Table 2. Treatment differences for PRO instruments.
| Estimated mean | |||||
|---|---|---|---|---|---|
| Instrument | Axitinib (n=361) | Sorafenib (n=362) | Difference | 95% CI | P-value |
|
FKSI-15 | |||||
| Treatment | 42.21 | 41.86 | 0.35 | −0.63, 1.34 | 0.4833 |
| Treatment-by-time |
|
|
|
|
0.3943 |
|
FKSI-DRS | |||||
| Treatment | 28.56 | 28.44 | 0.12 | −0.45, 0.69 | 0.6746 |
| Treatment-by-time |
|
|
|
|
0.8024 |
|
EQ-5D | |||||
| Treatment | 0.71 | 0.69 | 0.02 | −0.01, 0.05 | 0.1903 |
| Treatment-by-time |
|
|
|
|
0.8048 |
|
EQ-5D VAS | |||||
| Treatment | 68.11 | 68.64 | −0.53 | −2.77, 1.72 | 0.6454 |
| Treatment-by-time | 0.1799 | ||||
Abbreviations: CI=confidence interval; FKSI-15=Functional Assessment of Cancer Therapy Kidney Symptom Index-15; FKSI-DRS=Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms; PRO=patient-reported outcomes; VAS=visual analogue scale.
Analysis based on repeated measures mixed-effects model with terms for treatment, time, and treatment-by-time, with baseline as covariate and time assumed continuous. Larger values correspond to better health states. Individual FKSI items may be reverse coded, as appropriate.