Trial · NCT03583697
Outcomes55
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 55
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) by Severity Grade and Study Drug Treatment-emergent Adverse Events (TEAEs) | Up to Week 56 (Safety Follow-Up +/-7d) | Safety Population: The Safety Population was a subset of the FAS who received at least one dose of vosoritide or placebo in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Height Z-score at Week 52. | Baseline to Week 52 | FAS \& FAS (randomized) population:The FAS (randomized) was a subset of the FAS, which included 64 participants who were randomized to study treatment (32 participants randomized to vosoritide \& 32 participants randomized to placebo).~This is model-based analysis, it is true that the participants analyzed for placebo FAS \& FAS (randomized) are the same, but participants analyzed for vosoritide arm FAS \& FAS(randomized) are different, that's why the model-based results for placebo are different | Z-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Height at Week 52 | Baseline to Week 52 | FAS (randomized) Population and FAS population.~This is model-based analysis, it is true that the participants analyzed for placebo FAS \& FAS (randomized) are the same, but participants analyzed for vosoritide arm FAS \& FAS (randomized) are different, that's why the model-based results for placebo are different. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Annualized Growth Velocity (AGV) at Week 52 | Baseline to Week 52 | FAS (randomized) Population and FAS population.~This is model-based analysis, it is true that the participants analyzed for placebo FAS \& FAS (randomized) are the same, but participants analyzed for vosoritide arm FAS \& FAS (randomized) are different, that's why the model-based results for placebo are different. | cm/year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Upper to Lower Body Segment Ratio at Week 52 | Baseline to Week 52 | FAS (randomized) Population and FAS population.~This is model-based analysis, it is true that the participants analyzed for placebo FAS \& FAS (randomized) are the same, but participants analyzed for vosoritide arm FAS \& FAS (randomized) are different, that's why the model-based results for placebo are different. | Ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Other Growth Measures (Upper Body Length, Head Circumference, Arm Span, Upper Arm Length, Lower Arm Length, Lower Body Length, Upper Leg Length, Knee to Heel Length, and Tibial Length) at Week 52 | Baseline to Week 52 | FAS population.~Change from baseline was based on the participants with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 measurement is not available. | cm | MEAN |
| SECONDARY | Change From Baseline in Other Body Proportion Ratios (Arm Span to Height Ratio, Upper Arm Length to Lower Arm [Forearm] Length Ratio, Upper Leg Length [Thigh] to Knee to Heel Length Ratio, and Upper Leg Length (Thigh) to Tibial Length Ratio) at Week 52 | Baseline to Week 52 | FAS population.~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 measurement is not available | Ratio | MEAN |
| SECONDARY | Change From Baseline in Body Mass Index (BMI) at Week 52 | Baseline to Week 52 | FAS population.~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 measurement is not available. | kg/m^2 | MEAN |
| SECONDARY | Change From Baseline in BMI Z-score at Week 52 | Baseline to Week 52 | FAS population. | Z-Score | MEAN |
| SECONDARY | Change From Baseline in Weight Z-score at Week 52 | Baseline to Week 52 | FAS population~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 measurement is not available | Z-score | MEAN |
| SECONDARY | Change From Baseline in Infant Toddler Quality of Life (ITQoL) Scores at Week 52 | Baseline to Week 52 | FAS population.~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 assessment is not available. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in ITQoL-Behavior Scores at Week 52 | Baseline to Week 52 | Full Analysis Set.~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 assessment is not available. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in ITQoL-Global Behavior Scores at Week 52 | Baseline to Week 52 | FAS population.~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 assessment is not available. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in ITQoL-Getting On With Other Score at Week 52 | Baseline to Week 52 | FAS population.~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 assessment is not available. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in ITQoL-Health Score at Week 52 | Baseline to Week 52 | FAS population.~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 assessment is not available. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Functional Independence Measure for Children (WeeFIM-II) Score at Week 52 | Baseline to Week 52 | FAS population~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 assessment is not available. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) Scores at Week 52 | Baseline to Week 52 | FAS population~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 assessment is not available. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Child Behaviour Checklist (CBCL) at Week 52 | Baseline to Week 52 | Safety population~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 assessment is not available. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Bilateral X-rays of Lower Extremities at Week 52 | Baseline to Week 52 | Safety population~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 assessment is not available. | cm | MEAN |
| SECONDARY | Change From Baseline in Bilateral X-rays of Left/Right Tibia Bowing Angle at Week 52 | Baseline to Week 52 | Safety population~Change from baseline was based on the subjects with available measurements at both time points. Baseline is defined as Day 1 or screening if a Day 1 assessment is not available | Degrees | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT03583697/outcomes