Trial · NCT04820530
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Marginal Proportion (Expressed as Percentage) of Participants With Sustained Increase in Hemoglobin Levels From Baseline of ≥ 2 g/dL in the Absence of Red Blood Cell Transfusions | Baseline, hemoglobin between Day 126 and Day 168 and absence of transfusions between Day 14 and Day 168 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | Percentage of responders | NUMBER |
| SECONDARY | Marginal Proportion (Expressed as Percentage) With Sustained Hemoglobin Levels of ≥ 12 g/dL in the Absence of Red Blood Cell Transfusions | Hemoglobin between Day 126 and Day 168 and absence of transfusions between Day 14 and Day 168 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | Percentage of responders | NUMBER |
| SECONDARY | Marginal Proportion (Expressed as Percentage) of Participants Who Remain Free From Transfusions | Between Day 14 and Day 168 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hemoglobin Levels in the Core Treatment Period | Baseline, Day 126 to 168 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | g/dL | MEAN |
| SECONDARY | Percent Change From Baseline in LDH | Baseline, Day 126 to 168 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | Percent change from baseline in LDH | MEAN |
| SECONDARY | Adjusted Annualized Clinical BTH Rate in the Core Treatment Period | Between Day 1 and Day 168 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | BTH events/year | NUMBER |
| SECONDARY | Change From Baseline in Absolute Reticulocyte Count | Baseline and mean of visits between Day 126 and 168 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | x10^9 cells/L | MEAN |
| SECONDARY | Change From Baseline in FACIT-Fatigue Score | Baseline and mean of visits between Day 126 and Day 168 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | score on a scale | MEAN |
| SECONDARY | Adjusted Annualized Major Adverse Vascular Events Rate in the Core Treatment Period | Between Day 1 and Day 168 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | MAVE events/year | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Patients Meeting Hematological Response Criteria Irrespective of RBC Transfusions | Baseline, Day 336 | Full analysis set: All patients with confirmed eligibility to whom study treatment was assigned. Only participants with valid Hb measurements at Day 336 were analyzed. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Marginal Proportion (Expressed as Percentage) of Patients Not Receiving and Not Requiring RBC Transfusions | Between Day 14 and Day 336 | Full analysis set: All patients with confirmed eligibility to whom study treatment was assigned. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Hemoglobin Levels | Baseline, Day 336 | Full analysis set: All patients with confirmed eligibility to whom study treatment was assigned. Only participants with valid Hb measurements at Day 336 were analyzed. | g/dL | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in LDH at Visit Day 336 | Baseline, Day 336 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | U/L | MEAN |
| OTHER_PRE_SPECIFIED | Adjusted Annualized Clinical BTH Rate After the Start of LNP023 Treatment | Between Day 1 and Day 336 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | BTH events/year | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Absolute Reticulocyte Count at Day 336 | Baseline, Day 336 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. Only participants with valid absolute reticulocyte count measurements at baseline and Day 336 were analyzed. | x10^9 cells/L | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in FACIT-Fatigue Score | Baseline, Day 336 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. Only participants with valid FACIT-Fatigue scores at baseline and Day 336 were analyzed. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Adjusted Annualized Major Adverse Vascular Events Rate After the Start of LNP023 Treatment | Between Day 1 and Day 336 | Full Analysis Set (FAS): All patients with confirmed eligibility to whom study treatment was assigned. | MAVE events/year | 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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04820530/outcomes