Baseline patients’ characteristics in each study cohort
| . | Total N = 1467 . | HELIOS n = 578 . | iLLUMINATE n = 229 . | RESONATE n = 391 . | RESONATE2 n = 269 . | P value . |
|---|---|---|---|---|---|---|
| Arm of the clinical study, n (%) | <.001 | |||||
| Chlorambucil | 133 (9) | 0 (0) | 0 (0) | 0 (0) | 133 (49) | |
| Chlorambucil plus obinutuzumab | 116 (8) | 0 (0) | 116 (51) | 0 (0) | 0 (0) | |
| Ibrutinib | 331 (23) | 0 (0) | 0 (0) | 195 (50) | 136 (51) | |
| Ibrutinib plus bendamustine and rituximab | 289 (20) | 289 (50) | 0 (0) | 0 (0) | 0 (0) | |
| Ibrutinib plus obinutuzumab | 113 (8) | 0 (0) | 113 (49) | 0 (0) | 0 (0) | |
| Ofatumumab | 196 (13) | 0 (0) | 0 (0) | 196 (50) | 0 (0) | |
| Placebo plus bendamustine and rituximab | 289 (20) | 289 (50) | 0 (0) | 0 (0) | 0 (0) | |
| Diagnosis, n (%) | .002 | |||||
| CLL | 1350 (92) | 514 (89) | 214 (93) | 373 (95) | 249 (93) | |
| SLL | 117 (8) | 64 (11) | 15 (7) | 18 (5) | 20 (7) | |
| Age, y (IQR) | 65 (60-72) | 60 (55-70) | 70 (66-76) | 64 (60-72) | 70 (63-77) | <.001 |
| Sex, n (%) | .50 | |||||
| Male | 963 (66) | 382 (66) | 146 (64) | 266 (68) | 169 (63) | |
| Female | 504 (34) | 196 (34) | 83 (36) | 125 (32) | 100 (37) | |
| Weight, kg | .016 | |||||
| Median (IQR) | 75 (66-86) | 76 (68-87) | 74 (65-86) | 76 (66-88) | 72 (64-83) | |
| Missing, n (%) | 16 (1) | 8 (1) | 0 (0) | 8 (2) | 0 (0) | |
| ECOG PS2, n (%) | .32 | |||||
| 0 | 632 (43) | 251 (43) | 110 (48) | 159 (41) | 112 (42) | |
| ≥1 | 835 (57) | 327 (57) | 119 (52) | 232 (59) | 157 (58) | |
| Bulky disease ≥5 cm (Y/N), n (%) | <.001 | |||||
| Y | 714 (49) | 324 (56) | 74 (32) | 222 (57) | 94 (35) | |
| N | 744 (51) | 254 (44) | 155 (68) | 165 (42) | 170 (63) | |
| Missing | 9 (1) | 0 (0) | 0 (0) | 4 (1) | 5 (2) | |
| Time since initial diagnosis, mo (IQR) | 64 (31-106) | 70 (42-107) | 32 (11-61) | 91 (60-137) | 31 (9-74) | <.001 |
| Statin, pretreatment, n (%) | 424 (29) | 129 (22) | 77 (34) | 116 (30) | 102 (38) | <.001 |
| Beta-blockers, pretreatment, n (%) | 328 (22) | 113 (20) | 63 (28) | 81 (21) | 71 (26) | .026 |
| CCBs, pretreatment, n (%) | 193 (13) | 65 (11) | 41 (18) | 48 (12) | 39 (14) | .070 |
| ACEI/ARBs, pretreatment, n (%) | 414 (28) | 145 (25) | 86 (38) | 84 (21) | 99 (37) | <.001 |
| Diuretics, pretreatment, n (%) | 246 (17) | 84 (15) | 45 (20) | 58 (15) | 59 (22) | .022 |
| Comorbidity count | <.001 | |||||
| Median (IQR) | 7 (4-12) | 6 (3-10) | 8 (5-12) | 8 (5-15) | 8 (5-13) | |
| Missing, n (%) | 32 (2) | 24 (4) | 1 (<1) | 3 (1) | 4 (1) | |
| Cause of death, n (%) | <.001 | |||||
| Progressive disease | 133 (9) | 48 (8) | 5 (2) | 75 (19) | 5 (2) | |
| Other | 282 (19) | 135 (23) | 31 (14) | 101 (26) | 15 (6) | |
| . | Total N = 1467 . | HELIOS n = 578 . | iLLUMINATE n = 229 . | RESONATE n = 391 . | RESONATE2 n = 269 . | P value . |
|---|---|---|---|---|---|---|
| Arm of the clinical study, n (%) | <.001 | |||||
| Chlorambucil | 133 (9) | 0 (0) | 0 (0) | 0 (0) | 133 (49) | |
| Chlorambucil plus obinutuzumab | 116 (8) | 0 (0) | 116 (51) | 0 (0) | 0 (0) | |
| Ibrutinib | 331 (23) | 0 (0) | 0 (0) | 195 (50) | 136 (51) | |
| Ibrutinib plus bendamustine and rituximab | 289 (20) | 289 (50) | 0 (0) | 0 (0) | 0 (0) | |
| Ibrutinib plus obinutuzumab | 113 (8) | 0 (0) | 113 (49) | 0 (0) | 0 (0) | |
| Ofatumumab | 196 (13) | 0 (0) | 0 (0) | 196 (50) | 0 (0) | |
| Placebo plus bendamustine and rituximab | 289 (20) | 289 (50) | 0 (0) | 0 (0) | 0 (0) | |
| Diagnosis, n (%) | .002 | |||||
| CLL | 1350 (92) | 514 (89) | 214 (93) | 373 (95) | 249 (93) | |
| SLL | 117 (8) | 64 (11) | 15 (7) | 18 (5) | 20 (7) | |
| Age, y (IQR) | 65 (60-72) | 60 (55-70) | 70 (66-76) | 64 (60-72) | 70 (63-77) | <.001 |
| Sex, n (%) | .50 | |||||
| Male | 963 (66) | 382 (66) | 146 (64) | 266 (68) | 169 (63) | |
| Female | 504 (34) | 196 (34) | 83 (36) | 125 (32) | 100 (37) | |
| Weight, kg | .016 | |||||
| Median (IQR) | 75 (66-86) | 76 (68-87) | 74 (65-86) | 76 (66-88) | 72 (64-83) | |
| Missing, n (%) | 16 (1) | 8 (1) | 0 (0) | 8 (2) | 0 (0) | |
| ECOG PS2, n (%) | .32 | |||||
| 0 | 632 (43) | 251 (43) | 110 (48) | 159 (41) | 112 (42) | |
| ≥1 | 835 (57) | 327 (57) | 119 (52) | 232 (59) | 157 (58) | |
| Bulky disease ≥5 cm (Y/N), n (%) | <.001 | |||||
| Y | 714 (49) | 324 (56) | 74 (32) | 222 (57) | 94 (35) | |
| N | 744 (51) | 254 (44) | 155 (68) | 165 (42) | 170 (63) | |
| Missing | 9 (1) | 0 (0) | 0 (0) | 4 (1) | 5 (2) | |
| Time since initial diagnosis, mo (IQR) | 64 (31-106) | 70 (42-107) | 32 (11-61) | 91 (60-137) | 31 (9-74) | <.001 |
| Statin, pretreatment, n (%) | 424 (29) | 129 (22) | 77 (34) | 116 (30) | 102 (38) | <.001 |
| Beta-blockers, pretreatment, n (%) | 328 (22) | 113 (20) | 63 (28) | 81 (21) | 71 (26) | .026 |
| CCBs, pretreatment, n (%) | 193 (13) | 65 (11) | 41 (18) | 48 (12) | 39 (14) | .070 |
| ACEI/ARBs, pretreatment, n (%) | 414 (28) | 145 (25) | 86 (38) | 84 (21) | 99 (37) | <.001 |
| Diuretics, pretreatment, n (%) | 246 (17) | 84 (15) | 45 (20) | 58 (15) | 59 (22) | .022 |
| Comorbidity count | <.001 | |||||
| Median (IQR) | 7 (4-12) | 6 (3-10) | 8 (5-12) | 8 (5-15) | 8 (5-13) | |
| Missing, n (%) | 32 (2) | 24 (4) | 1 (<1) | 3 (1) | 4 (1) | |
| Cause of death, n (%) | <.001 | |||||
| Progressive disease | 133 (9) | 48 (8) | 5 (2) | 75 (19) | 5 (2) | |
| Other | 282 (19) | 135 (23) | 31 (14) | 101 (26) | 15 (6) | |
Data are median (IQR) or number of patients (%). P values per χ2 test for categorical data and Kruskal-Wallis test for continuous data.
CCB, calcium channel blocker; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IQR, interquartile range; N, no; Y, yes.