Trial · NCT03446612
Registered outcomes53
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 40 of 53
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 59 days | An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth effect. |
| Secondary | Number of Participants With Any AE of Special Interest (AESI) | Up to 59 days | AESIs were identified based on non-clinical studies with daprodustat, clinical experience with recombinant human erythropoietins (rhEPOs), and current information regarding hypoxia-inducible factor (HIF)-regulated pathways in mediating hypoxia-associated pathophysiology. The AESIs for daprodustat were identified as follows: Thrombosis and/or tissue ischemia secondary to excessive erythropoiesis; Death, MI, stroke, heart failure, thromboembolic events, thrombosis of vascular access; Cardiomyopathy; Pulmonary artery hypertension; Cancer-related mortality and tumor progression and recurrence Esophageal and gastric erosions; Proliferative retinopathy, macular edema, choroidal neovascularization; Exacerbation of rheumatoid arthritis and Worsening of hypertension. |
| Secondary | Number of Participants Discontinuing the Randomized Study Treatment | Up to Day 42 | Number of participants who discontinued the randomized study treatment were assessed. |
| Other | Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Days 1, 14, 28, 42 and 59 | DBP and SBP were measured in a semi-supine position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. |
| Other | Change From Baseline in DBP and SBP | Baseline (Day 1) and at Days 14, 28, 42 and 59 | DBP and SBP were measured in a semi-supine position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Other | Absolute Values of Electrocardiogram (ECG) Mean Heart Rate | Days 1, 42 and 59 | Full 12-lead ECG were recorded with the participant in a semi-supine position to measure heart rate. |
| Other | Change From Baseline in ECG Mean Heart Rate | Baseline (Day 1) and at Days 42 and 59 | Full 12-lead ECG were recorded with the participant in a semi-supine position to measure heart rate. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Other | Absolute Values of ECG Parameters- PR Interval, QRS Interval, and QT Interval and QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB) | Days 1, 42 and 59 | Full 12-lead ECGs were recorded with the participant in a semi-supine position to measure PR interval, QRS duration, QT interval and QTcB, calculated (machine read or manually). |
| Other | Change From Baseline in ECG Parameters- PR Interval, QRS Duration, and QT Interval and QTcB | Baseline (Day 1) and at Days 42 and 59 | Full 12-lead ECGs were recorded with the participant in a semi-supine position to measure PR interval, QRS duration, QT (uncorrected) interval and QTcB, calculated (machine read or manually). Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Other | Absolute Values of the Hematology Parameters of Platelet Count, White Blood Cell (WBC) Count (Absolute), Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Days 1, 42 and 59 | Blood samples were collected for the analysis of hematology parameters including platelet count, leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils. |
| Other | Change From Baseline in Hematology Parameters of Platelet Count, Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Day 1) and at Days 42 and 59 | Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count (Absolute), basophils, eosinophils, lymphocytes, monocytes and neutrophils. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Other | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) | Days 1, 42 and 59 | Blood samples were collected for the analysis of hematology parameters including RBC count and RC. |
| Other | Change From Baseline in Hematology Parameters of RBC Count and RC | Baseline (Day 1) and at Days 42 and 59 | Blood samples were collected for the analysis of hematology parameters including RBC count and RC. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Other | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Days 1, 42 and 59 | Blood samples were collected for the analysis of hematology parameters including hemoglobin and MCHC. |
| Other | Change From Baseline in Hematology Parameters- Hemoglobin and MCHC | Baseline (Day 1) and at Days 42 and 59 | Blood samples were collected for the analysis of hematology parameters including hemoglobin and MCHC. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Other | Absolute Values of Hematology Parameter: Hematocrit | Days 1, 42 and 59 | Blood samples were collected for the analysis of hematology parameters including hematocrit. |
| Other | Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1) and at Days 42 and 59 | Blood samples were collected for the analysis of hematology parameters including hematocrit. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Other | Absolute Values of Hematology Parameter of Red Blood Cell Distribution Width (RDW) | Days 1, 42 and 59 | Blood samples were collected for the analysis of hematology parameters including RDW. |
| Other | Change From Baseline in RDW | Baseline (Day 1) and at Days 42 and 59 | Blood samples were collected for the analysis of hematology parameters including RDW. Baseline value (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. |
| Other | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) | Days 1, 42 and 59 | Blood samples were collected for the analysis of hematology parameters including MCH. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03446612/registered?page=2