Trial · NCT04089566
Outcomes79
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 79
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part B Infantile-onset SMA: Change From Baseline in CHOP-INTEND Total Score for 50/28mg Nusinersen Versus CS3B Matched Sham Control Group | Baseline, Day 183 | As planned, analysis was performed in the Matched sham set. Matched sham set comprised of sham control participants of the CS3B study (NCT02193074) identified by a matching algorithm and all of current study 50/28 mg participants that were included in the ITT set. | score on scale | LEAST_SQUARES_MEAN |
| PRIMARY | Parts A and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | Part A: From the first dose of the study drug up to Day 389, Part C: From the first dose of the study drug up to Day 361 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters) | Parts A and C: Baseline up to Day 302 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. Number analyzed 'n' indicates the number of participants evaluable for analysis of the specified parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Hematology Parameters) | Parts A and C: Baseline up to Day 302 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Number analysed (n)' indicates the number of participants evaluable for the specified hematology parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts A and C: Number of Participants With Shifts From Baseline in Urinalysis | Parts A and C: Baseline up to Day 302 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Number analysed (n)' indicates the number of participants evaluable for the specified urinalysis parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts A and C: Number of Participants With Shifts From Baseline in Cerebrospinal Fluid (CSF) Parameters | Part A: Baseline up to Day 269, Part C: Baseline up to Day 241 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Number analysed (n)' indicates the number of participants evaluable for the specified urinalysis parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts A and C: Number of Participants With Shifts From Baseline in Electrocardiograms (ECGs) | Parts A and C: Baseline up to Day 302 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts A and C: Number of Participants With Abnormalities in Vital Sign Parameters | Parts A and C: Baseline up to Day 302 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts A and C: Change From Baseline in Growth Parameters (Body Height) | Parts A and C: Baseline, Day 302 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point. | centimeter (cm) | MEAN |
| PRIMARY | Part C: Change From Baseline in Growth Parameters (Head Circumference) | Baseline, Day 302 | ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point. | cm | MEAN |
| PRIMARY | Part C: Change From Baseline in Growth Parameters (Chest Circumference) | Baseline, Day 302 | ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point. | cm | MEAN |
| PRIMARY | Part C: Change From Baseline in Growth Parameters (Arm Circumference) | Baseline, Day 302 | ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point. | cm | MEAN |
| PRIMARY | Parts A and C: Change From Baseline in Growth Parameters (Ulnar Length) | Parts A and C: Baseline, Day 302 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point. | cm | MEAN |
| PRIMARY | Parts A and C: Change From Baseline in Growth Parameters (Weight for Age Percentile) | Parts A and C: Baseline, Day 302 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point. | percentile | MEAN |
| PRIMARY | Part C: Change From Baseline in Growth Parameters (Weight for Length Ratio) | Baseline, Day 302 | ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point. | ratio | MEAN |
| PRIMARY | Part C: Change From Baseline in Growth Parameters (Head-to-Chest Circumference Ratio) | Baseline, Day 302 | ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point. | ratio | MEAN |
| PRIMARY | Parts A and C: Number of Participants With Shifts From Baseline in Coagulation Parameters (Activated Partial Thromboplastin Time (aPTT)) | Parts A and C: Baseline up to Day 269 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C:ITT set included all participants who received at least one dose of nusinersen in the current study. 'Number analysed (n)' signifies number of participants evaluable for the specified category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts A and C: Number of Participants With Shifts From Baseline in Coagulation Parameters (Prothrombin Time (PT)) | Parts A and C: Baseline up to Day 269 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. 'Number analysed (n)' signifies number of participants evaluable for the specified category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts A and C: Number of Participants With Shifts From Baseline in Coagulation Parameters (International Normalized Ratio (INR)) | Parts A and C: Baseline up to Day 269 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Number analysed (n)' signifies number of participants evaluable for the specified category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Parts A and C: Change From Baseline in Urine Total Protein | Parts A and C: Baseline, Day 302 | Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at specified timepoint. | gram per litre (g/L) | 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.
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