Summary of findings 3. Tivozanib compared to sorafenib (targeted agent versus targeted agent).
| Patient or population: Treatment‐naïve metastatic renal cell carcinoma (clear cell type) Setting: Multinational muticentre/likely outpatient Intervention: Tivozanib Comparison: Sorafenib | |||||
| Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
| Risk with Sorafenib | Risk difference with Tivozanib | ||||
|
Progression‐free survival (absolute effect size estimates based on survival rate at 12 months) follow‐up: not reported |
517 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 | HR 0.79 (0.64 to 0.99) | Study population | |
| 360 per 1000 | 86 more per 1000 (4 more to 160 more) | ||||
|
Overall survival (absolute effect size estimates based on survival rate at 24 months) follow‐up: not reported |
517 (1 RCT) | ⊕⊕⊝⊝ LOW 3 4 | HR 1.25 (0.95 to 1.64) | Study population | |
| 620 per 1000 | 70 fewer per 1000 (163 fewer to 15 more) | ||||
| Serious adverse events (Grade 3 or 4) assessed with: CTCAE v3.0 | 516 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 | RR 0.85 (0.74 to 0.97) | Study population | |
| 689 per 1000 | 103 fewer per 1000 (179 fewer to 21 fewer) | ||||
| Health‐related quality of life assessed with: EQ‐5D Health State Index Scale from: ‐0.59 (worst health state) to 1 (best health state) follow‐up: 12 months | 506 (1 RCT) | ⊕⊕⊝⊝ LOW 2 5 | ‐ | The mean health‐related quality of life was ‐0.06 | MD 0.01 higher (0.05 lower to 0.07 higher) |
| *The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; CTCAE: Common Terminology Criteria for Adverse Events;EQ‐5D: EuroQol‐5D; HR: Hazard ratio; RCT: Randomized controlled trial; RR: Risk ratio | |||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | |||||
1 Downgraded by 1 level for imprecision; confidence interval crossed the assumed threshold of a clinically important difference (included benefit and little benefit)
2 Downgraded by 1 level for study limitations; high risk of performance, detection and other bias
3 Downgraded by 1 level for imprecision; confidence interval crossed the line of no difference and the assumed threshold of a clinically important difference (included harm and no harm)
4 Downgraded by 1 level for study limitations; high risk of other bias
5 Downgraded by 1 level for imprecision; confidence interval crossed the line of no difference and the assumed threshold of a clinically important difference (0.06 points, included benefit and no benefit)