Reasons enrolled as protocol deviations
| Reasons for ineligibility . | Total N = 272 n (%) . | White N = 220 n (%) . | Black N = 28 n (%) . | Asian N = 2 n (%) . | Other N = 11 n (%) . | Unknown N = 11 n (%) . |
|---|---|---|---|---|---|---|
| Disease related | 41 (15) | 35 (16) | 2 (7) | 0 | 4 (36) | NA |
| Failure to meet treatment related criteria | 44 (16) | 37 (17) | 3 (11) | 1 (50) | 1 (9) | 2 (18) |
| Received restricted investigational drugs or chemotherapy within time period | 29 (11) | 22 (10) | 5 (18) | 0 | 0 | 2 (18) |
| Hepatic function | 5 (2) | 5 (2) | 0 | 0 | 0 | 0 |
| Renal function | 11 (4) | 7 (3) | 3 (11) | 0 | 0 | 1 (9) |
| Cardiac function | 16 (6) | 14 (6) | 0 | 0 | 0 | 2 (18) |
| Pulmonary function | 11 (4) | 11 (5) | 0 | 0 | 0 | 0 |
| Hematology laboratory criteria | 37 (14) | 29 (13) | 8 (29) | 0 | 0 | 0 |
| Unspecified laboratory criteria | 45 (17) | 33 (15) | 6 (21) | 1 (50) | 1 (9) | 4 (36) |
| Active infection | 17 (6) | 14 (6) | 1 (4) | 0 | 2 (18) | 0 |
| HIV or hepatitis virus | 7 (3) | 7 (3) | 0 | 0 | 0 | 0 |
| Pre-existing neuropathy | 2 (1) | 2 (1) | 0 | 0 | 0 | 0 |
| Prior malignancy | 9 (3) | 6 (3) | 1 (4) | 0 | 2 (18) | 0 |
| Contraception related | 1 (<1) | 1 (<1) | 0 | 0 | 0 | 0 |
| Other IE exclusions | 14 (5) | 11 (5) | 2 (7) | 0 | 1 (9) | 0 |
| Reasons for ineligibility . | Total N = 272 n (%) . | White N = 220 n (%) . | Black N = 28 n (%) . | Asian N = 2 n (%) . | Other N = 11 n (%) . | Unknown N = 11 n (%) . |
|---|---|---|---|---|---|---|
| Disease related | 41 (15) | 35 (16) | 2 (7) | 0 | 4 (36) | NA |
| Failure to meet treatment related criteria | 44 (16) | 37 (17) | 3 (11) | 1 (50) | 1 (9) | 2 (18) |
| Received restricted investigational drugs or chemotherapy within time period | 29 (11) | 22 (10) | 5 (18) | 0 | 0 | 2 (18) |
| Hepatic function | 5 (2) | 5 (2) | 0 | 0 | 0 | 0 |
| Renal function | 11 (4) | 7 (3) | 3 (11) | 0 | 0 | 1 (9) |
| Cardiac function | 16 (6) | 14 (6) | 0 | 0 | 0 | 2 (18) |
| Pulmonary function | 11 (4) | 11 (5) | 0 | 0 | 0 | 0 |
| Hematology laboratory criteria | 37 (14) | 29 (13) | 8 (29) | 0 | 0 | 0 |
| Unspecified laboratory criteria | 45 (17) | 33 (15) | 6 (21) | 1 (50) | 1 (9) | 4 (36) |
| Active infection | 17 (6) | 14 (6) | 1 (4) | 0 | 2 (18) | 0 |
| HIV or hepatitis virus | 7 (3) | 7 (3) | 0 | 0 | 0 | 0 |
| Pre-existing neuropathy | 2 (1) | 2 (1) | 0 | 0 | 0 | 0 |
| Prior malignancy | 9 (3) | 6 (3) | 1 (4) | 0 | 2 (18) | 0 |
| Contraception related | 1 (<1) | 1 (<1) | 0 | 0 | 0 | 0 |
| Other IE exclusions | 14 (5) | 11 (5) | 2 (7) | 0 | 1 (9) | 0 |
IE, inclusion/exclusion.