Table 3.
Incidence of adverse events by preferred term
| SMA onset ≤ 6 months (n = 10) |
SMA onset > 6 months (n = 40) |
Overall (N = 50) |
|
|---|---|---|---|
| Participants with any adverse event, n (%) | 10 (100) | 35 (88) | 45 (90) |
| Upper respiratory tract infection | 2 (20) | 11 (28) | 13 (26) |
| Pneumonia | 6 (60) | 5 (13) | 11 (22) |
| Procedural pain | 3 (30) | 8 (20) | 11 (22) |
| Bronchitis | 1 (10) | 8 (20) | 9 (18) |
| Pyrexia | 0 | 6 (15) | 6 (12) |
| Urinary tract infection | 1 (10) | 4 (10) | 5 (10) |
| Nasopharyngitis | 0 | 4 (10) | 4 (8) |
| Anemia | 1 (10) | 2 (5) | 3 (6) |
| C-reactive protein increased | 1 (10) | 2 (5) | 3 (6) |
| COVID-19 | 0 | 3 (8) | 3 (6) |
| Gastroenteritis | 1 (10) | 2 (5) | 3 (6) |
| Hematuria | 1 (10) | 2 (5) | 3 (6) |
| Hypokalemia | 2 (20) | 1 (3) | 3 (6) |
| Diarrhea | 1 (10) | 1 (3) | 2 (4) |
| Headache | 1 (10) | 1 (3) | 2 (4) |
| Hyponatremia | 1 (10) | 1 (3) | 2 (4) |
| Iron deficiency | 0 | 2 (5) | 2 (4) |
| Neutrophil count decreased | 1 (10) | 1 (3) | 2 (4) |
| Post lumbar puncture syndrome | 0 | 2 (5) | 2 (4) |
| Vomiting | 0 | 2 (5) | 2 (4) |
| Weight decreased | 1 (10) | 1 (3) | 2 (4) |
Events shown are those occurring in at least two participants
SMA spinal muscular atrophy, COVID-19 coronavirus disease 2019