Trial · NCT03401229
Outcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total NPS at Week 40 | Baseline to week 40 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| PRIMARY | Change From Baseline in NBS at Week 40 | Baseline to week 40 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in SNOT-22 at Week 40 | Baseline to week 40 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Time to First NP Surgery and/or SCS Use for NP to Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Number of patients analyzed is number of patients who had NP surgery and/or SCS use. | months | NUMBER |
| SECONDARY | Time to the First NP Surgery up to Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Number of patients analyzed is number of patients who had NP surgery. | months | NUMBER |
| SECONDARY | Change From Baseline in DSS at Week 40 | Baseline to week 40 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in NPS at Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in NBS at Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in SNOT-22 at Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in DSS at Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in LMS at EOT/IPD | Baseline to EOT/IPD, up to 56 weeks | CT analysis set and patients with a baseline CT who are rescued by SCS\_NP by week 56 | Score on a scale | MEAN |
| SECONDARY | Percentage of Subjects With NP Surgery | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With SCS_NP | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With NP Surgery or SCS_NP | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First SCS_NP up to Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. | months | NUMBER |
| SECONDARY | Total Number of Courses of SCS for NP | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. | number of courses | MEAN |
| SECONDARY | Total SCS_NP Dose (a) Used (mg) | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. | milligrams | MEAN |
| SECONDARY | Total Duration of SCS_NP (Days) | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. | days | MEAN |
| SECONDARY | Annual SCS_NP Use Rate Comparison by Period, Negative Binomial Model | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. | number of courses for each patient | MEAN |
| SECONDARY | Change From Baseline in TSS at Week 40 | Baseline to week 40 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | 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/NCT03401229/outcomes