Cumulative incidences (95% CI) of csCMVi and secondary outcomes (CMV disease, OS, PFS, CIR, NRM) based on the risk of CMV infection and period
| . | Low-risk (n = 156) . | High-risk (n = 160) . | ||||
|---|---|---|---|---|---|---|
| Period 1n = 93 . | Period 2n = 63 . | P . | Period 1n = 93 . | Period 2n = 67 . | P . | |
| Letermovir (until wk 14) | 0 (0%) | 18/63 (28.6%) | 0 (0%) | 67 (100%) | ||
| csCMVi | .003 | < .001 | ||||
| 14-wk csCMVi | 29.0% (20.2-38.5) | 7.9% (2.9-16.3) | 51.6% (41.0-61.3) | 10.5% (4.6-19.2) | ||
| 24-wk csCMVi | 33.3% (23.9-43.0) | 11.2% (4.9-20.5) | 52.7% (42.0-62.3) | 16.9% (8.9-27.0) | ||
| 1-y csCMVi | 34.4% (24.9-44.1) | 12.9% (6.0-22.6) | 53.8% (43.0-63.3) | 28.2% (17.3-40.2) | ||
| CMV disease | .85 | .69 | ||||
| 14-wk CMV disease | 0% | 0% | 3.2% (0.9-8.4) | 0% | ||
| 24-wk CMV disease | 1.1% (0.1-5.3) | 1.7% (0.1-8.0) | 4.3% (1.4-9.9) | 1.5% (0.1-7.2) | ||
| 1-y CMV disease | 2.2% (0.4-6.9) | 1.7% (0.1-8.0) | 4.3% (1.4-9.9) | 3.3% (0.6-10.3) | ||
| OS | .56 | .08 | ||||
| 14-wk OS | 92.5% (84.9-96.3) | 90.5% (80.0-95.6) | 87.1% (78.4-92.5) | 89.6% (79.3-94.9) | ||
| 24-wk OS | 88.2% (79.7-93.3) | 85.6% (74.1-92.2) | 80.6% (71.1-87.3) | 89.6% (79.3-94.9) | ||
| 1-y OS | 78.5% (68.7-85.6) | 74.9% (61.8-84.1) | 70.9% (60.5-79.0) | 83.4% (71.0-90.8) | ||
| PFS | .52 | .06 | ||||
| 14-wk PFS | 89.2% (80.9-94.1) | 84.1% (72.5-91.1) | 82.8% (73.5-89.1) | 88.1% (77.5-93.8) | ||
| 24-wk PFS | 80.6% (71.1-87.3) | 76.1% (63.6-84.9) | 76.3% (66.3-83.7) | 86.6% (75.8-92.8) | ||
| 1-y PFS | 69.9% (59.5-78.1) | 65.3% (51.8-75.9) | 62.3% (51.6-71.2) | 77.6% (65.0-86.2) | ||
| CIR | .60 | .14 | ||||
| 14-wk CIR | 4.3% (1.4-9.9) | 6.4% (2.0-14.3) | 4.3% (1.4-9.9) | 1.5% (0.1-7.1) | ||
| 24-wk CIR | 11.8% (6.3-19.3) | 14.4% (7.0-24.2) | 7.5% (3.3-14.1) | 3.0% (0.6-9.3) | ||
| 1-y CIR | 18.3% (11.2-26.8) | 21.6% (12.1-32.8) | 17.3% (10.4-25.7) | 7.9% (2.9-16.2) | ||
| NRM | .80 | .31 | ||||
| 14-wk NRM | 6.5% (2.6-12.7) | 9.5% (3.8-18.3) | 12.9% (7.0-20.6) | 10.5% (4.6-19.2) | ||
| 24-wk NRM | 7.5% (3.3-14.1) | 9.5% (3.8-18.3) | 16.1% (9.5-24.3) | 10.5% (4.6-19.2) | ||
| 1-y NRM | 11.8% (6.3-19.3) | 13.1% (6.1-23.0) | 20.4% (12.9-29.2) | 14.5% (7.0-24.6) | ||
| Late csCMVi >14 wk | .52 | .20 | ||||
| 24-wk late csCMVi | 6.5% (2.6-12.7) | 3.4% (0.6-10.4) | 9.7% (4.7-16.8) | 7.9% (2.9-16.3) | ||
| 1-y late csCMVi | 9.7% (4.7-16.7) | 6.8% (2.1-15.1) | 11.8% (6.2-19.3) | 21.1% (11.5-32.7) | ||
| . | Low-risk (n = 156) . | High-risk (n = 160) . | ||||
|---|---|---|---|---|---|---|
| Period 1n = 93 . | Period 2n = 63 . | P . | Period 1n = 93 . | Period 2n = 67 . | P . | |
| Letermovir (until wk 14) | 0 (0%) | 18/63 (28.6%) | 0 (0%) | 67 (100%) | ||
| csCMVi | .003 | < .001 | ||||
| 14-wk csCMVi | 29.0% (20.2-38.5) | 7.9% (2.9-16.3) | 51.6% (41.0-61.3) | 10.5% (4.6-19.2) | ||
| 24-wk csCMVi | 33.3% (23.9-43.0) | 11.2% (4.9-20.5) | 52.7% (42.0-62.3) | 16.9% (8.9-27.0) | ||
| 1-y csCMVi | 34.4% (24.9-44.1) | 12.9% (6.0-22.6) | 53.8% (43.0-63.3) | 28.2% (17.3-40.2) | ||
| CMV disease | .85 | .69 | ||||
| 14-wk CMV disease | 0% | 0% | 3.2% (0.9-8.4) | 0% | ||
| 24-wk CMV disease | 1.1% (0.1-5.3) | 1.7% (0.1-8.0) | 4.3% (1.4-9.9) | 1.5% (0.1-7.2) | ||
| 1-y CMV disease | 2.2% (0.4-6.9) | 1.7% (0.1-8.0) | 4.3% (1.4-9.9) | 3.3% (0.6-10.3) | ||
| OS | .56 | .08 | ||||
| 14-wk OS | 92.5% (84.9-96.3) | 90.5% (80.0-95.6) | 87.1% (78.4-92.5) | 89.6% (79.3-94.9) | ||
| 24-wk OS | 88.2% (79.7-93.3) | 85.6% (74.1-92.2) | 80.6% (71.1-87.3) | 89.6% (79.3-94.9) | ||
| 1-y OS | 78.5% (68.7-85.6) | 74.9% (61.8-84.1) | 70.9% (60.5-79.0) | 83.4% (71.0-90.8) | ||
| PFS | .52 | .06 | ||||
| 14-wk PFS | 89.2% (80.9-94.1) | 84.1% (72.5-91.1) | 82.8% (73.5-89.1) | 88.1% (77.5-93.8) | ||
| 24-wk PFS | 80.6% (71.1-87.3) | 76.1% (63.6-84.9) | 76.3% (66.3-83.7) | 86.6% (75.8-92.8) | ||
| 1-y PFS | 69.9% (59.5-78.1) | 65.3% (51.8-75.9) | 62.3% (51.6-71.2) | 77.6% (65.0-86.2) | ||
| CIR | .60 | .14 | ||||
| 14-wk CIR | 4.3% (1.4-9.9) | 6.4% (2.0-14.3) | 4.3% (1.4-9.9) | 1.5% (0.1-7.1) | ||
| 24-wk CIR | 11.8% (6.3-19.3) | 14.4% (7.0-24.2) | 7.5% (3.3-14.1) | 3.0% (0.6-9.3) | ||
| 1-y CIR | 18.3% (11.2-26.8) | 21.6% (12.1-32.8) | 17.3% (10.4-25.7) | 7.9% (2.9-16.2) | ||
| NRM | .80 | .31 | ||||
| 14-wk NRM | 6.5% (2.6-12.7) | 9.5% (3.8-18.3) | 12.9% (7.0-20.6) | 10.5% (4.6-19.2) | ||
| 24-wk NRM | 7.5% (3.3-14.1) | 9.5% (3.8-18.3) | 16.1% (9.5-24.3) | 10.5% (4.6-19.2) | ||
| 1-y NRM | 11.8% (6.3-19.3) | 13.1% (6.1-23.0) | 20.4% (12.9-29.2) | 14.5% (7.0-24.6) | ||
| Late csCMVi >14 wk | .52 | .20 | ||||
| 24-wk late csCMVi | 6.5% (2.6-12.7) | 3.4% (0.6-10.4) | 9.7% (4.7-16.8) | 7.9% (2.9-16.3) | ||
| 1-y late csCMVi | 9.7% (4.7-16.7) | 6.8% (2.1-15.1) | 11.8% (6.2-19.3) | 21.1% (11.5-32.7) | ||