Trial · NCT05682326
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 56 weeks | The analysis was performed on the Safety Set that included all participants who were enrolled and took at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Event of Special Interests (AESIs) | Up to 56 weeks | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs Leading to Study Intervention Discontinuation | Up to 52 weeks | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Percentage of red blood cells in blood | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Ratio of Reticulocytes to Erythrocytes | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Trillion cells per Liter (10^12 cells/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Giga cells per Liter (10^9 cells/L) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Femtoliter (fL) | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Picogram (pg) | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | micromoles per Liter (µmol/L) | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | International units per liter | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | micromoles per Liter (µmol/L) | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameter: Protein | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Grams per liter | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | micrograms per liter (µg/L) | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Percentage (%) of transferrin saturation | MEAN |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | mL per minute per 1.73 square meter | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Ratio | MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Heart Rate (HR) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | beats per minute (bpm) | MEAN |
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
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GET https://conductscience.org/api/trials/v1/NCT05682326/outcomes