Trial · NCT03863080
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 18 | Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Open-Label Extension Period: Number of Participants Reporting AEs and SAEs | Up to Week 18 | Open-label Extension (OLE) Analysis Set comprised of all participants who enrolled in the OLE study phase and received at least 1 dose of study medication in the OLE. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Vital Signs | Up to Week 7 | Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Open-label Extension Period: Number of Participants With Clinically Significant Changes in Vital Signs | Up to Week 18 | OLE Analysis Set. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Double-blind Treatment Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | Up to Week 7 | Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Open-label Extension Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | Up to Week 18 | OLE Analysis Set. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | Up to Week 7 | Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Open-label Extension Period: Number of Participants With Clinically Significant Changes in ECG | Up to Week 18 | OLE Analysis Set. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Double-blind Treatment Period: Percent Change From Baseline in Levels of Total Immunoglobulin G (IgG) | Baseline (Day 1) and Up to Week 7 | Full Analysis Set comprised of all randomized participants who received at least 1 dose of randomized study medication with at least 1 valid post-treatment value. Only those participants with data available at specified time points has been presented. | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Double-blind Treatment Period: Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4 | Baseline (Day 1) and Up to Week 7 | Full Analysis Set. Only those participants with data available at specified time points has been presented. | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Double-Blind Treatment Period: Percent Change From Baseline in Anti-acetylcholine Receptor Immunoglobulin G (Anti-AChR-IgG) at Week 7 | Baseline (Day 1) and Week 7 | Full Analysis Set. Only those participants with data available at definite timepoints has been presented. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Treatment Period: Area Under the Concentration-time Curve From Time 0 to 168 Hours (AUC0-168h) of RVT-1401 | Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8 | Pharmacokinetic (PK) Analysis Set comprised of all participants who underwent PK sampling and had evaluable concentration-time data for analysis. As PK analyses were not conducted, a PK Analysis Set was not presented. | Hours*microgram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Open-label Extension Period: AUC0-168h of RVT-1401 | Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8, Week 9, Week 12 and Week 14 | Pharmacokinetic Analysis Set. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received. | Hours*microgram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Double-Blind Treatment Period: Maximum Concentration (Cmax) of RVT-1401 | Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8 | Pharmacokinetic Analysis Set. | micrograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Open-label Extension Period: Cmax of RVT-1401 | Pre-dose; Day 1, Day 3, Day 5, Day 8, Day 15, Day 22, Day 29, Day 36, Day 38, Day 40, Week 7, Week 8, Week 9, Week 12 and Week 14 | Pharmacokinetic Analysis Set. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received. | Micrograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Double-Blind Treatment Period: Trough Concentrations (Ctrough) of RVT-1401 | Pre-dose | Pharmacokinetic Analysis Set. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received. | Milligrams per liter | MEAN |
| SECONDARY | Open-label Extension Period: Ctrough of RVT-1401 | Pre-dose | Pharmacokinetic Analysis Set. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received. | Milligrams per liter | MEAN |
| SECONDARY | Double-blind Treatment Period: Change From Baseline in the Quantitative Myasthenia Gravis Score (QMG) Score | Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36) and Week 7 | Full Analysis Set. Only those participants with data available at specified time points has been represented (represented by n=X in the category titles). | Scores on a scale | MEAN |
| SECONDARY | Double-Blind Treatment Period: Percentage of Participants With an Improvement/ Response on the QMG Score From Baseline | Baseline (Day 1) to Week 7 | Full Analysis Set. Only those participants with data available at specified time points has been presented. | Percentage of participants | NUMBER |
| SECONDARY | Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score | Baseline (Day 1) and at Week 2, Week 3, Week 4, Week 5, Week 6 (Day 36), Week 7 | Full Analysis Set. Only those participants with data available at specified time points has been presented. | Scores on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03863080/outcomes