Table 1.

Baseline characteristics by treatment group for modified intent-to-treat population of activated patients

TXAPlacebo
165 165 
Age (y), mean (SD) 54.1 (13.0) 54.3 (13.2) 
Sex, n (%)   
 Male 92/165 (55.8) 100/165 (60.6) 
 Female 73/165 (44.2) 65/165 (39.4) 
Race, n (%)   
 American Indian or Alaska Native 3/160 (1.9) 6/162 (3.7) 
 Asian 3/160 (1.9) 13/162 (8.0) 
 Black or African American 11/160 (6.9) 14/162 (8.6) 
 Native Hawaiian or Pacific Islander 3/160 (1.9) 4/162 (2.5) 
 White 141/160 (88.1) 132/162 (81.5) 
 >1 race 1/160 (0.6) 5/162 (3.1) 
 Hispanic ethnicity, n (%) 8/139 (5.8) 5/132 (3.8) 
Primary diagnosis, n (%)   
 Acute myeloid leukemia 73/165 (44.2) 78/165 (47.3) 
 Myelodysplastic syndrome 21/165 (12.7) 16/165 (9.7) 
 Non-Hodgkin lymphoma 17/165 (10.3) 12/165 (7.3) 
 Myeloma 9/165 (5.5) 16/165 (9.7) 
 Acute lymphoblastic leukemia 11/165 (6.7) 10/165 (6.1) 
 Other* 9/165 (5.5) 10/165 (6.1) 
 Myelofibrosis 10/165 (6.1) 7/165 (4.2) 
 Hodgkin lymphoma 6/165 (3.6) 6/165 (3.6) 
 Aplastic anemia 4/165 (2.4) 5/165 (3.0) 
 Chronic myelogenous leukemia 5/165 (3.0) 3/165 (1.8) 
 Chronic lymphocytic leukemia 0/165 (0.0) 2/165 (1.2) 
Therapeutic group, n (%)   
 Acute chemo- or immunotherapy without transplant 66/165 (40.0) 64/165 (38.8) 
 Allogeneic transplant 63/165 (38.2) 65/165 (39.4) 
 Acute autologous transplant 36/165 (21.8) 36/165 (21.8) 
Baseline laboratory values   
 Platelets (1000/µL), mean (SD) n 20.9 (9.7) 163 19.8 (6.9) 162 
 Hematocrit, mean (SD) n 26.7 (3.4) 163 26.5 (3.3) 162 
 Serum creatinine (mg/dL), mean (SD) n 0.72 (0.22) 163 0.74 (0.24) 161 
 ANC (1000/µL), mean (SD) n 0.5 (1.7) 160 1.0 (5.0) 157 
TXAPlacebo
165 165 
Age (y), mean (SD) 54.1 (13.0) 54.3 (13.2) 
Sex, n (%)   
 Male 92/165 (55.8) 100/165 (60.6) 
 Female 73/165 (44.2) 65/165 (39.4) 
Race, n (%)   
 American Indian or Alaska Native 3/160 (1.9) 6/162 (3.7) 
 Asian 3/160 (1.9) 13/162 (8.0) 
 Black or African American 11/160 (6.9) 14/162 (8.6) 
 Native Hawaiian or Pacific Islander 3/160 (1.9) 4/162 (2.5) 
 White 141/160 (88.1) 132/162 (81.5) 
 >1 race 1/160 (0.6) 5/162 (3.1) 
 Hispanic ethnicity, n (%) 8/139 (5.8) 5/132 (3.8) 
Primary diagnosis, n (%)   
 Acute myeloid leukemia 73/165 (44.2) 78/165 (47.3) 
 Myelodysplastic syndrome 21/165 (12.7) 16/165 (9.7) 
 Non-Hodgkin lymphoma 17/165 (10.3) 12/165 (7.3) 
 Myeloma 9/165 (5.5) 16/165 (9.7) 
 Acute lymphoblastic leukemia 11/165 (6.7) 10/165 (6.1) 
 Other* 9/165 (5.5) 10/165 (6.1) 
 Myelofibrosis 10/165 (6.1) 7/165 (4.2) 
 Hodgkin lymphoma 6/165 (3.6) 6/165 (3.6) 
 Aplastic anemia 4/165 (2.4) 5/165 (3.0) 
 Chronic myelogenous leukemia 5/165 (3.0) 3/165 (1.8) 
 Chronic lymphocytic leukemia 0/165 (0.0) 2/165 (1.2) 
Therapeutic group, n (%)   
 Acute chemo- or immunotherapy without transplant 66/165 (40.0) 64/165 (38.8) 
 Allogeneic transplant 63/165 (38.2) 65/165 (39.4) 
 Acute autologous transplant 36/165 (21.8) 36/165 (21.8) 
Baseline laboratory values   
 Platelets (1000/µL), mean (SD) n 20.9 (9.7) 163 19.8 (6.9) 162 
 Hematocrit, mean (SD) n 26.7 (3.4) 163 26.5 (3.3) 162 
 Serum creatinine (mg/dL), mean (SD) n 0.72 (0.22) 163 0.74 (0.24) 161 
 ANC (1000/µL), mean (SD) n 0.5 (1.7) 160 1.0 (5.0) 157 
*

A list of other diagnoses is provided in supplemental File 2, Appendix E.

Baseline laboratory values were taken 24 hours before the first dose, when available. If baseline values were not available, measurements at the time of activation were used instead.

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