Trial · NCT02412787
Results by group105
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 105
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | Idursulfase-IT | 56 | Participants | ||
| Number of Participants With Clinically Significant Changes in Vital Signs | Idursulfase-IT | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Laboratory Parameters | Idursulfase-IT | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Findings | Idursulfase-IT | 0 | Participants | ||
| Maximum Observed Serum Concentration (Cmax) of Idursulfase | Idursulfase-IT 10 mg, Delayed IT | 128.19 | Standard Deviation 169.427 | nanograms per milliliter (ng/mL) | |
| Maximum Observed Serum Concentration (Cmax) of Idursulfase | Idursulfase-IT 10 mg, Early IT | 104.89 | Standard Deviation 66.879 | nanograms per milliliter (ng/mL) | |
| Maximum Observed Serum Concentration (Cmax) of Idursulfase | Idursulfase-IT 10 mg, Former Substudy | 120.23 | Standard Deviation 57.308 | nanograms per milliliter (ng/mL) | |
| Percent Change From Baseline in the Concentration of Glycosaminoglycan (GAG) in CSF at Month 67 | Idursulfase-IT | -71.15 | Standard Deviation 17.842 | percent change | |
| Percent Change From Baseline in the Concentration of GAG in Urine at Month 67 | Idursulfase-IT | -32.44 | Standard Deviation 29.366 | percent change | |
| Number of Participants Who Reported Positive for Anti-idursulfase Antibodies in CSF | Idursulfase-IT | 25 | Participants | ||
| Number of Participants Who Reported Positive for Anti-idursulfase Antibodies in Serum | Idursulfase-IT | 46 | Participants | ||
| Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Standard Cluster Scores at Month 67 | Idursulfase-IT | GCA | -6.0 | Standard Deviation 8.49 | score on a scale |
| Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Standard Cluster Scores at Month 67 | Idursulfase-IT | Verbal | -23.7 | Standard Deviation 21.59 | score on a scale |
| Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Standard Cluster Scores at Month 67 | Idursulfase-IT | Nonverbal | -20.5 | Standard Deviation 7.78 | score on a scale |
| Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Standard Cluster Scores at Month 67 | Idursulfase-IT | Spatial | 0.3 | Standard Deviation 18.88 | score on a scale |
| Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Standard Cluster Scores at Month 67 | Idursulfase-IT | SNC | -5.5 | Standard Deviation 6.36 | score on a scale |
| Change From Baseline in Standard Scores of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Domains at Month 67 | Idursulfase-IT | Communication | -13.5 | Standard Deviation 4.95 | score on a scale |
| Change From Baseline in Standard Scores of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Domains at Month 67 | Idursulfase-IT | Daily Living Skills | -9.5 | Standard Deviation 0.71 | score on a scale |
| Change From Baseline in Standard Scores of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Domains at Month 67 | Idursulfase-IT | Socialization | -14.5 | Standard Deviation 9.19 | score on a scale |
| Change From Baseline in Standard Scores of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Domains at Month 67 | Idursulfase-IT | Motor Skills | 11.5 | Standard Deviation 7.78 | score on a scale |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02412787/results