Reasons for discontinuation | High dose | Low dose | Placebo |
Subjects | 108 | 55 | 104 |
Total | 40 (37.0) | 15 (27.3) | 31 (29.8) |
Progression of disease | 8 (7.4) | 0 (0.0) | 15 (14.4) |
Death | 0 (0.0) | 0 (0.0) | 0 (0.0) |
10% decline in VC | 5 (4.6) | 0 (0.0) | 11 (10.6) |
Worsening of respiratory symptoms | 3 (2.8) | 0 (0.0) | 4 (3.7) |
Acute exacerbation | 4 (3.7) | 2 (3.6) | 4 (3.8) |
Adverse events# | 15 (13.9) | 9 (16.4) | 7 (6.7) |
Photosensitivity | 3 (2.8) | 2 (3.6) | 0 (0.0) |
Lung carcinoma | 2 (1.8) | 1 (1.8) | 1 (0.9) |
Fever | 2 (1.8) | 0 (0.0) | 0 (0.0) |
Respiratory failure¶ | 2 (1.8) | 0 (0.0) | 0 (0.0) |
Rash | 1 (0.9) | 1 (1.8) | 0 (0.0) |
AST and/or ALT increase | 1 (0.9) | 1 (1.8) | 0 (0.0) |
Gastric ulcer | 1 (0.9) | 0 (0.0) | 0 (0.0) |
Anorexia | 1 (0.9) | 0 (0.0) | 0 (0.0) |
Muscle pain | 1 (0.9) | 0 (0.0) | 0 (0.0) |
Dysgeusia | 1 (0.9) | 0 (0.0) | 0 (0.0) |
Loss of consciousness | 1 (0.9) | 0 (0.0) | 0 (0.0) |
Respiratory tract infection | 0 (0.0) | 2 (3.6) | 0 (0.0) |
Fatigue, drowsiness | 0 (0.0) | 1 (1.8) | 0 (0.0) |
Rheumatoid arthritis | 0 (0.0) | 1 (1.8) | 0 (0.0) |
Electrocardiogram abnormal | 0 (0.0) | 0 (0.0) | 2 (1.9) |
Nausea | 0 (0.0) | 0 (0.0) | 1 (0.9) |
Lung neoplasm | 0 (0.0) | 0 (0.0) | 1 (0.9) |
MPO–ANCA increase | 0 (0.0) | 0 (0.0) | 1 (0.9) |
Cerebral thrombosis | 0 (0.0) | 0 (0.0) | 1 (0.9) |
Suicide | 0 (0.0) | 0 (0.0) | 1 (0.9) |
Upper respiratory tract infection | 0 (0.0) | 0 (0.0) | 1 (0.9) |
Pneumothorax | 0 (0.0) | 0 (0.0) | 1 (0.9) |
Consent withdrawn | 12 (11.1) | 2 (3.6) | 4 (3.8) |
Other | 1 (0.9) | 2 (3.6) | 1 (1.0) |
Data are presented as n or n (%). VC: vital capacity; AST: aspartate aminotransferase; ALT: alanine aminotransferase: MPO–ANCA: myeloperoxidase-anti-neutrophil cytoplasmic antibody. #: other than acute exacerbation; ¶: one case was respiratory failure due to traumatic shock caused by a traffic accident.