Table 4.
Coefficients of mixed-effect regression model (OLS predicted utilities)
| Outcome | Estimated coefficient | Standard error | P-value |
|---|---|---|---|
| Single-variable analysis | |||
| Time since randomization (continuous measure, days) | −0.00004 | 0.0001 | 0.2900 |
| BRCA-mutation status | |||
| Positive | −0.0321 | 0.0162 | 0.0489 |
| Wild-type or not tested (reference) | – | – | – |
| Randomization group | |||
| Placebo | −0.0138 | 0.0163 | 0.3973 |
| Olaparib (reference) | – | – | – |
| AEs | |||
| Any grade 1 or 2 | −0.0188 | 0.0103 | 0.0685 |
| No grade 1 or 2 (reference) | – | – | – |
| AEs | |||
| Any grade 3 or above | −0.0204 | 0.0161 | 0.2065 |
| No grade 3 or above (reference) | – | – | – |
| AEs (categorical) | |||
| AE 3 or above | −0.0234 | 0.0485 | 0.6290 |
| Both-grade AEs* | −0.0178 | 0.0169 | 0.2920 |
| No AE | 0.0193 | 0.0104 | 0.0630 |
| AE 1 or 2 (reference) | – | – | – |
| Treatment status | |||
| Ongoing | 0.0559 | 0.0168 | 0.0001 |
| Discontinued (reference) | – | – | – |
| Radiological progression (RECIST criteria) | |||
| Progression | −0.0228 | 0.0123 | 0.0645 |
| No progression (reference) | – | – | – |
| First subsequent treatment post-discontinuation of study drug | |||
| Had a subsequent treatment | −0.0103 | 0.0039 | 0.7916 |
| No subsequent treatment (reference) | – | – | |
| Optimized multivariable analysis | |||
| Intercept | 0.745 | 0.0201 | – |
| BRCA status | |||
| Positive | −0.0316 | 0.0161 | 0.0511 |
| Wild-type (reference) | – | – | |
| Treatment status | |||
| Ongoing | 0.0557 | 0.01673 | 0.0009 |
| Discontinued (reference) | – | – | |
Notes:
*
HSUVs recorded at the time a patient was experiencing both a grade 1–2 AE and a grade 3 plus AE were recorded as “Both-grade AEs”; all analysis based on a sample of 1,428 observations.
Abbreviations: OLS, ordinary least squares; BRCA, breast cancer antigen; AE, adverse event; RECIST, Response Evaluation Criteria in Solid Tumors; HSUVs, health-state utility values.