Table 3. Incidence of adverse events in patients treated with FTY according to nadir ALC.
All (n=69) | Non-lymphopenia (n=1) | Gr-1 lymphopenia (n=4) | Gr-2 lymphopenia (n=16) | Gr-3 lymphopenia (n=41) | Gr-4 lymphopenia (n=7) | ||
---|---|---|---|---|---|---|---|
Any infection | 11 (15.9) | 0 (0.0) | 0 (0.0) | 5 (31.3) | 4 (9.8) | 2 (28.6) | |
Nasopharyngitis | 1 (1.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (14.3) | |
Otitis media | 2 (2.9) | 0 (0.0) | 0 (0.0) | 1 (6.3) | 0 (0.0) | 1 (14.3) | |
FUO | 1 (1.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.4) | 0 (0.0) | |
URI | 4 (5.8) | 0 (0.0) | 0 (0.0) | 2 (12.5) | 2 (4.9) | 0 (0.0) | |
UTI | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (6.3) | 0 (0.0) | 0 (0.0) | |
Prostatitis | 1 (1.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.4) | 0 (0.0) | |
Herpes zoster | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (6.3) | 0 (0.0) | 0 (0.0) | |
Elevated LFT (>3 times ULN) | 6 (8.7) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 4 (9.8) | 1 (14.3) | |
Skin rash | 2 (2.9) | 0 (0.0) | 0 (0.0) | 2 (12.5) | 0 (0.0) | 0 (0.0) | |
Neoplasm (benign) | 1 (1.4) | 0 (0.0) | 0 (0.0) | 1 (6.3) | 0 (0.0) | 0 (0.0) | |
Bradycardia | 2 (2.9) | 0 (0.0) | 0 (0.0) | 1 (6.3) | 1 (2.4) | 0 (0.0) |
Data are n (%) values.
ALC, absolute lymphocyte count; FTY, fingolimod; FUO, fever of unknown origin; LFT, liver function test; ULN, upper limit of normal; URI, upper respiratory tract infection; UTI, urinary tract infection.