Table 3. Major inclusion and exclusion criteria for patient selection.

Inclusion criteria	Exclusion criteria
1. ≥18 y of age	1. Diagnosis of primary brain tumour
2. Histologically confirmed solid malignancy including, but not limited to, pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (haematologic), with locally advanced or metastatic disease	2. Known history of brain metastases
3. ECOG PS 0–2	3. Haematologic malignancies with the exception of lymphoma
4. Khorana score ≥2	4. Bleeding diathesis, haemorrhagic lesions, active bleeding and other conditions with a high risk for bleeding
5. Adequate renal function: CrCl ≥ 30 mL/min	5. Life expectancy of ≤6 mo
6. Plan to initiate systemic cancer therapy within ± 1 wk of receiving first dose of study drug with the intent of continuing systemic cancer therapy with study drug during the double-blind treatment period	6. Evidence of VTE on screening CU or incidental VTE identified on spiral CT scans ordered primarily for staging or restaging of malignancy ≤30 d prior to randomization

Abbreviations: CrCl, creatinine clearance; CT, computed tomography; CU, compression ultrasonography; ECOG, Eastern Cooperative Oncology Group; PS, performance status; VTE, venous thromboembolism.