Table 1.
Baseline | Week 13 | Week 25 | Week 37 | Week 49 | Week 61 | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
EQ-5D dimensions | ENZA (n = 857), % | PBO (n = 826), % | P value | ENZA (n = 809), % | PBO (n = 624), % | P value | ENZA (n = 746), % | PBO (n = 367), % | P value | ENZA (n = 671), % | PBO (n = 267), % | P value | ENZA (n = 610), % | PBO (n = 176), % | P value | ENZA (n = 523), % | PBO (n = 117), % | P value |
Mobility | ||||||||||||||||||
Level 1 | 74.9% | 74.7% | 0.5940 | 74.7% | 71.3% | 0.3197 | 73.7% | 70.8% | 0.5823 | 70.4% | 70.3% | 0.8183 | 66.7% | 30.9% | 0.6454 | 68.5% | 71.8% | 0.7640 |
Level 2 or 3 | 25.1% | 25.3% | 25.4% | 28.8% | 26.3% | 29.1% | 29.7% | 29.7% | 33.3% | 69.1% | 31.6% | 28.3% | ||||||
Self-care | ||||||||||||||||||
Level 1 | 94.9% | 93.8% | 0.1726 | 93.9% | 92.0% | 0.2253 | 94.0% | 90.6% | 0.1034 | 92.4% | 91.7% | 0.2849 | 92.3% | 92.0% | 0.9186 | 6.9% | 10.2% | 0.0619 |
Level 2 or 3 | 5.1% | 6.2% | 6.1% | 8.0% | 6.0% | 9.3% | 7.7% | 8.3% | 7.7% | 8.0% | 93.1% | 89.7% | ||||||
Usual Activities | ||||||||||||||||||
Level 1 | 80.1% | 80.5% | 0.9685 | 74.9% | 69.3% | 0.0675 | 77.9% | 71.8% | 0.0262 | 76.2% | 76.7% | 0.3589 | 70.8% | 71.8% | 0.9266 | 72.7% | 69.8% | 0.6346 |
Level 2 or 3 | 20.0% | 19.5% | 25.1% | 30.6% | 22.1% | 28.2% | 23.9% | 23.4% | 29.3% | 28.2% | 27.31% | 30.2% | ||||||
Pain/Discomfort | ||||||||||||||||||
Level 1 | 55.8% | 58.5% | 0.4623 | 56.0% | 47.8% | 0.0051 | 59.8% | 50.7% | 0.0163 | 56.4% | 47.6% | 0.0475 | 52.6% | 52.8% | 0.6281 | 52.4% | 53.9% | 0.4483 |
Level 2 or 3 | 44.3% | 41.5% | 44.1% | 52.2% | 40.3% | 49.4% | 43.5% | 52.5% | 47.5% | 47.1% | 47.6% | 46.2% | ||||||
Anxiety/Depression | ||||||||||||||||||
Level 1 | 75.0% | 72.9% | 0.0690 | 74.4% | 67.6% | 0.0060 | 76.3% | 71.0% | 0.1610 | 75.9% | 72.9% | 0.5023 | 74.0% | 68.8% | 0.1762 | 70.8% | 71.8% | 0.7396 |
Level 2 or 3 | 25.0% | 27.2% | 25.6% | 32.4% | 23.8% | 29.1% | 24.1% | 27.0% | 26.0% | 31.3% | 29.2% | 28.2% |
ENZA enzalutamide, PBO placebo
Differences refer to the comparison between groups in the percentage of patients with (2 or 3) or without (1) problems in each dimension. They do not take into account whether patients are in level 2 or 3. There were very few patients at level 3 in any dimension, even at 61 weeks. P values refer only to the between-group differences