Table 3.
Grade 3/4 adverse events and adverse events resulting in discontinuation of the study drug
| Patients reporting an AE, n (%) |
||||
|---|---|---|---|---|
| Final study analysisa |
Long-term safetyb (n = 140) | |||
| Chemotherapy-naive (n = 65) | Postchemotherapy (n = 75) | Total (n = 140) | ||
| Any grade 3/4 AEc | 29 (45) | 41 (55) | 70 (50) | 73 (52) |
| Fatigue | 10 (15) | 9 (12.) | 19 (14) | 19 (14) |
| Anemia | 1 (1.5) | 6 (8.0) | 7 (5.0) | 7 (5.0) |
| Back pain | 1 (1.5) | 6 (8.0) | 7 (5.0) | 7 (5.0) |
| Spinal cord compression | 1 (1.5) | 2 (2.7) | 3 (2.1) | 5 (3.6) |
| Arthralgia | 2 (3.1) | 1 (1.3) | 3 (2.1) | 3 (2.1) |
| Asthenia | 1 (1.5) | 2 (2.7) | 3 (2.1) | 3 (2.1) |
| Constipation | 2 (3.1) | 1 (1.3) | 3 (2.1) | 3 (2.1) |
| Convulsion (seizure) | 0 | 3 (4.0) | 3 (2.1) | 3 (2.1) |
| Dizziness | 2 (3.1) | 1 (1.3) | 3 (2.1) | 3 (2.1) |
| Prolonged QT corrected interval on ECG | 2 (3.1) | 1 (1.3) | 3 (2.1) | 3 (2.1) |
| Syncope | 0 | 0 | 0 | 3 (2.1) |
| Any AE resulting in discontinuationc | 6 (9.2) | 16 (21) | 22 (16) | 23 (16) |
| Fatigue | 2 (3.1) | 2 (2.7) | 4 (2.9) | 4 (2.9) |
| Convulsion (seizure) | 0 | 3 (4.0) | 3 (2.1) | 3 (2.1) |
| Spinal cord compression | 1 (1.5) | 2 (2.7) | 3 (2.1) | 3 (2.1) |
AE = adverse event; ECG = electrocardiogram.
a
Based on the final study analysis conducted in September 2010.
b
Based on the long-term safety analysis conducted in September 2013 that included AE data collected for the 19 patients still being treated at the September 2010 analysis.
c
AEs were graded according to National Cancer Institute Common Terminology Criteria for AEs, version 3.0. Events listed are those reported by more than two patients in the total population.