Trial · NCT02594124
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to the end of the study (up to 2848 days) | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Vital Sign Abnormalities Reported as AEs | From Day 1 up to the end of the study (up to 2848 days) | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Weight Abnormalities Reported as AEs | From Day 1 up to the end of the study (up to 2848 days) | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. ' | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Neurological Abnormalities Reported as AEs | From Day 1 up to the end of the study (up to 2848 days) | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities Reported as AEs | From Day 1 up to the end of the study (up to 2848 days) | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Coagulation Parameters Reported as AEs | From Day 1 up to the end of the study (up to 2848 days) | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Shifts in12 Lead Electrocardiogram (ECG) Results | From Day 1 up to the end of the study (up to 2848 days) | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Number analyzed' signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Taking Any Concomitant Medication | From Day 1 up to the end of the study (up to 2848 days) | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Number of New Motor Milestones Achieved as Assessed by World Health Organization (WHO) Criteria | MMDR Period: At Day 1800 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. | motor milestone | MEAN |
| SECONDARY | Percentage of Participants With <2 Years of Age Who Attained Motor Milestones as Assessed by Section 2 of Hammersmith Infant Neurological Examination (HINE) | At Day 309 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. Only CS3A and CS3B arm groups were planned to be analyzed for this outcome measure (OM). | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Died or Met Permanent Ventilation | MMDR Period: Up to Day 1800 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Not Requiring Permanent Ventilation | MMDR Period: Up to Day 1800 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) Motor Function Scale | Baseline, Day 2198 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for OM analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified time point. Only CS3A and CS3B arm groups were planned to be analyzed for this OM. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) Total Score | MMDR Period: Baseline, MMDR Day 1800 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Revised Upper Limb Module (RULM) Total Score | MMDR Period: Baseline, MMDR Day 1800 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint. | score on scale | MEAN |
| SECONDARY | Change From Baseline in Total Distance Walked Over Time as Assessed by 6-Minute Walk Test (6MWT) | Baseline, Day 2670 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint. Only CS12 Type 2 and CS12 Type 3 arm groups were planned to be analysed for this end point. | meters | MEAN |
| SECONDARY | Number of Participants Who Experienced Contracture Assesment | MMDR Period: At MMDR Day 1800 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Compound Muscular Action Potential (CMAP) | MMDR Period: Baseline, MMDR Day 1800 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint. | millivolt (mV) | MEAN |
| SECONDARY | Change From Baseline in Body Length | MMDR Period: up to Day 1800 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. | centimeters (cm) | MEAN |
| SECONDARY | Change From Baseline in Weight | MMDR Period: up to Day 1800 | The safety analysis set included all participants who were enrolled and received at least 1 dose of nusinersen or underwent sham procedure during CS11. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. | kilograms (kg) | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02594124/outcomes