Foetal Growth Problem, Small for Gestational Age
Conditions
Brief summary
This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan. In the main period, subjects will receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks (two years) will continue with the same treatment for further 156 weeks (three years) while those subjects who received no treatment for 52 weeks (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In total, subjects participate in trial for 260 weeks (five years). Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517.
Interventions
DRUGsomatropin
0.033 mg/kg/day of NN-220 for s.c. injection in cartridge
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* For MAIN period (GHLIQUID-1516): * Born small for gestational age (SGA) with birth weight and birth length below the 10th percentile for gestational age, and additional either birth length below or equal to -2.0 standard deviation score (SDS) or birth weight below or equal to -2.0 SDS for gestational age * Growth failure with height at -2.0 SDS or below for chronological age (CA) * Normal growth hormone (GH) production, defined as peak GH level \> 10 ng/mL in one GH provocation test * For EXTENSION period (GHLIQUID-1517): * Subjects who completed the main period * Chronological age (CA) for boys at least 4 years, but maximum 11 years * Chronological age (CA) for girls at least 4 years, but maximum 10 years
Exclusion criteria
* Subjects with diabetes mellitus * Subjects suffering from malignancy * Several medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Week 0, week 260 | Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit |
| Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Week 0, week 208 | Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Week 0, week 260 | Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, …. |
| Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Week 0, week 208 | Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, …. |
| Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Weeks 0-260 | Yearly Height velocity SDS for chronological age were summarised and graphically presented |
| Adverse Events - Subjects Received NN220 Treatment for 4 Years | Weeks 0-208 | Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly |
| Adverse Events - Subjects Received NN220 Treatment for 5 Years | Weeks 0-260 | Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly |
| Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Weeks 0-208 | Yearly Height velocity SDS for chronological age were summarised and graphically presented |
Countries
Japan
Participant flow
Recruitment details
44 sites in Japan
Pre-assignment details
Subjects completed the main period and were offered to continue in the extension period.
Participants by arm
| Arm | Count |
|---|---|
| 0.033 mg / NN-220 In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | 35 |
| 0.067 mg / NN-220 In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime | 34 |
| No Treatment No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period | 15 |
| Total | 84 |
Baseline characteristics
| Characteristic | 0.033 mg / NN-220 | 0.067 mg / NN-220 | No Treatment | Total |
|---|---|---|---|---|
| Age, Continuous | 5.46 years STANDARD_DEVIATION 1.37 | 5.15 years STANDARD_DEVIATION 1.2 | 5.09 years STANDARD_DEVIATION 1.37 | 5.27 years STANDARD_DEVIATION 1.3 |
| Body weight | 13.31 kg STANDARD_DEVIATION 2.55 | 12.62 kg STANDARD_DEVIATION 1.81 | 12.47 kg STANDARD_DEVIATION 2.93 | 12.88 kg STANDARD_DEVIATION 2.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 34 Participants | 15 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 96.19 cm STANDARD_DEVIATION 8.48 | 94.57 cm STANDARD_DEVIATION 7.28 | 94.42 cm STANDARD_DEVIATION 8.48 | 95.22 cm STANDARD_DEVIATION 7.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 34 Participants | 15 Participants | 84 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 35 participants | 34 participants | 15 participants | 84 participants |
| Sex: Female, Male Female | 11 Participants | 14 Participants | 8 Participants | 33 Participants |
| Sex: Female, Male Male | 24 Participants | 20 Participants | 7 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 31 | 34 / 34 | 7 / 7 | 8 / 8 |
| serious Total, serious adverse events | 12 / 31 | 11 / 34 | 1 / 7 | 2 / 8 |
Outcome results
Primary
Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
Time frame: Week 0, week 208
Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| No Treatment --> 0.033 mg | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Week 0 | -2.9603 Standard Deviation Score (SDS) | Standard Error 0.6689 |
| No Treatment --> 0.033 mg | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Week 208 | 1.0997 Standard Deviation Score (SDS) | Standard Error 0.2453 |
| No Treatment --> 0.067 mg | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Week 0 | -2.7481 Standard Deviation Score (SDS) | Standard Error 0.3524 |
| No Treatment --> 0.067 mg | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years | Week 208 | 1.9151 Standard Deviation Score (SDS) | Standard Error 0.2275 |
Primary
Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
Time frame: Week 0, week 260
Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 0.033 mg / NN-220 | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Week 0 | -2.9488 Standard Deviation Score (SDS) | Standard Error 0.6368 |
| 0.033 mg / NN-220 | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Week 260 | 1.2066 Standard Deviation Score (SDS) | Standard Error 0.1102 |
| 0.067 mg / NN-220 | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Week 0 | -2.9047 Standard Deviation Score (SDS) | Standard Error 0.6718 |
| 0.067 mg / NN-220 | Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years | Week 260 | 2.0247 Standard Deviation Score (SDS) | Standard Error 0.1083 |
Secondary
Adverse Events - Subjects Received NN220 Treatment for 4 Years
Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly
Time frame: Weeks 0-208
Population: Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No Treatment --> 0.033 mg | Adverse Events - Subjects Received NN220 Treatment for 4 Years | AEs | 7 Subjects |
| No Treatment --> 0.033 mg | Adverse Events - Subjects Received NN220 Treatment for 4 Years | AEs possibly/probably relate | 1 Subjects |
| No Treatment --> 0.033 mg | Adverse Events - Subjects Received NN220 Treatment for 4 Years | SAEs | 0 Subjects |
| No Treatment --> 0.067 mg | Adverse Events - Subjects Received NN220 Treatment for 4 Years | AEs | 8 Subjects |
| No Treatment --> 0.067 mg | Adverse Events - Subjects Received NN220 Treatment for 4 Years | AEs possibly/probably relate | 3 Subjects |
| No Treatment --> 0.067 mg | Adverse Events - Subjects Received NN220 Treatment for 4 Years | SAEs | 1 Subjects |
Secondary
Adverse Events - Subjects Received NN220 Treatment for 5 Years
Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly
Time frame: Weeks 0-260
Population: Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.033 mg / NN-220 | Adverse Events - Subjects Received NN220 Treatment for 5 Years | AEs | 31 Subjects |
| 0.033 mg / NN-220 | Adverse Events - Subjects Received NN220 Treatment for 5 Years | AEs possibly/probably related | 9 Subjects |
| 0.033 mg / NN-220 | Adverse Events - Subjects Received NN220 Treatment for 5 Years | SAEs | 2 Subjects |
| 0.067 mg / NN-220 | Adverse Events - Subjects Received NN220 Treatment for 5 Years | AEs | 34 Subjects |
| 0.067 mg / NN-220 | Adverse Events - Subjects Received NN220 Treatment for 5 Years | AEs possibly/probably related | 16 Subjects |
| 0.067 mg / NN-220 | Adverse Events - Subjects Received NN220 Treatment for 5 Years | SAEs | 4 Subjects |
Secondary
Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years
Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, ….
Time frame: Week 0, week 208
Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment --> 0.033 mg | Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years | 6.54 years | Standard Deviation 1.26 |
| No Treatment --> 0.067 mg | Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years | 5.6 years | Standard Deviation 1.68 |
Secondary
Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years
Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, ….
Time frame: Week 0, week 260
Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.033 mg / NN-220 | Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years | 5.79 years | Standard Deviation 1.05 |
| 0.067 mg / NN-220 | Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years | 7.15 years | Standard Deviation 1.05 |
Secondary
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years
Yearly Height velocity SDS for chronological age were summarised and graphically presented
Time frame: Weeks 0-208
Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Treatment --> 0.033 mg | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Week 156, n=6, 7 | 1.7617 Standard Deviation Score (SDS) | Standard Deviation 2.0956 |
| No Treatment --> 0.033 mg | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Week 208, n=6, 6 | 0.5475 Standard Deviation Score (SDS) | Standard Deviation 1.6055 |
| No Treatment --> 0.033 mg | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Baseline, n=7,8 | 0.073 Standard Deviation Score (SDS) | Standard Deviation 1.5681 |
| No Treatment --> 0.033 mg | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Week 52, n=7, 8 | 2.1677 Standard Deviation Score (SDS) | Standard Deviation 0.61 |
| No Treatment --> 0.033 mg | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Week 104, n=6, 7 | 1.5268 Standard Deviation Score (SDS) | Standard Deviation 1.1715 |
| No Treatment --> 0.067 mg | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Week 104, n=6, 7 | 3.3979 Standard Deviation Score (SDS) | Standard Deviation 1.0542 |
| No Treatment --> 0.067 mg | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Week 52, n=7, 8 | 5.9303 Standard Deviation Score (SDS) | Standard Deviation 1.2096 |
| No Treatment --> 0.067 mg | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Week 208, n=6, 6 | 2.199 Standard Deviation Score (SDS) | Standard Deviation 1.5973 |
| No Treatment --> 0.067 mg | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Week 156, n=6, 7 | 2.3539 Standard Deviation Score (SDS) | Standard Deviation 1.3149 |
| No Treatment --> 0.067 mg | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years | Baseline, n=7,8 | -1.356 Standard Deviation Score (SDS) | Standard Deviation 0.708 |
Secondary
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years
Yearly Height velocity SDS for chronological age were summarised and graphically presented
Time frame: Weeks 0-260
Population: Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.033 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Baseline, n=31, 34 | -1.6299 Standard Deviation Score (SDS) | Standard Deviation 0.9738 |
| 0.033 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Week 52, n=29, 34 | 2.4717 Standard Deviation Score (SDS) | Standard Deviation 1.9848 |
| 0.033 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Week 104, n=29, 32 | 1.1344 Standard Deviation Score (SDS) | Standard Deviation 1.2782 |
| 0.033 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Week 156, n=25, 29 | 0.8015 Standard Deviation Score (SDS) | Standard Deviation 1.0583 |
| 0.033 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Week 208, n=25, 28 | 0.3991 Standard Deviation Score (SDS) | Standard Deviation 1.3006 |
| 0.033 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Week 260, n=23, 27 | 0.4612 Standard Deviation Score (SDS) | Standard Deviation 2.1558 |
| 0.067 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Week 208, n=25, 28 | 1.4724 Standard Deviation Score (SDS) | Standard Deviation 1.8696 |
| 0.067 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Baseline, n=31, 34 | -2.0303 Standard Deviation Score (SDS) | Standard Deviation 1.4527 |
| 0.067 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Week 156, n=25, 29 | 2.1641 Standard Deviation Score (SDS) | Standard Deviation 1.5929 |
| 0.067 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Week 52, n=29, 34 | 4.7875 Standard Deviation Score (SDS) | Standard Deviation 1.9365 |
| 0.067 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Week 260, n=23, 27 | 0.7973 Standard Deviation Score (SDS) | Standard Deviation 2.1822 |
| 0.067 mg / NN-220 | Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years | Week 104, n=29, 32 | 2.8877 Standard Deviation Score (SDS) | Standard Deviation 1.1272 |