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Trial · NCT02055157

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYOverall Summary of Adverse Events During Initial 6-Month PeriodUp to Month 6 ± 7 DaysSafety Analysis Population includes all subjects who received at least one dose of study treatment and were used for safety analysis in the initial 6-month period and entire study period.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYOverall Summary of Adverse Events During Entire Study PeriodUp to Month 25 ± 7 DaysSafety Analysis Population.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in Annualized Growth Velocity (AGV) During Initial 6-MonthAt 6 month (Day 183)
Efficacy Analysis Population includes all subjects who received at least one dose of study treatment and who had post treatment data for any efficacy endpoint in the corresponding period were included in the Efficacy Analysis and Extension Efficacy Analysis population.
cm/yearMEAN
SECONDARYChange From Baseline in Annualized Growth Velocity (AGV) During Entire Study Period - Cohort 3 and 4At month 24Efficacy Analysis Populationcm/yearMEAN
SECONDARYChange From Baseline in Annualized Growth Velocity (AGV) During Entire Study Period - Cohort 1 and 2 SwitchersAt month 24Efficacy Analysis Populationcm/yearMEAN
SECONDARYChange From Baseline in Height Z-Scores Using Centers for Disease Control and Prevention (CDC) Reference Standard During Initial 6-MonthsAt month 6 (Day 183)Efficacy Analysis Populationz scoreMEAN
SECONDARYChange From Baseline in Height Z-Scores Using CDC Reference Standard During Entire Study Period - Cohort 3 and 4At month 24Efficacy Analysis Populationz scoreMEAN
SECONDARYChange From Baseline in Height Z-Scores Using CDC Reference Standard During Entire Study Period - Cohort 1 and 2 SwitchersAt month 24Efficacy Analysis Populationz scoreMEAN
SECONDARYChange From Baseline in Upper to Lower Body Ratios During Initial 6-MonthsAt month 6 (Day 183)Efficacy Analysis PopulationRatioMEAN
SECONDARYChange From Baseline in Upper to Lower Body Ratios During Entire Study Period - Cohort 3 and 4At month 24Efficacy Analysis PopulationratioMEAN
SECONDARYChange From Baseline in Upper Arm Length to Lower Arm (Forearm) Length Ratio During Initial 6-MonthsAt month 6 (Day 183)Efficacy Analysis PopulationratioMEAN
SECONDARYChange From Baseline in Upper Arm to Lower Arm Length Ratio During Entire Study Period - Cohort 3 and 4At month 24Efficacy Analysis PopulationratioMEAN
SECONDARYChange From Baseline in Upper to Lower Body Ratios During Entire Study Period - Cohort 1 and 2 SwitchersAt month 24Efficacy Analysis PopulationratioMEAN
SECONDARYChange From Baseline in Upper Arm to Lower Arm Length Ratio During Entire Study Period - Cohort 1 and 2 SwitchersAt month 24Efficacy Analysis PopulationratioMEAN
SECONDARYChange From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Initial 6-monthsAt month 6 (Day 183)Efficacy Analysis PopulationratioMEAN
SECONDARYChange From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Entire Study Period - Cohort 3 and 4At month 24Efficacy Analysis PopulationratioMEAN
SECONDARYChange From Baseline in Upper Leg Length (Thigh) to Knee to Heel Length Ratio During Entire Study Period - Cohort 1 and 2 SwitchersAt month 24Efficacy Analysis PopulationratioMEAN
SECONDARYChange From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Initial 6-monthsAt month 6 (Day 183)Efficacy Analysis PopulationratioMEAN
SECONDARYChange From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Entire Study Period - Cohort 3 and 4At month 24Efficacy Analysis PopulationratioMEAN
SECONDARYChange From Baseline in Upper Leg Length (Thigh) to Tibial Length Ratio During Entire Study Period - Cohort 1 and 2 SwitchersAt month 24Efficacy Analysis PopulationratioMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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