Agnelli 2012.

Study characteristics
Methods	Trial acronym: SAVE‐ONCO study Design: multicentre, double‐blind RCT, with intention‐to‐treat for effectiveness and modified intention‐to‐treat analysis for safety outcomes, including participants who received ≥ 1 study dose Mean duration of follow‐up: not reported
Participants	Patients with metastatic or locally advanced solid cancer of the lung, pancreas, stomach, colon or rectum, bladder, or ovary who were beginning a course of chemotherapy Mean age: 59.8 years in semuloparin group; 59.4 years in placebo group Gender, n (%) males: 974 (60.6%) in semuloparin group; 956 (59.6%) in placebo group Metastatic disease: not reported Previous VTE: 2% in semuloparin group; 2.3% in placebo group
Interventions	Intervention: uLMWH semuloparin 20 mg SC, once daily Control: placebo The first dose of the study drug was administered on the first day of a course of chemotherapy (first regimen or a new regimen), continuing for the duration of chemotherapy (intended to be a minimum of 3 months). Median treatment duration was 3.5 months.
Outcomes	Primary efficacy outcome: composite of any symptomatic DVT, any non‐fatal PE, and death related to VTE Primary safety outcome: clinically relevant bleeding (major and non‐major) Secondary efficacy outcome: 1‐year overall survival or at study end date
Notes	Funding, quote: "Supported by Sanofi". "The study was designed by the steering committee members and sponsored by Sanofi. Data were collected through a clinical research organization and analyzed by Sanofi. No Sanofi employees were members of the steering committee or the data and safety monitoring board." Disclosure of potential conflicts of interest: in the section 'The Work Under Consideration for Publication,' some of the authors declared they were employed by Sanofi or had received consulting fee or honorarium and support for travel to meetings by Sanofi‐Aventis. Publication format: published as full text Marketing applications for semuloparin have been withdrawn worldwide, and it is, therefore, unlikely to ever be commercially available (EMEA 2012).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed centrally by means of an interactive voice‐response system." Comment: adequate method of sequence generation.
Allocation concealment (selection bias)	Low risk	Quote: "Randomization was performed centrally by means of an interactive voice‐response system." Comment: adequate method of allocation concealment.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "Efficacy and bleeding outcomes were assessed by a central independent adjudication committee, whose members were unaware of the study treatment" Comment: double‐blind RCT and blinding of outcome assessors.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "All patients who underwent randomization were included in the primary efficacy population (intention‐to‐treat population), and those who underwent randomization and received at least one dose of the study treatment were included in the safety population" Comment: for safety, 1589/1608 (98.8%) participants randomised were analysed in uLMWH group, 1583/1604 (98.7%) participants randomised were analysed in placebo group.
Selective reporting (reporting bias)	Low risk	All outcomes reported in the protocol and in the methods section of the full report were addressed in the results or discussion section, except for 1 outcome mentioned in the protocol only: "Secondary efficacy variables include the initiation of curative treatment by the investigator after VTE," We did not consider this outcome to be relevant for the current review.