Nonhematologic toxicity by treatment arm
| . | Grade of adverse event . | Total . | ||
|---|---|---|---|---|
| 3, n (%) . | 4, n (%) . | 5, n (%) . | ||
| Nonhematologic adverse events | ||||
| Fatigue (asthenia, lethargy, malaise) | ||||
| ADE | 12 (8) | 1 (<1) | 0 | 150 |
| ADEP | 14 (9) | 4 (3) | 0 | 148 |
| Rash/desquamation | ||||
| ADE | 15 (10) | 1 (<1) | 0 | 150 |
| ADEP | 19 (13) | 1 (<1) | 0 | 148 |
| Anorexia | ||||
| ADE | 9 (6) | 5 (3) | 0 | 150 |
| ADEP | 17 (11) | 24 (16) | 0 | 148 |
| Diarrhea | ||||
| ADE | 15 (10) | 0 | 1 (<1) | 150 |
| ADEP | 14 (9) | 0 | 0 | 148 |
| Esophagitis | ||||
| ADE | 6 (4) | 6 (4) | 0 | 150 |
| ADEP | 19 (13) | 9 (6) | 0 | 148 |
| Mucositis/stomatitis | ||||
| ADE | 9 (6) | 3 (2) | 0 | 150 |
| ADEP | 20 (14) | 15 (10) | 0 | 148 |
| Nausea | ||||
| ADE | 12 (8) | 0 | 0 | 150 |
| ADEP | 26 (18) | 0 | 0 | 148 |
| Bilirubin | ||||
| ADE | 7 (5) | 2 (1) | 0 | 150 |
| ADEP | 25 (17) | 10 (7) | 0 | 148 |
| Infection with unknown ANC | ||||
| ADE | 9 (6) | 1 (<1) | 0 | 150 |
| ADEP | 3 (2) | 0 | 1 (<1) | 148 |
| Febrile neutropenia | ||||
| ADE | 79 (53) | 2 (1) | 0 | 150 |
| ADEP | 66 (45) | 7 (5) | 0 | 148 |
| Infection (documented) | ||||
| ADE | 63 (42) | 9 (6) | 2 (1) | 150 |
| ADEP | 66 (45) | 8 (5) | 1 (<1) | 148 |
| Hypocalcemia | ||||
| ADE | 15 (10) | 7 (5) | 0 | 150 |
| ADEP | 15 (10) | 3 (2) | 0 | 148 |
| Hypokalemia | ||||
| ADE | 18 (12) | 9 (6) | 0 | 150 |
| ADEP | 19 (13) | 10 (7) | 0 | 148 |
| Hyponatremia | ||||
| ADE | 9 (6) | 0 | 0 | 150 |
| ADEP | 14 (9) | 2 (1) | 0 | 148 |
| Adult respiratory distress syndrome | ||||
| ADE | 0 | 8 (5) | 1 (<1) | 150 |
| ADEP | 0 | 3 (2) | 0 | 148 |
| Dyspnea | ||||
| ADE | 9 (6) | 7 (5) | 0 | 150 |
| ADEP | 9 (6) | 4 (3) | 1 (<1) | 148 |
| Pulmonary-Other | ||||
| ADE | 1 (<1) | 3 (2) | 1 (<1) | 150 |
| ADEP | 2 (1) | 1 (<1) | 0 | 148 |
| Thrombosis/thrombus/embolism | ||||
| ADE | 3 (2) | 0 | 0 | 150 |
| ADEP | 1 (<1) | 0 | 1 (<1) | 148 |
| Maximum nonhematologic adverse events | ||||
| ADE | 98 (65) | 37 (25) | 5 (3) | 150 |
| ADEP | 82 (55) | 59 (40) | 4 (3) | 148 |
| . | Grade of adverse event . | Total . | ||
|---|---|---|---|---|
| 3, n (%) . | 4, n (%) . | 5, n (%) . | ||
| Nonhematologic adverse events | ||||
| Fatigue (asthenia, lethargy, malaise) | ||||
| ADE | 12 (8) | 1 (<1) | 0 | 150 |
| ADEP | 14 (9) | 4 (3) | 0 | 148 |
| Rash/desquamation | ||||
| ADE | 15 (10) | 1 (<1) | 0 | 150 |
| ADEP | 19 (13) | 1 (<1) | 0 | 148 |
| Anorexia | ||||
| ADE | 9 (6) | 5 (3) | 0 | 150 |
| ADEP | 17 (11) | 24 (16) | 0 | 148 |
| Diarrhea | ||||
| ADE | 15 (10) | 0 | 1 (<1) | 150 |
| ADEP | 14 (9) | 0 | 0 | 148 |
| Esophagitis | ||||
| ADE | 6 (4) | 6 (4) | 0 | 150 |
| ADEP | 19 (13) | 9 (6) | 0 | 148 |
| Mucositis/stomatitis | ||||
| ADE | 9 (6) | 3 (2) | 0 | 150 |
| ADEP | 20 (14) | 15 (10) | 0 | 148 |
| Nausea | ||||
| ADE | 12 (8) | 0 | 0 | 150 |
| ADEP | 26 (18) | 0 | 0 | 148 |
| Bilirubin | ||||
| ADE | 7 (5) | 2 (1) | 0 | 150 |
| ADEP | 25 (17) | 10 (7) | 0 | 148 |
| Infection with unknown ANC | ||||
| ADE | 9 (6) | 1 (<1) | 0 | 150 |
| ADEP | 3 (2) | 0 | 1 (<1) | 148 |
| Febrile neutropenia | ||||
| ADE | 79 (53) | 2 (1) | 0 | 150 |
| ADEP | 66 (45) | 7 (5) | 0 | 148 |
| Infection (documented) | ||||
| ADE | 63 (42) | 9 (6) | 2 (1) | 150 |
| ADEP | 66 (45) | 8 (5) | 1 (<1) | 148 |
| Hypocalcemia | ||||
| ADE | 15 (10) | 7 (5) | 0 | 150 |
| ADEP | 15 (10) | 3 (2) | 0 | 148 |
| Hypokalemia | ||||
| ADE | 18 (12) | 9 (6) | 0 | 150 |
| ADEP | 19 (13) | 10 (7) | 0 | 148 |
| Hyponatremia | ||||
| ADE | 9 (6) | 0 | 0 | 150 |
| ADEP | 14 (9) | 2 (1) | 0 | 148 |
| Adult respiratory distress syndrome | ||||
| ADE | 0 | 8 (5) | 1 (<1) | 150 |
| ADEP | 0 | 3 (2) | 0 | 148 |
| Dyspnea | ||||
| ADE | 9 (6) | 7 (5) | 0 | 150 |
| ADEP | 9 (6) | 4 (3) | 1 (<1) | 148 |
| Pulmonary-Other | ||||
| ADE | 1 (<1) | 3 (2) | 1 (<1) | 150 |
| ADEP | 2 (1) | 1 (<1) | 0 | 148 |
| Thrombosis/thrombus/embolism | ||||
| ADE | 3 (2) | 0 | 0 | 150 |
| ADEP | 1 (<1) | 0 | 1 (<1) | 148 |
| Maximum nonhematologic adverse events | ||||
| ADE | 98 (65) | 37 (25) | 5 (3) | 150 |
| ADEP | 82 (55) | 59 (40) | 4 (3) | 148 |
ADE indicates cytosine arabinoside, daunorubicin, and etoposide; ADEP, cytosine arabinoside, daunorubicin, etoposide, and PSC-833; ANC, absolute neutrophil count.