Trial · NCT02019719
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | Baseline (Day 1) and Week 4 | Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on treatment assessment. Only those participants with data available at the indicated time points were analyzed. | grams/deciliter (g/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | CFB in Hgb Upto Week 8 | Baseline (Day 1) Upto Week 8 | ITT population. Only those participants available at the specified time points were analyzed. | g/dL | MEAN |
| SECONDARY | Number of Participants Who Achieved Hgb Response at Week 4 | Week 4 | ITT population. Only those participants available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Achieved Hgb Response at Week 4 | Week 4 | ITT population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | Upto Week 4 | ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4 | Baseline (Day 1) Upto Week 4 | ITT population. Only those participants with data available at the indicated time points were analyzed. | International units/liter | MEAN |
| SECONDARY | Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4 | Baseline (Day 1) Upto Week 4 | ITT population. Only those participants with data available at the indicated time points were analyzed. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Percent CFB in Hepcidine Upto Week 4 | Baseline (Day 1) Upto Week 4 | ITT population. Only those participants available at the specified time points were analyzed. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | CFB in Ferritin at Week 4 | Baseline (Day 1) and Week 4 | ITT population. Only those participants with data available at the specified time points were analyzed. | micrograms/liter | MEAN |
| SECONDARY | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | Baseline (Day 1) and Week 4 | ITT population. Only those participants available at the specified time points were analyzed. | micromoles/liter | MEAN |
| SECONDARY | CFB in Transferrin at Week 4 | Baseline (Day 1) and Week 4 | ITT population. Only those participants with data available at the indicated time points were analyzed. | grams/liter | MEAN |
| SECONDARY | Percent CFB in Transferrin Saturation (TS) at Week 4 | Baseline (Day 1) and Week 4 | ITT population. Only those participants with data available at the indicated time points were analyzed. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4 | Week 4 | Pharmacokinetic Population: All participants from whom a Pharmacokinetic sample was obtained and analyzed. Only those participants available at the indicated time points were analyzed. | micrograms/liter | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy | Upto Week 4 | Safety population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4 | Upto Week 4 | Safety population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4 | Upto Week 4 | Safety population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4 | Upto Week 4 | Safety population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4 | Upto Week 4 | Safety population. | Participants | COUNT_OF_PARTICIPANTS |
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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