Trial · NCT04930445
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | Grams per deciliter (g/dL) | MEAN |
| PRIMARY | Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | Percentage of reticulocytes | MEAN |
| PRIMARY | Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | 10^9 cells/Liter | MEAN |
| PRIMARY | Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of inform consent date). Here, 'N'=number of participants evaluable for this outcome measure and 'n'=participants evaluable for specified time-points. Indirect bilirubin data for month 54 and 60 was not collected as data collection was not mandatory for laboratory parameters since it is a non-interventional study. | milligrams per deciliter (mg/dL) | MEAN |
| PRIMARY | Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | Micrograms per liter | MEAN |
| PRIMARY | Change in Iron Overload as Measured by T2-weighted Magnetic Resonance Imaging (MRI) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) up to 60 months post-Oxbryta | No data was not collected for this outcome measure as the information regarding iron overload as measured by T2-weighted MRI was not available in the medical record for any of the participants. | ||
| PRIMARY | Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | milligrams per deciliter (mg/dL) | MEAN |
| PRIMARY | Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | Milligram per gram | MEAN |
| PRIMARY | Number of Participants According to Hemoglobinuria Results Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Serum Cystatin C Results From Pre-Oxbryta Treatment (Baseline) Through Month 30 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 12, 18, 24, 30 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | milligrams per liter (mg/L) | MEAN |
| PRIMARY | Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With SCD Complications | From date of first Oxbryta treatment through the end of study (up to Month 60) | Safety analysis set (SAS) included all participants in the FAS who received at least one dose of Oxbryta including participants who had received at least one dose of Oxbryta in C5341018 (NCT04930328) (RETRO) study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Initiation or Modification of SCD-related Medications | From date of first Oxbryta treatment through the end of study (up to Month 60) | Safety analysis set (SAS) included all participants in the FAS who received at least one dose of Oxbryta including participants who had received at least one dose of Oxbryta in C5341018 (NCT04930328) (RETRO) study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Red Blood Cell (RBC) Transfusions | From date of first Oxbryta treatment through the end of study (up to Month 60) | SAS included all participants in the FAS who received at least one dose of Oxbryta including participants who had received at least one dose of Oxbryta in C5341018 (NCT04930328) (RETRO) study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 | Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 | Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) According to Severity | From date of first Oxbryta treatment up to end of study (up to Month 60) | SAS included all participants in the FAS who received at least one dose of Oxbryta including participants who had received at least one dose of Oxbryta in C5341018 (NCT04930328) (RETRO) study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events (AEs) According to Severity | From date of first Oxbryta treatment up to end of study (up to Month 60) | SAS included all participants in the FAS who received at least one dose of Oxbryta including participants who had received at least one dose of Oxbryta in C5341018 (NCT04930328) (RETRO) study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs Leading to Dose Modification or Discontinuation of Oxbryta | From date of first Oxbryta treatment up to end of study (up to Month 60) | SAS included all participants in the FAS who received at least one dose of Oxbryta including participants who had received at least one dose of Oxbryta in C5341018 (NCT04930328) (RETRO) study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Positive Pregnancy Test and Fertility Complications | From date of first Oxbryta treatment up to end of study (up to Month 60) | SAS included all participants in the FAS who received at least one dose of Oxbryta including participants who had received at least one dose of Oxbryta in C5341018 (NCT04930328) (RETRO) study. | Participants | COUNT_OF_PARTICIPANTS |
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.
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