Prandoni 2004 (GALILEI).

Methods	Randomized controlled trial.
Participants	156 people with cancer (study subgroup) with DVT of lower extremities, PE, or both; minimum age 18 years; minimum life expectancy 3 months.
Interventions	Intervention: nadroparin 80 U/kg twice daily. Control: UFH 1st dose weight adjusted IV, subsequent doses SC twice daily (target aPTT 50‐90 s) x 5 days. Warfarin (target INR 2‐3) started the first 2 days x 12 weeks. Discontinued treatment: not reported for cancer subgroup.
Outcomes	Duration of follow‐up: 3 months. Mortality. Symptomatic recurrent VTE. Major bleeding. Screening and diagnostic testing for DVT: venogram, compression ultrasound. Screening and diagnostic testing for PE: pulmonary angiography or computed tomographic scan.
Notes	Setting: not reported. Funding: Gentium SpA, Como, Italy. Ethical approval: "The study was approved by the ethical board of all participating centers." Conflict of interest: "The Writing Committee for this article has no relevant financial interest in this article." ITT analysis: "analyses were performed on an intention‐to‐treat basis."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed with a computer algorithm."
Allocation concealment (selection bias)	Low risk	Quote: "Randomization was performed with a computer algorithm and the use of a 24 hour telephone service that recorded patient information before disclosure of the treatment assigned."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "open multicenter clinical trial." Comment: definitely not blinded; knowledge of the assigned intervention may have led to differential behaviors across intervention groups (e.g. differential dropout, differential cross‐over to an alternative intervention, or differential administration of cointerventions).
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Information on all suspected outcome events and deaths was reviewed and classified by a central adjudication committee blinded to treatment assignment." Comment: definitely blinded.
Incomplete outcome data addressed?	Low risk	Complete follow‐up.
Free of selective reporting?	Low risk	Study not registered and no published protocol identified. All relevant outcomes listed in the methods section were reported on in the results section.
Free of other bias?	Low risk	Study not reported as stopped early for benefit. No other bias suspected.