Trial · NCT01707992
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) | Baseline to Month 24 | ITT analysis set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15 | Baseline, Month 15 | The modified intent-to-treat 1 (mITT1) analysis set included data from all randomized participants at the Month 15 visit. Here, 'Overall number of participants analyzed' = Participants evaluable for this outcome measure. | percent change | MEAN |
| SECONDARY | Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse) | Baseline to Month 24 | ITT analysis set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months) | Baseline to Month 24 | ITT analysis set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months) | Baseline to Month 24 | ITT analysis set included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs) | Baseline up to Month 24 | Safety analysis set included all participants who were randomized and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Active-Treatment Phase: Number of Participants With AEs | Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase | Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities | Baseline up to Week 24 | Safety analysis set included all participants who were randomized and received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities | Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase | Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters | Baseline, Endpoint (Month 24) | Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed=participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters | Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase) | Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase and had ECG shift from baseline data available. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry | Baseline up to Month 24 | Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry | Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase | Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values | Baseline up to Month 24 | Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values | Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase | Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase. | Participants | COUNT_OF_PARTICIPANTS |
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/NCT01707992/outcomes