Table 6.
Treatment-emergent adverse events and laboratory abnormalities
| Event | Imatinib resistant (n = 200) |
Imatinib intolerant (n = 88) |
Total (N = 288) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All |
Gr 3/4 |
All |
Gr 3/4 |
All |
Gr 3/4 |
|||||||
| No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | |
| Nonhematologic TEAEs occurring with any grade in 10% or more of patients | ||||||||||||
| Diarrhea | 169 | 85 | 15 | 8 | 74 | 84 | 11 | 13 | 243 | 84 | 26 | 9 |
| Nausea | 84 | 42 | 0 | 0 | 44 | 50 | 4 | 5 | 128 | 44 | 4 | 1 |
| Rash* | 85 | 43 | 17 | 9 | 41 | 47 | 9 | 10 | 126 | 44 | 26 | 9 |
| Vomiting | 67 | 34 | 3 | 2 | 34 | 39 | 6 | 7 | 101 | 35 | 9 | 3 |
| Abdominal pain | 44 | 22 | 2 | 1 | 21 | 24 | 1 | 1 | 65 | 23 | 3 | 1 |
| Upper abdominal pain | 38 | 19 | 0 | 0 | 16 | 18 | 0 | 0 | 54 | 19 | 0 | 0 |
| Fatigue | 42 | 21 | 0 | 0 | 22 | 25 | 2 | 2 | 64 | 22 | 2 | 1 |
| Pyrexia | 48 | 24 | 1 | 1 | 12 | 14 | 0 | 0 | 60 | 21 | 1 | < 1 |
| Cough | 34 | 17 | 0 | 0 | 12 | 14 | 0 | 0 | 46 | 16 | 0 | 0 |
| Headache | 29 | 15 | 0 | 0 | 17 | 19 | 0 | 0 | 46 | 16 | 0 | 0 |
| Edema† | 28 | 14 | 1 | 1 | 14 | 16 | 0 | 0 | 42 | 15 | 1 | < 1 |
| Arthralgia | 26 | 13 | 0 | 0 | 13 | 15 | 1 | 1 | 39 | 14 | 1 | < 1 |
| Decreased appetite | 25 | 13 | 2 | 1 | 12 | 14 | 0 | 0 | 37 | 13 | 2 | 1 |
| Constipation | 17 | 9 | 0 | 0 | 15 | 17 | 1 | 1 | 32 | 11 | 1 | < 1 |
| Back pain | 12 | 6 | 0 | 0 | 16 | 18 | 0 | 0 | 28 | 10 | 0 | 0 |
| Nasopharyngitis | 19 | 10 | 0 | 0 | 10 | 11 | 0 | 0 | 29 | 10 | 0 | 0 |
| Hematologic laboratory abnormalities (all grades) | ||||||||||||
| Anemia‡ | 182 | 91 | 20 | 10 | 76 | 86 | 16 | 18 | 258 | 90 | 36 | 13 |
| Thrombocytopenia§ | 131 | 66 | 39 | 20 | 60 | 68 | 29 | 33 | 191 | 66 | 68 | 24 |
| Neutropenia¶ | 74 | 37 | 28 | 14 | 42 | 48 | 25 | 28 | 116 | 40 | 53 | 18 |
| Other laboratory abnormalities occurring with grade 3/4 severity in 4% or more of patients | ||||||||||||
| Elevated ALT | 111 | 56 | 20 | 10 | 58 | 66 | 10 | 11 | 169 | 59 | 30 | 10 |
| Elevated AST | 95 | 48 | 8 | 4 | 46 | 52 | 6 | 7 | 141 | 49 | 14 | 5 |
| Hypophosphatemia | 88 | 44 | 18 | 9 | 36 | 41 | 6 | 7 | 124 | 43 | 24 | 8 |
| Elevated uric acid | 89 | 45 | 12 | 6 | 31 | 35 | 5 | 6 | 120 | 42 | 17 | 6 |
| Hypocalcemia | 75 | 38 | 5 | 3 | 40 | 45 | 5 | 6 | 115 | 40 | 10 | 3 |
| Elevated lipase | 50 | 25 | 18 | 9 | 29 | 33 | 6 | 7 | 79 | 27 | 24 | 8 |
| Hypermagnesemia | 47 | 24 | 16 | 8 | 26 | 30 | 18 | 20 | 73 | 25 | 34 | 12 |
| Elevated INR | 52 | 26 | 3 | 2 | 19 | 22 | 4 | 5 | 71 | 25 | 7 | 2 |
| Hypomagnesemia | 44 | 22 | 1 | 1 | 12 | 14 | 0 | 0 | 56 | 19 | 1 | 0 |
ALT indicates alanine aminotransferase; AST, aspartate aminotransferase; Gr, grade; INR, international normalized ratio; and TEAE, treatment-emergent adverse event.
Rash includes acne, allergic dermatitis, erythema, exfoliative rash, folliculitis, heat rash, rash, rash erythematous, rash macular, rash papular, rash pruritic, and skin exfoliation.
Edema includes edema, face edema, localized edema, edema peripheral, periorbital edema, and pitting edema.
At baseline, anemia was reported by 125 (63%) imatinib-resistant patients and 45 (51%) imatinib-intolerant patients.
At baseline, thrombocytopenia was reported by 34 (17%) imatinib-resistant patients and 19 (22%) imatinib-intolerant patients.
At baseline, neutropenia was reported by 18 (9%) imatinib-resistant patients and 13 (15%) imatinib-intolerant patients.