Simonneau 1997.

Methods	Study design: randomised controlled trial. Method of randomisation: centrally controlled, computerised. Concealment of allocation: not blinded for treatment allocation, blinded for outcome assessment. Exclusions post‐randomisation: none. Lost to follow‐up: none.
Participants	Country: France, Belgium and Switzerland. Setting: hospital. No.: 612 participants. Age: mean 67 years. Sex: 172 males. Inclusion criteria: clinically suspected acute PE. PE objectively documented by pulmonary angiography or ventilation‐perfusion lung scanning indicating a high probability of PE or showing indeterminate results but accompanied by DVT confirmed by venography or compression ultrasonography. Exclusion criteria: massive PE requiring thrombolytic therapy or pulmonary embolectomy; active bleeding or disorders contraindicating anticoagulant therapy; anticoagulant therapy at a therapeutic dose for > 24 hours; life expectancy < 3 months; severe hepatic or renal failure; likely non‐compliance; pregnancy.
Interventions	Treatment: LMWH: tinzaparin, innohep in body weight‐adjusted fixed dose, s.c., o.d. Control: UFH: APTT‐adjusted dose, continuous i.v. infusion after an initial i.v. bolus of 50 IU/kg. Treatment duration: at least 5 days; treatment cessation if INR was 2.0 or above on 2 measurements made 24 hours apart. Oral anticoagulation: started between the first and third days of initial treatment and continued for at least 3 months; INR 2.0 to 3.0.
Outcomes	Primary: symptomatic recurrent VTE during initial treatment (8 days) and at the end of follow‐up (day 90); major haemorrhage during initial treatment (8 days) and at the end of follow‐up (day 90); death at end of follow‐up (day 90).
Notes	Follow‐up: 90 days. 1 participant allocated to UFH and 3 participants allocated to LMWH did not receive the study drug.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Central randomisation was performed with the use of a 24‐hour computer service.
Allocation concealment (selection bias)	Low risk	Central randomisation was performed with the use of a 24‐hour computer service.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Not blinded for treatment allocation. Comment: given the clinical outcomes of the study, review authors judged that the non‐blinding of the participants and staff was unlikely to have affected the outcomes.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Data on all potential outcome events were submitted to an independent adjudication committee whose members were unaware of the treatment assignments.
Incomplete outcome data (attrition bias) All outcomes	Low risk	An intention‐to‐treat analysis was performed, but the authors do not give any information about loss to follow‐up.
Selective reporting (reporting bias)	Low risk	Published report includes all expected outcomes.
Other bias	Low risk	The study appears to be free of other sources of bias.