Trial Outcomes & Findings for Study to Assess the Effect of Long-term Treatment With Voxelotor in Participants Who Have Completed Treatment in Study GBT440-031 (NCT NCT03573882)
NCT ID: NCT03573882
Last Updated: 2025-11-18
Results Overview
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs were defined as AEs with onset on or after the date of informed consent until 28 days after last dose of study drug. SCD-related TEAEs included preferred terms (PTs) of sickle cell anaemia with crisis, acute chest syndrome (ACS), pneumonia, priapism, and osteonecrosis. The number of participants with any SCD-related TEAEs was reported in this outcome measure.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
179 participants
Primary outcome timeframe
From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Results posted on
2025-11-18
Participant Flow
This was an open label extension (OLE) study which included eligible participants from study GBT440-031 (NCT03036813). All participants were administered voxelotor 1500 milligrams (mg) in this study. Results were stratified according to previous treatment in GBT440-031 (NCT03036813).
A total of 179 participants were enrolled in the study. The study was terminated as emerging clinical data observed in studies other than the current study (GBT440-034) indicated that risk profile of voxelotor in people with sickle cell disease (SCD) exceeded benefits observed in previously generated global research and required further assessment.
Participant milestones
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500mg in GBT440-031(NCT03036813)
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Overall Study
STARTED
|
63
|
58
|
58
|
|
Overall Study
Treated
|
62
|
58
|
58
|
|
Overall Study
COMPLETED
|
16
|
11
|
19
|
|
Overall Study
NOT COMPLETED
|
47
|
47
|
39
|
Reasons for withdrawal
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500mg in GBT440-031(NCT03036813)
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
22
|
17
|
18
|
|
Overall Study
Withdrawal by Subject
|
6
|
11
|
7
|
|
Overall Study
Adverse Event
|
7
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
3
|
|
Overall Study
Physician Decision
|
4
|
3
|
2
|
|
Overall Study
Participant is Noncompliant with Study Drug
|
1
|
2
|
1
|
|
Overall Study
Pregnancy
|
1
|
2
|
0
|
|
Overall Study
Other
|
4
|
2
|
2
|
Baseline Characteristics
Study to Assess the Effect of Long-term Treatment With Voxelotor in Participants Who Have Completed Treatment in Study GBT440-031
Baseline characteristics by cohort
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=62 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.5 Years
STANDARD_DEVIATION 10.80 • n=202 Participants
|
28.5 Years
STANDARD_DEVIATION 11.90 • n=283 Participants
|
29.0 Years
STANDARD_DEVIATION 13.00 • n=120 Participants
|
28.7 Years
STANDARD_DEVIATION 11.84 • n=122 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=202 Participants
|
35 Participants
n=283 Participants
|
37 Participants
n=120 Participants
|
100 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=202 Participants
|
23 Participants
n=283 Participants
|
21 Participants
n=120 Participants
|
78 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=202 Participants
|
3 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
9 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=202 Participants
|
55 Participants
n=283 Participants
|
56 Participants
n=120 Participants
|
168 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
African
|
14 Participants
n=202 Participants
|
8 Participants
n=283 Participants
|
12 Participants
n=120 Participants
|
34 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Arab
|
9 Participants
n=202 Participants
|
10 Participants
n=283 Participants
|
9 Participants
n=120 Participants
|
28 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
26 Participants
n=202 Participants
|
27 Participants
n=283 Participants
|
26 Participants
n=120 Participants
|
79 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
5 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
9 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
4 Participants
n=120 Participants
|
13 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
4 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=202 Participants
|
4 Participants
n=283 Participants
|
4 Participants
n=120 Participants
|
10 Participants
n=122 Participants
|
PRIMARY outcome
Timeframe: From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)Population: The safety population included all enrolled participants who received treatment with study drug voxelotor in the current study.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs were defined as AEs with onset on or after the date of informed consent until 28 days after last dose of study drug. SCD-related TEAEs included preferred terms (PTs) of sickle cell anaemia with crisis, acute chest syndrome (ACS), pneumonia, priapism, and osteonecrosis. The number of participants with any SCD-related TEAEs was reported in this outcome measure.
Outcome measures
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=62 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500 mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Number of Participants With Sickle Cell Disease (SCD)-Related Treatment Emergent Adverse Events (TEAEs)
|
47 Participants
|
42 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)Population: The safety population included all enrolled participants who received treatment with study drug voxelotor in the current study.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs were defined as AEs with onset on or after the date of informed consent until 28 days after last dose of study drug. Non-SCD-related TEAEs included all the PTs of TEAEs other than SCD- related TEAEs. The number of participants with any non-SCD-related TEAEs was reported in this outcome measure.
Outcome measures
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=62 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500 mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Number of Participants With Non- SCD-Related TEAEs
|
59 Participants
|
49 Participants
|
52 Participants
|
PRIMARY outcome
Timeframe: From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)Population: The safety population included all enrolled participants who received treatment with study drug voxelotor in the current study.
An SAE is an AE at any dose, in view of investigator resulted in any of following outcomes: death; life-threatening AE; inpatient hospitalization/prolongation of existing hospitalization; persistent/significant incapacity or disability; a congenital anomaly/birth defect and important medical events (IME) that may not result in death, be immediately life threatening; or require hospitalization may be considered serious when based upon medical judgement, they may jeopardize study participant and may require medical or surgical intervention to prevent one of outcomes listed in definition. TESAEs were defined as SAEs with onset on or after the date of informed consent until 28 days after last dose of study drug. Number of participants with SCD-Related TESAEs was reported in this outcome measure.
Outcome measures
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=62 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500 mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Number of Participants With SCD-Related Treatment Emergent Serious Adverse Events (TESAEs)
|
39 Participants
|
33 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)Population: The safety population included all enrolled participants who received treatment with study drug voxelotor in the current study.
An SAE is an AE at any dose, in view of investigator resulted in any of following outcomes: death; life-threatening AE; inpatient hospitalization/prolongation of existing hospitalization; persistent/significant incapacity or disability; a congenital anomaly/birth defect and IME that may not result in death, be immediately life threatening; or require hospitalization may be considered serious when based upon medical judgement, they may jeopardize study participant and may require medical or surgical intervention to prevent one of outcomes listed in definition. TESAEs were defined as SAEs with onset on or after the date of informed consent until 28 days after last dose of study drug. Number of participants with non-SCD related TESAEs was reported in this outcome measure.
Outcome measures
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=62 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500 mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Number of Participants With Non-SCD-Related TESAEs
|
18 Participants
|
14 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: From date of informed consent up to earlier of 28 days after last dose of study drug or end of study date (maximum up to 300.7 weeks)Population: The safety population included all enrolled participants who received treatment with study drug voxelotor in the current study.
Annualized incidence rate was defined as total number of events (i.e. complications observed for all participants) divided by total person years. Total person-years= sum of participant summary period in years where summary period=date of informed consent until the earlier of 28 days after last dose of study drug or end of study date. SCD related complications included acute chest syndrome, cerebrovascular accident, hepatic sequestration, ocular icterus, osteonecrosis, pneumonia, priapism, pulmonary hypertension, retinopathy, sickle cell anaemia with crisis, skin ulcer and splenic sequestration. The 95% CI was based on exact Poisson confidence limits. Incidence rate of all SCD related complications is reported in this outcome measure.
Outcome measures
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=62 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500 mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Annualized Incidence Rate (Events Per Person Years) of SCD-Related Complications
|
1.181 Events per person years
Interval 1.031 to 1.347
|
1.084 Events per person years
Interval 0.924 to 1.264
|
1.045 Events per person years
Interval 0.905 to 1.2
|
PRIMARY outcome
Timeframe: From date of informed consent to last dose of study drug (maximum up to 296.7 weeks)Population: The safety population included all enrolled participants who received treatment with study drug voxelotor in the current study.
Annualized incidence rate was defined as total number of VOC events divided by total person years. Total person-years= sum of participant summary period in years where summary period=date of informed consent to last dose of study drug. VOC during the treatment period was defined as composite of acute painful crisis or acute chest syndrome (ACS) and included the following: moderate to severe pain lasting at least 2 hours; no explanation other than VOC; required oral or parenteral opioids, ketorolac, or other analgesics prescribed or directed by a healthcare professional. The 95% CI was based on exact Poisson confidence limits.
Outcome measures
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=62 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500 mg in GBT440-031(NCT03036813)
n=58 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Annualized Incidence Rate (VOC Events Per Person Years) of On-Treatment Vaso-occlusive Crisis (VOCs)
|
1.038 VOC events per person years
Interval 0.896 to 1.195
|
0.926 VOC events per person years
Interval 0.778 to 1.095
|
0.889 VOC events per person years
Interval 0.76 to 1.034
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: The safety population included all enrolled participants who received treatment with study drug voxelotor in the current study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for specified rows.
Change from baseline in hemoglobin at Week 48 was reported in this outcome measure. Baseline value was defined as the last available value (including Week 72, end of treatment \[EOT\], or end of study \[EOS\] visits in the parent study GBT440-031 \[NCT03036813\]) collected on or prior to first dose in GBT440-034.
Outcome measures
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=57 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=53 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500 mg in GBT440-031(NCT03036813)
n=55 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin Level at Week 48
Baseline
|
8.8 Gram per deciliter (g/dL)
Standard Deviation 1.32
|
9.0 Gram per deciliter (g/dL)
Standard Deviation 1.52
|
9.5 Gram per deciliter (g/dL)
Standard Deviation 1.61
|
|
Change From Baseline in Hemoglobin Level at Week 48
Change at Week 48
|
1.2 Gram per deciliter (g/dL)
Standard Deviation 1.50
|
0.7 Gram per deciliter (g/dL)
Standard Deviation 1.48
|
0.2 Gram per deciliter (g/dL)
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: The safety population included all enrolled participants who received treatment with study drug voxelotor in the current study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Percent change from baseline in reticulocytes percentage at Week 48 was reported in this outcome measure. Baseline value was defined as the last available value (including Week 72, EOT, or EOS visits in the parent study GBT440-031 \[NCT03036813\]) collected on or prior to first dose in GBT440-034.
Outcome measures
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=38 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=33 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500 mg in GBT440-031(NCT03036813)
n=35 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Percent Change From Baseline in Reticulocytes Percentage at Week 48
|
-24.9 Percent change
Standard Deviation 58.13
|
-15.3 Percent change
Standard Deviation 55.82
|
-21.0 Percent change
Standard Deviation 81.29
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: The safety population included all enrolled participants who received treatment with study drug voxelotor in the current study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Percent change from baseline in absolute reticulocytes at Week 48 was reported in this outcome measure. Baseline value was defined as the last available value (including Week 72, EOT, or EOS visits in the parent study GBT440-031 \[NCT03036813\]) collected on or prior to first dose in GBT440-034.
Outcome measures
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=33 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=23 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500 mg in GBT440-031(NCT03036813)
n=31 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Percent Change From Baseline in Absolute Reticulocytes at Week 48
|
-25.2 Percent change
Interval -71.3 to 4123.7
|
-25.7 Percent change
Interval -76.4 to 139.2
|
-25.8 Percent change
Interval -74.9 to 259.6
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: The safety population included all enrolled participants who received treatment with study drug voxelotor in the current study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Percent change from baseline in indirect bilirubin at Week 48 was reported in this outcome measure. Baseline value was defined as the last available value (including Week 72, EOT, or EOS visits in the parent study GBT440-031 \[NCT03036813\]) collected on or prior to first dose in GBT440-034.
Outcome measures
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=35 Participants
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=32 Participants
Participants who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500 mg in GBT440-031(NCT03036813)
n=33 Participants
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Percent Change From Baseline in Indirect Bilirubin at Week 48
|
-39.3 Percent change
Standard Deviation 40.70
|
3.8 Percent change
Standard Deviation 70.47
|
1.2 Percent change
Standard Deviation 84.21
|
Adverse Events
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
Serious events: 42 serious events
Other events: 60 other events
Deaths: 3 deaths
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
Serious events: 35 serious events
Other events: 50 other events
Deaths: 2 deaths
Prior Treatment of Voxelotor 1500mg in GBT440-031(NCT03036813)
Serious events: 26 serious events
Other events: 54 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=62 participants at risk
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=58 participants at risk
Participant who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500mg in GBT440-031(NCT03036813)
n=58 participants at risk
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
58.1%
36/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
55.2%
32/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
34.5%
20/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
3/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Vitreous haemorrhage
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Peptic ulcer
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Pyrexia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Gait disturbance
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Pain
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Pneumonia
|
6.5%
4/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Osteomyelitis
|
4.8%
3/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Coronavirus infection
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Influenza
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Malaria
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Sepsis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Infection
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Parvovirus infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Delayed haemolytic transfusion reaction
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
White blood cell count increased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Bone infarction
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Central nervous system lesion
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Cerebral infarction
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Priapism
|
2.9%
1/34 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
4.3%
1/23 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
9.5%
2/21 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute chest syndrome
|
12.9%
8/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
12.1%
7/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
6.9%
4/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
Other adverse events
| Measure |
Prior Treatment of Placebo in GBT440-031 (NCT03036813)
n=62 participants at risk
Participants who received placebo in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 900mg in GBT440-031(NCT03036813)
n=58 participants at risk
Participant who received voxelotor 900 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
Prior Treatment of Voxelotor 1500mg in GBT440-031(NCT03036813)
n=58 participants at risk
Participants who received voxelotor 1500 mg in study GBT440-031 (NCT03036813) were administered voxelotor 1500 mg once daily in this study as long as they received clinical benefit and/or until the participant had access to voxelotor from an alternative source.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
45.2%
28/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
41.4%
24/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
53.4%
31/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Haemolysis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
3/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Reticulocytopenia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Microcytosis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Cardiac disorders
Palpitations
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Cardiac disorders
Cardiomegaly
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Cardiac disorders
Atrial flutter
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Cardiac disorders
Heart failure with reduced ejection fraction
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Cardiac disorders
Sinus tachycardia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Retinopathy sickle cell
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Retinal haemorrhage
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Vision blurred
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Vitreous haemorrhage
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Astigmatism
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Blepharitis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Cataract
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Dry eye
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Glaucoma
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Retinal neovascularisation
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Retinopathy
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Retinopathy proliferative
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Eye disorders
Visual impairment
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Nausea
|
22.6%
14/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
19.0%
11/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
6.9%
4/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Vomiting
|
14.5%
9/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
13.8%
8/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.7%
11/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
6.9%
4/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Constipation
|
8.1%
5/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
15.5%
9/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
8/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
6.9%
4/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
4/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Toothache
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Faeces soft
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Oral pain
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Pain
|
19.4%
12/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
12.1%
7/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
13.8%
8/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Pyrexia
|
14.5%
9/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Fatigue
|
8.1%
5/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Non-cardiac chest pain
|
6.5%
4/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Oedema peripheral
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Influenza like illness
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Malaise
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Peripheral swelling
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Asthenia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Administration site irritation
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Chest pain
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Facial pain
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Feeling hot
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Hernia pain
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Hunger
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Physical deconditioning
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
General disorders
Swelling face
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Ocular icterus
|
4.8%
3/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Immune system disorders
Seasonal allergy
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Upper respiratory tract infection
|
19.4%
12/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
6.9%
4/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
24.1%
14/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
COVID-19
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
6.9%
4/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
15.5%
9/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
4/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Urinary tract infection
|
8.1%
5/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Tonsillitis
|
9.7%
6/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Gastroenteritis
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
6.9%
4/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Malaria
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Pneumonia
|
4.8%
3/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Bronchitis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Pharyngitis
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Cellulitis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Infection
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Influenza
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Tooth abscess
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Coronavirus infection
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Body tinea
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Cystitis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Folliculitis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Furuncle
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Orchitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Paraspinal abscess
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Parotitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Penile infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Pilonidal disease
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Skin infection
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Subcutaneous abscess
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Tinea capitis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Tinea versicolour
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Urethritis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Urinary tract candidiasis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Vaginal infection
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Vulval abscess
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
5/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
3/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
C-reactive protein increased
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Cardiac murmur
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Weight decreased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Blood corticotrophin decreased
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Blood iron decreased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Blood potassium increased
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Foetal haemoglobin decreased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Helicobacter test positive
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Mean cell volume decreased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Neutrophil count decreased
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Urine protein/creatinine ratio increased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.8%
3/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Metabolism and nutrition disorders
Multi-vitamin deficiency
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.1%
10/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
15.5%
9/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
25.9%
15/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.6%
14/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
15.5%
9/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
15.5%
9/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.1%
10/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
19.0%
11/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.1%
5/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.8%
3/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Bone infarction
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Osteosclerosis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Headache
|
25.8%
16/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
17.2%
10/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
24.1%
14/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Dizziness
|
6.5%
4/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
12.1%
7/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Lethargy
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Hypoaesthesia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Burning sensation
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Migraine
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Facial paralysis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Head discomfort
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Hemiparaesthesia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Hyperaesthesia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Presyncope
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Sciatica
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Nervous system disorders
Vestibular migraine
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Psychiatric disorders
Insomnia
|
6.5%
4/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Psychiatric disorders
Initial insomnia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Dysuria
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Renal hypertrophy
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Priapism
|
8.8%
3/34 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
13.0%
3/23 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
19.0%
4/21 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
10.3%
6/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
17.2%
10/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
4/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
8.6%
5/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
3/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
5.2%
3/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute chest syndrome
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung hypoinflation
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vascular disorder
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
6.9%
4/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
3.4%
2/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.8%
3/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Vascular disorders
Hypotension
|
6.5%
4/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.2%
2/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Neutrophilic dermatosis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Social circumstances
Menopause
|
0.00%
0/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Vascular disorders
Hypertension
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
1.7%
1/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Vascular disorders
Superficial vein thrombosis
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
|
Vascular disorders
Systolic hypertension
|
1.6%
1/62 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
0.00%
0/58 • From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious and non-serious event during the study. Safety population included all enrolled participants who received treatment with study drug voxelotor in current study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER