Secondary outcomes for all patients and for the VUD subgroup
| . | Control . | Intervention . | P . | |||
|---|---|---|---|---|---|---|
| All (n = 73) . | VUD (n = 45) . | All (n = 72) . | VUD (n = 50) . | All . | VUD . | |
| Engraftment | ||||||
| Incomplete neutrophil recovery by 30 d, n (%) | 0 (0) | 0 (0) | 4 (6) | 4 (8) | ||
| Neutrophil recovery, d | ||||||
| Median (range) | 15 (11-24) | 15 (11, 22) | 18 (9-35) | 17 (9-35) | ||
| Difference, median (95% CI) | 3 (1.0-5.0) | 2 (0.2-3.8) | .004 | .031 | ||
| Platelet recovery, d | ||||||
| Median (range) | 16 (9-36) | 17 (12-32) | 19 (11-389) | 19 (12-61) | ||
| Difference, median (95% CI) | 3 (0.1-5.9) | 2 (1.1-5.1) | .043 | .197 | ||
| Liver toxicity | ||||||
| Patients with ≥1 grade ≥3 liver AE | ||||||
| n (%) | 10 (14) | 6 (13) | 11 (15) | 9 (18) | ||
| OR (95% CI) | — | — | 1.14 (0.45-2.88) | 1.43 (0.46-4.41) | .788 | .537 |
| No. of grade ≥3 liver AEs, n (%) | ||||||
| 1 | 7 (10) | 5 (11) | 7 (10) | 5 (10) | ||
| 2 | 2 (3) | 0 (0) | 3 (4) | 3 (6) | ||
| 3 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| 4 | 1 (1) | 1 (2) | 1 (1) | 1 (2) | ||
| IRR (95% CI) | — | — | 1.15 (0.45-2.94) | 1.5 (0.46-4.92) | .776 | .504 |
| No. of grade ≥3 liver AEs within 60 d, n (%) | ||||||
| 1 | 6 (8) | 4 (9) | 5 (7) | 5 (10) | ||
| 2 | 2 (3) | 0 (0) | 4(6) | 4 (8) | ||
| 3 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| 4 | 1 (1) | 1 (2) | 0 (0) | 0 (0) | ||
| IRR (95% CI) | — | — | 0.91 (0.37-2.24) | 1.38 (0.41-4.58) | .832 | .604 |
| Possibly TCZ-related grade ≥3 liver AEs | ||||||
| n (%) | 3 (4) | 2 (4) | 2 (3) | 2 (4) | ||
| OR (95% CI) | 0.67 (0.11-4.14) | 0.90 (0.12-6.71) | .663 | .915 | ||
| Infection | ||||||
| Patients with ≥1 grade ≥2 infection AE | ||||||
| n (%) | 47 (64) | 28 (62) | 51 (71) | 36 (72) | ||
| OR (95% CI) | — | — | 1.34 (0.67-2.71) | 1.56 (0.66-3.72) | .409 | .314 |
| No. of infection AEs, n (%) | ||||||
| 1 | 25 (34) | 17 (38) | 19 (26) | 14 (28) | ||
| 2 | 10 (14) | 4 (9) | 16 (22) | 8 (16) | ||
| 3 | 7 (10) | 3 (7) | 10 (14) | 8 (16) | ||
| 4+ | 5 (7) | 4 (9) | 6 (8) | 6 (12) | ||
| IRR (95% CI) | — | — | 1.06 (0.74-1.54) | 1.13 (0.68-1.88) | .740 | .631 |
| No. of grade ≥2 infection AEs within 60 d, n (%) | ||||||
| 1 | 31 (42) | 19 (42) | 21 (29) | 15 (30) | ||
| 2 | 7 (10) | 2 (4) | 14 (19) | 8 (16) | ||
| 3 | 5 (7) | 3 (7) | 11 (15) | 11 (22) | ||
| 4+ | 2 (3) | 2 (4) | 0 (0) | 0 (0) | ||
| IRR (95% CI) | — | — | 1.17 (0.82-1.67) | 1.34 (0.83-2.15) | .380 | .226 |
| Possibly TCZ-related infection AEs | ||||||
| n (%) | 12 (16) | 6 (13) | 9 (13) | 6 (12) | ||
| OR (95% CI) | 0.73 (0.28-1.85) | 0.89 (0.26-2.99) | .503 | .846 | ||
| CMV reactivation | ||||||
| n (%) | 17 (32) | 13 (43) | 11 (22) | 6 (16) | ||
| OR (95% CI) | 0.60 (0.25-1.45) | 0.25 (0.08-0.77) | .255 | .016 | ||
| Ganciclovir therapy | ||||||
| n (%) | 15 (28) | 12 (40) | 10 (20) | 6 (16) | ||
| OR (95% CI) | 0.63 (0.25-1.59) | 0.28 (0.09-0.88) | .330 | .030 | ||
| . | Control . | Intervention . | P . | |||
|---|---|---|---|---|---|---|
| All (n = 73) . | VUD (n = 45) . | All (n = 72) . | VUD (n = 50) . | All . | VUD . | |
| Engraftment | ||||||
| Incomplete neutrophil recovery by 30 d, n (%) | 0 (0) | 0 (0) | 4 (6) | 4 (8) | ||
| Neutrophil recovery, d | ||||||
| Median (range) | 15 (11-24) | 15 (11, 22) | 18 (9-35) | 17 (9-35) | ||
| Difference, median (95% CI) | 3 (1.0-5.0) | 2 (0.2-3.8) | .004 | .031 | ||
| Platelet recovery, d | ||||||
| Median (range) | 16 (9-36) | 17 (12-32) | 19 (11-389) | 19 (12-61) | ||
| Difference, median (95% CI) | 3 (0.1-5.9) | 2 (1.1-5.1) | .043 | .197 | ||
| Liver toxicity | ||||||
| Patients with ≥1 grade ≥3 liver AE | ||||||
| n (%) | 10 (14) | 6 (13) | 11 (15) | 9 (18) | ||
| OR (95% CI) | — | — | 1.14 (0.45-2.88) | 1.43 (0.46-4.41) | .788 | .537 |
| No. of grade ≥3 liver AEs, n (%) | ||||||
| 1 | 7 (10) | 5 (11) | 7 (10) | 5 (10) | ||
| 2 | 2 (3) | 0 (0) | 3 (4) | 3 (6) | ||
| 3 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| 4 | 1 (1) | 1 (2) | 1 (1) | 1 (2) | ||
| IRR (95% CI) | — | — | 1.15 (0.45-2.94) | 1.5 (0.46-4.92) | .776 | .504 |
| No. of grade ≥3 liver AEs within 60 d, n (%) | ||||||
| 1 | 6 (8) | 4 (9) | 5 (7) | 5 (10) | ||
| 2 | 2 (3) | 0 (0) | 4(6) | 4 (8) | ||
| 3 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| 4 | 1 (1) | 1 (2) | 0 (0) | 0 (0) | ||
| IRR (95% CI) | — | — | 0.91 (0.37-2.24) | 1.38 (0.41-4.58) | .832 | .604 |
| Possibly TCZ-related grade ≥3 liver AEs | ||||||
| n (%) | 3 (4) | 2 (4) | 2 (3) | 2 (4) | ||
| OR (95% CI) | 0.67 (0.11-4.14) | 0.90 (0.12-6.71) | .663 | .915 | ||
| Infection | ||||||
| Patients with ≥1 grade ≥2 infection AE | ||||||
| n (%) | 47 (64) | 28 (62) | 51 (71) | 36 (72) | ||
| OR (95% CI) | — | — | 1.34 (0.67-2.71) | 1.56 (0.66-3.72) | .409 | .314 |
| No. of infection AEs, n (%) | ||||||
| 1 | 25 (34) | 17 (38) | 19 (26) | 14 (28) | ||
| 2 | 10 (14) | 4 (9) | 16 (22) | 8 (16) | ||
| 3 | 7 (10) | 3 (7) | 10 (14) | 8 (16) | ||
| 4+ | 5 (7) | 4 (9) | 6 (8) | 6 (12) | ||
| IRR (95% CI) | — | — | 1.06 (0.74-1.54) | 1.13 (0.68-1.88) | .740 | .631 |
| No. of grade ≥2 infection AEs within 60 d, n (%) | ||||||
| 1 | 31 (42) | 19 (42) | 21 (29) | 15 (30) | ||
| 2 | 7 (10) | 2 (4) | 14 (19) | 8 (16) | ||
| 3 | 5 (7) | 3 (7) | 11 (15) | 11 (22) | ||
| 4+ | 2 (3) | 2 (4) | 0 (0) | 0 (0) | ||
| IRR (95% CI) | — | — | 1.17 (0.82-1.67) | 1.34 (0.83-2.15) | .380 | .226 |
| Possibly TCZ-related infection AEs | ||||||
| n (%) | 12 (16) | 6 (13) | 9 (13) | 6 (12) | ||
| OR (95% CI) | 0.73 (0.28-1.85) | 0.89 (0.26-2.99) | .503 | .846 | ||
| CMV reactivation | ||||||
| n (%) | 17 (32) | 13 (43) | 11 (22) | 6 (16) | ||
| OR (95% CI) | 0.60 (0.25-1.45) | 0.25 (0.08-0.77) | .255 | .016 | ||
| Ganciclovir therapy | ||||||
| n (%) | 15 (28) | 12 (40) | 10 (20) | 6 (16) | ||
| OR (95% CI) | 0.63 (0.25-1.59) | 0.28 (0.09-0.88) | .330 | .030 | ||
AE, adverse event.