Table 3.
All-cause adverse events occurring in >10 % of patients
| Preferred Term | Continuous Dosing (N =57) | Intermittent Dosing (N = 12) | Total (N =69) |
|---|---|---|---|
| Subjects With Any Event, n (%) | 57 (100) | 12 (100) | 69 (100) |
| Rasha | 43 (75) | 8(67) | 51 (74) |
| Diarrhea | 35 (61) | 7(58) | 42 (61) |
| Vomiting | 28 (49) | 3 (25) | 31 (45) |
| Fatigue | 22 (39) | 5 (42) | 27 (39) |
| Mucositisb | 19 (33) | 5 (42) | 24 (35) |
| Nausea | 21 (37) | 3 (25) | 24 (35) |
| Edema peripheral | 16(28) | 7(58) | 23 (33) |
| Decreased appetite | 17 (30) | 5 (42) | 22 (32) |
| Dehydration | 17 (30) | 1 (8) | 18(26) |
| Pyrexia | 14 (25) | 2(17) | 16 (23) |
| Constipation | 13 (23) | 1 (8) | 14 (20) |
| Dry skin | 12(21) | 2 (17) | 14 (20) |
| Anemia | 11 (19) | 2 (17) | 13 (19) |
| Dyspnea | 12(21) | 1 (8) | 13 (19) |
| Headache | 11 (19) | 1 (8) | 12(17) |
| Abdominal pain | 7(12) | 4 (33) | 11 (16) |
| Asthenia | 9(16) | 2 (17) | 11 (16) |
| Pruritus | 9(16) | 2 (17) | 11 (16) |
| Dry mouth | 8(14) | 2(17) | 10(14) |
| Hypertension | 8(14) | 2(17) | 10(14) |
| Insomnia | 9(16) | 0 | 9(13) |
| Aspartate aminotransferase increased | 5 (9) | 3(25) | 8(12) |
| Back pain | 7(12) | 1 (8) | 8(12) |
| Chills | 7(12) | 1 (8) | 8(12) |
| Cough | 8(14) | 0 | 8(12) |
| Dizziness | 6(11) | 2(17) | 8(12) |
| Hypokalemia | 8(14) | 0 | 8(12) |
| Pleural effusion | 6(11) | 2(17) | 8(12) |
| Pneumonia | 7(12) | 1 (8) | 8(12) |
| Abdominal distension | 6(11) | 1 (8) | 7(10) |
| Hypomagnesemia | 6(11) | 1 (8) | 7(10) |
| Hyponatremia | 7(12) | 0 | 7(10) |
| Hypotension | 6(11) | 1 (8) | 7(10) |
| Skin fissures | 5 (9) | 2(17) | 7(10) |
| Thrombocytopenia | 5 (9) | 2(17) | 7(10) |
a
The category of rash was comprised of the following collapsed preferred terms: dermatitis acneiform, erythema, rash, rash erythematous, rash macular, and rash maculo-papular
b
The category of mucositis was comprised of the following collapsed preferred terms: aphthous stomatitis, mouth ulceration, mucosal inflammation, and stomatitis