Larocca 2012.

Study characteristics
Methods	Open‐label, phase III, randomised study, multicentre
Participants	Previously untreated patients with myeloma who received lenalidomide‐containing regimens 402 participants had been assigned to thalidomide‐containing regimens, of which 342 were enrolled into the substudy. Median age 57 in ASA group and 58 in LMWH group
Interventions	Intervention 1: aspirin given at 100 mg/d orally during four 28‐day cycles of lenalidomide and dexamethasone Intervention 2: LMWH (enoxaparin) given at 40 mg/d subcutaneously during four 28‐day cycles of lenalidomide and dexamethasone Co‐intervention: participants in both arms assigned to Mel 200 (melphalan) consolidation stopped prophylaxis at this point (after the four 28‐cycles). Participants assigned to MPR (melphalan‐prednisone‐lenalidomide) consolidation continued prophylaxis for the six 28‐day cycles of MPR. The median duration of prophylaxis was 3.6 and 3.5 months in the ASA and LMWH groups, respectively. Screening/diagnostic testing for DVT/PE: not reported
Outcomes	Duration of follow‐up for the following outcomes: 6 months Symptomatic DVT Symptomatic PE Sudden unexplained death Major and minor bleeding
Notes	Funding: the study RV‐MM‐PI209 was supported by Fondazione Neoplasie angue Onlus. Conflict of interest: personal fees (consultancy, advisory role, honoraria), research funding ITT: all efficacy and safety analyses were performed according to the intention‐to‐treat principle.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "a simple randomization sequence run by a central computer, which generated an automated assignment procedure that was concealed from the investigators in each study center."
Allocation concealment (selection bias)	Low risk	Quote: "a simple randomization sequence run by a central computer, which generated an automated assignment procedure that was concealed from the investigators in each study center."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study Comment: definitely not blinded; knowledge of the assigned intervention would likelylead to differential behaviours across intervention groups (e.g. differential dropout, differential cross‐over to an alternative intervention, or differential administration of co‐interventions)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Not reported Comment: probably not blinded; knowledge of the assigned intervention would likelynot impact the assessment of the physiological outcomes (all‐cause mortality, DVT, PE, bleeding, etc.)
Incomplete outcome data (attrition bias) All outcomes	Low risk	Study does not report on incomplete outcome data.
Selective reporting (reporting bias)	Low risk	Current substudy not registered. Substudy of another registered study. All outcomes listed in the methods section were reported in the results section.
Other bias	Low risk	Study not reported as stopped early for benefit. No other bias suspected.