Trial · NCT04667949
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| POST_HOC | Participant Based Annualized Relapse Rate (ARR) | Baseline to Month 24 | Full Analysis Set (FAS): all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | relapses per participant-year | MEAN |
| POST_HOC | Time Based Annualized Relapse Rate (ARR) | Baseline to Month 24 | Full Analysis Set (FAS): all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | relapses per participant-year | NUMBER |
| PRIMARY | Adjusted Annualized Relapse Rate (ARR) in Adult Group | Baseline to Month 24 | Adult participants in the Full Analysis Set (FAS). FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | relapses per participant-year | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AE) and Serious Adverse Events (SAE) | From first dose of study treatment to 45 days after last study dose up to aproximately 25.5 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Annualized Rate of the Number of New or Newly Enlarged T2 Lesions | Baseline to end of treatment (up to Month 24) | Adult participants in the Full Analysis Set (FAS) with available data for the outcome measure.. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Lesions per participant-year | NUMBER |
| SECONDARY | Change From Baseline in Number of New or Newly Enlarged T2 Lesions | Baseline up to Month 24 | Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | new / newly enlarged T2 lesions | MEAN |
| SECONDARY | Change From Baseline in T2 Lesion Volume | Baseline up to Month 24 | Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | milliliters | MEDIAN |
| SECONDARY | Number of Gd-enhancing T1 Lesions Per Scan in Adult Group | Baseline up to Month 24 | Adult participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | Lesions per participant per scan | NUMBER |
| SECONDARY | Number of Gd-enhancing T1 Lesions | Baseline up to Month 24 | Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | T1 lesions | MEAN |
| SECONDARY | Change From Baseline in Gd-enhancing T1 Lesion Volume | Baseline up to Month 24 | Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | microliters | MEDIAN |
| SECONDARY | Number of T1 Hypo-intense Lesions | Baseline up to Month 24 | Participants in the Full Analysis Set (FAS) with available data for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | T1 hypo-intense lesions | MEAN |
| SECONDARY | Change From Baseline in T1 Hypo-intense Lesion Volume | Baseline up to Month 24 | Participants in the Full Analysis Set (FAS) with non-missing, non-zero baseline and post-baseline values for the outcome measure. FAS: all participants who had signed the Informed Consent and who had received at least one dose of study treatment. | microliters | MEDIAN |
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/NCT04667949/outcomes