Trial · NCT02476916
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Experiencing at Least One Adverse Event (AEs) in the Core Period | Up to Week 24 | The Safety Analysis Set included all participants who had received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing at Least One AE Over the Duration of the Extension Period | Up to approximately 8.5 years | |||
| SECONDARY | Change From Baseline in Hemoglobin (Hb) Value at Week 24 | Baseline and Week 24 | The Efficacy Analysis Set included all participants who enrolled and received any study treatment for at least 3 weeks. Number analyzed is the number of participants with evaluable data at the given time-point. | grams per deciliter (g/dL) | MEAN |
| SECONDARY | Change From Baseline in Hb Value Over the Duration of the Extension Period | Up to approximately 8.5 years | |||
| SECONDARY | Change From Baseline in Hematocrit at Week 24 | Baseline and Week 24 | The Safety Analysis Set included all participants who had received at least one dose of study drug. Number analyzed is the number of participants with evaluable data at the given time-point. | volume per volume (V/V) | MEAN |
| SECONDARY | Change From Baseline in Hematocrit Over the Duration of the Extension Period | Up to approximately 8.5 years | |||
| SECONDARY | Change From Baseline in Reticulocyte Count at Week 24 | Baseline and Week 24 | The Safety Analysis Set included all participants who had received at least one dose of study drug. Number analyzed is the number of participants with evaluable data at the given time-point. | cells * 10^9/liter | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Count Over the Duration of the Extension Period | Up to approximately 8.5 years | |||
| SECONDARY | Change From Baseline in Haptoglobin at Week 24 | Baseline and Week 24 | The Safety Analysis Set included all participants who had received at least one dose of study drug. Number analyzed is the number of participants with evaluable data at the given time-point. | gram per liter (g/L) | MEAN |
| SECONDARY | Change From Baseline in Haptoglobin Over the Duration of the Extension Period | Up to approximately 8.5 years | |||
| SECONDARY | Change From Baseline in Carbon Monoxide at Week 24 | Baseline and Week 24 | The Safety Analysis Set included all participants who had received at least one dose of study drug. Number analyzed is the number of participants with evaluable data at the given time-point. | percentage Hb bound to carbon monoxide | MEAN |
| SECONDARY | Change From Baseline in Carbon Monoxide Over the Duration of the Extension Period | Up to approximately 8.5 years | |||
| SECONDARY | Change From Baseline in Lactate Dehydrogenase (LDH) at Week 24 | Baseline and Week 24 | The Safety Analysis Set included all participants who had received at least one dose of study drug. Number analyzed is the number of participants with evaluable data at the given time-point. | units per liter (U/L) | MEAN |
| SECONDARY | Change From Baseline in LDH Over the Duration of the Extension Period | Up to approximately 8.5 years | |||
| SECONDARY | Change From Baseline in Total Bilirubin at Week 24 | Baseline and Week 24 | The Safety Analysis Set included all participants who had received at least one dose of study drug. Number analyzed is the number of participants with evaluable data at the given time-point. | milligrams per deciliter (mg/dL) | MEAN |
| SECONDARY | Change From Baseline in Total Bilirubin Over the Duration of the Extension Period | Up to approximately 8.5 years | |||
| SECONDARY | Change From Baseline in Indirect Bilirubin at Week 24 | Baseline and Week 24 | The Safety Analysis Set included all participants who had received at least one dose of study drug. Number analyzed is the number of participants with evaluable data at the given time-point. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Indirect Bilirubin Over the Duration of the Extension Period | Up to approximately 8.5 years | |||
| SECONDARY | Change From Baseline in Erythropoietin (EPO) at Week 24 | Baseline and Week 24 | The Safety Analysis Set included all participants who had received at least one dose of study drug. Number analyzed is the number of participants with evaluable data at the given time-point. | international units per liter (IU/L) | MEAN |
| SECONDARY | Change From Baseline in EPO Over the Duration of the Extension Period | Up to approximately 8.5 years |
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.
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GET https://conductscience.org/api/trials/v1/NCT02476916/outcomes