Table 1 TE infection events by grade and treatment arm in the safety population of the FIRST trial (1613 patients, including 532, 540, and 541 in the Rd continuous, Rd18, and MPT arms, respectively)
TE infection events, na | Grade 1 (mild) infections | Grade 2 (moderate) infections | Grade 3 (severe) infections | Grade 4 (life-threatening) infections | Grade 5 (death) infections | Unknown grade infections | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rd cont | Rd18 | MPT | Total | Rd cont | Rd18 | MPT | Total | Rd cont | Rd18 | MPT | Total | Rd cont | Rd18 | MPT | Total | Rd cont | Rd18 | MPT | Total | Rd cont | Rd18 | MPT | Total | |
Events in the first 4 months | 134 | 136 | 85 | 355 | 157 | 170 | 114 | 441 | 57 | 68 | 62 | 187 | 17 | 16 | 15 | 48 | 11 | 10 | 9 | 30 | 0 | 3 | 0 | 3 |
Events in the first 18 months | 339 | 356 | 190 | 885 | 440 | 422 | 307 | 1169 | 148 | 145 | 105 | 398 | 35 | 27 | 24 | 86 | 20 | 20 | 15 | 55 | 0 | 3 | 2 | 5 |
Events beyond 18 months | 175 | 4 | 4 | 183 | 174 | 3 | 1 | 178 | 62 | 1 | 0 | 63 | 6 | 0 | 0 | 6 | 2 | 0 | 0 | 2 | 1 | 0 | 0 | 1 |
Total | 514 | 360 | 194 | 1068 | 614 | 425 | 308 | 1347 | 210 | 146 | 105 | 461 | 41 | 27 | 24 | 92 | 22 | 20 | 15 | 57 | 1 | 3 | 2 | 6 |