Human Growth Hormone

Type 2 Diabetes Mellitus in GH-treated Participants

Effect of Norditropin® treatment on height gain (change in height) in children

Number of adverse events

the change in height standard deviation score

Number of Participants With Treatment Related Adverse Events.

Near final height (NFH) standard deviation score (SDS) measured in scores

Number of Participants With Adverse Drug Reaction (ADR)

Growth in height

height growth rate

Auxological characteristics (height and weight, head circumference, growth curve used, bone age) and Clinical examination (cardiac frequency, systolic blood pressure, diastolic blood pressure, Tanner pubertal stage)

Improvement of an integrated score which consists of Quality of Life (QoL), body composition, lipid metabolism, bone mineral density

Functional connectivity patterns

Psychological well-being through the Psychological Well-Being Scales (PWB)

Change in High-sensitivity C-reactive Protein

Number of adverse drug reactions (ADR)

Change in Visceral Adipose Tissue Area From Baseline to 18 Months

Primary objective is to investigate changes in height Standard Deviation Score (SDS)

Intima-media thickness at common carotid arteries at baseline and after 5 years

Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment

Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve)

The relationship between changes in serum levels of Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and YKL-40 vs. changes in serum levels og IGF-I

Rate of overall treatment adherence

to compare the effect of GH on IMCL content in the two subject groups (Turner syndrome vs. ISS)

The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)

Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1

Numbers of oocytes retrieved and number of fertilized oocytes

The change in lean body weight (kg) from baseline

clinical pregnancy rate

Safety

Change from baseline in total volume of parenteral nutrition (PN/IV) support at Week 4 of the study (PS, Parenteral Support)

Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®

the percentage of liver fat

Change From Baseline in Annualized Height Velocity (AHV) at Week 52

Change in percentage ejection fraction in subjects during the transition phase from childhood to adulthood

Proportion of patients HIV+ that recover the immunospecific responses against tetanus toxoid and Hepatitis A at 24 weeks of rhGH administration (time of treatment interruption).

Left ventricular mass measured with ultrasonography

To evaluate the effect of growth hormone on infants aged 1 to 2 years with CRI and growth retardation growth retardation despite an adequate dietary intake

Maximum Oxygen Uptake at Baseline.

Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36

Left Ventricular systolic function

Mortality - Time to All-cause Death

Absolute On-target Difference (AOTD) at 24 Months

Efficacy data : measurement of height

Insulin-Like Growth Factor I (IGF-I) Levels Measured Using the Timed Capillary Blood Spot Samples

Annual Height Velocity in Main Study Phase

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation

The 2 different doses used are non-inferior to each other

Height Velocity: In-trial Observation Period

Change in height standard deviation score

QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults)

Height Velocity

Change in height standard deviation score

Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]

Growth velocity (HV, cm/year).

Percent change in truncal fat (kg) from baseline

Change of height standard deviation score for chronological age (△Ht SDSCA)

Percentage of Participants With Less Than 11 Tender Points at Month 6

Percent change in truncal fat (kg)

Height, height velocity

Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years

Incidence of Adverse Events

Total Score Related to Overall Life Interference Assessed at Baseline, Using Dyad Clinical Outcomes Assessment 1 (DCOA 1) Questionnaire

Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)

Adverse events (especially injection site reactions)

Long-term safety of growth hormone replacement in adult patients with growth hormone deficiency

Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months

Final height

Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population

Annual Height Velocity (HV) After 12 Months

Glucose tolerance

Change in left ventricular endsystolic volume

Final height, compared to the expected familial target height

Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint

Correlation Between Gene Expression Profiling and Catch-up Growth in Small for Gestational Age (SGA) Children

Change in height SDS (Standard Deviation Score) (referenced to normal population)

To confirm the clinical efficacy of Serostim compared with placebo, based on an endpoint of exercise function change.

the growth-velocity

Lean body mass

Time from surgery until fracture has healed

Change of yearly height velocity (ΔHV)

Change in declarative memory, including total recall scores on three tests of memory and on dual task response time (RT), a test of executive function.

Change in surrogate markers of nutrition

Growth velocity

Change of IGF-I levels in function of time, and dose strengths

To determine the safety and efficacy of Nutropin AQ in treating growth restriction and increasing lean body mass (LBM) in children with cystic fibrosis (CF) and growth restriction.

Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index

Annual Height Velocity

Annualized Height Velocity (AHV) (cm/year)

Primary endpoint is the N-acetylaspartate/Creatine ratio in the motor cortex assessed with magnetic resonance spectroscopy.

Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)

MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.

Frequency of Adverse events (AEs)

Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III)

Pharmacokinetic profiles of growth hormone

Phase Ib: Treatment Emergent Adverse Events （TEAEs）

change from baseline in height SDS (standard deviation score)

Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation

Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation

GH administration may elicit clinical significant and relevant changes in the human immune system

Area under the serum hGH(human growth hormone)concentration-time curve

Incidence of adverse events (AEs)

The primary efficacy endpoint will be based in the investigation of pharmacokinetics and pharmacodynamics of somatropin in research subjects after administration of single dose, sc, of the drug.

Bioavailability

Urinary nitrate excretion

Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation

Change in brain function assessed by functional MRI

Cartilage T2 map score