Table 3.

Primary and secondary end points and transplantation outcomes

End pointsrhTPO group (n = 59)Control group (n = 60)P
Cumulative incidence of 60-d platelet engraftment, % (95% CI) 83.1 (70.3-90.7) 66.7 (53.0-77.2) .020* 
Median time to platelet engraftment (range), d 38 (18-144) 43 (19-170) .238† 
Cumulative incidence of 120-d platelets ≥50 × 109/L, % (95% CI) 81.4 (68.3-89.4) 65.0 (51.3-75.7) .032* 
Median time to platelets ≥50 × 109/L (range), d 43 (25-171) 53 (28-198) .053† 
Number of platelet transfusions (range), U 6 (0-21) 8 (2-28) .026† 
Cumulative incidence of 42-d ANC recovery, % (95% CI) 98.3 (75.6-99.9) 95.0 (84.1-98.5) .148* 
Median time to ANC recovery (range), d 17.5 (11-29) 17 (12-32) .924† 
Cumulative incidence of 2-y transplant-related mortality, % (95% CI) 30.5 (19.3-42.5) 30.0 (18.9-41.9) .906* 
2-y cumulative incidence of relapse, % (95% CI) 13.6 (6.3-23.7) 20.0 (10.9-31.0) .298* 
Cumulative incidence of grades II-IV acute GVHD, % (95% CI) 39.0 (26.5-51.2) 30.0 (18.9-41.9) .327* 
Cumulative incidence of grades III-IV acute GVHD, % (95% CI) 28.8 (17.8-40.7) 20.0 (11.0-31.0) .287* 
Cumulative incidence of 2-y chronic GVHD, % (95% CI) 32.4 (20.5-45.0) 29.2 (17.1-42.3) .595* 
Cumulative incidence of 2-y extensive chronic GVHD, % (95% CI) 10.5 (4.2-20.1) 19.4 (9.7-31.5) .331* 
Blood stream infection, no. of patients (%) 20 (33.8) 25 (41.7) .451‡ 
Fungal infection (proven and probable), no. of patients (%) 5 (8.5) 7 (11.7) .762‡ 
CMV viremia, no. of patients (%) 49 (83.1) 44 (73.3) .268‡ 
PES, no. of patients (%) 43 (72.9) 42 (70) .840‡ 
Median occurrence time of PES (range), d 10 (6-17) 10 (5-18) .730† 
2-y disease free survival, % (95% CI) 55.9 (42.4-67.5) 50.0 (36.8-61.8) .469§ 
2-y GRFS, % (95% CI) 45.8 (32.8-57.8) 41.7 (29.2-53.7) .816§ 
2-y overall survival, % (95% CI) 64.4 (50.8-75.1) 51.7 (38.4-63.4) .236§ 
End pointsrhTPO group (n = 59)Control group (n = 60)P
Cumulative incidence of 60-d platelet engraftment, % (95% CI) 83.1 (70.3-90.7) 66.7 (53.0-77.2) .020* 
Median time to platelet engraftment (range), d 38 (18-144) 43 (19-170) .238† 
Cumulative incidence of 120-d platelets ≥50 × 109/L, % (95% CI) 81.4 (68.3-89.4) 65.0 (51.3-75.7) .032* 
Median time to platelets ≥50 × 109/L (range), d 43 (25-171) 53 (28-198) .053† 
Number of platelet transfusions (range), U 6 (0-21) 8 (2-28) .026† 
Cumulative incidence of 42-d ANC recovery, % (95% CI) 98.3 (75.6-99.9) 95.0 (84.1-98.5) .148* 
Median time to ANC recovery (range), d 17.5 (11-29) 17 (12-32) .924† 
Cumulative incidence of 2-y transplant-related mortality, % (95% CI) 30.5 (19.3-42.5) 30.0 (18.9-41.9) .906* 
2-y cumulative incidence of relapse, % (95% CI) 13.6 (6.3-23.7) 20.0 (10.9-31.0) .298* 
Cumulative incidence of grades II-IV acute GVHD, % (95% CI) 39.0 (26.5-51.2) 30.0 (18.9-41.9) .327* 
Cumulative incidence of grades III-IV acute GVHD, % (95% CI) 28.8 (17.8-40.7) 20.0 (11.0-31.0) .287* 
Cumulative incidence of 2-y chronic GVHD, % (95% CI) 32.4 (20.5-45.0) 29.2 (17.1-42.3) .595* 
Cumulative incidence of 2-y extensive chronic GVHD, % (95% CI) 10.5 (4.2-20.1) 19.4 (9.7-31.5) .331* 
Blood stream infection, no. of patients (%) 20 (33.8) 25 (41.7) .451‡ 
Fungal infection (proven and probable), no. of patients (%) 5 (8.5) 7 (11.7) .762‡ 
CMV viremia, no. of patients (%) 49 (83.1) 44 (73.3) .268‡ 
PES, no. of patients (%) 43 (72.9) 42 (70) .840‡ 
Median occurrence time of PES (range), d 10 (6-17) 10 (5-18) .730† 
2-y disease free survival, % (95% CI) 55.9 (42.4-67.5) 50.0 (36.8-61.8) .469§ 
2-y GRFS, % (95% CI) 45.8 (32.8-57.8) 41.7 (29.2-53.7) .816§ 
2-y overall survival, % (95% CI) 64.4 (50.8-75.1) 51.7 (38.4-63.4) .236§ 

ANC, absolute neutrophil count; CMV, cytomegalovirus; PES, pre-engraftment syndrome.

*

Cumulative incidence of competing events and Gray’s test.

†

Mann-Whitney U test.

‡

Pearson χ2 test.

§

Kaplan-Meier analysis and log-rank test.

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