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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

    Summary
    EudraCT number
    		 2020-005286-13
    Trial protocol
    		 FR   DE   IT  
    Global end of trial date
    06 Jun 2024

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

    Trial information

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    Trial identification
    Sponsor protocol code
    C5361001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04935879
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Other Study ID: GBT2104-131
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    66 Hudson Boulevard East, New York, United States, NY 10001
    Public contact
    PfizerClinicalTrials.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-003219-PIP01-22
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Aug 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the safety and efficacy of treatment every 12-week with inclacumab to reduce the incidence of Vaso-occlusive Crises (VOCs) in participants with sickle cell disease (SCD).
    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 trials participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Oct 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 25
    Country: Number of subjects enrolled
    Colombia: 15
    Country: Number of subjects enrolled
    Egypt: 19
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Kenya: 56
    Country: Number of subjects enrolled
    Lebanon: 8
    Country: Number of subjects enrolled
    Nigeria: 60
    Country: Number of subjects enrolled
    Oman: 4
    Country: Number of subjects enrolled
    Saudi Arabia: 3
    Country: Number of subjects enrolled
    Tanzania, United Republic of: 11
    Country: Number of subjects enrolled
    Türkiye: 10
    Country: Number of subjects enrolled
    United States: 26
    Worldwide total number of subjects
    241
    EEA total number of subjects
    4
    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)
    39
    Adults (18-64 years)
    202
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult and adolescent participants with sickle cell disease (SCD) were enrolled across 12 countries.

    Pre-assignment
    Screening details
    		 A total of 241 participants were enrolled and randomized in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Double blind method was used.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Inclacumab
    Arm description
    		 Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of “48-Week Treatment Period”. Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Inclacumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received inclacumab at a dose of 30 mg/kg, IV, Q12W on Day 1 on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of “48-Week Treatment Period”.

    Arm title
    		 Placebo
    Arm description
    		 Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of “48-Week Treatment Period”. Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received placebo IV, Q12W on Day 1 on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of “48-Week Treatment Period”.

    Number of subjects in period 1
    		Inclacumab Placebo
    Started
    119
    122
    Treated
    118
    121
    Completed
    103
    108
    Not completed
    16
    14
         Consent withdrawn by subject
    8
    6
         Adverse event, non-fatal
    2
    1
         Pregnancy
    2
    3
         Unspecified
    3
    3
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Inclacumab
    Reporting group description
    		 Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of “48-Week Treatment Period”. Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of “48-Week Treatment Period”. Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

    Reporting group values
    		 Inclacumab Placebo Total
    Number of subjects
    		 119 122
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.0 ( 7.14 ) 24.6 ( 8.34 ) -
    Gender categorical
    Units: Subjects
        Male
    		 55 59 114
        Female
    		 64 63 127
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 18 19 37
        Not Hispanic or Latino
    		 92 102 194
        Unknown or Not Reported
    		 9 1 10
    Race/Ethnicity, Customized
    Units: Subjects
        Race African
    		 63 58 121
        Race American Indian or Alaska Native
    		 3 2 5
        Race Arab
    		 1 2 3
        Race Black or African American
    		 16 24 40
        Race Middle Eastern
    		 1 0 1
        Race White
    		 7 10 17
        Race Other
    		 2 1 3
        Race Multiracial
    		 22 25 47
        Race Not Reported
    		 4 0 4
    Age categorical
    Units: Subjects
        >= 16 to less than (<) 18 years
    		 12 27 39
        >= 18 to 65 years
    		 107 95 202

    End points

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    End points reporting groups
    Reporting group title
    Inclacumab
    Reporting group description
    		 Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of “48-Week Treatment Period”. Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of “48-Week Treatment Period”. Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

    Primary: Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48

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    End point title
    		 Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48
    End point description
    Rate of VOCs during the 48-week treatment period. A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. The rate of VOC was defined as number of VOC events per 48 weeks and presented in this endpoint. The intent-to treat (ITT) population included all randomized participants.
    End point type
    Primary
    End point timeframe
    Randomization (Day 1) up to Week 48
    End point values
    		 Inclacumab Placebo
    Number of subjects analysed
    119
    122
    Units: Events per 48 weeks
        number (confidence interval 95%)
    1.49 (1.22 to 1.83)
    1.58 (1.30 to 1.93)
    Statistical analysis title
    		 Inclacumab vs placebo
    Statistical analysis description
    Adjusted rates are based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline hydroxyurea (HU) use (yes, no), number of VOCs in 12 months prior to screening visit (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of world).
    Comparison groups
    Inclacumab v Placebo
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.6967
    Method
    		 Negative binomial regression model
    Parameter type
    		 Rate ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.25
    Notes
    [1] - Rate ratio = Ratio of rate of VOC for inclacumab group to placebo group.

    Secondary: Time to First VOC Through Week 48

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    End point title
    		 Time to First VOC Through Week 48
    End point description
    A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to first VOC was the time between randomization date and onset date of first VOC event during 48 weeks. Kaplan-Meier method was used for estimation. The ITT population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Randomization (Day 1) up to Week 48
    End point values
    		 Inclacumab Placebo
    Number of subjects analysed
    119
    122
    Units: Weeks
        median (confidence interval 95%)
    28.7 (15.7 to 43.1)
    21.6 (17.3 to 28.7)
    Statistical analysis title
    		 Inclacumab vs placebo
    Statistical analysis description
    Analysis was stratified by baseline HU use (yes, no), number of VOCs in 12 months prior to screening visit (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of world).
    Comparison groups
    Inclacumab v Placebo
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4298
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.22

    Secondary: Time to Second VOC Through Week 48

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    End point title
    		 Time to Second VOC Through Week 48
    End point description
    A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to second VOC was the time between randomization date and onset date of second VOC event during 48 weeks. Kaplan-Meier method was used for estimation. The ITT population included all randomized participants. 99999 signifies: Median, upper and lower limit of 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
    End point type
    Secondary
    End point timeframe
    Randomization (Day 1) up to Week 48
    End point values
    		 Inclacumab Placebo
    Number of subjects analysed
    119
    122
    Units: Weeks
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With no VOCs Through Week 48

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    End point title
    		 Percentage of Participants With no VOCs Through Week 48
    End point description
    A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Participants without an observed VOC who discontinued the study prior to the end of the 48-week treatment period were assumed to had experienced at least one VOC. The ITT population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Randomization (Day 1) up to Week 48
    End point values
    		 Inclacumab Placebo
    Number of subjects analysed
    119
    122
    Units: Percentage of participants
        number (confidence interval 95%)
    36.0 (27.1 to 45.0)
    25.7 (17.7 to 33.7)
    Statistical analysis title
    		 Inclacumab vs placebo
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) test stratified by baseline HU use (yes, no), number of VOCs in the 12 months prior to study entry (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of world).
    Comparison groups
    Inclacumab v Placebo
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0912
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentage
    Point estimate
    10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 22.2

    Secondary: Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48

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    End point title
    		 Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48
    End point description
    A VOC that required admission to a healthcare facility and treatment with parenteral pain medication where admission included: a hospital admission or an admission to an emergency room, observation unit, or infusion center for >= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. The rate of VOC was defined as number of VOC events per 48 weeks; rate of VOCs which required admission to a healthcare facility and treatment with parenteral pain medication is presented in this endpoint. The ITT population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Randomization (Day 1) up to Week 48
    End point values
    		 Inclacumab Placebo
    Number of subjects analysed
    119
    122
    Units: Events per 48 weeks
        number (confidence interval 95%)
    0.85 (0.65 to 1.10)
    0.83 (0.64 to 1.08)
    Statistical analysis title
    		 Inclacumab vs placebo
    Statistical analysis description
    Adjusted rates are based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline HU use (yes, no), number of VOCs in the 12 months prior to screening visit (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of the world).
    Comparison groups
    Inclacumab v Placebo
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.9246
    Method
    		 Negative binomial regression model
    Parameter type
    		 Rate Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.47
    Notes
    [2] - Rate ratio = Ratio of rate of VOC for inclacumab group to placebo group.

    Secondary: Rate of Inpatient Hospitalization Days for a VOC Through Week 48

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    End point title
    		 Rate of Inpatient Hospitalization Days for a VOC Through Week 48
    End point description
    A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility hospitalization. For each VOC event requiring inpatient hospitalization (regardless of treatment received) during the 48-week, the number of days hospitalized were determined based on the hospital admission and discharge dates. The rate of inpatient hospitalization days was defined as number of inpatient hospitalization days for a VOC per 48 weeks and presented in this endpoint. The ITT population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Randomization (Day 1) up to Week 48
    End point values
    		 Inclacumab Placebo
    Number of subjects analysed
    119
    122
    Units: Hospitalization days per 48 weeks
        number (confidence interval 95%)
    4.96 (3.05 to 8.07)
    5.37 (3.34 to 8.62)
    Statistical analysis title
    		 Inclacumab vs placebo
    Statistical analysis description
    Adjusted rates are based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline HU use (yes, no), number of VOCs in 12 months prior to screening visit (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of world).
    Comparison groups
    Inclacumab v Placebo
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8263 [3]
    Method
    		 Negative binomial regression model
    Parameter type
    		 Rate ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.87
    Notes
    [3] - Rate ratio = Ratio of rate of VOC for inclacumab group to placebo group.

    Secondary: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs)
    End point description
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE was defined as an AE with an onset after the initiation of dosing for the first dose of study drug. A serious adverse events (SAE) or serious suspected adverse reaction is an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization and congenital anomaly/birth defect. AEs included both serious and all non-SAEs. Safety population included randomized participants who received treatment with study drug.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 60 (12 week of follow-up post Week 48)
    End point values
    		 Inclacumab Placebo
    Number of subjects analysed
    118
    121
    Units: Participants
    87
    97
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to Week 60 (12 week of follow-up post Week 48)
    Adverse event reporting additional description
    Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety population included randomized participants who received treatment with study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v28.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of “48-Week Treatment Period”. Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

    Reporting group title
    Inclacumab
    Reporting group description
    		 Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of “48-Week Treatment Period”. Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

    Serious adverse events
    		 Placebo Inclacumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 121 (22.31%)
    23 / 118 (19.49%)
         number of deaths (all causes)
    2
    3
         number of deaths resulting from adverse events
    2
    3
    Vascular disorders
    Deep vein thrombosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Disorientation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Migraine
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 121 (6.61%)
    3 / 118 (2.54%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolysis
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Umbilical hernia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urethral stenosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 121 (4.13%)
    5 / 118 (4.24%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bacterial infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 121 (2.48%)
    2 / 118 (1.69%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 118 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 121 (5.79%)
    5 / 118 (4.24%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Inclacumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    90 / 121 (74.38%)
    83 / 118 (70.34%)
    Vascular disorders
    Hyperaemia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Phlebitis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 121 (0.83%)
    3 / 118 (2.54%)
         occurrences all number
    1
    5
    Flushing
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Haematoma
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    2
    Hypertension
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    5 / 121 (4.13%)
    6 / 118 (5.08%)
         occurrences all number
    7
    8
    Pyrexia
         subjects affected / exposed
    4 / 121 (3.31%)
    7 / 118 (5.93%)
         occurrences all number
    4
    7
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 121 (0.83%)
    4 / 118 (3.39%)
         occurrences all number
    1
    4
    Asthenia
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 118 (1.69%)
         occurrences all number
    1
    2
    Chest pain
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    2
    Chest discomfort
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Gait disturbance
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Malaise
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    2
    Injury associated with device
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Sluggishness
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Swelling
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 121 (1.65%)
    3 / 118 (2.54%)
         occurrences all number
    2
    3
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    2
    Hypersensitivity
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Priapism
         subjects affected / exposed
    2 / 121 (1.65%)
    2 / 118 (1.69%)
         occurrences all number
    2
    2
    Penile swelling
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    2
    Erectile dysfunction
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Vaginal discharge
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Hypoxia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Asthma
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    6 / 121 (4.96%)
    3 / 118 (2.54%)
         occurrences all number
    7
    3
    Dyspnoea
         subjects affected / exposed
    0 / 121 (0.00%)
    3 / 118 (2.54%)
         occurrences all number
    0
    3
    Cough
         subjects affected / exposed
    3 / 121 (2.48%)
    3 / 118 (2.54%)
         occurrences all number
    3
    3
    Painful respiration
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Tachypnoea
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Sinus disorder
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Pulmonary embolism
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Pleural effusion
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 121 (0.00%)
    3 / 118 (2.54%)
         occurrences all number
    0
    4
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    2 / 121 (1.65%)
    1 / 118 (0.85%)
         occurrences all number
    2
    1
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    3 / 121 (2.48%)
    3 / 118 (2.54%)
         occurrences all number
    3
    4
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 118 (1.69%)
         occurrences all number
    1
    2
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    2
    Platelet count decreased
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Blood bilirubin increased
         subjects affected / exposed
    2 / 121 (1.65%)
    1 / 118 (0.85%)
         occurrences all number
    2
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Blood fibrinogen decreased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Blood potassium increased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    C-reactive protein
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Coagulation test abnormal
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Serum ferritin increased
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Reticulocyte percentage increased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Reticulocyte count increased
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Prothrombin time shortened
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Protein total decreased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Platelet count increased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Neutrophil count abnormal
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Blood iron decreased
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    3 / 121 (2.48%)
    0 / 118 (0.00%)
         occurrences all number
    4
    0
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 118 (0.00%)
         occurrences all number
    2
    0
    Contusion
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Infusion related reaction
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Limb injury
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Road traffic accident
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Concussion
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Joint injury
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Muscle injury
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Vascular access site pruritus
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    2
    Cor pulmonale acute
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Cardiomegaly
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 118 (1.69%)
         occurrences all number
    1
    2
    Headache
         subjects affected / exposed
    21 / 121 (17.36%)
    16 / 118 (13.56%)
         occurrences all number
    31
    22
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Epilepsy
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Psychogenic seizure
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    3 / 121 (2.48%)
    1 / 118 (0.85%)
         occurrences all number
    3
    1
    Amputation stump pain
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Amnesia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Ageusia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    21 / 121 (17.36%)
    21 / 118 (17.80%)
         occurrences all number
    33
    36
    Anaemia
         subjects affected / exposed
    9 / 121 (7.44%)
    5 / 118 (4.24%)
         occurrences all number
    10
    8
    Thrombocytopenia
         subjects affected / exposed
    0 / 121 (0.00%)
    4 / 118 (3.39%)
         occurrences all number
    0
    5
    Neutropenia
         subjects affected / exposed
    0 / 121 (0.00%)
    3 / 118 (2.54%)
         occurrences all number
    0
    4
    Leukocytosis
         subjects affected / exposed
    2 / 121 (1.65%)
    1 / 118 (0.85%)
         occurrences all number
    2
    1
    Neutrophilia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Thrombocytosis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Lymphadenitis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Haemolysis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Vertigo
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Pterygium
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Photophobia
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Retinopathy sickle cell
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 118 (1.69%)
         occurrences all number
    1
    2
    Nausea
         subjects affected / exposed
    1 / 121 (0.83%)
    7 / 118 (5.93%)
         occurrences all number
    1
    7
    Diarrhoea
         subjects affected / exposed
    2 / 121 (1.65%)
    5 / 118 (4.24%)
         occurrences all number
    2
    5
    Abdominal pain
         subjects affected / exposed
    3 / 121 (2.48%)
    3 / 118 (2.54%)
         occurrences all number
    3
    3
    Vomiting
         subjects affected / exposed
    1 / 121 (0.83%)
    3 / 118 (2.54%)
         occurrences all number
    1
    3
    Abdominal pain upper
         subjects affected / exposed
    2 / 121 (1.65%)
    2 / 118 (1.69%)
         occurrences all number
    2
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 118 (1.69%)
         occurrences all number
    1
    2
    Peptic ulcer
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 118 (1.69%)
         occurrences all number
    1
    2
    Toothache
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    3
    Flatulence
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Reflux gastritis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Tooth disorder
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Dental caries
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 118 (0.00%)
         occurrences all number
    2
    0
    Gastritis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Hyperchlorhydria
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 118 (1.69%)
         occurrences all number
    1
    3
    Hepatobiliary disorders
    Hepatic cytolysis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Cholecystitis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Cholelithiasis
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Cholestasis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 121 (1.65%)
    1 / 118 (0.85%)
         occurrences all number
    2
    1
    Ocular icterus
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pityriasis alba
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Blister
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Skin lesion
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Rash papular
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Skin ulcer
         subjects affected / exposed
    1 / 121 (0.83%)
    4 / 118 (3.39%)
         occurrences all number
    1
    5
    Pruritus
         subjects affected / exposed
    0 / 121 (0.00%)
    3 / 118 (2.54%)
         occurrences all number
    0
    4
    Dermatitis allergic
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 118 (1.69%)
         occurrences all number
    1
    2
    Ecchymosis
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Pruritus allergic
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Nephropathy
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Hypertonic bladder
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Dysuria
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Acute kidney injury
         subjects affected / exposed
    0 / 121 (0.00%)
    3 / 118 (2.54%)
         occurrences all number
    0
    4
    Endocrine disorders
    Thyroid mass
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    12 / 121 (9.92%)
    15 / 118 (12.71%)
         occurrences all number
    19
    30
    Back pain
         subjects affected / exposed
    14 / 121 (11.57%)
    10 / 118 (8.47%)
         occurrences all number
    23
    12
    Pain in extremity
         subjects affected / exposed
    5 / 121 (4.13%)
    7 / 118 (5.93%)
         occurrences all number
    6
    10
    Muscle fatigue
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Joint swelling
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Costochondritis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Osteoporosis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Muscle twitching
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Osteonecrosis
         subjects affected / exposed
    2 / 121 (1.65%)
    2 / 118 (1.69%)
         occurrences all number
    2
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 121 (1.65%)
    3 / 118 (2.54%)
         occurrences all number
    2
    4
    Bone pain
         subjects affected / exposed
    3 / 121 (2.48%)
    4 / 118 (3.39%)
         occurrences all number
    5
    4
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Malaria
         subjects affected / exposed
    24 / 121 (19.83%)
    18 / 118 (15.25%)
         occurrences all number
    40
    30
    Nasopharyngitis
         subjects affected / exposed
    2 / 121 (1.65%)
    9 / 118 (7.63%)
         occurrences all number
    3
    10
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 121 (9.92%)
    9 / 118 (7.63%)
         occurrences all number
    25
    14
    COVID-19
         subjects affected / exposed
    3 / 121 (2.48%)
    4 / 118 (3.39%)
         occurrences all number
    4
    4
    Urinary tract infection
         subjects affected / exposed
    4 / 121 (3.31%)
    4 / 118 (3.39%)
         occurrences all number
    4
    4
    Gastroenteritis
         subjects affected / exposed
    3 / 121 (2.48%)
    2 / 118 (1.69%)
         occurrences all number
    3
    2
    Influenza
         subjects affected / exposed
    2 / 121 (1.65%)
    2 / 118 (1.69%)
         occurrences all number
    2
    2
    Pneumonia
         subjects affected / exposed
    3 / 121 (2.48%)
    2 / 118 (1.69%)
         occurrences all number
    4
    2
    Respiratory tract infection
         subjects affected / exposed
    2 / 121 (1.65%)
    2 / 118 (1.69%)
         occurrences all number
    2
    2
    Bacteraemia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Herpes simplex reactivation
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Otitis media acute
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    3 / 121 (2.48%)
    1 / 118 (0.85%)
         occurrences all number
    4
    1
    Sepsis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    7 / 121 (5.79%)
    1 / 118 (0.85%)
         occurrences all number
    9
    1
    Vulvovaginitis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Bacterial infection
         subjects affected / exposed
    8 / 121 (6.61%)
    0 / 118 (0.00%)
         occurrences all number
    10
    0
    Bronchitis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Infected skin ulcer
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Wound sepsis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Metabolic acidosis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Iron deficiency
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Hyperferritinaemia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Diabetes mellitus
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    0
    1
    Decreased appetite
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 118 (0.85%)
         occurrences all number
    1
    1
    Dehydration
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 118 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2020
    Amendment 1: The purpose of this amendment was to include the addition of biomarkers removal of exclusion criteria for positive HepB, HepC, or HIV and removal of exclusion criteria for participants with significant infections.
    21 Jan 2021
    Amendment 2: The purpose of this amendment was to change the duration of contraception for females and males after completion of treatment with study drug and to collect whole blood for voxelotor PK.
    11 Apr 2022
    Amendment 3: The purpose of this amendment was to add addictive condition” to “behavioral condition, clarified rules for management of infusion-related reactions; added treatment compliance assessment; and removed thrombin-antithrombin complex and tissue factory laboratory tests.
    13 Jul 2023
    Amendment 4: The purpose of this amendment was to add a futility analysis and align the protocol with language in Pfizer protocol template and standard operating procedures.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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