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Trial · NCT04348136

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOccurrence of adverse eventsFrom the start of study (Week 52 of preceding study) up to the end of study, up to approximately 10.6 years
PrimaryOccurrence of adverse reactionsFrom the start of study (Week 52 of preceding study) up to the end of study, up to approximately 10.6 years
PrimaryIncidence of abnormal vital signsWeek 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 yearsLaboratory tests (hematology)
PrimaryIncidence of abnormal vital signsWeek 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 yearsLaboratory tests (biochemistry)
PrimaryIncidence of abnormal vital signsWeek 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 yearsLaboratory tests (iron-related tests)
PrimaryLaboratory tests (urinalysis)Week 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryVital signs (pulse rate)Week 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryVital signs (body temperature)Week 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryVital signs (blood pressure)Week 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
Primary12-lead electrocardiogramWeek 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 yearsThe presence or absence of abnormal findings (if present, specific findings and whether or not they are reported as adverse events)
PrimaryAntibody tests (anti-JR-141 antibodies)Week 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryIARFrom the start of study (Week 52 of preceding study) up to the end of study, up to approximately 10.6 years
PrimaryTime course of developmental assessment data (Kyoto Scale of Psychological Development 2001) from initial dosing in the preceding studyWeek 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryTime course of developmental assessment data (Vineland-II) from initial dosing in the preceding studyWeek 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryTime course of developmental assessment data (Bayley-III or KABC-II) from initial dosing in the preceding studyWeek 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryTime course of CSF substrate (HS and DS) concentrations from initial dosing in the preceding studyWeek 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryTime course of serum HS and DS concentrations from initial dosing in the preceding studyWeek 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryTime course of urinary HS concentration from initial dosing in the preceding studyWeek 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryTime course of urinary DS concentration from initial dosing in the preceding studyWeek 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 years
PrimaryTime course of uronic acid concentration from initial dosing in the preceding studyWeek 78, 104, an average of 52 weeks after Week 104, up to approximately 10.6 years

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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