Table 1.
Baseline characteristics of the CLL11 and RESONATE-2 trial populations before and after matching for base case and sensitivity analysis for the removal of IGHV status from matching
| Trial data | MAIC results | ||||
|---|---|---|---|---|---|
| CLL11 [9] | RESONATE-2 | RESONATE-2 | |||
| ITT | ITT | After exclusiona | Base case matched (n = 13 variables) | SA matched (n = 12 variables) | |
| N (Neff) | 589 | 269 | 191 | 115 (35) | 152 (48) |
| CIRS score (median) | 8 | 5 | 6 | 8 | 8 |
| CIRS score ≤6 (%) | 26 | 64 | 56 | 26 | 26 |
| Age (median) | 73 | 73 | 73 | 73 | 73 |
| Age (≥75 years) (%) | 43 | 35 | 40 | 43 | 43 |
| Binet stage A (%) | 22 | 19 | 19 | 22 | 22 |
| Binet stage B (%) | 42 | 43 | 40 | 42 | 42 |
| Binet stage C (%) | 36 | 38 | 41 | 36 | 36 |
| β2-Microglobulin ≥3.5 mg/L (%) | 35 | 71 | 77 | 35 | 35 |
| del11q (%) | 17 | 22 | 24 | 17 | 17 |
| ECOG (median) | 1 | 1 | 1 | 1 | 1 |
| Creatinine clearance (median, mL/min) | 62 | 61.21 | 55.35 | 62.02 | 62.02 |
| Male (%) | 62 | 63 | 59 | 62 | 62 |
| Unmutated IGHV (%) | 61 | 59 | 58 | 61 | 57b |
CIRS Cumulative Illness Rating Scale, ECOG Eastern Cooperative Oncology Group, IGHV immunoglobulin heavy variable cluster, ITT intention to treat population, N number of patients analyzed, n number of variables matched, Neff effective sample size, SA sensitivity analysis
aExcludes patients from RESONATE-2 with CIRS ≤6 and creatinine clearance ≥70 mL/min, patients with creatinine clearance <30 mL/min, and SLL patients
bBaseline characteristic that was not matched and hence value represents the average for the characteristic unadjusted