Trial · NCT04400487
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Daily Physical Activity (Counts Per Minute) to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Counts per minute | MEAN |
| PRIMARY | Change From Baseline in Total Daily Physical Activity (Counts Per Minute) to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Counts per minute | MEAN |
| PRIMARY | Change From Baseline in Light Physical Activity to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | minutes/day | MEAN |
| PRIMARY | Change From Baseline in Light Physical Activity to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | minutes/day | MEAN |
| PRIMARY | Change From Baseline in Moderate Physical Activity to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | minutes/day | MEAN |
| PRIMARY | Change From Baseline in Moderate Physical Activity to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | minutes/day | MEAN |
| PRIMARY | Change From Baseline in Vigorous Physical Activity to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | minutes/day | MEAN |
| PRIMARY | Change From Baseline in Vigorous Physical Activity to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Minutes/day | MEAN |
| PRIMARY | Change From Baseline in Total Nocturnal Sleep Time to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Minutes/day | MEAN |
| PRIMARY | Change From Baseline in Total Nocturnal Sleep Time to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Minutes/day | MEAN |
| PRIMARY | Change From Baseline in Wake Time After Sleep Onset to Week 10-12 | Baseline, Week 10-12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Minutes/day | MEAN |
| PRIMARY | Change From Baseline in Wake Time After Sleep Onset to Week 22-24 | Baseline, Week 22-24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Minutes/day | MEAN |
| PRIMARY | Change From Baseline in Sleep Efficiency to Week 10-12 | Baseline, Week 10-12 | Data for this outcome measure could not be analyzed and reported as data for 'time in bed' was not collected which was required to calculate sleep efficiency. | ||
| PRIMARY | Change From Baseline in Sleep Efficiency to Week 22-24 | Baseline, Week 22-24 | Data for this outcome measure could not be analyzed and reported as data for 'time in bed' was not collected which was required to calculate sleep efficiency. | ||
| PRIMARY | Percentage of Participants With a More Than (>)1 Grams Per Deciliter (g/dL) Increase in Hemoglobin (Hb) at Week 12 | Week 12 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a >1 g/dL Increase in Hemoglobin (Hb) at Week 24 | Week 24 | Participants who received at least 1 dose of voxelotor were included in the safety population. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Change From Baseline in Mean Overnight Oxygen Saturation (SpO2 Percentage [%]) to Week 10-12 | Baseline, Week 10-12 | Data for this outcome measure was not analyzed and reported because SpO2 data was not collected as the device that was supposed to measure SpO2 did not work. | ||
| PRIMARY | Change From Baseline in Mean Overnight SpO2 % to Week 22-24 | Baseline, Week 22-24 | Data for this outcome measure was not analyzed and reported because SpO2 data was not collected as the device that was supposed to measure SpO2 did not work. | ||
| PRIMARY | Change From Baseline in Median Number of Overnight SpO2 Dips > 3% Per Hour to Week 10-12 | Baseline, Week 10-12 | Data for this outcome measure was not analyzed and reported because SpO2 data was not collected as the device that was supposed to measure SpO2 did not work. | ||
| PRIMARY | Change From Baseline in Median Number of Overnight SpO2 Dips > 3% Per Hour to Week 22-24 | Baseline, Week 22-24 | Data for this outcome measure was not analyzed and reported because SpO2 data was not collected as the device that was supposed to measure SpO2 did not work. |
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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GET https://conductscience.org/api/trials/v1/NCT04400487/outcomes