Trial Outcomes & Findings for Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals With SCD (NCT NCT04930445)

NCT ID: NCT04930445

Last Updated: 2025-12-31

Results Overview

The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

• Recruitment status: TERMINATED
• Target enrollment: 265 participants
• Primary outcome timeframe: Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta
• Results posted on: 2025-12-31

Participant Flow

The study was conducted at 24 sites in the United States. The study was terminated as emerging clinical data indicated that the risk profile of Oxbryta (voxelotor) in participants with sickle cell disease (SCD) exceeded the benefits observed in previously generated global research and required further assessment. Screen failure was defined as participants who did not start or restart Oxbryta within six months of informed consent.

A total of 265 participants with SCD (all genotypes) aged greater than or equal to (>=) 5 years were enrolled in this study. Data was collected from participants medical records and other secondary data sources such as insurance and pharmacy claims. Participants were followed for up to 5 years after their first dose of Oxbryta treatment (irrespective of how long participants were on Oxbryta when they were enrolled in the study), or until they withdrew consent or were discontinued from study.

Participant milestones

Measure	All Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Overall Study STARTED	265
Overall Study Treated	260
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	265

Reasons for withdrawal

Measure	All Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Overall Study Other	2
Overall Study Adverse Event	7
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	1
Overall Study Lack of Efficacy	1
Overall Study Study Terminated by Sponsor	245
Overall Study Screen Failure	8

Baseline Characteristics

Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals With SCD

Baseline characteristics by cohort

Measure	All Participants n=265 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Age, Continuous	32.0 Years STANDARD_DEVIATION 14.78 • n=1000 Participants
Sex: Female, Male Female	154 Participants n=1000 Participants
Sex: Female, Male Male	111 Participants n=1000 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=1000 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	240 Participants n=1000 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=1000 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=1000 Participants
Race (NIH/OMB) Asian	0 Participants n=1000 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1000 Participants
Race (NIH/OMB) Black or African American	246 Participants n=1000 Participants
Race (NIH/OMB) White	6 Participants n=1000 Participants
Race (NIH/OMB) More than one race	0 Participants n=1000 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=1000 Participants

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta

Population: 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.

The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

Outcome measures

Measure	All Participants n=220 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 3 months Post-Oxbryta	0.5 Grams per deciliter (g/dL) Standard Deviation 1.33
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 6 months Post-Oxbryta	0.6 Grams per deciliter (g/dL) Standard Deviation 1.47
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 9 months Post-Oxbryta	0.5 Grams per deciliter (g/dL) Standard Deviation 1.45
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 12 months Post-Oxbryta	0.6 Grams per deciliter (g/dL) Standard Deviation 1.36
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 18 months Post-Oxbryta	0.7 Grams per deciliter (g/dL) Standard Deviation 1.35
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 24 months Post-Oxbryta	0.6 Grams per deciliter (g/dL) Standard Deviation 1.46
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 30 months Post-Oxbryta	0.5 Grams per deciliter (g/dL) Standard Deviation 1.62
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 36 months Post-Oxbryta	0.6 Grams per deciliter (g/dL) Standard Deviation 1.62
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 42 months Post-Oxbryta	0.4 Grams per deciliter (g/dL) Standard Deviation 1.48
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 48 months Post-Oxbryta	0.7 Grams per deciliter (g/dL) Standard Deviation 1.47
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 54 months Post-Oxbryta	0.1 Grams per deciliter (g/dL) Standard Deviation 1.68
Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 60 months Post-Oxbryta	-0.2 Grams per deciliter (g/dL) Standard Deviation 1.36

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta

Population: 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.

The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

Outcome measures

Measure	All Participants n=169 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 3 months Post-Oxbryta	-0.9 Percentage of reticulocytes Standard Deviation 5.50
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 6 months Post-Oxbryta	-1.1 Percentage of reticulocytes Standard Deviation 6.01
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 9 months Post-Oxbryta	-1.1 Percentage of reticulocytes Standard Deviation 5.97
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 12 months Post-Oxbryta	-1.2 Percentage of reticulocytes Standard Deviation 6.34
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 18 months Post-Oxbryta	-1.6 Percentage of reticulocytes Standard Deviation 6.69
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 24 months Post-Oxbryta	-0.7 Percentage of reticulocytes Standard Deviation 6.32
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 30 months Post-Oxbryta	-1.0 Percentage of reticulocytes Standard Deviation 6.92
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 36 months Post-Oxbryta	-1.3 Percentage of reticulocytes Standard Deviation 7.04
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 42 months Post-Oxbryta	-0.2 Percentage of reticulocytes Standard Deviation 7.45
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 48 months Post-Oxbryta	0.2 Percentage of reticulocytes Standard Deviation 6.70
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 54 months Post-Oxbryta	-0.3 Percentage of reticulocytes Standard Deviation 6.59
Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 60 months Post-Oxbryta	1.9 Percentage of reticulocytes Standard Deviation 3.84

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta

Population: 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.

The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

Outcome measures

Measure	All Participants n=136 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 18 months Post-Oxbryta	-17.8 10^9 cells/Liter Standard Deviation 175.27
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 24 months Post-Oxbryta	31.4 10^9 cells/Liter Standard Deviation 242.25
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 30 months Post-Oxbryta	0.1 10^9 cells/Liter Standard Deviation 134.67
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 36 months Post-Oxbryta	-15.3 10^9 cells/Liter Standard Deviation 228.15
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 42 months Post-Oxbryta	2.7 10^9 cells/Liter Standard Deviation 142.52
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 48 months Post-Oxbryta	4.4 10^9 cells/Liter Standard Deviation 119.59
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 54 months Post-Oxbryta	3.3 10^9 cells/Liter Standard Deviation 140.03
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 60 months Post-Oxbryta	21.7 10^9 cells/Liter Standard Deviation 93.55
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 3 months Post-Oxbryta	1.5 10^9 cells/Liter Standard Deviation 134.05
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 6 months Post-Oxbryta	-4.1 10^9 cells/Liter Standard Deviation 137.59
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 9 months Post-Oxbryta	-15.6 10^9 cells/Liter Standard Deviation 188.54
Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 12 months Post-Oxbryta	2.4 10^9 cells/Liter Standard Deviation 130.76

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta

Population: 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.

The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. Abbreviations used: overall number of participants analyzed=N and Number analyzed= n

Outcome measures

Measure	All Participants n=194 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 3 months Post-Oxbryta: Direct	0.0 milligrams per deciliter (mg/dL) Standard Deviation 0.57
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 6 months Post-Oxbryta: Direct	-0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.46
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 9 months Post-Oxbryta: Direct	0.0 milligrams per deciliter (mg/dL) Standard Deviation 0.35
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 12 months Post-Oxbryta: Direct	0.1 milligrams per deciliter (mg/dL) Standard Deviation 1.22
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 18 months Post-Oxbryta: Direct	0.1 milligrams per deciliter (mg/dL) Standard Deviation 1.57
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 24 months Post-Oxbryta: Direct	0.1 milligrams per deciliter (mg/dL) Standard Deviation 1.01
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 30 months Post-Oxbryta: Direct	0.2 milligrams per deciliter (mg/dL) Standard Deviation 0.81
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 36 months Post-Oxbryta: Direct	-0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.31
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 42 months Post-Oxbryta: Direct	0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.62
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 48 months Post-Oxbryta: Direct	-0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.37
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 54 months Post-Oxbryta: Direct	-0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.28
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 60 months Post-Oxbryta: Direct	-0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.37
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 3 months Post-Oxbryta: Indirect	-0.4 milligrams per deciliter (mg/dL) Standard Deviation 1.19
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 6 months Post-Oxbryta: Indirect	-0.3 milligrams per deciliter (mg/dL) Standard Deviation 1.28
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 9 months Post-Oxbryta: Indirect	0.0 milligrams per deciliter (mg/dL) Standard Deviation 2.23
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 12 months Post-Oxbryta: Indirect	-0.5 milligrams per deciliter (mg/dL) Standard Deviation 1.22
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 18 months Post-Oxbryta: Indirect	0.4 milligrams per deciliter (mg/dL) Standard Deviation 2.64
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 24 months Post-Oxbryta: Indirect	0.2 milligrams per deciliter (mg/dL) Standard Deviation 1.23
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 30 months Post-Oxbryta: Indirect	0.2 milligrams per deciliter (mg/dL) Standard Deviation 1.40
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 36 months Post-Oxbryta: Indirect	0.0 milligrams per deciliter (mg/dL) Standard Deviation 0.97
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 42 months Post-Oxbryta: Indirect	-0.4 milligrams per deciliter (mg/dL) Standard Deviation 0.78
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 48 months Post-Oxbryta: Indirect	-0.1 milligrams per deciliter (mg/dL) Standard Deviation 1.45
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 3 months Post-Oxbryta: Total	-0.5 milligrams per deciliter (mg/dL) Standard Deviation 1.71
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 6 months Post-Oxbryta: Total	-0.5 milligrams per deciliter (mg/dL) Standard Deviation 1.97
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 9 months Post-Oxbryta: Total	-0.2 milligrams per deciliter (mg/dL) Standard Deviation 2.76
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 12 months Post-Oxbryta: Total	-0.4 milligrams per deciliter (mg/dL) Standard Deviation 2.66
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 18 months Post-Oxbryta: Total	-0.5 milligrams per deciliter (mg/dL) Standard Deviation 2.24
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 24 months Post-Oxbryta: Total	-0.4 milligrams per deciliter (mg/dL) Standard Deviation 2.27
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 30 months Post-Oxbryta: Total	-0.3 milligrams per deciliter (mg/dL) Standard Deviation 2.10
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 36 months Post-Oxbryta: Total	-0.5 milligrams per deciliter (mg/dL) Standard Deviation 2.48
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 42 months Post-Oxbryta: Total	-0.5 milligrams per deciliter (mg/dL) Standard Deviation 2.90
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 48 months Post-Oxbryta: Total	-0.8 milligrams per deciliter (mg/dL) Standard Deviation 2.59
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 54 months Post-Oxbryta: Total	-0.6 milligrams per deciliter (mg/dL) Standard Deviation 2.56
Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 60 months Post-Oxbryta: Total	-0.1 milligrams per deciliter (mg/dL) Standard Deviation 1.33

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta

Population: 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.

The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

Outcome measures

Measure	All Participants n=84 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 3 months Post-Oxbryta	74.0 Micrograms per liter Standard Deviation 1696.32
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 6 months Post-Oxbryta	105.2 Micrograms per liter Standard Deviation 1995.71
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 9 months Post-Oxbryta	-60.7 Micrograms per liter Standard Deviation 2200.70
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 12 months Post-Oxbryta	136.9 Micrograms per liter Standard Deviation 1614.56
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 18 months Post-Oxbryta	148.0 Micrograms per liter Standard Deviation 1973.60
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 24 months Post-Oxbryta	94.0 Micrograms per liter Standard Deviation 2111.95
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 30 months Post-Oxbryta	-248.1 Micrograms per liter Standard Deviation 1761.49
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 36 months Post-Oxbryta	-220.5 Micrograms per liter Standard Deviation 1765.71
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 42 months Post-Oxbryta	667.5 Micrograms per liter Standard Deviation 2577.61
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 48 months Post-Oxbryta	896.7 Micrograms per liter Standard Deviation 3142.23
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 54 months Post-Oxbryta	1672.8 Micrograms per liter Standard Deviation 3975.50
Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 60 months Post-Oxbryta	4512.5 Micrograms per liter Standard Deviation 5500.90

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) up to 60 months post-Oxbryta

Population: 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.

The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta

Population: 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.

The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

Outcome measures

Measure	All Participants n=206 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 3 months Post-Oxbryta	0.0 milligrams per deciliter (mg/dL) Standard Deviation 0.37
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 6 months Post-Oxbryta	0.0 milligrams per deciliter (mg/dL) Standard Deviation 0.46
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 9 months Post-Oxbryta	0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.60
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 12 months Post-Oxbryta	0.0 milligrams per deciliter (mg/dL) Standard Deviation 0.37
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 18 months Post-Oxbryta	0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.43
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 24 months Post-Oxbryta	0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.51
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 30 months Post-Oxbryta	0.2 milligrams per deciliter (mg/dL) Standard Deviation 0.60
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 36 months Post-Oxbryta	0.2 milligrams per deciliter (mg/dL) Standard Deviation 0.92
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 42 months Post-Oxbryta	0.3 milligrams per deciliter (mg/dL) Standard Deviation 1.04
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 48 months Post-Oxbryta	0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.52
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 54 months Post-Oxbryta	0.4 milligrams per deciliter (mg/dL) Standard Deviation 1.17
Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta 60 months Post-Oxbryta	0.1 milligrams per deciliter (mg/dL) Standard Deviation 0.25

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 months post-Oxbryta

Population: 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.

The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

Outcome measures

Measure	All Participants n=20 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 3 months Post-Oxbryta	67.5 Milligram per gram Standard Deviation 451.66
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 6 months Post-Oxbryta	-42.1 Milligram per gram Standard Deviation 137.70
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 9 months Post-Oxbryta	59.6 Milligram per gram Standard Deviation 129.88
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 12 months Post-Oxbryta	-32.1 Milligram per gram Standard Deviation 158.67
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 18 months Post-Oxbryta	125.2 Milligram per gram Standard Deviation 330.70
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 24 months Post-Oxbryta	7.7 Milligram per gram Standard Deviation 178.23
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 30 months Post-Oxbryta	80.3 Milligram per gram Standard Deviation 164.48
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 36 months Post-Oxbryta	14.4 Milligram per gram Standard Deviation 130.58
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 42 months Post-Oxbryta	38.2 Milligram per gram Standard Deviation 96.87
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 48 months Post-Oxbryta	273.3 Milligram per gram Standard Deviation 599.99
Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta 54 months Post-Oxbryta	873.3 Milligram per gram Standard Deviation 1488.60

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta

Population: 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).

Hemoglobinuria was defined as urine dipstick results positive for blood +1 or greater and <=2 red blood cells (RBC) by high power field. Number of participants according to hemoglobinuria results (none/negative, trace, 1+, 2+, 3+, other: large, moderate, small, small=0-3, hereditary persistence of fetal hemoglobin [HPF], missing) was reported in this outcome measure. Small corresponded to trace or 1+ on dipstick, medium indicated 2+, large indicated 3+ or higher on dipstick. The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

Outcome measures

Measure	All Participants n=265 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants According to Hemoglobinuria Results Post-Oxbryta Pre-Oxbryta · None/Negative	22 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta Pre-Oxbryta · Trace	7 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta Pre-Oxbryta · 1+	3 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta Pre-Oxbryta · 2+	6 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta Pre-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta Pre-Oxbryta · Other: Large	3 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta Pre-Oxbryta · Other: Moderate	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta Pre-Oxbryta · Other: Small	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta Pre-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta Pre-Oxbryta · Missing	223 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 3 months Post-Oxbryta · None/Negative	7 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 3 months Post-Oxbryta · Trace	4 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 3 months Post-Oxbryta · 1+	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 3 months Post-Oxbryta · 2+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 3 months Post-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 3 months Post-Oxbryta · Other: Large	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 3 months Post-Oxbryta · Other: Moderate	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 3 months Post-Oxbryta · Other: Small	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 3 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 3 months Post-Oxbryta · Missing	251 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 6 months Post-Oxbryta · None/Negative	12 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 6 months Post-Oxbryta · Trace	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 6 months Post-Oxbryta · 1+	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 6 months Post-Oxbryta · 2+	3 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 6 months Post-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 6 months Post-Oxbryta · Other: Large	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 6 months Post-Oxbryta · Other: Moderate	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 6 months Post-Oxbryta · Other: Small	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 6 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 6 months Post-Oxbryta · Missing	247 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 9 months Post-Oxbryta · None/Negative	8 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 9 months Post-Oxbryta · Trace	3 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 9 months Post-Oxbryta · 1+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 9 months Post-Oxbryta · 2+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 9 months Post-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 9 months Post-Oxbryta · Other: Large	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 9 months Post-Oxbryta · Other: Moderate	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 9 months Post-Oxbryta · Other: Small	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 9 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 9 months Post-Oxbryta · Missing	254 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 12 months Post-Oxbryta · None/Negative	11 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 12 months Post-Oxbryta · Trace	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 12 months Post-Oxbryta · 1+	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 12 months Post-Oxbryta · 2+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 12 months Post-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 12 months Post-Oxbryta · Other: Large	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 12 months Post-Oxbryta · Other: Moderate	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 12 months Post-Oxbryta · Other: Small	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 12 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 12 months Post-Oxbryta · Missing	250 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 18 months Post-Oxbryta · None/Negative	18 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 18 months Post-Oxbryta · Trace	6 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 18 months Post-Oxbryta · 1+	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 18 months Post-Oxbryta · 2+	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 18 months Post-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 18 months Post-Oxbryta · Other: Large	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 18 months Post-Oxbryta · Other: Moderate	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 18 months Post-Oxbryta · Other: Small	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 18 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 18 months Post-Oxbryta · Missing	236 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 24 months Post-Oxbryta · None/Negative	17 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 24 months Post-Oxbryta · Trace	4 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 24 months Post-Oxbryta · 1+	3 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 24 months Post-Oxbryta · 2+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 24 months Post-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 24 months Post-Oxbryta · Other: Large	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 24 months Post-Oxbryta · Other: Moderate	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 24 months Post-Oxbryta · Other: Small	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 24 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 24 months Post-Oxbryta · Missing	239 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 30 months Post-Oxbryta · None/Negative	16 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 30 months Post-Oxbryta · Trace	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 30 months Post-Oxbryta · 1+	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 30 months Post-Oxbryta · 2+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 30 months Post-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 30 months Post-Oxbryta · Other: Large	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 30 months Post-Oxbryta · Other: Moderate	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 30 months Post-Oxbryta · Other: Small	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 30 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 30 months Post-Oxbryta · Missing	246 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 36 months Post-Oxbryta · None/Negative	13 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 36 months Post-Oxbryta · Trace	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 36 months Post-Oxbryta · 1+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 36 months Post-Oxbryta · 2+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 36 months Post-Oxbryta · 3+	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 36 months Post-Oxbryta · Other: Large	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 36 months Post-Oxbryta · Other: Moderate	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 36 months Post-Oxbryta · Other: Small	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 36 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 36 months Post-Oxbryta · Missing	247 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 42 months Post-Oxbryta · None/Negative	12 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 42 months Post-Oxbryta · Trace	4 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 42 months Post-Oxbryta · 1+	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 42 months Post-Oxbryta · 2+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 42 months Post-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 42 months Post-Oxbryta · Other: Large	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 42 months Post-Oxbryta · Other: Moderate	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 42 months Post-Oxbryta · Other: Small	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 42 months Post-Oxbryta · Other: Small- 0-3 HPF	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 42 months Post-Oxbryta · Missing	245 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 48 months Post-Oxbryta · None/Negative	12 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 48 months Post-Oxbryta · Trace	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 48 months Post-Oxbryta · 1+	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 48 months Post-Oxbryta · 2+	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 48 months Post-Oxbryta · 3+	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 48 months Post-Oxbryta · Other: Large	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 48 months Post-Oxbryta · Other: Moderate	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 48 months Post-Oxbryta · Other: Small	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 48 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 48 months Post-Oxbryta · Missing	247 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 54 months Post-Oxbryta · None/Negative	8 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 54 months Post-Oxbryta · Trace	2 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 54 months Post-Oxbryta · 1+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 54 months Post-Oxbryta · 2+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 54 months Post-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 54 months Post-Oxbryta · Other: Large	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 54 months Post-Oxbryta · Other: Moderate	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 54 months Post-Oxbryta · Other: Small	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 54 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 54 months Post-Oxbryta · Missing	253 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 60 months Post-Oxbryta · None/Negative	1 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 60 months Post-Oxbryta · Trace	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 60 months Post-Oxbryta · 1+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 60 months Post-Oxbryta · 2+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 60 months Post-Oxbryta · 3+	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 60 months Post-Oxbryta · Other: Large	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 60 months Post-Oxbryta · Other: Moderate	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 60 months Post-Oxbryta · Other: Small	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 60 months Post-Oxbryta · Other: Small- 0-3 HPF	0 Participants
Number of Participants According to Hemoglobinuria Results Post-Oxbryta 60 months Post-Oxbryta · Missing	264 Participants

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) 3, 6, 12, 18, 24, 30 months post-Oxbryta

Population: 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.

The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

Outcome measures

Measure	All Participants n=2 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Change in Serum Cystatin C Results From Pre-Oxbryta Treatment (Baseline) Through Month 30 Post-Oxbryta 30 months Post-Oxbryta	-0.1 milligrams per liter (mg/L) Standard Deviation 0.07
Change in Serum Cystatin C Results From Pre-Oxbryta Treatment (Baseline) Through Month 30 Post-Oxbryta 3 months Post-Oxbryta	0.1 milligrams per liter (mg/L) Standard Deviation NA Standard deviation could not be estimated as a single participant was analyzed.
Change in Serum Cystatin C Results From Pre-Oxbryta Treatment (Baseline) Through Month 30 Post-Oxbryta 6 months Post-Oxbryta	-0.1 milligrams per liter (mg/L) Standard Deviation 0.07
Change in Serum Cystatin C Results From Pre-Oxbryta Treatment (Baseline) Through Month 30 Post-Oxbryta 12 months Post-Oxbryta	0.2 milligrams per liter (mg/L) Standard Deviation 0.07
Change in Serum Cystatin C Results From Pre-Oxbryta Treatment (Baseline) Through Month 30 Post-Oxbryta 18 months Post-Oxbryta	-0.2 milligrams per liter (mg/L) Standard Deviation 0.07
Change in Serum Cystatin C Results From Pre-Oxbryta Treatment (Baseline) Through Month 30 Post-Oxbryta 24 months Post-Oxbryta	0.0 milligrams per liter (mg/L) Standard Deviation 0.11

PRIMARY outcome

Timeframe: Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta

Population: 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).

Estimated GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Number of participants according to estimated GFR results (stage 1 [G1] - GFR >=90 milliliter/minute [mL/min] per 1.73 square meters [m^2], stage 2 [G2] - GFR 60 to 89 mL/min per 1.73 m^2, stage 3a [G3a] - GFR 45 to 59 mL/min per 1.73 m^2, stage 3b [G3b] - GFR 30 to 44 mL/min per 1.73 m^2, stage 4 [G4] - GFR 15 to 29 mL/min per 1.73 m^2, stage 5 [G5] - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis, missing) was reported descriptively in this outcome measure. Stages 1 and 2 indicate mild damage, while stages 3 to 5 reflected progressive severity, leading to potential renal failure. The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used.

Outcome measures

Measure	All Participants n=265 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 36 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	4 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 36 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 36 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 36 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 36 months Post-Oxbryta · Missing	203 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 42 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	42 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 42 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	12 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 42 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	5 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 42 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	0 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 42 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	3 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 42 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 42 months Post-Oxbryta · Missing	202 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 48 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	33 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 48 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	10 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 48 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	4 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 48 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 48 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	5 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 48 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	0 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 48 months Post-Oxbryta · Missing	212 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 54 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	23 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 54 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	6 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 54 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	3 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 54 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	0 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 54 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	3 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 54 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 54 months Post-Oxbryta · Missing	228 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 60 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	7 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 60 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 60 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 60 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	0 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 60 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	0 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 60 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	0 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 60 months Post-Oxbryta · Missing	256 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta Pre-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	63 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta Pre-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	24 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta Pre-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	8 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta Pre-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta Pre-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	3 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta Pre-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta Pre-Oxbryta · Missing	164 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 3 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	47 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 3 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	21 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 3 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 3 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 3 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	4 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 3 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 3 months Post-Oxbryta · Missing	189 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 6 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	51 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 6 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	17 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 6 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	3 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 6 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 6 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	3 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 6 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 6 months Post-Oxbryta · Missing	187 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 9 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	44 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 9 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	21 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 9 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 9 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 9 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	3 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 9 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 9 months Post-Oxbryta · Missing	193 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 12 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	50 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 12 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	22 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 12 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 12 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 12 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 12 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 12 months Post-Oxbryta · Missing	186 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 18 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	60 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 18 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	29 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 18 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	5 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 18 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	0 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 18 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	3 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 18 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	3 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 18 months Post-Oxbryta · Missing	165 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 24 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	55 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 24 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	22 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 24 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	3 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 24 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 24 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 24 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	2 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 24 months Post-Oxbryta · Missing	180 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 30 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	53 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 30 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	21 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 30 months Post-Oxbryta · G3a - GFR 45 to 59 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 30 months Post-Oxbryta · G3b - GFR 30 to 44 mL/min per 1.73 m^2	4 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 30 months Post-Oxbryta · G4 - GFR 15 to 29 mL/min per 1.73 m^2	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 30 months Post-Oxbryta · G5 - GFR < 15 mL/min per 1.73 m^2 or treatment by dialysis	1 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 30 months Post-Oxbryta · Missing	184 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 36 months Post-Oxbryta · G1 - GFR >=90 mL/min per 1.73 m^2	39 Participants
Number of Participants According to Estimated Glomerular Filtration Rate (GFR) Results Post-Oxbryta 36 months Post-Oxbryta · G2 - GFR 60 to 89 mL/min per 1.73 m^2	15 Participants

PRIMARY outcome

Timeframe: From date of first Oxbryta treatment through the end of study (up to Month 60)

Population: 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.

SCD complications included acute pain crisis, acute chest syndrome (ACS), priapism, stroke, chronic or end stage kidney disease iron overload, leg ulcers, cardiac malfunction and pulmonary hypertension (PH) and RBC transfusions.

Outcome measures

Measure	All Participants n=260 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants With SCD Complications	205 Participants

PRIMARY outcome

Timeframe: From date of first Oxbryta treatment through the end of study (up to Month 60)

Population: 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.

Number of participants with treatment initiation or modification of SCD related medications is reported in this outcome measure.

Outcome measures

Measure	All Participants n=260 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants With Treatment Initiation or Modification of SCD-related Medications	259 Participants

PRIMARY outcome

Timeframe: From date of first Oxbryta treatment through the end of study (up to Month 60)

Population: 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.

Number of participants with RBC transfusions is reported in this outcome measure.

Outcome measures

Measure	All Participants n=260 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants With Red Blood Cell (RBC) Transfusions	172 Participants

PRIMARY outcome

Timeframe: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60

Population: 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.

PGIC was a single question that reflected a participant's or caregiver's belief about the effectiveness of treatment with Oxbryta on a 7-point scale depicting a participant's rating of overall improvement. Participants/caregivers rated their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse".

Outcome measures

Measure	All Participants n=48 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 6 · Very much improved	4 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 6 · Much improved	6 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 6 · Minimally improved	6 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 6 · No change	5 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 6 · Minimally worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 3 · Very much improved	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 3 · Much improved	2 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 3 · Minimally improved	3 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 3 · No change	4 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 3 · Minimally worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 3 · Much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 3 · Very much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 6 · Much worse	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 6 · Very much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 9 · Very much improved	6 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 9 · Much improved	6 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 9 · Minimally improved	8 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 9 · No change	10 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 9 · Minimally worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 9 · Much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 9 · Very much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 12 · Very much improved	2 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 12 · Much improved	12 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 12 · Minimally improved	8 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 12 · No change	15 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 12 · Minimally worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 12 · Much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 12 · Very much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 18 · Very much improved	4 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 18 · Much improved	17 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 18 · Minimally improved	11 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 18 · No change	7 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 18 · Minimally worse	2 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 18 · Much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 18 · Very much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 24 · Very much improved	3 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 24 · Much improved	14 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 24 · Minimally improved	9 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 24 · No change	13 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 24 · Minimally worse	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 24 · Much worse	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 24 · Very much worse	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 30 · Very much improved	6 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 30 · Much improved	12 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 30 · Minimally improved	11 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 30 · No change	11 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 30 · Minimally worse	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 30 · Much worse	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 30 · Very much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 36 · Very much improved	4 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 36 · Much improved	12 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 36 · Minimally improved	16 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 36 · No change	5 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 36 · Minimally worse	2 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 36 · Much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 36 · Very much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 42 · Very much improved	8 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 42 · Much improved	11 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 42 · Minimally improved	17 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 42 · No change	11 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 42 · Minimally worse	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 42 · Much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 42 · Very much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 48 · Very much improved	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 48 · Much improved	17 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 48 · Minimally improved	9 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 48 · No change	7 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 48 · Minimally worse	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 48 · Much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 48 · Very much worse	1 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 54 · Very much improved	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 54 · Much improved	5 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 54 · Minimally improved	3 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 54 · No change	6 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 54 · Minimally worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 54 · Much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 54 · Very much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 60 · Very much improved	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 60 · Much improved	2 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 60 · Minimally improved	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 60 · No change	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 60 · Minimally worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 60 · Much worse	0 Participants
Number of Participants According to Responses to Patient Global Impression of Change (PGIC) at Month 3 Through Month 60 Month 60 · Very much worse	0 Participants

PRIMARY outcome

Timeframe: Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60

Population: 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.

CGIC was a brief, stand-alone assessment of the clinician's view of the participant's global functioning prior to and after initiating Oxbryta. The CGI provided an overall clinician-determined summary measure that took into account all available information, including a knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. Participants rated their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," "very much worse," or "not assessed".

Outcome measures

Measure	All Participants n=30 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 18 · No change	9 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 3 · Very much improved	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 3 · Much improved	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 3 · Minimally improved	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 3 · No change	2 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 3 · Minimally worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 3 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 3 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 3 · Not assessed	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 6 · Very much improved	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 6 · Much improved	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 6 · Minimally improved	6 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 6 · No change	5 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 6 · Minimally worse	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 6 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 6 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 6 · Not assessed	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 9 · Very much improved	3 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 9 · Much improved	4 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 9 · Minimally improved	7 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 9 · No change	5 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 9 · Minimally worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 9 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 9 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 9 · Not assessed	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 12 · Very much improved	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 12 · Much improved	4 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 12 · Minimally improved	7 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 12 · No change	7 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 12 · Minimally worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 12 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 12 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 12 · Not assessed	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 18 · Very much improved	6 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 18 · Much improved	7 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 18 · Minimally improved	6 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 18 · Minimally worse	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 18 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 18 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 18 · Not assessed	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 24 · Very much improved	3 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 24 · Much improved	13 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 24 · Minimally improved	6 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 24 · No change	2 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 24 · Minimally worse	2 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 24 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 24 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 24 · Not assessed	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 30 · Very much improved	2 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 30 · Much improved	2 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 30 · Minimally improved	9 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 30 · No change	5 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 30 · Minimally worse	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 30 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 30 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 30 · Not assessed	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 36 · Very much improved	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 36 · Much improved	8 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 36 · Minimally improved	6 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 36 · No change	4 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 36 · Minimally worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 36 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 36 · Very much worse	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 36 · Not assessed	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 42 · Very much improved	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 42 · Much improved	12 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 42 · Minimally improved	10 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 42 · No change	8 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 42 · Minimally worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 42 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 42 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 42 · Not assessed	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 48 · Very much improved	2 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 48 · Much improved	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 48 · Minimally improved	10 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 48 · No change	6 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 48 · Minimally worse	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 48 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 48 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 48 · Not assessed	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 54 · Very much improved	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 54 · Much improved	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 54 · Minimally improved	2 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 54 · No change	4 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 54 · Minimally worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 54 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 54 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 54 · Not assessed	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 60 · Very much improved	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 60 · Much improved	1 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 60 · Minimally improved	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 60 · No change	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 60 · Minimally worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 60 · Much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 60 · Very much worse	0 Participants
Number of Participants According to Responses to Clinical Global Impression of Change (CGIC) at Month 3 Through Month 60 Month 60 · Not assessed	0 Participants

PRIMARY outcome

Timeframe: From date of first Oxbryta treatment up to end of study (up to Month 60)

Population: 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.

An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other important medical events. Severity was classified using common terminology criteria for adverse events (CTCAE), version 5.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe. Mild - SAEs does not interfere with participant's usual function b) moderate - SAEs interferes to some extent with participant's usual function c) severe - SAEs interferes significantly with participant's usual function.

Outcome measures

Measure	All Participants n=260 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants With Serious Adverse Events (SAEs) According to Severity Mild	8 Participants
Number of Participants With Serious Adverse Events (SAEs) According to Severity Moderate	55 Participants
Number of Participants With Serious Adverse Events (SAEs) According to Severity Severe	87 Participants

PRIMARY outcome

Timeframe: From date of first Oxbryta treatment up to end of study (up to Month 60)

Population: 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.

An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. Severity was classified using CTCAE, version 5.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function. AEs included both SAEs and non-SAEs.

Outcome measures

Measure	All Participants n=260 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants With Adverse Events (AEs) According to Severity Mild	28 Participants
Number of Participants With Adverse Events (AEs) According to Severity Moderate	83 Participants
Number of Participants With Adverse Events (AEs) According to Severity Severe	99 Participants

PRIMARY outcome

Timeframe: From date of first Oxbryta treatment up to end of study (up to Month 60)

Population: 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.

An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with AEs leading to dose modification or discontinuation of Oxbryta were reported in this outcome measure.

Outcome measures

Measure	All Participants n=260 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants With AEs Leading to Dose Modification or Discontinuation of Oxbryta	7 Participants

PRIMARY outcome

Timeframe: From date of first Oxbryta treatment up to end of study (up to Month 60)

Population: 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.

Number of participants with positive pregnancy test and fertility complications were reported in this outcome measure.

Outcome measures

Measure	All Participants n=260 Participants Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Number of Participants With Positive Pregnancy Test and Fertility Complications	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of first Oxbryta treatment through the end of study (up to Month 60)

Population: Data for this outcome measure was not collected due to premature termination of the study. Only limited efficacy data to support the benefit-risk evaluation of Oxbryta was collected.

Outpatient visits (including infusion center, acute care, or telemedicine visit) were planned to be analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of first Oxbryta treatment through the end of study (up to Month 60)

Population: Data for this outcome measure was not collected due to premature termination of the study. Only limited efficacy data to support the benefit-risk evaluation of Oxbryta was collected.

ED visits were planned to be analyzed in this outcome measure.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of first Oxbryta treatment through the end of study (up to Month 60)

Population: Data for this outcome measure was not collected due to premature termination of the study. Only limited efficacy data to support the benefit-risk evaluation of Oxbryta was collected.

Number of hospitalizations were planned to be analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of first Oxbryta treatment through the end of study (up to Month 60)

Population: Data for this outcome measure was not collected due to premature termination of the study. Only limited efficacy data to support the benefit-risk evaluation of Oxbryta was collected.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of first Oxbryta treatment through the end of study (up to Month 60)

Population: Data for this outcome measure was not collected due to premature termination of the study. Only limited efficacy data to support the benefit-risk evaluation of Oxbryta was collected.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 150 serious events

Other events: 185 other events

Deaths: 6 deaths

Serious adverse events

Measure	All Participants n=260 participants at risk Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Blood and lymphatic system disorders Anaemia	1.5% 4/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Aplastic anaemia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Haemolytic anaemia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Hypersplenism	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Pancytopenia	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	50.4% 131/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Splenomegaly	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Thrombocytopenia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Thrombocytosis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Cardiac disorders Acute coronary syndrome	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Cardiac disorders Angina pectoris	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Cardiac disorders Cardiac arrest	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Cardiac disorders Pulmonary valve incompetence	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Congenital, familial and genetic disorders Sickle cell anaemia	3.1% 8/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Endocrine disorders Goitre	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Abdominal pain	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Diarrhoea	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Ileus	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Nausea	1.2% 3/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Tooth impacted	1.2% 3/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Vomiting	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
General disorders Chest pain	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
General disorders Non-cardiac chest pain	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
General disorders Pain	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
General disorders Pyrexia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
General disorders Sudden death	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
General disorders Systemic inflammatory response syndrome	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Hepatobiliary disorders Bile duct stone	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Hepatobiliary disorders Cholelithiasis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Hepatobiliary disorders Hypertransaminasaemia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Hepatobiliary disorders Liver disorder	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Immune system disorders Anaphylactic reaction	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Abdominal wall abscess	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations COVID-19	2.3% 6/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Clostridium difficile colitis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Corynebacterium bacteraemia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Gastroenteritis viral	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Influenza	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Mycobacterial infection	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Pneumonia	7.3% 19/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Pyelonephritis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Sepsis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Septic shock	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Staphylococcal bacteraemia	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Staphylococcal sepsis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Upper respiratory tract infection	1.2% 3/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Injury, poisoning and procedural complications Delayed haemolytic transfusion reaction	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Injury, poisoning and procedural complications Pelvic fracture	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Investigations Alanine aminotransferase increased	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Investigations Epstein-Barr virus test positive	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Investigations Staphylococcus test positive	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Metabolism and nutrition disorders Hyperkalaemia	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Metabolism and nutrition disorders Iron overload	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Musculoskeletal and connective tissue disorders Flank pain	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Musculoskeletal and connective tissue disorders Joint effusion	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Musculoskeletal and connective tissue disorders Muscular weakness	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Musculoskeletal and connective tissue disorders Osteonecrosis	3.1% 8/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Nervous system disorders Cerebrovascular accident	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Nervous system disorders Generalised tonic-clonic seizure	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Nervous system disorders Headache	1.5% 4/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Nervous system disorders Middle cerebral artery stroke	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Nervous system disorders Migraine	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Nervous system disorders Psychogenic seizure	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Nervous system disorders Transient ischaemic attack	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Psychiatric disorders Hallucination	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Psychiatric disorders Mental status changes	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Renal and urinary disorders Acute kidney injury	1.2% 3/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Acute chest syndrome	22.7% 59/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.9% 5/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Skin and subcutaneous tissue disorders Skin ulcer	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Vascular disorders Brachiocephalic artery occlusion	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Vascular disorders Deep vein thrombosis	1.9% 5/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Vascular disorders Jugular vein occlusion	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Vascular disorders Peripheral vascular disorder	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Vascular disorders Subclavian vein occlusion	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Vascular disorders Vena cava thrombosis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.

Other adverse events

Measure	All Participants n=260 participants at risk Participants with SCD who were treated with Oxbryta in study C5341018 (NCT04930328) or were prescribed Oxbryta by their physician as part of their usual care were included.
Blood and lymphatic system disorders Anaemia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Haemolysis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	59.2% 154/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Cardiac disorders Atrial thrombosis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Cardiac disorders Mitral valve incompetence	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Congenital, familial and genetic disorders Sickle cell anaemia	3.5% 9/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Eye disorders Ophthalmic artery aneurysm	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Eye disorders Retinopathy	1.2% 3/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Abdominal pain	11.5% 30/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Abdominal pain upper	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Diarrhoea	18.1% 47/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Haematochezia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Nausea	14.6% 38/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Pancreatitis acute	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Pancreatitis chronic	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Gastrointestinal disorders Vomiting	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
General disorders Chest pain	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
General disorders Drug ineffective	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
General disorders Fatigue	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
General disorders Pain	1.2% 3/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Hepatobiliary disorders Cholelithiasis	1.9% 5/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Hepatobiliary disorders Hypertransaminasaemia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Hepatobiliary disorders Jaundice	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Bacteraemia	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations COVID-19	1.2% 3/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Pneumonia	3.1% 8/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Pyelonephritis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Pyelonephritis acute	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Infections and infestations Sepsis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Investigations Blood bilirubin unconjugated increased	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Investigations Blood lactate dehydrogenase increased	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Metabolism and nutrition disorders Iron overload	1.2% 3/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Musculoskeletal and connective tissue disorders Muscular weakness	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Musculoskeletal and connective tissue disorders Osteonecrosis	5.0% 13/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Nervous system disorders Cerebral infarction	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Nervous system disorders Headache	15.4% 40/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Nervous system disorders Intracranial aneurysm	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Renal and urinary disorders End stage renal disease	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Reproductive system and breast disorders Priapism	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Acute chest syndrome	9.2% 24/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.77% 2/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Skin and subcutaneous tissue disorders Pruritus	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Skin and subcutaneous tissue disorders Rash	6.2% 16/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Skin and subcutaneous tissue disorders Skin ulcer	1.5% 4/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Vascular disorders Deep vein thrombosis	1.9% 5/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.
Vascular disorders Superficial vein thrombosis	0.38% 1/260 • From date of first Oxbryta treatment up to end of study (up to Month 60) Same event may occur as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. 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.

Additional Information

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