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. 2020 Dec 18;2020(12):CD008500. doi: 10.1002/14651858.CD008500.pub5

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
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
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
Outcomes Primary outcome: overall survival
Secondary outcomes were progression‐free survival, incidence of VTE and haemorrhagic events
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
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