Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of adverse drug reactions (ADR) |
Count of events |
Weeks 0-208 |
|
Secondary |
Number of serious adverse drug reaction (SADR) |
Count of events |
Week 0-208 |
|
Secondary |
Number of serious adverse event (SAE) |
Count of events |
Week 0-208 |
|
Secondary |
Number of cardiac adverse event (AE) |
Count of events |
Week 0-208 |
|
Secondary |
Change in insulin like growth factor I (IGF-I) for non-naïve patients |
Measured in ng/mL |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in insulin like growth factor I (IGF-I) for naïve patients |
Measured in ng/mL |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in insulin like growth factor I standard deviation score (IGF-I SDS) for non-naïve patients |
Presented as standard deviation (SD) score |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in insulin like growth factor I standard deviation score (IGF-I SDS) for naïve patients |
Presented as SD score |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in haemoglobin A1c (HbA1c) for non-naïve patients |
Measured in % |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in haemoglobin A1c (HbA1c) for naïve patients |
Measured in % |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in aspartate aminotransferase (AST) for non-naïve patients |
Measured in IU/L |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in aspartate aminotransferase (AST) for naïve patients |
Measured in IU/L |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in alanine aminotransferase (ALT) for non-naïve patients |
Measured in IU/L |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in alanine aminotransferase (ALT) for naïve patients |
Measured in IU/L |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in total cholesterol (T-CHO) for non-naïve patients |
Measured in mg/dL |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in total cholesterol (T-CHO) for naïve patients |
Measured in mg/dL |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in high-density lipoprotein cholesterol (HDL-C) for non-naïve patients |
Measured in mg/dL |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in high-density lipoprotein cholesterol (HDL-C) for naïve patients |
Measured in mg/dL |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in Low-density lipoprotein cholesterol (LDL-C) for non-naïve patients |
Measured in mg/dL |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in Low-density lipoprotein cholesterol (LDL-C) for naïve patients |
Measured in mg/dL |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in triglyceride (TG) for non-naïve patients |
Measured in mg/dL |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in triglyceride (TG) for naïve patients |
Measured in mg/dL |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in thyroid stimulation hormone(TSH) for non-naïve patients |
Measured in µU/mL |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in thyroid stimulation hormone(TSH) for naïve patients |
Measured in µU/mL |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in free triiodothyronine (FT-3) for non-naïve patients |
Measured in pg/mL |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in free triiodothyronine (FT-3) for naïve patients |
Measured in pg/mL |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in free thyroxine (FT-4) for non-naïve patients |
Measured in ng/mL |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in free thyroxine (FT-4) for naïve patients |
Measured in ng/mL |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in white blood cell (WBC) for non-naïve patients |
Measured in µ/L |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in white blood cell (WBC) for naïve patients |
Measured in µ/L |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in platelet (PLT) for non-naïve patients |
Measured in 10^4/µL |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in platelet (PLT) for naïve patients |
Measured in 10^4/µL |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in bone age (BA) for non-naïve patients |
Measured in year |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in bone age (BA) for naïve patients |
Measured in year |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in bone age/chronological age (BA/CA) for non-naïve patients |
Presented as ratio |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in bone age/chronological age (BA/CA) for naïve patients |
Presented as ratio |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in electrocardiogram (ECG) for non-naïve patients |
Assessment of change in ECG is measured by categories recorded in case report forms (CRFs): normal, abnormal not clinically significant and abnormal clinically significant. |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in electrocardiogram (ECG) for naïve patients |
Assessment of change in ECG is measured by categories recorded in CRFs: normal, abnormal not clinically significant and abnormal clinically significant. |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Change in height standard deviation score (HSDS) for non-naïve patients |
Presented as SD score |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Change in height standard deviation score (HSDS) for naïve patients |
Presented as SD score |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Height velocity standard deviation score (HVSDS) for non-naïve patients |
Presented as SD score |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Height velocity standard deviation score (HVSDS) for naïve patients |
Presented as SD score |
Weeks 0, 52, 104, 156, and 208 weeks |
|
Secondary |
Height velocity (HV) for non-naïve patients |
Measured in cm/year |
Weeks 0, 52, 104, 156, 208, 260, 312, 364, 416, and 442 weeks |
|
Secondary |
Height velocity (HV) for naïve patients |
Measured in cm/year |
Weeks 0, 52, 104, 156, and 208 weeks |
|