Adverse events that have been reported in at least 20% of the patients in at least one of the treatment arms
. | DNR/Ara-C; N = 211 . | . | DNR/Ara-C + PSC-833; N = 202* . | . | ||
|---|---|---|---|---|---|---|
| AE . | CTC 1-2, % . | CTC 3-4, % . | CTC 1-2, % . | CTC 3-4, % . | ||
| Abdominal pain | 21 | 1 | 31 | 3 | ||
| Anorexia | 16 | 4 | 17 | 3 | ||
| Constipation | 26 | 1 | 34 | 1 | ||
| Coughing | 23 | 1 | 25 | 2 | ||
| Diarrhea | 43 | 8 | 58 | 6 | ||
| Dizziness | 11 | 1 | 25 | 2 | ||
| Dyspnea | 18 | 10 | 22 | 11 | ||
| Epistaxis | 21 | 1 | 20 | 1 | ||
| Febrile neutropenia/fever | 51 | 38 | 51 | 33 | ||
| Fluid overload | 18 | 3 | 21 | 2 | ||
| Headache | 25 | 1 | 24 | 2 | ||
| Herpes simplex | 20 | 1 | 22 | 3 | ||
| Hypertension | 5 | 8 | 17 | 8 | ||
| Hypokalemia | 31 | 4 | 35 | 4 | ||
| Hypotension | 9 | 6 | 16 | 9 | ||
| Infection | 11 | 14 | 11 | 13 | ||
| Injection site reaction | 28 | 4 | 25 | 6 | ||
| Mucositis n.o.s. | 18 | 4 | 20 | 8 | ||
| Nausea | 49 | 5 | 47 | 9 | ||
| Purpura | 17 | 2 | 22 | 0 | ||
| Rash | 30 | 2 | 29 | 6 | ||
| Rash erythematous | 24 | 1 | 27 | 4 | ||
| Rigors | 27 | 1 | 27 | 2 | ||
| Sepsis | 12 | 24 | 20 | 19 | ||
| Thrombocytopenia | 4 | 19 | 3 | 17 | ||
| Vomiting | 43 | 0 | 48 | 2 | ||
. | DNR/Ara-C; N = 211 . | . | DNR/Ara-C + PSC-833; N = 202* . | . | ||
|---|---|---|---|---|---|---|
| AE . | CTC 1-2, % . | CTC 3-4, % . | CTC 1-2, % . | CTC 3-4, % . | ||
| Abdominal pain | 21 | 1 | 31 | 3 | ||
| Anorexia | 16 | 4 | 17 | 3 | ||
| Constipation | 26 | 1 | 34 | 1 | ||
| Coughing | 23 | 1 | 25 | 2 | ||
| Diarrhea | 43 | 8 | 58 | 6 | ||
| Dizziness | 11 | 1 | 25 | 2 | ||
| Dyspnea | 18 | 10 | 22 | 11 | ||
| Epistaxis | 21 | 1 | 20 | 1 | ||
| Febrile neutropenia/fever | 51 | 38 | 51 | 33 | ||
| Fluid overload | 18 | 3 | 21 | 2 | ||
| Headache | 25 | 1 | 24 | 2 | ||
| Herpes simplex | 20 | 1 | 22 | 3 | ||
| Hypertension | 5 | 8 | 17 | 8 | ||
| Hypokalemia | 31 | 4 | 35 | 4 | ||
| Hypotension | 9 | 6 | 16 | 9 | ||
| Infection | 11 | 14 | 11 | 13 | ||
| Injection site reaction | 28 | 4 | 25 | 6 | ||
| Mucositis n.o.s. | 18 | 4 | 20 | 8 | ||
| Nausea | 49 | 5 | 47 | 9 | ||
| Purpura | 17 | 2 | 22 | 0 | ||
| Rash | 30 | 2 | 29 | 6 | ||
| Rash erythematous | 24 | 1 | 27 | 4 | ||
| Rigors | 27 | 1 | 27 | 2 | ||
| Sepsis | 12 | 24 | 20 | 19 | ||
| Thrombocytopenia | 4 | 19 | 3 | 17 | ||
| Vomiting | 43 | 0 | 48 | 2 | ||
Per treatment arm and per AE, the proportion of patients with a maximum grade 1-2 or 3-4 are shown. Proportions are rounded to the nearest integer. AEs were graded according to the NCIC Expanded CTC.
n.o.s. indicates not otherwise specified.
The 6 patients in the PSC-833 arm who did not receive any protocol treatment have been excluded.