Summary of findings 6. Ultra‐low‐molecular‐weight heparin versus placebo.
| uLMWH (semuloparin) compared with placebo for primary thromboprophylaxis in ambulatory cancer patients receiving chemotherapy | |||||||
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Patient or population: ambulatory cancer patients receiving chemotherapy Settings: outpatient clinics Intervention: semuloparin Comparison: placebo | |||||||
| Outcomes | Relative effect (95% CI) | Illustrative comparative risks* (95% CI) | Differenceb (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | What it means | |
| Assumed riska | Corresponding risk | ||||||
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With placebo Number of events per 1000 participants |
With semuloparin Number of events per 1000 participants |
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Symptomatic VTE Follow‐up: median 3.5 months |
RR 0.36 (0.22 to 0.60) | Intermediate‐risk populationc | 22 per 1000 fewer events (14 fewer to 27 fewer) | 3212 (1) | ⊕⊕⊕⊕ High |
Semuloparin decreases the incidence of symptomatic VTE across different cancer types. | |
| 34 per 1000 | 12 per 1000 (8 to 21) | ||||||
|
Major bleeding Follow‐up: median 3.5 months |
RR 1.05 (0.55 to 2.0) | Intermediate‐risk populationc | 1 per 1000 more events (5 fewer to 11 more) | 3172 (1) | ⊕⊕⊕⊝ Moderated |
Semuloparin probably has little effect on major bleedings across different cancer types. | |
| 11 per 1000 | 12 per 1000 (6 to 23) | ||||||
|
Symptomatic PE Follow‐up: median 3.5 months |
RR 0.48 (0.22 to 1.01) | Intermediate‐risk populationc | 7 per 1000 fewer events (0 fewer to 10 fewer) | 3212 (1) | ⊕⊕⊕⊝ Moderated |
Semuloparin probably decreases the incidence of symptomatic PE across different cancer types. | |
| 13 per 1000 | 6 per 1000 (3 to 13) | ||||||
|
Symptomatic DVT Follow‐up: median 3.5 months |
RR 0.32 (0.16 to 0.63) | Intermediate‐risk populationc | 14 per 1000 fewer events (8 fewer to 18 fewer) | 3212 (1) | ⊕⊕⊕⊕ High |
Semuloparin decreases the incidence of symptomatic DVT across different cancer types. | |
| 21 per 1000 | 7 per 1000 (3 to 13) | ||||||
|
Any VTE Follow‐up: median 3.5 months |
RR 0.36 (0.22 to 0.60) | Intermediate‐risk populationc | 22 per 1000 fewer (14 fewer to 27 fewer) | 3212 (1) | ⊕⊕⊕⊕ High |
Semuloparin decreases the incidence of any VTE across different cancer type. | |
| 34 per 1000 | 12 per 1000 (8 to 21) | ||||||
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1‐year overall mortality Follow‐up: 1 year |
RR 1.02 (0.96 to 1.08) | Intermediate‐risk populationc | 11 per 1000 more events (22 fewer to 44 more) | 3212 (1) | ⊕⊕⊕⊝ Moderated |
Semuloparin probably has no effect on 1‐year overall mortality across different cancer types. | |
| 555 per 1000 | 566 per 1000 (533 to 599) | ||||||
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Clinically relevant bleeding Follow‐up: median 3.5 months |
RR 1.40 (0.90 to 2.19) | Intermediate‐risk populationc | 8 per 1000 more events (2 fewer to 24 more) | 3172 (1) | ⊕⊕⊕⊝ Moderated |
Semuloparin probably increases the incidence of clinically relevant bleeding across different cancer types. | |
| 20 per 1000 | 28 per 1000 (18 to 44) | ||||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. 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; DVT: deep vein thrombosis; NA: not applicable; PE: pulmonary embolism; RR: risk ratio; uLMWH: ultra‐low‐molecular‐weight heparin; VTE: venous thromboembolism. | |||||||
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GRADE Working Group grades of evidence High certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: 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 certainty: we are very uncertain about the estimate. | |||||||
aThe assumed risk was calculated from the medium observed control group risk in the study. bDifference calculated as the absolute risk difference between the assumed risk and corresponding risk, expressed per 1000. cIntermediate risk population refers to the observed median risk to experience symptomatic VTE in the single trial contributing to the analyses (34 per 1000). Rates between 2% and 7% are considered intermediate risk (Khorana 2008). dDowngraded one level because of imprecision.