Ek 2018.
Study characteristics | ||
Methods | Trial acronym: none reported Design: international, open‐label RCT Median follow‐up: 41 (IQR 21–81) months for participants still alive |
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Participants | Patients with histologically or cytologically verified newly diagnosed small‐cell lung cancer of all stages Mean age: 67 (SD 7.9) years in enoxaparin group; 68 (SD 8.5) years in control group Gender, n (%) males: 78 (42%) in enoxaparin group; 82 (43%) in control group Metastatic disease, n (%): extensive disease: 114 (61%) in enoxaparin group; 113 (59%) in control group Previous VTE: not reported |
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Interventions | Intervention: enoxaparin at a supraprophylactic dose (1 mg/kg) in addition to standard treatment. Enoxaparin was started on day 1 of chemotherapy and continued until the 21st day of the last chemotherapy cycle Control: standard treatment |
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Outcomes | Primary outcome: overall survival Secondary outcomes were progression‐free survival, incidence of VTE and haemorrhagic events |
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Notes | Funding: Swedish Research Councile (to MB, grant number: 2014‐3421); the Swedish Cancer Society (to MB, grant number: 2014/378); the Skane University Hospital donation funds (to MB, no grant number); the Medical Faculty, Lund University (to MB, no grant number); the Governmental funding of clinical research within the national health services (ALF) (to MB and EG, no grant number); the Gunnar Nilsson, Anna Lisa and Sven Eric Lundgren and Kamprad Foundations (to MB, no grant number); a restricted grant support from Sanofi Aventis, Sweden (to LE, no grant number); a donation by Viveca Jeppsson (to MB, no grant number); and received honoraria from Leo Pharma, AstraZeneca and Pfizer (to MB, no grant number) Disclosure of potential conflicts of interest: "the authors have declared no conflicts of interest." Publication format: full‐text publication |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomization procedure was conducted at the Clinical Research Unit at Lund University Hospital, using a computer algorithm." Comment: adequate method of sequence generation. |
Allocation concealment (selection bias) | Low risk | Quote: "The randomization procedure was conducted at the Clinical Research Unit at Lund University Hospital, using a computer algorithm." Comment: adequate method of allocation concealment. |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "international, open‐label trial." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 13/574 (3.3%) participants enrolled in the study were not considered for the analysis. Exclusions per trial group were reported. |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported in the methods section were addressed in the results or discussion section |