95
Odd ratio - 2.821 - 0.912 0.816 2.258 - 1.127 0.819 3.353 - - - 1.127 1.545 0.932
95% CI (lower limit; upper limit) - 0.899; 8.850 - 0.635; 1.308 0.559; 1.191 0.851;
5.992		 - 0.815; 1.559 0.563; 1.192 0.120; 93.835 - - - 0.815; 1.559 0.067; 35.431 0.653; 1.331
Z-value - 1.778 - −0.502 −1.052 1.636 - 0.724 −1.041 0.712 - - - 0.724 0.272 −0.387
I2 (%) - 0 - 29 0 0 - 34 0 0 - - - 34 0 36
P-value - 0.075 - 0.616 0.293 0.102 - 0.469 0.298 0.477 - - - 0.469 0.785 0.699
Infections Number of reported AEs (active arm/placebo arm) -/- 3/0 -/- 1/3 -/- 1/3 -/- 5/3 1/3 -/- -/- -/- -/- 5/3 -/- 4/3
Odd ratio - 3.316 - 0.310 - 0.310 - 0.926 0.310 - - - - 0.926 - 0.780
95% CI (lower limit; upper limit) - 0.167; 65.718 - 0.028; 3.364 - 0.028; 3.364 - 0.184; 4.647 0.028; 3.364 - - - - 0.184; 4.647 - 0.121; 5.028
Z-value - 0.787 - −0.963 - −0.963 - −0.094 −0.963 - - - - −0.094 - −0.262
I2 (%) - 0 - 0 - 0 - 0 0 - - - - 0 - 32
P-value - 0.432 - 0.335 - 0.335 - 0.925 0.335 - - - - 0.925 - 0.793
CV system AEs Number of reported AEs (active arm/placebo arm) -/- 0/1 0/2 71/53 71/54 1/3 -/- 73/60 71/54 -/- -/- 0/1 -/- 73/60 -/- 71/57
Odd ratio - 0.149 0.191 1.441 1.409 0.450 - 1.247 1.409 - - 0.333 - 1.247 - 1.313
95% CI (lower limit; upper limit) - 0.006; 3.733 0.009; 4.214 0.950; 2.186 0.932; 2.130 0.056; 3.608 - 0.838; 1.854 0.932; 2.130 - - 0.012; 9.068 - 0.838; 1.854 - 0.875; 1.972
Z-value - −1.159 −1.049 1.720 1.625 −0.752 - 1.089 1.625 - - −0.652 - 1.089 - 1.314
I2 (%) - 0 0 0 0 0 - 16 0 - - 0 - 16 - 27
P-value - 0.247 0.294 0.085 0.104 0.452 - 0.276 0.104 - - 0.515 - 0.276 - 0.189
Hospitalisation Number of reported AEs (active arm/placebo arm) -/- 4/0 -/- 2/0 -/- 2/0 -/- 4/0 -/- -/- -/- 2/0 -/- 4/0 2/0 2/0
Odd ratio - 5.657 - 5.145 - 5.145 - 5.657 - - - 5.145 - 5.657 6.224 5.145
95% CI (lower limit; upper limit) - 0.642; 49.849 - 0.238; 111.087 - 0.238; 111.087 - 0.642; 49.849 - - - 0.238; 111.087 - 0.642; 49.849 0.285; 135.784 0.238; 111.087
Z-value - 1.561 - 1.045 - 1.045 - 1.561 - - - 1.045 - 1.561 1.163 1.045
I2 (%) - 0 - 0 - 0 - 0 - - - 0 - 0 0 0
P-value - 0.119 - 0.296 - 0.296 - 0.119 - - - 0.296 - 0.119 0.245 0.296
Death Number of reported AEs (active arm/placebo arm) -/- 0/2 4/5 -/- -/- 1/2 -/- 6/12 1/3 -/- -/- -/- -/- 6/12 0/2 6/9
Odd ratio - 0.215 0.777 - - 0.529 - 0.558 0.468 - - - - 0.558 0.215 0.657
95% CI (lower limit; upper limit) - 0.010; 4.690 0.192; 3.142 - - 0.046; 6.109 - 0.210; 1.483 0.066; 3.300 - - - - 0.210; 1.483 0.010; 4.690 0.222; 1.947
Z-value - −0.977 −0.354 - - −0.510 - −1.169 −0.762 - - - - −1.169 −0.977 −0.758
I2 (%) - 0 0 - - 0 - 0 0 - - - - 0 0 0
P-value - 0.328 0.724 - - 0.610 - 0.242 0.446 - - - - 0.242 0.328 0.448

AEs = Adverse events; CI = Confidence Intervals.