Kakkar 2004.

Study characteristics
Methods	Trial acronym: FAMOUS Design: double‐blind, placebo‐controlled, multicentre RCT; modified intention‐to‐treat analysis for both effectiveness and safety analyses, including participants with ≥ 1 study dose and 1 follow‐up visit Median duration of follow‐up: 10 months in dalteparin group; 9 months in placebo group
Participants	Patients aged 18–80 years with histologically confirmed advanced stage III or IV (locally advanced or metastatic) malignant disease of the breast, lung, gastrointestinal tract, pancreas, liver, genitourinary tract, ovary, or uterus. Mean age: 62 (IQR 54–68) years in dalteparin group; 60.9 (IQR 52–69) years in placebo group Gender, n (%) males: 77 (40.5%) in dalteparin group; 84 (45.7%) in placebo group Metastatic disease, n (%): 161 (85%) in dalteparin group; 161 (87.5%) in placebo group Previous VTE: 0/385 (0%)
Interventions	Intervention: LMWH, dalteparin 5000 IU SC, once daily Control: placebo (0.9% normal saline) Study treatment given for 1 year or until the participant died, whichever occurred sooner
Outcomes	Primary outcomes: mortality after 1 year of therapy Secondary outcomes: symptomatic, objectively confirmed VTE disease and bleeding complications
Notes	Funding: Pharmacia Corp, New York, NY Disclosure of potential conflicts of interest: the lead author declared having acted as a consultant for Pfizer. Quote: "The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Acted as a consultant within the last 2 years: Ajay K. Kakkar, Pfizer. Received more than $2,000 a year from a company for either of the last 2 years: Ajay K. Kakkar, Pfizer." Publication format: full‐text publication
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed centrally by computer‐generated code." Comment: adequate method of sequence generation.
Allocation concealment (selection bias)	Low risk	Quote: "Randomization was performed centrally by computer‐generated code." Comment: adequate method of allocation concealment.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "placebo (0.9% normal saline), each supplied in 0.2‐mL prefilled syringes." Comment: trial reported as double‐blind, with active substance or placebo provided in prefilled syringes. It is not reported whether syringes were identical in appearance or if outcome assessor were blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: both for effectiveness and safety, 190/196 (96.9%) participants were analysed in the LMWH group and 184/189 (97.4%) participants were analysed in the placebo group.
Selective reporting (reporting bias)	Low risk	Comment: all outcomes reported in the methods section were addressed in the results or discussion section.