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. 2013 Jul 9;2013(7):CD006910. doi: 10.1002/14651858.CD006910.pub2

3.

Adverse events related to PLD dose (<50 mg/and 50 mg/) 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/PLD 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/PLD 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/PLD 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/PLD 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.