Trial · NCT02536755
Outcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Mobility Status Assessments at Study Baseline, Weeks 52, 104, 156 and 208 | Study Baseline, Weeks 52, 104, 156 and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Bone Pain Levels During the Past 4 Weeks at Study Baseline, Weeks 52, 104, 156 and 208 | Study Baseline, Weeks 52, 104, 156 and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Bone Crisis at Study Baseline, Weeks 52, 104, 156 and 208 | Study Baseline, Weeks 52, 104, 156 and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Current Study Baseline in Total Bone Marrow Burden (BMB) Scores at Weeks 52, 104, 156 and 208 | Study Baseline, Weeks 52, 104, 156 and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | score on a scale | MEAN |
| PRIMARY | Change From Eliglustat Baseline in Total Bone Marrow Burden (BMB) Scores at Weeks 52, 104, 156 and 208 | Eliglustat Baseline, Weeks 52, 104, 156 and 208 of the current study | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed in reference to eliglustat baseline separately for participants from Phase 2, ENGAGE and EDGE studies (GD treatment naïve participants) and from ENCORE study (participants switched from Enzyme Replacement Therapy \[ERT\]). | score on a scale | MEAN |
| PRIMARY | Change From Current Study Baseline in Total Spine and Femur Bone Mineral Density (BMD) at Weeks 52, 104, 156 and 208 | Study Baseline, Weeks 52, 104, 156 and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | grams per centimeter square (g/cm^2) | MEAN |
| PRIMARY | Change From Eliglustat Baseline in Total Spine and Femur Bone Mineral Density (BMD) at Weeks 52, 104, 156 and 208 | Eliglustat Baseline, Weeks 52, 104, 156 and 208 of the current study | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Data for this outcome measure was was planned to be collected and analyzed in reference to eliglustat baseline separately for participants from Phase 2, ENGAGE and EDGE studies (GD treatment naïve participants) and from ENCORE study (participants switched from ERT). | g/cm^2 | MEAN |
| PRIMARY | Change From Current Study Baseline in Spine and Femur Total T-Scores for BMD at Weeks 52, 104, 156 and 208 | Study Baseline, Weeks 52, 104, 156 and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | T-score | MEAN |
| PRIMARY | Change From Eliglustat Baseline in Spine and Femur Total T-Scores for BMD at Weeks 52, 104, 156 and 208 | Eliglustat Baseline, Weeks 52, 104, 156 and 208 of the current study | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Here, 0 signifies that none of the participants were available for assessment at the specified timepoint. Data for this outcome measure was planned to be collected and analyzed in reference to eliglustat baseline separately for participants from Phase 2, ENGAGE and EDGE studies (GD treatment naïve participants) and from ENCORE study (participants switched from ERT). | T-score | MEAN |
| PRIMARY | Change From Current Study Baseline in Spine and Femur Total Z-Scores for BMD at Weeks 52, 104, 156 and 208 | Study Baseline, Weeks 52, 104, 156 and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | Z-score | MEAN |
| PRIMARY | Change From Eliglustat Baseline in Spine and Femur Total Z-Scores for BMD at Weeks 52, 104, 156 and 208 | Eliglustat Baseline, Weeks 52, 104, 156 and 208 of the current study | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed in reference to eliglustat baseline separately for participants from Phase 2, ENGAGE and EDGE studies (GD treatment naïve participants) and from ENCORE study (participants switched from ERT). | Z-score | MEAN |
| PRIMARY | Total Number of New or Worsening Osteonecrosis Events for Spine and Femur at Study Baseline, Week 52, 104, 156 and 208 | Study Baseline, Weeks 52, 104, 156 and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | events | MEAN |
| PRIMARY | Total Number of New or Worsening Fracture Events for Spine and Femur at Study Baseline, Week 52, 104, 156 and 208 | Study Baseline, Weeks 52, 104, 156 and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | events | MEAN |
| PRIMARY | Total Number of New or Worsening Infarcts Events for Spine and Femur at Study Baseline, Week 52, 104, 156 and 208 | Study Baseline, Weeks 52, 104, 156 and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | events | MEAN |
| PRIMARY | Total Number of New or Worsening Lytic Lesions Events for Spine at Study Baseline, Week 104, and 208 | Study Baseline, Weeks 104, and 208 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | events | MEAN |
| PRIMARY | Observed Annual Incidence Rate for Spine and Femur Osteonecrosis at Week 52, 104, 156 and 208 | For 52 Weeks (i.e., 1 year),104 Weeks (i.e., 2 year), 156 Weeks (i.e., 3 year) and 208 Weeks (i.e., 4 years) | Analysis was performed on FAS population. | events per participant-year | NUMBER |
| PRIMARY | Observed Annual Incidence Rate for Spine and Femur Fracture at Week 52, 104, 156 and 208 | For 52 Weeks (i.e., 1 year),104 Weeks (i.e., 2 year), 156 Weeks (i.e., 3 year) and 208 Weeks (i.e., 4 years) | Analysis was performed on FAS population. | events per participant-year | NUMBER |
| PRIMARY | Observed Annual Incidence Rate for Spine and Femur Infarcts at Week 52, 104, 156 and 208 | For 52 Weeks (i.e., 1 year),104 Weeks (i.e., 2 year), 156 Weeks (i.e., 3 year) and 208 Weeks (i.e., 4 years) | Analysis was performed on FAS population. | events per participant-year | NUMBER |
| PRIMARY | Observed Annual Incidence Rate for Spine Lytic Lesion at Week 104, and 208 | For 104 Weeks (i.e., 2 year), and 208 Weeks (i.e., 4 years) | Analysis was performed on FAS population. | events per participant-year | NUMBER |
| PRIMARY | Change From Current Study Baseline in Bone Biomarker Level: Macrophage Inflammatory Protein 1 Beta (MIP-1β) at Weeks 26, 52, 78, 104, 130, 156,182, 208 and 234 | Study Baseline, Weeks 26, 52, 78, 104, 130, 156, 182, 208 and 234 | Analysis was performed on FAS population. Here, number analyzed = participants with available data for each specified category. Baseline refers to the current study baseline, which was defined as status at this study (EFC13781) entry. | picograms per milliliter (pg/mL) | MEAN |
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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