Table 8.
Total adverse events | BFD (n = 70) | STD (n = 70) | INN (n = 70) |
Subjects with at least one adverse event (%) | 62 (88.6%) | 57 (81.4%) | 61 (87.1%) |
Total number | 227 | 291 | 282 |
Mild—Grade 1 | 211 | 284 | 259 |
Moderate—Grade 2 | 3 | 3 | 7 |
Severe—Grade 3 | 0 | 0 | 0 |
Potentially fatal—Grade 4 | 0 | 0 | 0 |
Lethal—Grade 5 | 0 | 0 | 0 |
Unknown | 13 | 4 | 16 |
Adverse events related to feeding | BFD (n = 70) | STD (n = 70) | INN (n = 70) |
Subjects with at least one adverse event (%) | 1 (1.4%) | 1 (1.4%) | 1 (1.4%) |
Total number | 1 | 2 | 2 |
Mild—Grade 1 | 1 | 2 | 2 |
Moderate—Grade 2 | 0 | 0 | 0 |
Severe—Grade 3 | 0 | 0 | 0 |
Potentially fatal—Grade 4 | 0 | 0 | 0 |
Lethal—Grade 5 | 0 | 0 | 0 |
Unknown | 0 | 0 | 0 |
Data are expressed as counts and percentages.