Prior FIL exposure | No prior FIL exposure | Overall | Total | ||||
---|---|---|---|---|---|---|---|
FIL200 | FIL100 | FIL200 | FIL100 | FIL200 | FIL100 | (N=2729) | |
(n=1195) | (n=863) | (n=335) | (n=336) | (n=1530) | (n=1199) | ||
Decreased lymphocytes | 228 (19.1) | 125 (14.5) | 41 (12.3) | 40 (12.0) | 269 (17.6) | 165 (13.8) | 434 (16.0) |
(any grade), n (%) | |||||||
Grade 1 | 48 (4.0) | 35 (4.1) | 14 (4.2) | 7 (2.1) | 62 (4.1) | 42 (3.5) | 104 (3.8) |
Grade 2 | 159 (13.3) | 82 (9.5) | 21 (6.3) | 26 (7.8) | 180 (11.8) | 108 (9.1) | 288 (10.6) |
Grade 3 | 21 (1.8) | 8 (0.9) | 6 (1.8) | 7 (2.1) | 27 (1.8) | 15 (1.3) | 42 (1.5) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
A treatment-emergent laboratory decrease in lymphocytes was defined as an increase of ≥1 toxicity grade from baseline at any time post-baseline up to and including the date of last study drug dose + 30 days. Severity grades were defined per CTCAE (lower limit of normal: <0.8 × 109/L [Grade 1]; <0.8–0.5 × 109/L [2]; <0.5–0.2 × 109/L [3]; <0.2 × 109/L [4]).