Table 6.
Weight kappa statistic demonstrating agreement between CTCAE and patient reported outcome measures (EPIC-26 and IPSS) is different timepoints.
| Patient Reported Outcome Measures |
n = 842 * (%) | Timepoint | Weighted Kappa (95% CI) | Time Difference (Days) between CTCAE and PRO Completion (Mean, SD) |
|---|---|---|---|---|
| EPIC-26 urinary bother | 800 (95) | Baseline | 0.28 (0.25–0.31) | 9 (20) |
| 700 (83) | Week 4 | 0.20 (0.15–0.24) | 2 (11) | |
| 760 (90) | Week 12 | 0.29 (0.26–0.31) | 4 (19) | |
| 630 (75) | 6 months | 0.31 (0.30–0.32) | 4 (15) | |
| 744 (88) | 12 months | 0.44 (0.41–0.47) | 4 (18) | |
| 659 (78) | 24 months | 0.41 (0.34–0.45) | 5 (18) | |
| EPIC-26 bowel bother | 766 (91) | Baseline | 0.08 (0.00–0.17) | 9 (20) |
| 675 (80) | Week 4 | 0.31 (0.22–0.35) | 2 (11) | |
| 723 (86) | Week 12 | 0.30 (0.21–0.32) | 4 (19) | |
| 596 (71) | 6 months | 0.26 (0.22–0.28) | 4 (15) | |
| 691 (82) | 12 months | 0.31 (0.24–0.35) | 4 (18) | |
| 621 (74) | 24 months | 0.32 (0.27–0.38) | 5 (18) | |
| IPSS total | 747 (89) | Baseline | 0.26 (0.20–0.31) | 9 (20) |
| 661 (80) | Week 4 | 0.29 (0.25–0.34) | 3 (11) | |
| 728 (86) | Week 12 | 0.25 (0.24–0.28) | 4 (19) | |
| 705 (84) | 6 months | 0.29 (0.27–0.38) | 4 (15) | |
| 720 (86) | 12 months | 0.35 (0.33–0.39) | 5 (20) | |
| 593 (70) | 24 months | 0.35 (0.28–0.44) | 5 (17) |
* Represented as proportion of patients included in the acute/late association analysis. EPIC-26 = Expanded Prostate Cancer Index Composite-26; IPSS = International prostate symptom score.