Trial · NCT02965573
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) | Day 1 to Day 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline in Vital Signs: Blood Pressure | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received.~Only patients with data available for analysis are presented. | millimeters mercury | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs: Heart Rate | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received.~Only patients with data available for analysis are presented. | beats/minute | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs: Temperature | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received.~Only patients with data available for analysis are presented. | degrees Centigrade | MEAN |
| PRIMARY | Mean Change From Baseline in Vital Signs: Weight | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received.~Only patients with data available for analysis are presented. | kg | MEAN |
| PRIMARY | Number of Patients With Abnormal Clinically Relevant Findings in Electrocardiogram (ECG) Parameters | Day 1 to Day 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With Abnormal Clinical Laboratory Findings Reported as TEAEs | Day 1 to Day 78 | The safety analysis set included all patients in the randomized population who received at least 1 dose or part of a dose. The safety analysis was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The full analysis set (FAS) included all randomized patients with at least 1 of the MG-ADL, Quantitative Myasthenia Gravis (QMG), Myasthenia Gravis Composite (MGC), and 15-item Quality of Life scale for Myasthenia Gravis revised version (MGQoL15r) scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. Only patients with data available for analysis are presented. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in QMG Score | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The FAS includes all randomized patients with at least 1 of the MG-ADL, QMG, MGC, and MGQoL15r scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. Only patients with data available for analysis are presented. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in MGC Score | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The FAS includes all randomized patients with at least 1 of the MG-ADL, QMG, MGC, and MGQoL15r scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. Only patients with data available for analysis are presented. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in MGQoL15r Score | Baseline and Days 8,15, 22, 29, 36, 43, 50, 64 and 78 | The FAS includes all randomized patients with at least 1 of the MG-ADL, QMG, MGC, and MGQoL15r scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. Only patients with data available for analysis are presented. | score on a scale | MEAN |
| SECONDARY | Maximum Reduction From Baseline in MG-ADL Score | Day 1 to Day 78 | The FAS includes all randomized patients with at least 1 of the MG-ADL, QMG, MGC, and MGQoL15r scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. | score on a scale | MEAN |
| SECONDARY | Maximum Reduction From Baseline in QMG Score | Day 1 to Day 78 | The FAS includes all randomized patients with at least 1 of the MG-ADL, QMG, MGC, and MGQoL15r scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. | score on a scale | MEAN |
| SECONDARY | Maximum Reduction From Baseline in MGC Score | Day 1 to Day 78 | The FAS includes all randomized patients with at least 1 of the MG-ADL, QMG, MGC, and MGQoL15r scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. | score on a scale | MEAN |
| SECONDARY | Maximum Reduction From Baseline in MGQoL15r Score | Day 1 to Day 78 | The FAS includes all randomized patients with at least 1 of the MG-ADL, QMG, MGC, and MGQoL15r scales available for 1 of the postbaseline assessments up to Day 78 along with the corresponding baseline value. | score on a scale | MEAN |
| SECONDARY | Pharmacokinetic (PK) Parameters - Plasma Concentrations of ARGX-113 | Days 1, 8, 15 and 22 | The PK analysis set included all patients in the randomized population who had at least 1 plasma concentration data value available for ARGX-113 without major protocol deviations thought to impact PK. Patients who did not receive ARGX-113 were not included in the PK analysis set. Only patients with data available for analysis are presented. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK Parameters - Median Time of Occurrence of Cmax (Tmax) of ARGX-113 | Days 1, 8 15 and 22. | The PK analysis set included all patients in the randomized population who had at least 1 plasma concentration data value available for ARGX-113 without major protocol deviations thought to impact PK. Patients who did not receive ARGX-113 were not included in the PK analysis set. Only patients with data available for analysis are presented. | hours | MEDIAN |
| SECONDARY | PK Parameters - Apparent Terminal Half-life (t1/2 Lambda z) of ARGX-113 | Day 22 | The PK analysis set included all patients in the randomized population who had at least 1 plasma concentration data value available for ARGX-113 without major protocol deviations thought to impact PK. Patients who did not receive ARGX-113 were not included in the PK analysis set. | hours | GEOMETRIC_MEAN |
| SECONDARY | PK Parameters - Accumulation Ratio (Rac) of ARGX-113 | Days 1 and 22. | The PK analysis set included all patients in the randomized population who had at least 1 plasma concentration data value available for ARGX-113 without major protocol deviations thought to impact PK. Patients who did not receive ARGX-113 were not included in the PK analysis set. Only patinents with data available for analysis are presented. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Mean Percent Change From Baseline in Immunoglobulins (IgGs) | Baseline, Days 22 and 78 | The PD analysis set included all patients in the randomized population who had at least 1 non-missing post-dose PD measurement available without major protocol deviations thought to impact PD. Only patients with data available for analysis are presented. | percentage change | 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.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.
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