Table 2. . The number of eligibility criteria, the number of eligible patients and the hazard ratio of the progression-free survival of the original clinical trials and emulated RRMM trials with eligibility criteria under three scenarios using Flatiron Health database: the original criteria used in the trial, fully relaxed criteria and robust data-driven criteria (i.e., bootstrap AI pathfinder).
| Trial name | Clinical trial | Original trial computable EC | Fully relaxed EC | Robust data-driven computable EC | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| EC (n) | Pat. (n) | HR | EC (n) | Pat. (n) | HR | Pat. (n) | HR | EC (n) | Pat. (n) | HR | |
| CASTOR | 34 | 498 | 0.39 (0.28–0.53) | 18 | 203 | 1.08 (0.69–1.71) | 442 | 1.12 (0.82–1.52) | 16 | 237 | 1.06 (0.70–1.62) |
| ASPIRE | 40 | 792 | 0.69 (0.57–0.83) | 16 | 325 | 0.60 (0.26–1.39) | 982 | 1.26 (0.98–1.62) | 16 | 325 | 0.60 (0.26–1.39) |
| ENDEAVOR | 42 | 929 | 0.79 (0.65–0.96) | 16 | 290 | 1.19 (0.84–1.69) | 803 | 1.39 (1.12–1.72) | 15 | 303 | 1.17 (0.82–1.65) |
| ELOQUENT2 | 42 | 646 | 0.70 (0.57–0.85) | 18 | 317 | 1.59 (0.96–2.66) | 713 | 1.79 (1.25–2.56) | 15 | 378 | 1.38 (0.86–2.23) |
| POLLUX | 26 | 569 | 0.37 (0.27–0.52) | 18 | 315 | 0.68 (0.46–1.01) | 676 | 0.83 (0.62–1.11) | 17 | 335 | 0.62 (0.42–0.93) |
| NIMBUS | 35 | 455 | 0.48 (0.39–0.60) | 15 | 113 | 1.22 (0.63–2.37) | 456 | 1.06 (0.79–1.44) | 11 | 282 | 0.91 (0.62–1.36) |
| APOLLO | 40 | 304 | 0.63 (0.47–0.85) | 20 | 141 | 0.64 (0.39–1.05) | 554 | 0.70 (0.54–0.90) | 17 | 228 | 0.47 (0.32–0.70) |
| CANDOR | 58 | 466 | 0.63 (0.46–0.85) | 18 | 107 | 0.94 (0.37–2.38) | 358 | 0.98 (0.66–1.45) | 15 | 135 | 0.68 (0.28–1.66) |
| TOURMALINE | 27 | 722 | 0.74 (0.59–0.94) | 14 | 340 | 1.15 (0.80–1.67) | 695 | 1.57 (1.18–2.08) | 13 | 354 | 1.11 (0.78–1.59) |
The fully relaxed criteria correspond to evaluating the hazard ratio of PFS of all the patients in the Flatiron Health database who took the treatments in the relevant line of therapy.
EC: Eligibility criteria; HR: Hazard ratio; Pat.: Patient; RRMM: Relapsed and refractory multiple myeloma.