This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.
Study Type
OBSERVATIONAL
Enrollment
179
oral
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kanto, Japan
Overall survival
Time frame: Up to three years
Respiratory function test value (%FVC, %DLco)
Respiratory function is evaluated by % FVC ( percent-predicted forced vital capacity) amd %DLco (diffusion capacity of CO).
Time frame: Up to three years
Arterial blood gas analysis value (PaO2, AaDO2)
Arterial blood gas analysis by PaO2 (arterial O2 pressure) and AaDO2 (alveolar-arterial oxygen difference)
Time frame: Up to three years
Chest CT findings
CT: computed tomography
Time frame: Up to three years
Serum KL-6 value (serum SP-D value)
KL-6 (sialylated carbohydrate antigen KL-6) and SP-D (surfactant protein D) are used as marker of interstitial pneumonia
Time frame: Up to three years
Patient disposition
patient disposition includes 1)number of case report forms collected, 2)number of patients analyzed for safety, 3)number of patients analysed for efficacy
Time frame: Up to three years
Safety assessed by the incidence of adverse events
Any adverse events which include adverse events leading to death, white blood cell count, erythrocyte sedimentation rate and other abnormal findings from laboratory tests
Time frame: Up to three years
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Unnamed facility
Kyushu, Japan
Unnamed facility
Shikoku, Japan
Unnamed facility
Tōhoku, Japan