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Trial · NCT04089566

Results by group934

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Part B Infantile-onset SMA: Change From Baseline in CHOP-INTEND Total Score for 50/28mg Nusinersen Versus CS3B Matched Sham Control GroupPart B: Infantile-Onset SMA: 50/28 mg Nusinersen42.995% Confidence Interval 38.7 to 47.2score on scale
Part B Infantile-onset SMA: Change From Baseline in CHOP-INTEND Total Score for 50/28mg Nusinersen Versus CS3B Matched Sham Control GroupCS3B Matched Sham Control Group16.995% Confidence Interval 10.1 to 23.7score on scale
Parts A and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)Part A: Nusinersen 28/28 mgTEAEs4Participants
Parts A and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)Part C: Nusinersen 50/28 mgTEAEs37Participants
Parts A and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)Part A: Nusinersen 28/28 mgTESAEs1Participants
Parts A and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)Part C: Nusinersen 50/28 mgTESAEs6Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part A: Nusinersen 28/28 mgAlkaline Phosphatase Shift to High1Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part C: Nusinersen 50/28 mgAlkaline Phosphatase Shift to High2Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part A: Nusinersen 28/28 mgAlanine Aminotransferase Shift to High0Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part C: Nusinersen 50/28 mgAlanine Aminotransferase Shift to High6Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part A: Nusinersen 28/28 mgAspartate Aminotransferase Shift to High0Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part C: Nusinersen 50/28 mgAspartate Aminotransferase Shift to High8Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part A: Nusinersen 28/28 mgBicarbonate Shift to Low1Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part C: Nusinersen 50/28 mgBicarbonate Shift to Low6Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part A: Nusinersen 28/28 mgBicarbonate Shift to High0Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part C: Nusinersen 50/28 mgBicarbonate Shift to High2Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part A: Nusinersen 28/28 mgBilirubin Shift to High0Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part C: Nusinersen 50/28 mgBilirubin Shift to High1Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part A: Nusinersen 28/28 mgIndirect Bilirubin Shift to Low4Participants
Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)Part C: Nusinersen 50/28 mgIndirect Bilirubin Shift to Low12Participants

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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