Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of participants with adverse events, adverse reactions, severe adverse events and severe adverse reactions as a measure of safety and tolerability during the study period |
To determine the incidence, type and severity of adverse events, adverse reactions, severe adverse events and severe adverse reactions in patients up to 96 weeks. |
up to 96 weeks |
|
Primary |
Absolute Change in Weight (Unit: kg) From Baseline Over Time |
The patient's weight will be determined, and it's one kind of Physical examination. |
Baseline, 24, 48, 72 and 96 weeks. |
|
Primary |
Absolute Change in Height (Unit: m) From Baseline Over Time |
The patient's height will be determined, and it's one kind of Physical examination. |
Baseline,24, 48, 72 and 96 weeks. |
|
Primary |
Absolute Change in Hormon (total and free testosterone in men, follicle-generating hormone and luteinizing hormon in women) From Baseline Over Time |
Hormon will be determined, and it's one kind of laboratory test. |
Baseline, 24, 48, 72 and 96 weeks. |
|
Primary |
Absolute Change in Temperature (Unit: ?)From Baseline Over Time |
The patient's temperature will be determined, and it's one kind of vital signs checks. |
Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Blood pressure (Unit: mmHg ) From Baseline Over Time |
Both patient's systolic and diastolic blood pressure will be measured, and it's one kind of vital signs checks. |
Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Heart rate (Unit: bpm) From Baseline Over Time |
The patient's heart rate will be determined, and it's one kind of vital signs checks. |
Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Respiration (Unit: bpm) From Baseline Over Time |
The patient's respiration will be determined, and it's one kind of vital signs checks. |
Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Electrocardiogram (P-R (Unit: ms), QRS (Unit: ms), QTc (Unit: ms), etc) From Baseline Over Time |
The patient's electrocardiogram will be measured, and it's one kind of laboratory test. |
Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Change in Auditory Function From Baseline Over Time |
The patient's auditory function will be determined by otorhinolaryngology. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in White Blood Count (Unit: 10E9/L) From Baseline Over Time |
The patient's white blood count will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Neutrophil Count (Unit: 10E9/L) From Baseline Over Time |
The patient's neutrophil count will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Lymphocyte Count (Unit: 10E9/L) From Baseline Over Time |
The patient's lymphocyte count will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Monocyte Count (Unit: 10E9/L) From Baseline Over Time |
The patient's monocyte count will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Eosinophilic Count (Unit: 10E9/L) From Baseline Over Time |
The patient's eosinophilic count will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Basophilic Count (Unit: 10E9/L) From Baseline Over Time |
The patient's basophilic count will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Red Blood Count (Unit: 10E9/L) From Baseline Over Time |
The patient's red blood count will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Hemoglobin (Unit: g/L) From Baseline Over Time |
The patient's hemoglobin will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Hematocrit (Unit:%) From Baseline Over Time |
The patient's hematocrit will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Blood Platelet Count (Unit: 10E9/L) From Baseline Over Time |
The patient's blood platelet count will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Thrombocytocrit (Unit: %) From Baseline Over Time |
The patient's thrombocytocrit will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Alanine Aminotransferase (Unit: U/L) From Baseline Over Time |
The patient's alanine aminotransferase will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Total Bilirubin (Unit:µmol/L) From Baseline Over Time |
The patient's total bilirubin will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Total Protein (Unit:g/L) From Baseline Over Time |
The patient's total protein will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Albumin (Unit: g/L) From Baseline Over Time |
The patient's albumin will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Globulin (Unit: g/L) From Baseline Over Time |
The patient's globulin will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Alkaline Phosphatase (Unit: U/L) From Baseline Over Time |
The patient's alkaline phosphatase will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Lactate Dehydrogenase (Unit: IU/L) From Baseline Over Time |
The patient's lactate dehydrogenase will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Urea (Unit: mmol/L) From Baseline Over Time |
The patient's urea will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Creatinine (Unit:µmol/L) From Baseline Over Time |
The patient's creatinine will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Glucose (Unit: mmol/L) From Baseline Over Time |
The patient's glucose will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Potassium (Unit: mmol/L) From Baseline Over Time |
The patient's potassium will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Sodium (Unit: mmol/L) From Baseline Over Time |
The patient's sodium will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Chlorine (Unit: mmol/L) From Baseline Over Time |
The patient's chlorine will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Calcium (Unit: mmol/L) From Baseline Over Time |
The patient's calcium will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Aspartate Aminotransferase (Unit: U/L) From Baseline Over Time |
The patient's aspartate aminotransferase will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Fibrinogen (Unit: g/L) From Baseline Over Time |
The patient's fibrinogen will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Prothrombin time (Unit: s) From Baseline Over Time |
The patient's prothrombin time will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Activated Partial Thromboplastin Time (APTT, Unit: s) From Baseline Over Time |
The patient's APTT will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Thyroid and para-gland function (Serum total thyroxine, parathyroid hormone, total triiodothyronine and thyrotropin) From Baseline Over Time |
The patient's thyroid and para-gland function will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Urine Glucose (Unit: mmol/L) From Baseline Over Time |
The patient's urine glucose will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Urine Protein (Unit: g/L)) From Baseline Over Time |
The patient's urine protein will be determined, and it's one kind of laboratory test. |
Baseline, 2, 12, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Dosage(mg/kg)during the study period |
The dosages will be investigated up to 96 weeks. |
Up to 96 weeks |
|
Primary |
Duration of Administration during the study period |
The duration of administration will be investigated up to 96 weeks. |
Up to 96 weeks |
|
Primary |
Number of Participants during the study period |
The number of participants will be investigated up to 96 weeks. |
Up to 96 weeks |
|
Primary |
Absolute Change in Serum ferritin (Unit: µg/L) From Baseline Over Time |
Serum ferritin will be determined, and it's one kind of laboratory test. |
Baseline, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96 weeks. |
|
Primary |
Absolute Change in Liver iron content (MRI R2) From Baseline Over Time |
Liver iron content will be determined by liver magnetic resonance. |
Baseline, 12, 24, 48, 72 and 96 weeks. |
|
Primary |
Absolute Change in Heart iron content (MRI T2*) From Baseline Over Time |
Heart iron content will be determined by cardio magnetic resonance. |
Baseline, 12, 24, 48, 72 and 96 weeks. |
|