Table 3.
Adverse events by cycle of chemotherapy reported between groups.
| Adverse Events | Control Group (n = 346) |
Olanzapine Group (n = 383) |
|---|---|---|
| Sedation | ||
| Grade 1 | 26.6% | 35.8% |
| Grade 2 | 14.2% | 18.3% |
| Grade 3/4 | 0.0% | <1.0% |
| Fatigue | ||
| Grade 1 | 49.1% | 47.2% |
| Grade 2 | 27.4% | 25.6% |
| Grade 3/4 | 0.0% | <1.0% |
| Insomnia | ||
| Grade 1 | 22.5% | 22.4% |
| Grade 2 | 9.5% | 4.2% |
| Grade 3/4 | 0.0% | 0.0% |
| Gait disturbance | ||
| Grade 1 | <1.0% | <1.0% |
| Grade 2 | 0.0% | 0.0% |
| Grade 3/4 | 0.0% | 0.0% |
| Extrapyramidal symptoms | ||
| Grade 1 | 13.3% | 16.2% |
| Grade 2 | <1.0% | 1.6% |
| Grade 3/4 | 0.0% | 0.0% |
| Arm muscle movements | 1.1% | 2.6% |
| Eye twitching | 2.8% | 3.4% |
| Leg muscle movements | <1.0% | 0.0% |
| Restless legs | 2.0% | <1.0% |
| Restlessness | 3.1% | 4.1% |
| Other | 3.4% | 6.7% |
| Increased appetite | 6.6% | 12.8% |
| Dose reductions of study druga | 23 of 105 patients (12.4%) | 23 of 113 patients (20.3%) |
| Drug discontinuation | 0 of 105 patients (0%) | 7 of 113 patients (6.2%)b |
a
The dose reductions were for several reasons such as dizziness, drowsiness, extrapyramidal symptoms, fatigue, headache, increased appetite.
b
All of the drug discontinuations were due to sedation.