Trial · NCT00835770
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) | Day 1 up to Week 561 | Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Had Relapses | Day 1 up to Week 384 | ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this outcome measure (OM) was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | percentage of participants | NUMBER |
| SECONDARY | Annualized Relapse Rate (ARR) | Day 1 up to Week 384 | ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | relapses per participant-years | NUMBER |
| SECONDARY | Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384 | Baseline, Week 384 | ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | score on a scale | MEAN |
| SECONDARY | Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | lesions | MEAN |
| SECONDARY | Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | millimeter cube (mm^3) | MEAN |
| SECONDARY | Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | lesions | MEAN |
| SECONDARY | Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | mm^3 | MEAN |
| SECONDARY | Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | lesions | MEAN |
| SECONDARY | Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | mm^3 | MEAN |
| SECONDARY | Percent Change From Baseline in Brain Atrophy | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Magnetization Transfer Ratio (MTR) | Baseline up to Week 288 | MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | percent change | MEAN |
| SECONDARY | Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384 | Baseline, Week 384 | ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | score on a scale | MEAN |
| SECONDARY | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384 | Baseline, Week 384 | ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | score on a scale | MEAN |
| SECONDARY | Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384 | Baseline, Week 384 | ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Visual Function Test Scores at Week 384 | Baseline, Week 384 | ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451). | 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.
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GET https://conductscience.org/api/trials/v1/NCT00835770/outcomes