Trial · NCT04114539
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) and Their Relationship (Unrelated, Possibly Related, or Probably Related) | From start of study drug administration until 30 days after last dose (Up to Month 13) | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Hematology Parameters: Basophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | percentage of cells | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Eosinophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | percentage of cells | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Erythrocytes | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | 10^12 cells per liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Hematocrit | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | liter of cells per liter of blood (L/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Hemoglobin | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | millimoles per liter (mmoL/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Leukocytes and Platelets | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | 10^9 cells per liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | percentage of cells | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Monocytes to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | percentage of cells | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Neutrophils to Leukocytes Ratio Reported in Percentage of Cells | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | percentage of cells | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Lactase Dehydrogenase | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and Number Analyzed signifies participants who were evaluable at the specified categories. | units per liter (U/L) | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameters: Albumin, Globulin and Protein | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | grams per liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglyceride and Urea Nitrogen | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | millimoles per liter (mmol/L) | MEAN |
| PRIMARY | Change From Baseline in Serum Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and Number Analyzed signifies participants who were evaluable at the specified categories. | mcmol/L | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin A1c (HbA1c) | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | percentage of HbA1c | MEAN |
| PRIMARY | Change From Baseline in Vital Signs Parameter: Diastolic Blood Pressure and Systolic Blood Pressure | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and Number Analyzed signifies participants who were evaluable at the specified categories. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Vital Signs Parameter: Pulse Rate | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and Number Analyzed signifies participants who were evaluable at the specified categories. | beats per minute (bpm) | MEAN |
| PRIMARY | Change From Baseline in Vital Signs Parameter: Body Mass Index [BMI] | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | kilograms per square meter (kg/m^2) | MEAN |
| PRIMARY | Change From Baseline in Vital Signs Parameter: Height | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | centimeter (cm) | MEAN |
| PRIMARY | Change From Baseline in Vital Signs Parameter: Weight | Baseline up to Month 12 | The Safety Set included all participants who received at least one dose of study drug from the open labelled study. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | kilogram (kg) | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04114539/outcomes