Reported adverse effects possibly related to CEP-701
. | No. (%) . | . | |
|---|---|---|---|
| Effect . | Grades 1, 2 . | Grades 3, 4 . | |
| Anorexia/nausea* | 7 (41) | 0 (0) | |
| Emesis* | 5 (29) | 0 (0) | |
| General weakness, fatigue* | 1 (6) | 3 (18) | |
| Dizziness | 1 (6) | 0 (0) | |
| Arthralgia, myalgia | 1 (6) | 1 (6) | |
| Diaphoresis | 1 (6) | 0 (0) | |
| Diarrhea | 3 (18) | 0 (0) | |
| Constipation | 1 (6) | 0 (0) | |
| Skin rash/pruritus | 1 (6) | 0 (0) | |
| Stomatitis | 1 (6) | 0 (0) | |
| Melena/gastrointestinal bleeding | 0 (0) | 1 (6) | |
| Epistaxis | 0 (0) | 1 (6) | |
| Congestive heart failure, cardiomyopathy | 0 (0) | 1 (6) | |
| Dyspnea | 0 (0) | 1 (6) | |
| Volume overload | 1 (6) | 0 (0) | |
| Hypoglycemia | 1 (6) | 0 (0) | |
| Hyperbilirubinemia | 1 (6) | 0 (0) | |
. | No. (%) . | . | |
|---|---|---|---|
| Effect . | Grades 1, 2 . | Grades 3, 4 . | |
| Anorexia/nausea* | 7 (41) | 0 (0) | |
| Emesis* | 5 (29) | 0 (0) | |
| General weakness, fatigue* | 1 (6) | 3 (18) | |
| Dizziness | 1 (6) | 0 (0) | |
| Arthralgia, myalgia | 1 (6) | 1 (6) | |
| Diaphoresis | 1 (6) | 0 (0) | |
| Diarrhea | 3 (18) | 0 (0) | |
| Constipation | 1 (6) | 0 (0) | |
| Skin rash/pruritus | 1 (6) | 0 (0) | |
| Stomatitis | 1 (6) | 0 (0) | |
| Melena/gastrointestinal bleeding | 0 (0) | 1 (6) | |
| Epistaxis | 0 (0) | 1 (6) | |
| Congestive heart failure, cardiomyopathy | 0 (0) | 1 (6) | |
| Dyspnea | 0 (0) | 1 (6) | |
| Volume overload | 1 (6) | 0 (0) | |
| Hypoglycemia | 1 (6) | 0 (0) | |
| Hyperbilirubinemia | 1 (6) | 0 (0) | |
Toxicity seen at all dosing levels (40 mg, 60 mg, 80 mg) with twice-a-day dosing.