Summary of findings 3.
Summary of findings: Adverse Events
| PARP inhibitors versus other treatments or placebo for ovarian cancer | ||||||
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Patient or population: women with recurrent ovarian cancer Settings: specialist hospital Intervention: PARP inhibitor Comparison: Other treatment or placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Severe adverse events ‐ Nausea (G3‐4) | 20 per 1000 | 25 per 1000 (7 to 92) | RR 1.23 (0.33 to 4.60) | 592 (4) | ⊕⊕⊕⊝ moderate | Downgraded due to imprecision |
| Severe adverse events ‐ Neutropenia (G3‐4) | 270 per 1000 | 159 per 1000 (24 to 1000) | RR 0.59 (0.09 to 3.98) | 220 (2) | ⊕⊕⊝⊝ low | Downgraded due to heterogeneity and imprecision |
| Severe adverse events ‐ Anaemia (G3‐4) | 10 per 1000 | 22 per 1000 (9 to 52) | RR 2.15 (0.89 to 5.21) | 592 (4) | ⊕⊕⊕⊝ moderate | Downgraded due to imprecision |
| Adverse events during maintenance treatment only (grade 3/4) ‐ Nausea | 0 per 1000 | 20 per 10001 | RR 4.21 (0.48 to 36.69) | 385 (2) | ⊕⊕⊕⊝ moderate | Downgraded due to imprecision |
| Adverse events during maintenance treatment only (grade 3/4) ‐ Fatigue | 20 per 1000 | 42 per 1000 (13 to 134) | RR 2.12 (0.67 to 6.71) | 385 (2) | ⊕⊕⊕⊝ moderate | Downgraded due to imprecision |
| Adverse events during maintenance treatment only (grade 3/4) ‐ Anaemia | 10 per 1000 | 53 per 1000 (12 to 230) | RR 5.26 (1.19 to 23.20) | 385 (2) | ⊕⊕⊕⊝ moderate | Downgraded due to imprecision |
| Any severe adverse event during maintenance treatment | 180 per 1000 |
310 per 1000 (220 to 450) |
RR 1.74 (1.22 to 2.49) | 385 (2) |
⊕⊕⊕⊕ high | |
| *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 | ||||||
| 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. | ||||||
1 Based on the mean experimental group risk across included studies (due to no events in the control group)