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    Clinical Trial Results:
    An Open Label Extension (OLE) Study of Voxelotor (GBT440) Administered Orally to Subjects With Sickle Cell Disease who Have Participated in Voxelotor Clinical Trials

    Summary
    EudraCT number
    		 2017-004045-25
    Trial protocol
    		 GB   FR   NL   IT  
    Global end of trial date
    11 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Aug 2025
    First version publication date
    15 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C5341022
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03573882
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Other study ID: GBT440-034
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    66 Hudson Boulevard East, New York, United States, NY 10001-2192
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002356-PIP02-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Jun 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this open-label extension (OLE) study was to assess the long-term safety and treatment effect of voxelotor in subjects who had completed treatment in study GBT440-031 (NCT03036813), using the following parameters: safety based upon adverse events (AEs), clinical laboratory tests, physical examinations (PE) and other clinical measures; frequency of sickle cell disease-related complications and hemolytic anemia as measured by hematological laboratory parameters (example hemoglobin, reticulocytes and unconjugated bilirubin).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Egypt: 33
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Kenya: 37
    Country: Number of subjects enrolled
    Lebanon: 6
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Oman: 8
    Country: Number of subjects enrolled
    Türkiye: 8
    Country: Number of subjects enrolled
    United States: 55
    Worldwide total number of subjects
    178
    EEA total number of subjects
    9
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    28
    Adults (18-64 years)
    150
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was an OLE study which included eligible participants from study GBT440-031 (NCT03036813). All participants were administered voxelotor 1500 milligrams (mg) in this study and results were stratified according to previous treatment in GBT440-031 (NCT03036813).

    Pre-assignment
    Screening details
    		 A total of 179 participants enrolled, 178 received treatment and 1 did not receive treatment. The study was terminated as emerging clinical data observed in studies other than GBT440-034 indicated that risk profile of voxelotor in people with SCD exceeded benefits observed in previously generated global research and required further assessment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prior treatment of placebo in GBT440-031 (NCT03036813)
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Voxelotor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received voxelotor 1500 mg orally once daily.

    Arm title
    		 Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813)
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Voxelotor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received voxelotor 1500 mg orally once daily.

    Arm title
    		 Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Voxelotor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received voxelotor 1500 mg orally once daily.

    Number of subjects in period 1
    		Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Started
    62
    58
    58
    Completed
    16
    11
    19
    Not completed
    46
    47
    39
         Consent withdrawn by subject
    5
    11
    7
         Physician decision
    4
    3
    2
         Adverse event, non-fatal
    7
    5
    6
         Pregnancy
    1
    2
    -
         Subject was Noncompliant with Study Drug
    1
    2
    1
         Unspecified
    4
    2
    2
         Study Terminated by Sponsor
    22
    17
    18
         Lost to follow-up
    2
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prior treatment of placebo in GBT440-031 (NCT03036813)
    Reporting group description
    		 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.

    Reporting group title
    Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813)
    Reporting group description
    		 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.

    Reporting group title
    Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Reporting group description
    		 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.

    Reporting group values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813) Total
    Number of subjects
    		 62 58 58
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 28.5 ( 10.80 ) 28.5 ( 11.90 ) 29.0 ( 13.00 ) -
    Gender categorical
    Units: Subjects
        Male
    		 34 23 21 78
        Female
    		 28 35 37 100
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 5 3 1 9
        Not Hispanic or Latino
    		 57 55 56 168
        Unknown or Not Reported
    		 0 0 1 1
    Race
    Units: Subjects
        African
    		 14 8 12 34
        Arab
    		 9 10 9 28
        Asian
    		 0 0 1 1
        Black or African American
    		 26 27 26 79
        Middle Eastern
    		 5 2 2 9
        White
    		 4 5 4 13
        Other
    		 2 2 0 4
        Multiracial
    		 2 4 4 10

    End points

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    End points reporting groups
    Reporting group title
    Prior treatment of placebo in GBT440-031 (NCT03036813)
    Reporting group description
    		 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.

    Reporting group title
    Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813)
    Reporting group description
    		 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.

    Reporting group title
    Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Reporting group description
    		 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.

    Primary: Number of Participants With Non- SCD-Related TEAEs

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    End point title
    		 Number of Participants With Non- SCD-Related TEAEs [1]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no statistical analysis for this primary endpoint.
    End point values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Number of subjects analysed
    62
    58
    58
    Units: Participants
    59
    49
    52
    No statistical analyses for this end point

    Primary: Number of Participants With Sickle Cell Disease (SCD)-Related Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Sickle Cell Disease (SCD)-Related Treatment Emergent Adverse Events (TEAEs) [2]
    End point description
    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, ACS, pneumonia, priapism, and osteonecrosis. The number of participants with any SCD-related TEAEs was reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no statistical analysis for this primary endpoint.
    End point values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Number of subjects analysed
    62
    58
    58
    Units: Participants
    47
    42
    42
    No statistical analyses for this end point

    Primary: Annualized Incidence Rate of On-Treatment Vaso-occlusive Crisis (VOCs)

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    End point title
    		 Annualized Incidence Rate of On-Treatment Vaso-occlusive Crisis (VOCs) [3]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    From date of informed consent to last dose of study drug (maximum up to 296.7 weeks)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no statistical analysis for this primary endpoint.
    End point values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Number of subjects analysed
    62
    58
    58
    Units: VOC events per person year
        number (confidence interval 95%)
    1.038 (0.896 to 1.195)
    0.926 (0.778 to 1.095)
    0.889 (0.760 to 1.034)
    No statistical analyses for this end point

    Primary: Annualized Incidence Rate of SCD-Related Complications

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    End point title
    		 Annualized Incidence Rate of SCD-Related Complications [4]
    End point description
    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 and 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 all SCD related complication is reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no statistical analysis for this primary endpoint.
    End point values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Number of subjects analysed
    62
    58
    58
    Units: Events per person year
        number (confidence interval 95%)
    1.181 (1.031 to 1.347)
    1.084 (0.924 to 1.264)
    1.045 (0.905 to 1.200)
    No statistical analyses for this end point

    Primary: Number of Participants With SCD-Related Treatment Emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants With SCD-Related Treatment Emergent Serious Adverse Events (TESAEs) [5]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no statistical analysis for this primary endpoint.
    End point values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Number of subjects analysed
    62
    58
    58
    Units: Participants
    39
    33
    22
    No statistical analyses for this end point

    Primary: Number of Participants With Non-SCD-Related TESAEs

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    End point title
    		 Number of Participants With Non-SCD-Related TESAEs [6]
    End point description
    A SAE at any dose, in view of either investigator or Pfizer, results 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. A TESAE was defined as an SAE that emerges on or after initiation of study drug (having been absent pretreatment), or an AE that existed pretreatment and worsened on treatment (relative to pretreatment state). Number of participants with Non- SCD-Related TESAEs was reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no statistical analysis for this primary endpoint.
    End point values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Number of subjects analysed
    62
    58
    58
    Units: Participants
    18
    14
    15
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hemoglobin Level at Week 48

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    End point title
    		 Change From Baseline in Hemoglobin Level at Week 48
    End point description
    Change from baseline in hemoglobin at Week 48 was reported in this endpoint. 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. The safety population included all enrolled subjects who received treatment with study drug voxelotor in the current study. Here, 'Subjects Analyzed'= number of subjects evaluable for this endpoint and n= number of subjects evaluable for specified rows.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Number of subjects analysed
    57
    53
    55
    Units: Gram per deciliter (g/dL)
    arithmetic mean (standard deviation)
        Baseline (n=57,53,55)
    8.8 ( 1.32 )
    9.0 ( 1.52 )
    9.5 ( 1.61 )
        Change at Week 48 (n=40,35,39)
    1.2 ( 1.50 )
    0.7 ( 1.48 )
    0.2 ( 1.15 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Reticulocytes Percentage at Week 48

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    End point title
    		 Percent Change From Baseline in Reticulocytes Percentage at Week 48
    End point description
    Percent change from baseline in reticulocytes percentage at week 48 was reported in this endpoint. 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. The safety population included all enrolled subjects who received treatment with study drug voxelotor in the current study. Here, 'Subjects Analyzed'= number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Number of subjects analysed
    38
    33
    35
    Units: Percent change
        arithmetic mean (standard deviation)
    -24.9 ( 58.13 )
    -15.3 ( 55.82 )
    -21.0 ( 81.29 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Absolute Reticulocytes at Week 48

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    End point title
    		 Percent Change From Baseline in Absolute Reticulocytes at Week 48
    End point description
    Percent change from baseline in absolute reticulocytes at week 48 was reported in this endpoint. 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. The safety population included all enrolled subjects who received treatment with study drug voxelotor in the current study. Here, 'Subjects Analyzed'= number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Number of subjects analysed
    33
    23
    31
    Units: Percent change
        arithmetic mean (standard deviation)
    111.3 ( 721.86 )
    -11.5 ( 50.14 )
    -12.2 ( 58.18 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Indirect Bilirubin at Week 48

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    End point title
    		 Percent Change From Baseline in Indirect Bilirubin at Week 48
    End point description
    Percent change from baseline in indirect bilirubin at week 48 was reported in this endpoint. 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. The safety population included all enrolled subjects who received treatment with study drug voxelotor in the current study. Here, 'Subjects Analyzed'= number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Number of subjects analysed
    35
    32
    33
    Units: Percent change
        arithmetic mean (standard deviation)
    -39.3 ( 40.70 )
    3.8 ( 70.47 )
    1.2 ( 84.21 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From date of informed consent up to 28 days after last dose of study drug (maximum up to 300.7 weeks)
    Adverse event reporting additional description
    Safety population included all enrolled participants who received treatment with study drug voxelotor in current study. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or one participant may have experienced both a serious & non-serious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v27.1
    Reporting groups
    Reporting group title
    Prior treatment of placebo in GBT440-031 (NCT03036813)
    Reporting group description
    		 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.

    Reporting group title
    Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813)
    Reporting group description
    		 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.

    Reporting group title
    Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813)
    Reporting group description
    		 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.

    Serious adverse events
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    42 / 62 (67.74%)
    26 / 58 (44.83%)
    35 / 58 (60.34%)
         number of deaths (all causes)
    3
    5
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Superficial vein thrombosis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 58 (3.45%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Respiratory tract infection
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Priapism
         subjects affected / exposed [1]
    1 / 34 (2.94%)
    2 / 21 (9.52%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute chest syndrome
         subjects affected / exposed
    8 / 62 (12.90%)
    4 / 58 (6.90%)
    7 / 58 (12.07%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    White blood cell count increased
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Delayed haemolytic transfusion reaction
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Sickle cell anaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Central nervous system lesion
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    36 / 62 (58.06%)
    20 / 58 (34.48%)
    32 / 58 (55.17%)
         occurrences causally related to treatment / all
    0 / 101
    0 / 59
    2 / 67
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Haemolysis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    3 / 62 (4.84%)
    1 / 58 (1.72%)
    5 / 58 (8.62%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Eye disorders
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperchlorhydria
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone infarction
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    4 / 62 (6.45%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parvovirus infection
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This PT term was reported for male population only.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Prior treatment of placebo in GBT440-031 (NCT03036813) Prior treatment of voxelotor 1500mg in GBT440-031(NCT03036813) Prior treatment of voxelotor 900mg in GBT440-031(NCT03036813)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 62 (96.77%)
    54 / 58 (93.10%)
    50 / 58 (86.21%)
    Vascular disorders
    Superficial vein thrombosis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Hypotension
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    4
    0
    0
    Systolic hypertension
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    12 / 62 (19.35%)
    8 / 58 (13.79%)
    7 / 58 (12.07%)
         occurrences all number
    14
    11
    13
    Asthenia
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    2
    Malaise
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    2 / 58 (3.45%)
         occurrences all number
    1
    1
    2
    Influenza like illness
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 58 (5.17%)
    0 / 58 (0.00%)
         occurrences all number
    1
    3
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 58 (3.45%)
    1 / 58 (1.72%)
         occurrences all number
    2
    2
    1
    Non-cardiac chest pain
         subjects affected / exposed
    4 / 62 (6.45%)
    5 / 58 (8.62%)
    6 / 58 (10.34%)
         occurrences all number
    9
    6
    9
    Fatigue
         subjects affected / exposed
    5 / 62 (8.06%)
    5 / 58 (8.62%)
    5 / 58 (8.62%)
         occurrences all number
    5
    6
    5
    Pyrexia
         subjects affected / exposed
    9 / 62 (14.52%)
    6 / 58 (10.34%)
    6 / 58 (10.34%)
         occurrences all number
    11
    6
    7
    Administration site irritation
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Swelling face
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Physical deconditioning
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hernia pain
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Facial pain
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Hunger
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Social circumstances
    Menopause
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Priapism
         subjects affected / exposed [2]
    3 / 34 (8.82%)
    4 / 21 (19.05%)
    3 / 23 (13.04%)
         occurrences all number
    3
    5
    4
    Dysmenorrhoea
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 58 (5.17%)
    1 / 58 (1.72%)
         occurrences all number
    1
    13
    1
    Intermenstrual bleeding
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Menstruation irregular
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Abnormal uterine bleeding
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Vaginal discharge
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Menometrorrhagia
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Menstruation delayed
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    2
    Penile pain
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Polycystic ovaries
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Erectile dysfunction
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 62 (3.23%)
    10 / 58 (17.24%)
    6 / 58 (10.34%)
         occurrences all number
    3
    10
    8
    Oropharyngeal pain
         subjects affected / exposed
    4 / 62 (6.45%)
    2 / 58 (3.45%)
    5 / 58 (8.62%)
         occurrences all number
    5
    9
    6
    Nasal congestion
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 58 (3.45%)
    2 / 58 (3.45%)
         occurrences all number
    3
    2
    2
    Rhinorrhoea
         subjects affected / exposed
    0 / 62 (0.00%)
    3 / 58 (5.17%)
    2 / 58 (3.45%)
         occurrences all number
    0
    3
    2
    Dyspnoea
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    2
    Acute chest syndrome
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    2
    1
    0
    Hypoxia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    2
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Tonsillar hypertrophy
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Atelectasis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Bronchial disorder
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Asthma
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    2
    Lung consolidation
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Lung hypoinflation
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Nasal septum deviation
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Painful respiration
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Pharyngeal swelling
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Pleural effusion
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Throat irritation
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary vascular disorder
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Rales
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Respiratory failure
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Sneezing
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Sputum discoloured
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Pulmonary hypertension
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Throat tightness
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Depression
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    0
    3
    Confusional state
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Delirium
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    3
    Delusion
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    4 / 62 (6.45%)
    2 / 58 (3.45%)
    2 / 58 (3.45%)
         occurrences all number
    4
    2
    2
    Initial insomnia
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Paranoia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 62 (8.06%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    8
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    5
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Cardiac murmur
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    2
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Blood iron decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Liver function test abnormal
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Helicobacter test positive
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Foetal haemoglobin decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Eosinophil count increased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Blood corticotrophin decreased
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Mean cell volume decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    3
    0
    Vitamin D decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Staphylococcus test positive
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary function test decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Urine protein/creatinine ratio increased
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Ligament injury
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Joint dislocation
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Immunisation reaction
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Fall
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Lower limb fracture
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Toxicity to various agents
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    4
    Procedural pain
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Foot fracture
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    2 / 58 (3.45%)
         occurrences all number
    1
    1
    2
    Ankle fracture
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Radius fracture
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Skin wound
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Soft tissue injury
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Thermal burn
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Transfusion reaction
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Wound complication
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    1
    Tachycardia
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Cardiomegaly
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Arrhythmia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Atrial flutter
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Heart failure with reduced ejection fraction
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Silent myocardial infarction
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 62 (25.81%)
    14 / 58 (24.14%)
    10 / 58 (17.24%)
         occurrences all number
    23
    22
    16
    Dizziness
         subjects affected / exposed
    4 / 62 (6.45%)
    7 / 58 (12.07%)
    2 / 58 (3.45%)
         occurrences all number
    4
    8
    3
    Lethargy
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    3
    0
    2
    Hypoaesthesia
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Burning sensation
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Cerebral infarction
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    0
    2
    Migraine
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Ageusia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Balance disorder
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Facial paralysis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Head discomfort
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hemiparaesthesia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperaesthesia
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Presyncope
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Tension headache
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Vestibular migraine
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 58 (5.17%)
    3 / 58 (5.17%)
         occurrences all number
    2
    3
    5
    Sickle cell anaemia with crisis
         subjects affected / exposed
    28 / 62 (45.16%)
    31 / 58 (53.45%)
    24 / 58 (41.38%)
         occurrences all number
    80
    111
    70
    Thrombocytopenia
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 58 (3.45%)
    2 / 58 (3.45%)
         occurrences all number
    1
    3
    2
    Abdominal lymphadenopathy
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Reticulocytopenia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Thrombocytosis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    0
    2
    Microcytosis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Neutrophilia
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    2 / 58 (3.45%)
         occurrences all number
    0
    1
    2
    Haemolysis
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Cerumen impaction
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Astigmatism
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Retinopathy sickle cell
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Retinal haemorrhage
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Vision blurred
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Vitreous haemorrhage
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Blepharitis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Cataract
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Visual impairment
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Retinopathy proliferative
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Retinopathy
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal neovascularisation
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal detachment
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Glaucoma
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Dry eye
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    14 / 62 (22.58%)
    4 / 58 (6.90%)
    11 / 58 (18.97%)
         occurrences all number
    20
    4
    13
    Vomiting
         subjects affected / exposed
    9 / 62 (14.52%)
    6 / 58 (10.34%)
    8 / 58 (13.79%)
         occurrences all number
    11
    6
    10
    Diarrhoea
         subjects affected / exposed
    11 / 62 (17.74%)
    4 / 58 (6.90%)
    6 / 58 (10.34%)
         occurrences all number
    13
    5
    7
    Dyspepsia
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Flatulence
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    2 / 58 (3.45%)
         occurrences all number
    0
    2
    2
    Abdominal pain lower
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Abdominal discomfort
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 58 (3.45%)
    2 / 58 (3.45%)
         occurrences all number
    2
    2
    3
    Gastritis
         subjects affected / exposed
    1 / 62 (1.61%)
    5 / 58 (8.62%)
    2 / 58 (3.45%)
         occurrences all number
    1
    13
    2
    Abdominal pain upper
         subjects affected / exposed
    4 / 62 (6.45%)
    6 / 58 (10.34%)
    3 / 58 (5.17%)
         occurrences all number
    6
    6
    7
    Abdominal pain
         subjects affected / exposed
    8 / 62 (12.90%)
    6 / 58 (10.34%)
    4 / 58 (6.90%)
         occurrences all number
    10
    8
    5
    Constipation
         subjects affected / exposed
    5 / 62 (8.06%)
    5 / 58 (8.62%)
    9 / 58 (15.52%)
         occurrences all number
    7
    5
    12
    Umbilical hernia
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Anal haemorrhage
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    0
    3
    Faecaloma
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    1
    Abdominal distension
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Dental caries
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences all number
    1
    2
    0
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Glossitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Hyperchlorhydria
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Lip disorder
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Oesophagitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Oral pain
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Faeces soft
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Gastric ulcer
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Tongue discolouration
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Ocular icterus
         subjects affected / exposed
    3 / 62 (4.84%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    3
    1
    1
    Cholelithiasis
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    2
    0
    2
    Hepatomegaly
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Hepatic cytolysis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic cyst
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Cholestasis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Cholecystitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Biliary dilatation
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    2
    Jaundice
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    4
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 58 (3.45%)
    4 / 58 (6.90%)
         occurrences all number
    3
    2
    5
    Rash
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 58 (3.45%)
    1 / 58 (1.72%)
         occurrences all number
    2
    2
    2
    Skin ulcer
         subjects affected / exposed
    3 / 62 (4.84%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    4
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Erythema
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Alopecia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Drug eruption
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Dry skin
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Night sweats
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Hypertrichosis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    2
    Purpura
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Pigmentation disorder
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Neutrophilic dermatosis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Neurodermatitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Livedo reticularis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Skin plaque
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Skin hypopigmentation
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    3 / 58 (5.17%)
         occurrences all number
    1
    1
    4
    Acute kidney injury
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Chronic kidney disease
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    2
    Haematuria
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Renal injury
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Nephropathy
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Renal cyst
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Renal hypertrophy
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Microalbuminuria
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary retention
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    10 / 62 (16.13%)
    11 / 58 (18.97%)
    6 / 58 (10.34%)
         occurrences all number
    18
    19
    10
    Arthralgia
         subjects affected / exposed
    14 / 62 (22.58%)
    9 / 58 (15.52%)
    9 / 58 (15.52%)
         occurrences all number
    17
    14
    13
    Pain in extremity
         subjects affected / exposed
    10 / 62 (16.13%)
    15 / 58 (25.86%)
    9 / 58 (15.52%)
         occurrences all number
    12
    28
    21
    Bone pain
         subjects affected / exposed
    5 / 62 (8.06%)
    3 / 58 (5.17%)
    3 / 58 (5.17%)
         occurrences all number
    13
    7
    3
    Musculoskeletal chest pain
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 58 (3.45%)
    2 / 58 (3.45%)
         occurrences all number
    3
    2
    3
    Bone lesion
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Bone infarction
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Arthritis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Tenosynovitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    0
    2
    Spinal pain
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    2
    1
    0
    Sjogren's syndrome
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Pain in jaw
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Neck pain
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    2 / 58 (3.45%)
         occurrences all number
    0
    1
    3
    Myalgia
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    1 / 58 (1.72%)
         occurrences all number
    0
    2
    1
    Osteonecrosis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    3 / 58 (5.17%)
         occurrences all number
    0
    1
    3
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Osteopenia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Osteosclerosis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Patellofemoral pain syndrome
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Tendonitis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Synovitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Muscular weakness
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Joint swelling
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Groin pain
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Flank pain
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    2
    Sacral pain
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 62 (19.35%)
    14 / 58 (24.14%)
    4 / 58 (6.90%)
         occurrences all number
    23
    26
    10
    COVID-19
         subjects affected / exposed
    2 / 62 (3.23%)
    9 / 58 (15.52%)
    4 / 58 (6.90%)
         occurrences all number
    3
    12
    4
    Pharyngitis
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 58 (3.45%)
    1 / 58 (1.72%)
         occurrences all number
    2
    2
    1
    Bronchitis
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 58 (3.45%)
    2 / 58 (3.45%)
         occurrences all number
    1
    2
    2
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 58 (1.72%)
    3 / 58 (5.17%)
         occurrences all number
    3
    1
    5
    Cellulitis
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 58 (3.45%)
    1 / 58 (1.72%)
         occurrences all number
    1
    3
    1
    Malaria
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 58 (5.17%)
    5 / 58 (8.62%)
         occurrences all number
    2
    3
    16
    Gastroenteritis
         subjects affected / exposed
    2 / 62 (3.23%)
    4 / 58 (6.90%)
    5 / 58 (8.62%)
         occurrences all number
    3
    10
    5
    Tonsillitis
         subjects affected / exposed
    6 / 62 (9.68%)
    6 / 58 (10.34%)
    1 / 58 (1.72%)
         occurrences all number
    9
    13
    1
    Urinary tract infection
         subjects affected / exposed
    5 / 62 (8.06%)
    3 / 58 (5.17%)
    6 / 58 (10.34%)
         occurrences all number
    6
    4
    9
    Nasopharyngitis
         subjects affected / exposed
    4 / 62 (6.45%)
    5 / 58 (8.62%)
    5 / 58 (8.62%)
         occurrences all number
    4
    7
    5
    Pneumonia
         subjects affected / exposed
    3 / 62 (4.84%)
    3 / 58 (5.17%)
    2 / 58 (3.45%)
         occurrences all number
    3
    4
    2
    Infection
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    1
    Influenza
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 58 (3.45%)
    1 / 58 (1.72%)
         occurrences all number
    1
    2
    1
    Rhinitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    0
    2
    Laryngitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    2
    1
    Helicobacter infection
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Coronavirus infection
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Anal abscess
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    2 / 58 (3.45%)
         occurrences all number
    0
    1
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Tooth abscess
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    1
    0
    2
    Abscess limb
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Hepatitis C
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Gingivitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Furuncle
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Orchitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchiolitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Body tinea
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Bacterial infection
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Acarodermatitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Otitis media
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Urethritis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Tinea versicolour
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea capitis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Suspected COVID-19
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Skin infection
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Pilonidal disease
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Penile infection
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Parotitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Paraspinal abscess
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract candidiasis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Wound sepsis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Vulval abscess
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Vaginal infection
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    1
    Hyperkalaemia
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 58 (3.45%)
    1 / 58 (1.72%)
         occurrences all number
    1
    2
    1
    Gout
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Haemochromatosis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Decreased appetite
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 58 (3.45%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 58 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    0
    2
    Hypercalcaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Multi-vitamin deficiency
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Magnesium deficiency
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Iron overload
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 58 (1.72%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This PT term was reported for male population only.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jun 2018
    The study design was updated to reflect the varying conditions that allow enrollment into the study. Efficacy endpoint was removed (Measures of hemolysis previously captured under “Efficacy endpoints” were moved to “Treatment effects”).

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 Sep 2024
    Pfizer discontinue voxelotor Study GBT440-034 (C5341022) on 25 September 2024. Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicated that the risk profile of voxelotor in people with SCD exceeded the benefits observed.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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