Table 3.
AEs | Number of included studies | Sample size | P | I 2 | t 2 | Effect of model | R% (95%CI) |
---|---|---|---|---|---|---|---|
Overall rate of AEs | 11 | 819 | <0.01 | 97% | 0.026 | Random | 83.51% (95% CI: 73.55%–93.46%) |
Serious AEs | 10 | 791 | <0.01 | 95% | 0.071 | Random | 33.04% (18.15%–49.91%) |
Definite Nusinersen-related AEs | 8 | 498 | <0.01 | 84 | 0.026 | Random | 0.57% (0–3.97%) |
Probable Nusinersen-related AEs | 8 | 498 | <0.01 | 88 | 0.038 | Random | 7.76% (1.85%–17.22%) |
Upper respiratory tract infection | 9 | 577 | <0.01 | 83 | 0.022 | Random | 39.94% (29.43%–50.94%) |
Pneumonia | 7 | 576 | <0.01 | 79 | 0.013 | Random | 26.62% (17.99% –36.25%) |
Vomiting | 11 | 619 | <0.01 | 76 | 0.016 | Random | 21.04% (14.15%–28.89%) |
Constipation | 9 | 482 | <0.01 | 82 | 0.02 | Random | 19.59% (10.23%–31.09%) |
Diarrhea | 3 | 64 | 0.97 | 0 | 0 | Fixed | 28.11% (17.86%–39.67%) |
Fever | 11 | 763 | <0.01 | 94 | 0.066 | Random | 40.07% (25.14%–56.02%) |
Pain | 8 | 608 | <0.01 | 76 | 0.013 | Random | 22.75% (15.25%–31.25%) |
Cough | 7 | 488 | <0.01 | 85 | 0.024 | Random | 31.81% (20.32%–44.57%) |
Respiratory failure | 6 | 440 | 0 | 65 | 0.08 | Random | 18.77% (11.9%–26.77%) |
Gastroesophageal reflux disease | 4 | 142 | <0.01 | 78 | 0.028 | Random | 10.08% (1.78%–24.02%) |
Atelectasis | 4 | 399 | <0.01 | 91 | 0.043 | Random | 16.2% (3.71%–35.17%) |
Dysphagia | 2 | 99 | 0.48 | 0 | 0 | Fixed | 8.98% (4.18%–15.37%) |
Aspiration pneumonia | 4 | 189 | <0.01 | 0 | 0 | Fixed | 17.83% (11.13%–25.71%) |
Respiratory distress | 4 | 359 | 0.1 | 53 | 0.05 | Random | 17.83% (11.13%–25.71) |
Nasopharyngitis | 5 | 388 | <0.01 | 83 | 0.022 | Random | 21.19% (10.38%–34.58%) |
Skin rash | 4 | 194 | <0.01 | 94 | 0.104 | Random | 7.16% (0–31.82%) |
Otitis media | 4 | 148 | <0.01 | 93 | 0.115 | Random | 12.56% (0.03%–42.34%) |
Thrombocytopenia | 6 | 442 | <0.01 | 92 | 0.047 | Random | 1.81% (0–9.95%) |
Post–lumbar puncture syndrome | 11 | 828 | <0.01 | 78 | 0.01 | Random | 14.16% (9.13%–20.1%) |
motor milestone change | 7 | 350 | <0.01 | 95 | 0.098 | Random | 61.38% (37.60%–82.58%) |
AEs, adverse events.