Subjects n | 43 | 40 | |
Patients completing 2-yr course of study drug | 18 (41.9) | 28 (70.0) | 0.01 |
Reasons for study drug discontinuation (drop-out) | 3 (7.0) | 5 (12.5) | 0.39 |
Decision of investigator | | | |
Gastrointestinal intolerance | 0 (0.0) | 2 (5.0) | |
Pulmonary malignancy | 1 (2.3) | 1 (2.5) | |
Severe sepsis | 0 (0.0) | 1 (2.5) | |
Suture stenosis | 0 (0.0) | 1 (2.5) | |
Decision of patient | | | |
Withdrawal from study | 2 (4.6) | 0 (0.0) | |
BOS at 2 yrs after transplantation | 19 (44.2) | 5 (12.5) | 0.0017 |
Onset of BOS days after transplantation | 331.8±198.8 | 270.8±222.6 | 0.60 |
Retransplantation at 2 yrs after transplantation | 2 (4.7) | 1 (2.5) | 1.0 |
Time to retransplantation days | 531.5±211.4 | 534.0±0.0 | NA |
Mortality at 2 yrs after transplantation | 8 (18.6) | 6 (15.0) | 0.77 |
Cause of death | | | 0.78 |
Pulmonary infection | 4 (9.3) | 2 (5.0) | |
Other infection | 1 (2.3) | 2 (5.0) | |
Respiratory insufficiency due to BOS | 1 (2.3) | 1 (2.5) | |
Malignancy | 1 (2.3) | 1 (2.5) | |
Diffuse alveolar damage | 1 (2.3) | 0 (0.0) | |
Time to post-operative death days | 393.9±150.9 | 447.8±182.5 | 0.79 |
Time of BOS to retransplantation or post-operative death, days | 228.9±183.4 | 330.5±143.5 | 0.33 |