Table 1.
Q‐TWiST: Base‐Case Analysis and Sensitivity Analysis
| Q‐TWiST, mo (95% CI) | Difference, | |||
|---|---|---|---|---|
| Definition of TOX | Placebo | Regorafenib | mo (95% CI) | P |
| Base‐case analysis: every classic adverse event ≥ grade 3 | 5.68 (4.92‐6.45) | 7.97 (6.96‐8.97) | 2.28 (1.02‐3.55) | <.001 |
| 1. Every toxicity regarded as at least slightly unacceptable by at least 20% of interviewed patients | 5.38 (4.65‐6.11) | 6.52 (5.70‐7.33) | 1.14 (0.04‐2.24) | .043 |
| 2. Every toxicity regarded as at least slightly unacceptable by at least 33% of interviewed patients | 5.52 (4.80‐6.23) | 6.81 (5.95‐7.69) | 1.30 (0.19‐2.41) | .022 |
| 3. Every toxicity regarded as at least slightly unacceptable by at least 50% of interviewed patients | 5.60 (4.85‐6.35) | 7.27 (6.33‐8.21) | 1.67 (0.46‐2.88) | .007 |
| 4. Every toxicity regarded as unacceptable or totally unacceptable by at least 20% of interviewed patients | 5.58 (4.83‐6.34) | 7.09 (6.18‐8.0) | 1.51 (0.33‐2.70) | .012 |
| 5. Every toxicity regarded as unacceptable or totally unacceptable by at least 33% of interviewed patients | 5.71 (4.95‐6.47) | 7.49 (6.59‐8.40) | 1.79 (0.58‐2.99) | .004 |
| 6. Every toxicity regarded as unacceptable or totally unacceptable by at least 50% of interviewed patients | 5.74 (4.99‐6.49) | 7.85 (6.86‐8.84) | 2.11 (0.87‐3.35) | .001 |
Abbreviations: CI, confidence interval; Q‐TWiST, quality‐adjusted time without symptoms of progression or toxicity; TOX, time with a grade 3 or 4 adverse event.