Sample attrition in the process of generating gene expression data in the 024, 025, 039, and 040 trials, and the number of response- and survival-evaluable samples obtained from each trial
. | Trial 024 . | Trial 025 . | Trial 039 . | Trial 040 . |
---|---|---|---|---|
No. of patients | 54 | 202 | 669 | 263† |
Phase | Phase 2 | Phase 2 | Phase 3 | Phase 3 companion |
Disease/prior therapy entry criteria | Relapsed or refractory | Relapsed and refractory | 1-3 prior lines | > 3 prior lines |
Patients providing consent for pharmacogenomics analysis,* no. (%) | 32/54 (59) | 126/202 (62) | 505/669 (75)‡ | 213/263 (81)‡ |
Samples collected, no. (%) | 29/32 (91) | 121/126 (96) | 459/669 (69) | 205/263 (78) |
Samples that passed RNA QC, no. (%) | 17/29 (59) | 76/121 (63) | 190/459 (41) | 72/205 (35) |
Samples that passed Affymetrix hyb QC, no. (%) | 12/17 (71) | 65/76 (86) | 173/190 (91) | 63/72 (88) |
Samples that passed purity analysis, no. (%) | 10/12 (83) | 54/65 (83) | 156/173 (90) | 58/63 (92) |
Response evaluable, no. | 7 | 39 | 141 (71 bortezomib, 70 Dex) | 52 |
Survival evaluable, no. | 7 | 44 | 156 (80 bortezomib, 76 Dex) | 57 |
. | Trial 024 . | Trial 025 . | Trial 039 . | Trial 040 . |
---|---|---|---|---|
No. of patients | 54 | 202 | 669 | 263† |
Phase | Phase 2 | Phase 2 | Phase 3 | Phase 3 companion |
Disease/prior therapy entry criteria | Relapsed or refractory | Relapsed and refractory | 1-3 prior lines | > 3 prior lines |
Patients providing consent for pharmacogenomics analysis,* no. (%) | 32/54 (59) | 126/202 (62) | 505/669 (75)‡ | 213/263 (81)‡ |
Samples collected, no. (%) | 29/32 (91) | 121/126 (96) | 459/669 (69) | 205/263 (78) |
Samples that passed RNA QC, no. (%) | 17/29 (59) | 76/121 (63) | 190/459 (41) | 72/205 (35) |
Samples that passed Affymetrix hyb QC, no. (%) | 12/17 (71) | 65/76 (86) | 173/190 (91) | 63/72 (88) |
Samples that passed purity analysis, no. (%) | 10/12 (83) | 54/65 (83) | 156/173 (90) | 58/63 (92) |
Response evaluable, no. | 7 | 39 | 141 (71 bortezomib, 70 Dex) | 52 |
Survival evaluable, no. | 7 | 44 | 156 (80 bortezomib, 76 Dex) | 57 |
CR indicates complete response; PR, partial response; QC, quality control.
In trials 039 and 040, based on the informed consent of all patients in trial; not all patients who consented had a sample collected; see following row (Samples collected).
Non-crossover population.
Consent for whole genome analysis.