Table 5.
Clinical AEs (possible, probable, or definite attribution to the drug)
| AEs | Grade 1 and 2 AEs |
Grade 3 AEs |
||||||
|---|---|---|---|---|---|---|---|---|
| Arm A |
Arm B |
Arm A |
Arm B |
|||||
| No. | % | No. | % | No. | % | No. | % | |
| No. of patients | 19 | 37 | 19 | 37 | ||||
| Constitutional | ||||||||
| Fatigue | 14 | 74 | 23 | 62 | 2 | 11 | 7 | 19 |
| Weight loss | 11 | 58 | 32 | 89 | 1 | 5 | 2 | 5 |
| Anorexia | 11 | 53 | 21 | 57 | — | — | — | — |
| Taste changes | 4 | 21 | 8 | 22 | — | — | — | — |
| GI | ||||||||
| Ileus | — | — | — | — | — | — | 1 | 3 |
| Colon perforation | — | — | — | — | 1 | 5 | — | — |
| Diarrhea | 15 | 79 | 25 | 68 | 1 | 5 | 1 | 3 |
| Stomatitis | 2 | 11 | 6 | 17 | 1 | 5 | — | — |
| Pain tongue or tooth | 2 | 11 | 5 | 14 | 1 | 5 | — | — |
| Pain abdomen or rectal | 17 | 89 | 18 | 49 | 1 | 5 | 2 | 6 |
| Nausea | 10 | 53 | 21 | 58 | — | — | — | — |
| Vomiting | 7 | 37 | 3 | 8 | — | — | — | — |
| Heartburn | 7 | 37 | 15 | 42 | — | — | — | — |
| Flatulence | 15 | 79 | 24 | 65 | — | — | — | — |
| Dry mouth | 1 | 5 | 2 | 6 | — | — | — | — |
| Musculoskeletal | ||||||||
| Proximal myopathy | 1 | 5 | — | — | ||||
| Hand-foot skin reaction | 11 | 58 | 20 | 56 | 2 | 11 | 2 | 5 |
| Back pain | — | — | 4 | 11 | 1 | 5 | 1 | 3 |
| Chest pain | 1 | 5 | 3 | 8 | — | — | 4 | 11 |
| Scalp pain | 5 | 26 | 8 | 22 | — | — | 1 | 3 |
| Pain (general) | 2 | 11 | 5 | 14 | 1 | 5 | 1 | 3 |
| Hand or foot pain | 14 | 74 | 12 | 33 | 1 | 5 | 6 | 16 |
| Arthralgia | 13 | 68 | 21 | 58 | 1 | 5 | 5 | 14 |
| Myalgia | 2 | 11 | 4 | 11 | — | — | — | — |
| Muscle cramps | 10 | 53 | 10 | 28 | — | — | — | — |
| Dermatologic | ||||||||
| Skin rash | 14 | 74 | 28 | 76 | 1 | 5 | 1 | 3 |
| Flushing | 6 | 32 | 12 | 32 | — | — | — | — |
| Brown skin spots | 3 | 16 | 6 | 16 | — | — | — | — |
| Dry skin | 16 | 84 | 31 | 84 | — | — | — | — |
| Pruritis | 15 | 79 | 28 | 75 | — | — | — | — |
| Nail changes | 13 | 68 | 20 | 54 | — | — | — | — |
| Skin sores | 4 | 21 | 2 | 5 | — | — | — | — |
| Alopecia | 15 | 79 | 29 | 78 | — | — | — | — |
| Vascular | ||||||||
| Hypertension | 8 | 42 | 14 | 38 | 1 | 5 | 1 | 3 |
| Hemoptysis | 1 | 5 | 1 | 3 | 0 | 2 | 6 | |
| Epistaxis | 1 | 5 | 1 | 3 | — | — | — | — |
| Retinal hem/vein occlusion | 1 | 5 | 1 | 3 | — | — | — | — |
| Gum bleeding | 0 | 1 | 3 | — | — | — | — | |
| Tumor bleeding | 0 | 1 | 3 | — | — | — | — | |
| Wound healing (slow) | 0 | 1 | 3 | — | — | — | — | |
| Cardiac | ||||||||
| Left ventricular dysfunction | — | — | — | — | 0 | 1 | 3 | |
| Atrial fib or SVT | 0 | 2 | 6 | 0 | 1 | 3 | ||
| Sinus bradycardia | 0 | 1 | 3 | — | — | — | — | |
| Palpitation | 1 | 5 | 2 | 6 | — | — | — | — |
| Neurological | ||||||||
| Syncope | — | — | — | — | 0 | 1 | 3 | |
| Anxiety | 0 | 1 | 3 | — | — | — | — | |
| Dizziness | 2 | 11 | 5 | 14 | — | — | — | — |
| Headache | 3 | 16 | 6 | 17 | — | — | — | — |
| Neuropathy (sensory) | 4 | 21 | 8 | 22 | — | — | — | — |
| Respiratory | ||||||||
| Cough | 0 | 1 | 3 | — | — | — | — | |
| Dyspnea | 3 | 16 | 5 | 14 | — | — | — | — |
| Hoarseness | 2 | 11 | 2 | 6 | — | — | — | — |
| Endocrine changes | ||||||||
| Irregular menses | 0 | 2 | 6 | — | — | — | — | |
| Infection | ||||||||
| Infection | 0 | 2 | 6 | — | — | 1 | 3 | |
| Abscess | 2 | 11 | 0 | — | — | — | — | |
| Osteomyelitis-actinomycosis | — | — | — | — | 0 | 1 | 3 | |
| Other tumors | ||||||||
| Acute myeloid leukemia | — | — | — | — | 1 | 5 | 0 | |
| Keratocanthoma | — | — | — | — | 0 | 2 | 5 | |
NOTE. Worst grade experienced by patient on study is counted in the above table. Please see text for grade 4-5 AEs.
Abbreviations: AE, adverse event; SVT, supraventricular tachycardia.