Trial · NCT04218084
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Time-Averaged Maximum of Mean Velocity (TAMMV) Arterial Cerebral Blood Flow at Week 24 | Baseline (value at screening), Week 24 | ITT analysis population included all randomized participants. Here, Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | cm/sec | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in TAMMV Arterial Cerebral Blood Flow at Week 48 | Baseline (value at Screening), Weeks 48 | ITT analysis population included all randomized participants. Here, Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | cm/sec | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Conversion to Abnormal TCD Flow | Up to 96 weeks | ITT analysis population included all randomized participants. Participants in the analysis included all randomized participants (Intent-to Treat) population. Participants with an event after postbaseline HU initiation or without event are censored at the earliest date of last non-missing TAMMV assessment prior to start of HU or end of study date. | Weeks | MEDIAN |
| SECONDARY | Time to Reversion to Normal TCD Flow | Up to 96 weeks | ITT analysis population included all randomized participants. Here, Overall Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. | Weeks | MEDIAN |
| SECONDARY | Percentage of Participants With TAMMV Reduced by >=15 cm/Sec From Baseline at Weeks 24, 48 and 96 | At Weeks 24, 48 and 96 | ITT analysis population=all randomized participants and at each timepoint ITT= total number of all randomized participants used in the analysis. Participants with any of the following scenarios were counted as non-responders:(i) TCD missing at assessment timepoint (including due to abnormal TCD discontinuation) (ii) post-randomization HU use prior to assessment timepoint for subjects with no HU use at baseline.For any missing values, data was imputed using last TAMMV value prior to transfusion. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hemoglobin (Hb) at Weeks 24, 48 and 96 | Baseline (value at Screening), Weeks 24, 48 and 96 | ITT analysis population included all randomized participants. Here, Overall Number of Participants Analyzed'' = number of participants evaluable for this outcome. All participants reported under Overall Number of Participants Analyzed'' contributed data to table but may not have evaluable data for every row. Number Analyzed = participants evaluable for each row. | Grams per deciliter (g/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Unconjugated Bilirubin at Weeks 24, 48 and 96 | Baseline (value at Screening), Weeks 24, 48 and 96 | ITT analysis population included all randomized participants. Here, Overall Number of Participants Analyzed'' = number of participants evaluable for this outcome. All participants reported under Overall Number of Participants Analyzed'' contributed data to table but may not have evaluable data for every row. Number Analyzed = participants evaluable for each row. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Reticulocyte at Weeks 24, 48 and 96 | Baseline (value at Screening), Weeks 24, 48 and 96 | ITT analysis population included all randomized participants. Here, Overall Number of Participants Analyzed'' = number of participants evaluable for this outcome. All participants reported under this contributed data to table but may not have evaluable data for every row. 'Number Analyzed'=participants evaluable for each row. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Absolute Reticulocyte at Weeks 24, 48 and 96 | Baseline (value at Screening), Weeks 24, 48 and 96 | ITT analysis population included all randomized participants. Here, Overall Number of Participants Analyzed'' = number of participants evaluable for this outcome. All participants reported under this contributed data to table but may not have evaluable data for every row. 'Number Analyzed'= participants evaluable for each row. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lactate Dehydrogenase (LDH) at Weeks 24, 48 and 96 | Baseline (value at Screening), Weeks 24, 48 and 96 | ITT analysis population included all randomized participants. Here, Overall Number of Participants Analyzed'' = number of participants evaluable for this outcome. All participants reported under this contributed data to table but may not have evaluable data for every row. 'Number Analyzed'= participants evaluable for each row. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Annualized Incidence Rate of Vaso-Occlusive Crises (VOCs) | From randomization to the last dose date, post-randomization HU initiation with no HU at baseline, end of study or study termination, whichever occurred earlier (maximum up to 110 weeks) | ITT analysis population included all randomized participants. | Events/ person-years | 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04218084/outcomes