3.
| Adverse events related to PLD dose (<50 mg/m²and 50 mg/m²) in studies that compared PLD alone with non‐PLD agent/s for relapsed ovarian cancer | ||||||
|
Patient or population: women with relapsed ovarian cancer Settings: inpatient or outpatient setting Intervention: PLD Comparison: other non‐PLD drug/s | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| non‐PLD agent/s | PLD alone | |||||
| SAE: HFS (grade 3) subgrouped by PLD dose | < 50 mg/m²PLD dose every 4 weeks |
RR 4.63 (1.32 to 16.19) RR 50.75 (12.57 to 204.97) |
1344 (4) 1544 (4) |
⊕⊕⊕⊕
high ⊕⊕⊕⊕ high |
Tests for subgroup differences were significant (P value 0.01). | |
| < 1 per 1000 | 5 per 1000 (1 to16) | |||||
| 50 mg/m²PLD dose every 4 weeks | ||||||
| < 1 per 1000 | 51 per 1000 (13 to 205) | |||||
| SAE: Stomatitis (grade 3 to 4) subgrouped by PLD dose | <50 mg/m²PLD dose every 4 week |
RR 2.22 (0.87 to 5.67) RR 12.19 (4.62 to 32.20) |
1283
(4) 1544 (4) |
⊕⊕⊕⊕
high ⊕⊕⊕⊕ high |
Tests for subgroup differences were significant (P value 0.01). | |
| 1 per 1000 | 2 per 1000 (1 to 6) | |||||
| 50 mg/m²PLD dose every 4 weeks | ||||||
| 1 per 1000 | 12 per 1000 (5 to 32) | |||||
| *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio; PLD: pegylated liposomal doxorubicin | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||