Adverse events of interest (safety population)
| Adverse event, n (%) . | Nonintensive pathway (n = 851) . | Intensive pathway (n = 1111) . | ||||||
|---|---|---|---|---|---|---|---|---|
| MP (n = 424) . | CTDa (n = 427) . | CVAD (n = 556) . | CTD (n = 555) . | |||||
| ZOL . | CLO . | ZOL . | CLO . | ZOL . | CLO . | ZOL . | CLO . | |
| (n = 213) . | (n = 211) . | (n = 215) . | (n = 212) . | (n = 278) . | (n = 278) . | (n = 277) . | (n = 278) . | |
| Acute renal failure | 15 (7) | 13 (6) | 13 (6) | 14 (7) | 14 (5) | 17 (6) | 15 (5) | 16 (6) |
| ONJ* | 10 (5) | 0 (0)† | 4 (2) | 1 (< 1) | 13 (5) | 2 (1)† | 8 (3) | 0 (0)† |
| Thromboembolic event | 10 (5) | 10 (5) | 43 (20) | 25 (12)† | 59 (21) | 41 (15) | 45 (16) | 41 (15) |
| Infection SAE | 4 (2) | 4 (2) | 12 (6) | 14 (7) | 28 (10) | 37 (13) | 24 (9) | 25 (9) |
| All SAEs | 97 (46) | 81 (38) | 115 (53) | 117 (55) | 167 (60) | 155 (56) | 160 (58) | 125 (45)† |
| TESAEs | 27 (13) | 18 (9) | 63 (29) | 67 (32) | 74 (27) | 69 (25) | 84 (30) | 72 (26) |
| Adverse event, n (%) . | Nonintensive pathway (n = 851) . | Intensive pathway (n = 1111) . | ||||||
|---|---|---|---|---|---|---|---|---|
| MP (n = 424) . | CTDa (n = 427) . | CVAD (n = 556) . | CTD (n = 555) . | |||||
| ZOL . | CLO . | ZOL . | CLO . | ZOL . | CLO . | ZOL . | CLO . | |
| (n = 213) . | (n = 211) . | (n = 215) . | (n = 212) . | (n = 278) . | (n = 278) . | (n = 277) . | (n = 278) . | |
| Acute renal failure | 15 (7) | 13 (6) | 13 (6) | 14 (7) | 14 (5) | 17 (6) | 15 (5) | 16 (6) |
| ONJ* | 10 (5) | 0 (0)† | 4 (2) | 1 (< 1) | 13 (5) | 2 (1)† | 8 (3) | 0 (0)† |
| Thromboembolic event | 10 (5) | 10 (5) | 43 (20) | 25 (12)† | 59 (21) | 41 (15) | 45 (16) | 41 (15) |
| Infection SAE | 4 (2) | 4 (2) | 12 (6) | 14 (7) | 28 (10) | 37 (13) | 24 (9) | 25 (9) |
| All SAEs | 97 (46) | 81 (38) | 115 (53) | 117 (55) | 167 (60) | 155 (56) | 160 (58) | 125 (45)† |
| TESAEs | 27 (13) | 18 (9) | 63 (29) | 67 (32) | 74 (27) | 69 (25) | 84 (30) | 72 (26) |