Confirmed treatment-emergent clinically serious pulmonary events, as determined by the EPP
| . | Treatment group . | Total, N = 645 (%) . | P* . | |
|---|---|---|---|---|
| Test, N = 318 (%) . | Reference, N = 327 (%) . | |||
| Any subject with a clinically serious pulmonary AE | 55 (17.3) | 45 (13.8) | 100 (15.5) | .232 |
| Tracheal bronchial tree | 4 (1.3) | 2 (0.6) | 6 (0.9) | .445 |
| Bronchospasm | 3 (0.9) | 2 (0.6) | 5 (0.8) | .682 |
| Hemorrhage | 1 (0.3) | 0 (0.0) | 1 (0.2) | .493 |
| Bronchitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
| Lung parenchyma | 55 (17.3) | 45 (13.8) | 100 (15.5) | .232 |
| Pneumonitis any | 39 (12.3) | 32 (9.8) | 71 (11.0) | .379 |
| Pneumonitis without ALI or ARDS | 20 (6.3) | 16 (4.9) | 36 (5.6) | .495 |
| Pneumonitis with ALI or ARDS | 19 (6.0) | 16 (4.9) | 35 (5.4) | .604 |
| Pneumonitis with ALI only | 7 (2.2) | 11 (3.4) | 18 (2.8) | .475 |
| Pneumonitis with ARDS only | 12 (3.8) | 5 (1.5) | 17 (2.6) | .088 |
| Atelectasis/other | 16 (5.0) | 13 (4.0) | 29 (4.5) | .572 |
| LAH with infiltrates | 16 (5.0) | 12 (3.7) | 28 (4.3) | .443 |
| Pleural space | 18 (5.7) | 20 (6.1) | 38 (5.9) | .868 |
| Pleuritis | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
| Pleural effusion | 18 (5.7) | 20 (6.1) | 38 (5.9) | .868 |
| Pnemothorax | 0 (0.0) | 1 (0.3) | 1 (0.2) | 1.000 |
| . | Treatment group . | Total, N = 645 (%) . | P* . | |
|---|---|---|---|---|
| Test, N = 318 (%) . | Reference, N = 327 (%) . | |||
| Any subject with a clinically serious pulmonary AE | 55 (17.3) | 45 (13.8) | 100 (15.5) | .232 |
| Tracheal bronchial tree | 4 (1.3) | 2 (0.6) | 6 (0.9) | .445 |
| Bronchospasm | 3 (0.9) | 2 (0.6) | 5 (0.8) | .682 |
| Hemorrhage | 1 (0.3) | 0 (0.0) | 1 (0.2) | .493 |
| Bronchitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
| Lung parenchyma | 55 (17.3) | 45 (13.8) | 100 (15.5) | .232 |
| Pneumonitis any | 39 (12.3) | 32 (9.8) | 71 (11.0) | .379 |
| Pneumonitis without ALI or ARDS | 20 (6.3) | 16 (4.9) | 36 (5.6) | .495 |
| Pneumonitis with ALI or ARDS | 19 (6.0) | 16 (4.9) | 35 (5.4) | .604 |
| Pneumonitis with ALI only | 7 (2.2) | 11 (3.4) | 18 (2.8) | .475 |
| Pneumonitis with ARDS only | 12 (3.8) | 5 (1.5) | 17 (2.6) | .088 |
| Atelectasis/other | 16 (5.0) | 13 (4.0) | 29 (4.5) | .572 |
| LAH with infiltrates | 16 (5.0) | 12 (3.7) | 28 (4.3) | .443 |
| Pleural space | 18 (5.7) | 20 (6.1) | 38 (5.9) | .868 |
| Pleuritis | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
| Pleural effusion | 18 (5.7) | 20 (6.1) | 38 (5.9) | .868 |
| Pnemothorax | 0 (0.0) | 1 (0.3) | 1 (0.2) | 1.000 |
NA indicates not applicable; LAH, Left Atrial Hypertension.
Based on Fisher exact test.