Brock 2001.

Methods	Study design: parallel RCT Language: English Type of publication: Journal article Overall quality assessment: High risk of bias
Participants	Setting: single centre, Johns Hopkins University School of Medicine Country: USA Number: ATG (34); muromonab‐CD3 (30) Sex (M/F): ATG (16/18); muromonab‐CD3 (14/16) Mean age ± SD years: ATG (51 ± 11); muromonab‐CD3 (51 ± 12) Inclusion criteria: all patients who met standard criteria for lung transplantation and were classified as NYHA Class IV at transplantation Indication (No., %) COPD: ATG (15, 44%); muromonab‐CD3 (11, 38%) Pulmonary fibrosis: ATG (5, 15%); muromonab‐CD3 (8, 28%) Cystic fibrosis: ATG (1, 3%); muromonab‐CD3 (2, 7%) Sarcoidosis: ATG (2, 6%); muromonab‐CD3 (1, 3%) Pulmonary hypertension: ATG (6, 18%); muromonab‐CD3 (1, 3%) Bronchiectasis: ATG (0, 0%); muromonab‐CD3 (1, 3%) Scleroderma: ATG (4, 12%); muromonab‐CD3 (0, 0%) Other: ATG (1, 3%); muromonab‐CD3 (1, 3%) Transplant procedure (No., %) Single lung: ATG (27, 79%); muromonab‐CD3 (17, 57%) Double lung: ATG (7, 21%); muromonab‐CD3 (13, 43%) All patients with cystic fibrosis or severe pulmonary hypertension (mean pulmonary artery pressure > 50 mm Hg) preferentially received bilateral lung transplantation. All other patients had single lung transplants
Interventions	Treatment group 1 Induction was initiated based on the schema outlined for each study group. The first doses of muromonab‐CD3 and ATG were given within 24 hours of surgery, and then both drugs were continued daily for 7 consecutive days post‐transplant. Muromonab‐CD3 5 mg/d was given initially for patients > 80 kg and 2.5 mg/d for patients < 80 kg. It was then adjusted daily thereafter to maintain a peripheral CD3 count of 5% of the total lymphocyte count or 50 cells/mm³. Treatment group 2 Horse ATG was started at an initial dose of 15 mg/kg/d and then adjusted daily based on the same CD3 criteria as muromonab‐CD3. Concomitant immunosuppressive treatment The immunosuppressive regimen consisted of cyclosporin, azathioprine, and corticosteroids Preoperative: all patients received oral doses of azathioprine 4 mg/kg and cyclosporin 5 to 10 mg/kg. Intraoperative therapy: solumedrol 500 mg IV infused before allograft perfusion. Early postoperative: cyclosporin 1 to 4 mg/h IV was used, switching to oral cyclosporin as soon as an oral diet was tolerated. Daily cyclosporin levels were maintained at a level of 100 to 200 ng/dL by whole blood radioimmunoassay during the first 3 postoperative days and at a therapeutic level of 300 to 350 ng/dL by 1 week postoperatively Perioperative: azathioprine, 2 mg/kg IV, was titrated to a white blood cell count of 5000 to 8000 cells/high powered field. Subsequent oral dosing of azathioprine was similar to the IV preparation. Methylprednisolone 125 mg every 8 hours was given for the first 24 hours, followed by hydrocortisone 100 mg twice daily for 3 days, then 100 mg/d. This was continued until the patient tolerated oral prednisone starting at 0.5 mg/kg to a maximum of 40 mg/d. Prednisone was tapered based on clinical stability to 0.2 mg/kg by 3 months Follow‐up: 2 years
Outcomes	Early rejection Infection Survival Bronchiolitis obliterans syndrome
Notes	Sample size calculation: not reported Sources of funding: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Pair‐wise randomisation, not further specified
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No blinding reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No blinding reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No patients were lost to follow‐up
Selective reporting (reporting bias)	Low risk	No protocol was available, but the study reported on mortality, rejection, infection, bronchiolitis obliterans syndrome, PTLD and adverse events
Other bias	Low risk	Study appears to be free of other bias components