Table 1.
Summary statistics of patient covariates by study
| Parameter | Study 1001 (n = 49) | Study 1053 (n = 74) | Pooled population (n = 123) |
|---|---|---|---|
| Median age, y (range) | 57.0 (40.0–77.0) | 60.0 (36.0–84.0) | 58.0 (36.0–84.0) |
| Race, n (%) | |||
| White | 46 (94) | 66 (89) | 112 (91) |
| Nonwhite | 3 (6) | 5 (7) | 8 (7) |
| Missing* | 0 (0) | 3 (4) | 3 (2) |
| Male, n (%) | 41 (84) | 59 (80) | 100 (81) |
| Median weight, kg (range) | 86.0 (52.1–152.0) | 80.0 (42.4–123.1) | 82.8 (42.4–152.0) |
| Median ALT, U/L (range) | 26.0 (13.0–77.0) | 17.5 (6.0–53.0) | 20.0 (6.0–77.0) |
| Median AST, U/L (range) | 20.0 (7.0–41.0) | 20.0 (0.5–57.0) | 20.0 (6.0–77.0) |
| Median albumin, g/dL (range) | 3.6 (2.9–4.8) | 4.1 (2.7–4.9) | 3.9 (2.7–4.9) |
| Median blood urea nitrogen, mg/dL (range) | 14.0 (8.0–27.0) | 15.1 (7.1–50.0) | 15.1 (7.1–50.0) |
| Missing, n (%)* | 0 (0) | 19 (26) | 19 (15) |
| Median creatinine clearance, mL/min (range) | 107.6 (62.0–187.9) | 106.1 (42.0–238.8) | 107.3 (42.0–238.8) |
| Median spleen size, cm (range)† | 14.0 (0.01–22.5) | 13.1 (0.01–20.9) | 13.3 (0.01–22.5) |
| Missing % (n/total)* | 1 (2) | 1 (1) | 2 (2) |
| BM infiltration by leukaemia | |||
| Median BM infiltration by leukaemia, % (range) | 80.0 (5.0–99.0) | 70.0 (0.0–95.0) | 75.0 (0.0–99.0) |
| Missing, n (%)* | 3 (6) | 1 (1) | 4 (3) |
| Process material, n (%) | |||
| 1 | 32 (65) | 0 | 32 (26) |
| 2 | 17 (35) | 0 | 17 (14) |
| 3 | 0 | 74 (100) | 74 (60) |
| Prior rituximab use, n (%) | 22 (45) | 53 (72) | 75 (61) |
| Median baseline CD19+ B‐cell count, cells/μL (range) | N/A | 80.5 (1.0–17,487) | 80.5 (1.0–17,487) |
| Missing, n (%)* | 49 (100) | 16 (22) | 65 (53) |
| Median baseline lymphocyte count, 109 cells/L (range) | N/A | 0.8 (0.2–29.9) | 0.8 (0.2–29.9) |
| Missing, n (%)* | 49 (100) | 16 (22) | 65 (53) |
| Median baseline lymph node SPD, mm (range) | N/A | 988 (144–23,930) | 988 (144–23,930) |
| Missing, n (%)* | 49 (100) | 57 (77) | 106 (86) |
| Positive baseline ADA, % (n/N) | 4 (1/28) | 61 (43/71) | 44 (44/99) |
| Missing/NE, n (%)* | 43 (21/49) | 4 (3/74) | 20 (24/123) |
| ADA positive anytime, % (n/N) | 68 (19/28) | 87 (64/74) | 81 (83/102) |
| NE, % (n/total)* | 43 (21/49) | 0 (0/74) | 17 (21/123) |
| Positive NAb at baseline, % (n/N) | 0 (0/44) | 55 (39/71) | 34 (39/115) |
| Missing, % (n/N)* | 10 (5/49) | 4 (3/74) | 7 (8/123) |
| NAb‐positive anytime, % (n/N) | 74 (36/47) | 82 (61/74) | 80 (97/121) |
| Missing, % (n/N)* | 4 (2/49) | 0 (0/74) | 2 (2/123) |
*
Total number of patients including those with missing covariates.
†
For patients with splenectomies, baseline spleen size was imputed to a very small value (0.01 cm).
ADA, antidrug antibody; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BM, bone marrow; BUN, blood urea nitrogen; N/A, not available; NAb, neutralizing antibody; NE, not evaluated; SPD, sum of product of diameters.