Trial · NCT02278341
Outcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 45
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] | Baseline and weeks 28 to 36 | The analysis population was the Per Protocol Set (PPS) which consisted of all Full Analysis Set (FAS) participants who did not meet any of exclusion criteria from the PPS. The FAS consisted of all randomized participants who received at least one dose of study drug and had at least one post-dose valid Hb assessment. | g/dL | LEAST_SQUARES_MEAN |
| PRIMARY | Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)] | Baseline and weeks 28 to 52 | The analysis population was the All Randomized, which consisted of participants who received at least one dose of study drug, and who had available data. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hb Response During Weeks 28 to 36 | Weeks 28 to 36 | The analysis population was the PPS. | Percentage of participants | NUMBER |
| SECONDARY | Change From BL in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the FAS, with participants who had available data. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Monthly Intravenous (IV) Iron Use | Day 1 to week 36 | The analysis population was the FAS, with participants who had available data. | mg per month | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in Short Form-36 (SF-36) Health Survey Physical Functioning (PF) Sub-score to the Average of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the PPS, with participants who had available data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in SF-36 Vitality (VT) Sub-score to the Average of Weeks 12 to 28 | Baseline and weeks 12 to 28 | The analysis population was the PPS, with participants who had available data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in Mean Arterial Pressure (MAP) to the Average of Weeks 20 to 28 | Baseline and weeks 20 to 28 | The analysis population was the PPS, with participants who had available data. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Occurrence of an Increase in Blood Pressure | Weeks 1 to 36 | The analysis population was the PPS, with participants who had available data. | Percentage of participants | NUMBER |
| SECONDARY | Change From BL in Mean Arterial Pressure (MAP) to the Average MAP Value of Weeks 20 to 28 | Baseline and weeks 20 to 28 | The analysis population was the FAS, with participants who had available data. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Occurrence of an Increase in Blood Pressure | Weeks 1 to 36 | The analysis population was the FAS, with participants who had available data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Hb Response During Weeks 28 and 36 Regardless of Use of Rescue Therapy | Weeks 28 to 36 | The analysis population was the FAS. | Percentage of participants | NUMBER |
| SECONDARY | Change From BL in Hb to Each Postdosing Time Point | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 16, 18,20, 22, 24, 26, 28, 30, 32, 34, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72,76, 80, 84, 88, 92, 96, 100, and 104 | The analysis population was the FAS. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Hb Level Averaged Over Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy | Weeks 28 to 36, 44 to 52, and 96 to 104 | The analysis population was the FAS. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From BL in Hb to the Average of Weeks 28 to 36, 44 to 52, and 96 to 104 Regardless of the Use of Rescue Therapy | Baseline and weeks 28 to 36, 44 to 52, and 96 to 104 | The analysis population was the FAS. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Hb Values ≥ 10 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy | Weeks 28-36, 44-52 and 96-104 | The analysis population was the FAS. | percentage of Hb values | MEAN |
| SECONDARY | Percentage of Hb Values Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy | Weeks 28-36, 44-52 and 96-104 | The analysis population was the FAS. | percentage of Hb values | MEAN |
| SECONDARY | Number of Hospitalizations | Baseline to End of Treatment (EOT) (Up to week 104) | The analysis population was the FAS, with participants who had available data. | Hospitalizations | MEAN |
| SECONDARY | Number of Days of Hospitalization Per Year | Baseline to EOT (Up to week 104) | The analysis population was the FAS, with participants who had available data. | Days per year | MEAN |
| SECONDARY | Time to First Hospitalization | Baseline to EOT (Up to week 104) | The analysis population was the FAS. | Percentage of participants | NUMBER |
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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