Table 4.
Adverse Events over Time During Treatment with GPB
Switch Over Period | 12 Months Treatment with GPB | ||||||
---|---|---|---|---|---|---|---|
NaPBA 1–7 days (N=26) |
GPB 7–10 days (N=26) |
0–<3 Months (N=49) |
3–<6 Months (N=48) |
6–<9 Months (N=47) |
9–<12 Months (N=46) |
Overall 12 Months (N=49) |
|
Upper respiratory tract infection | 0 | 1 (3.8%) | 8 (16.3%) | 7 (14.6%) | 5 (10.6%) | 9 (19.6%) | 19 (38.8%) |
Vomiting | 0 | 3 (11.5%) | 8 (16.3%) | 3 (6.3%) | 6 (12.8%) | 7 (15.2%) | 18 (36.7%) |
Hyperammonaemia | 0 | 0 | 3 (6.1%) | 5 (10.4%) | 4 (8.5%) | 4 (8.7%) | 12 (24.5%) |
Pyrexia | 0 | 0 | 5 (10.2%) | 3 (6.3%) | 3 (6.4%) | 3 (6.5%) | 11 (22.4%) |
Cough | 0 | 0 | 6 (12.2%) | 2 (4.2%) | 1 (2.1%) | 1 (2.2%) | 9 (18.4%) |
Diarrhoea | 0 | 0 | 4 (8.2%) | 2 (4.2%) | 2 (4.3%) | 3 (6.5%) | 9 (18.4%) |
Gastroenteritis | 0 | 0 | 2 (4.1%) | 2 (4.2%) | 1 (2.1%) | 2 (4.3%) | 6 (12.2%) |
Nasopharyngitis | 0 | 0 | 1 (2.0%) | 1 (2.1%) | 2 (4.3%) | 2 (4.3%) | 6 (12.2%) |
Decreased appetite | 1 (3.8%) | 0 | 4 (8.2%) | 1 (2.1%) | 2 (4.3%) | 1 (2.2%) | 6 (12.2%) |
Pharyngitis streptococcal | 0 | 0 | 2 (4.1%) | 2 (4.2%) | 1 (2.1%) | 0 | 5 (10.2%) |