Trial · NCT01201356
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death | Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod | Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Annual number of relapses per patient | NUMBER |
| SECONDARY | Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod | Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Participants | NUMBER |
| SECONDARY | Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod | Month 0 (Core Baseline) to End of Study (an average of Month 156) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Annual number of T2 lesions per patient | NUMBER |
| SECONDARY | Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume | Month 3 to End of Study (Study Completion Visit) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | mm^3 | MEAN |
| SECONDARY | Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume | Month 3 to End of Study (Study Completion Visit) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | mm^3 | MEAN |
| SECONDARY | Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod | Month 3 to Month 156 | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Percent change | MEAN |
| SECONDARY | Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod | Month 3 to Month 156 | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Ratio | MEAN |
| SECONDARY | Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod | Month 12 to Month 156 | Fingolimod full analysis set | Participants | NUMBER |
| SECONDARY | Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score | Month 3 to Month 6 Follow-up | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) | Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months) | Fingolimod full analysis set. Only participants with an observed value were considered for the analysis. | EDDS Overall Score | 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/NCT01201356/outcomes