Trial · NCT04697381
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Month 12 in Lean Body Mass Measured by Dual-Energy X-ray Absorptiometry (DEXA): Adult Cohort | Baseline, Month 12 | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure and this time point. | Percentage of body mass | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to Month 12 in Lean Body Mass Measured by DEXA: GH Naive Pediatric and GH Treated Pediatric Cohort | Baseline, Month 12 | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure and this time point. | Percentage of body mass | MEAN |
| SECONDARY | Change From Baseline to Month 12 in Lean Body Mass Measured by Bioelectrical Impedance Analysis (BIA)-Adult Cohort | Baseline, Month 12 | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure and this time point. | Percentage of body mass | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Month 12 in Lean Body Mass Measured by BIA-GH Naive Pediatric and GH Treated Pediatric Cohort | Baseline, Month 12 | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure and this time point. | Percentage of body mass | MEAN |
| SECONDARY | Change From Baseline to Month 12 in Body Fat (Percentage) Measured by DEXA: Adult Cohort | Baseline, Month 12 | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure and this time point. | Percentage of body fat | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Month 12 in Body Fat (Percentage) Measured by DEXA: GH Naive Pediatric and GH Treated Pediatric Cohort | Baseline, Month 12 | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure and this time point. | Percentage of body fat | MEAN |
| SECONDARY | Change From Baseline to Month 12 in Adipose Tissue Distribution Measured by Abdominal Computed Tomography (CT) | Baseline, Month 12 | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure and this time point. | Centimeter square (cm^2) | MEAN |
| SECONDARY | Change From Baseline to Month 6 in Lean Body Mass Measured by DEXA: Adult Cohort Only | Baseline, Month 6 | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. | Percentage of body mass | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events | From day 1 up to 28 days after end of study treatment (maximum duration up to 38 months) | Full analysis set (FAS) included all participants assigned to study intervention and who took at least one dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities | From Day 1 up to 28 days after end of study treatment (maximum duration up to 38 months) | FAS included all participants assigned to study intervention and who took at least one dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Bone Maturation | 12 months | FAS included all participants assigned to study intervention and who took at least one dose of study intervention. | Participants | NUMBER |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04697381/outcomes