TABLE 2.
Placebo (N = 46) | Palifermin (N = 48) | |
---|---|---|
Adverse events (AEs) | 45 (98) | 48 (100) |
Serious AEs | 30 (65) | 21 (44) |
Treatment-related AEs | 6 (13) | 13 (27) |
Serious AEs | 4 (9) | 2 (4) |
Most frequent (≥5%) treatment-related AEs | ||
Rash | 3 (7) | 2 (4) |
Diarrhea | 0 (0) | 3 (6) |
Erythema | 0 (0) | 3 (6) |
Flushing | 0 (0) | 3 (6) |
Incidence of second primary tumors | 0 (0) | 0 (0) |
Unresolved grade ≥2 dysphagia at month 6 | 2 (4) | 0 (0) |
On-study death | 5 (11) | 2 (4) |
Values are given as n (%).