Table 2—

Reasons for discontinuing the study(full analysis set)

Reasons for discontinuationHigh doseLow dosePlacebo
Subjects10855104
Total40 (37.0)15 (27.3)31 (29.8)
Progression of disease8 (7.4)0 (0.0)15 (14.4)
 Death0 (0.0)0 (0.0)0 (0.0)
 10% decline in VC5 (4.6)0 (0.0)11 (10.6)
 Worsening of respiratory symptoms3 (2.8)0 (0.0)4 (3.7)
Acute exacerbation4 (3.7)2 (3.6)4 (3.8)
Adverse events#15 (13.9)9 (16.4)7 (6.7)
 Photosensitivity3 (2.8)2 (3.6)0 (0.0)
 Lung carcinoma2 (1.8)1 (1.8)1 (0.9)
 Fever2 (1.8)0 (0.0)0 (0.0)
 Respiratory failure2 (1.8)0 (0.0)0 (0.0)
 Rash1 (0.9)1 (1.8)0 (0.0)
 AST and/or ALT increase1 (0.9)1 (1.8)0 (0.0)
 Gastric ulcer1 (0.9)0 (0.0)0 (0.0)
 Anorexia1 (0.9)0 (0.0)0 (0.0)
 Muscle pain1 (0.9)0 (0.0)0 (0.0)
 Dysgeusia1 (0.9)0 (0.0)0 (0.0)
 Loss of consciousness1 (0.9)0 (0.0)0 (0.0)
 Respiratory tract infection0 (0.0)2 (3.6)0 (0.0)
 Fatigue, drowsiness0 (0.0)1 (1.8)0 (0.0)
 Rheumatoid arthritis0 (0.0)1 (1.8)0 (0.0)
 Electrocardiogram abnormal0 (0.0)0 (0.0)2 (1.9)
 Nausea0 (0.0)0 (0.0)1 (0.9)
 Lung neoplasm0 (0.0)0 (0.0)1 (0.9)
 MPO–ANCA increase0 (0.0)0 (0.0)1 (0.9)
 Cerebral thrombosis0 (0.0)0 (0.0)1 (0.9)
 Suicide0 (0.0)0 (0.0)1 (0.9)
 Upper respiratory tract infection0 (0.0)0 (0.0)1 (0.9)
 Pneumothorax0 (0.0)0 (0.0)1 (0.9)
Consent withdrawn12 (11.1)2 (3.6)4 (3.8)
Other1 (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.