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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

    Summary
    EudraCT number
    		 2021-003434-36
    Trial protocol
    		 CZ   DE   HU   BE   FR   AT   PL   NL   IT   ES   NO  
    Global end of trial date
    11 Apr 2024

    Results information
    Results version number
    		 v2(current)
    This version publication date
    19 Apr 2025
    First version publication date
    19 Mar 2025
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    To update endpoint data as per NIH review.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-590-6154
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05079230
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Israel Clinical Research Site: MOH_2022-08-15_011983
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    11 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The goal of this clinical study was to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who were not able to have chemotherapy.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 2022
    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
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 93
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Belgium: 17
    Country: Number of subjects enrolled
    Czechia: 26
    Country: Number of subjects enrolled
    France: 40
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Netherlands: 21
    Country: Number of subjects enrolled
    Norway: 4
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Spain: 52
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Hong Kong: 9
    Country: Number of subjects enrolled
    Taiwan: 22
    Country: Number of subjects enrolled
    Australia: 18
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 12
    Worldwide total number of subjects
    378
    EEA total number of subjects
    207
    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)
    0
    Adults (18-64 years)
    30
    From 65 to 84 years
    324
    85 years and over
    24

    Subject disposition

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    Recruitment
    Recruitment details
    		 502 participants were screened.

    Pre-assignment
    Screening details
    		 Participants were enrolled at study sites in Asia, Europe, North America and Australia.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Magrolimab + Venetoclax + Azacitidine
    Arm description
    		 Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Magrolimab
    Investigational medicinal product code
    Other name
    GS-4721
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously (IV)

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Administered according to region-specific drug labeling, either subcutaneously (SC) or intravenously (IV)

    Investigational medicinal product name
    Venetoclax
    Investigational medicinal product code
    Other name
    VENCLEXTA
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered orally

    Arm title
    		 Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Arm description
    		 Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Magrolimab Matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously (IV)

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Administered according to region-specific drug labeling, either subcutaneously (SC) or intravenously (IV)

    Investigational medicinal product name
    Venetoclax
    Investigational medicinal product code
    Other name
    VENCLEXTA
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered orally

    Number of subjects in period 1
    		Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Started
    189
    189
    Completed
    0
    0
    Not completed
    189
    189
         Death
    72
    66
         Study Terminated by Sponsor
    101
    102
         Withdrew consent
    16
    18
         Lost to follow-up
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Magrolimab + Venetoclax + Azacitidine
    Reporting group description
    		 Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.

    Reporting group title
    Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Reporting group description
    		 Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.

    Reporting group values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine Total
    Number of subjects
    		 189 189 378
    Age categorical
    Units: Subjects
        < 75 Years
    		 93 91 184
        >= 75 Years
    		 96 98 194
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 74 ( 7.0 ) 74 ( 8.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 73 83 156
        Male
    		 116 106 222
    Race
    Units: Subjects
        White
    		 130 130 260
        Not Collected
    		 26 30 56
        Asian
    		 26 25 51
        Other or More Than One Race
    		 4 2 6
        Black or African American
    		 3 2 5
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 18 12 30
        Not Hispanic or Latino
    		 149 149 298
        Unknown or Not Reported
    		 22 28 50

    End points

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    End points reporting groups
    Reporting group title
    Magrolimab + Venetoclax + Azacitidine
    Reporting group description
    		 Participants received magrolimab 1 mg/kg priming dose intravenously (IV) on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses, and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3, and daily thereafter; azacitidine 75 mg/m² subcutaneously (SC) or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.

    Reporting group title
    Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Reporting group description
    		 Participants received magrolimab matching placebo IV on Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter; venetoclax 100 mg orally on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; azacitidine 75 mg/m^2 SC or IV on Days 1-7 or Days 1-5 and 8-9 of each cycle up to 1.4 years. Each cycle was of 28 days.

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was measured from the date of randomization to the date of death from any cause. Participants were censored at last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis. Analysis Population Description: Participants in the Intent-to-Treat Analysis Set were analyzed. The Intent-to-Treat Analysis Set included all randomized participants according to the treatment arm to which the participants were randomized, unless otherwise specified. 9999: Upper limit of confidence interval (CI) was not estimable due to low number of participants with events.
    End point type
    Primary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    189
    189
    Units: months
        median (confidence interval 95%)
    10.7 (8.7 to 14.9)
    14.1 (9.7 to 9999)
    Statistical analysis title
    		 Experimental Group vs Control Group
    Comparison groups
    Magrolimab + Venetoclax + Azacitidine v Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3276 [1]
    Method
    		 stratified log-rank test
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.178
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.848
         upper limit
    		 1.637
    Notes
    [1] - The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization. Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.

    Secondary: Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh)

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    End point title
    		 Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh)
    End point description
    The CR + CRh rate was defined as the percentage of participants who achieved a CR (including CR without minimal residual disease (CRMRD-) and CR with positive or unknown MRD (CRMRD+/unk)) or CRh as defined by CR with partial platelet and absolute neutrophil count recovery within 6 cycles of treatment while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT). CRMRD- and CRMRD+/unk: neutrophils >1.0 ×10^9/L, platelets >100 ×10^9/L, <5% bone marrow blasts, no circulating blasts or extramedullary disease (confirmed by flow cytometry <0.1% sensitivity for CRMRD-) within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days. Analysis Population Description: Participants in the Intent-to-Treat analysis set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    189
    189
    Units: percentage of participants
        number (confidence interval 95%)
    47.6 (40.3 to 55.0)
    53.4 (46.1 to 60.7)
    Statistical analysis title
    		 Experimental Group vs Control Group
    Comparison groups
    Magrolimab + Venetoclax + Azacitidine v Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3616 [2]
    Method
    		 Stratum-adjusted Mantel-Haenszel
    Parameter type
    		 Stratified Odds Ratio
    Point estimate
    0.826
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.545
         upper limit
    		 1.251
    Notes
    [2] - Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.

    Secondary: Rate of Complete Remission (CR)

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    End point title
    		 Rate of Complete Remission (CR)
    End point description
    CR was defined as the percentage of the participants who achieved CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment as determined by the investigator while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT) within the response assessment window of 1.6 years. Definitions for CRMRD- and CRMRD+/unk were mentioned in outcome measure #2. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days. Analysis Population Description: Participants in the Intent-To-Treat Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    189
    189
    Units: percentage of participants
        number (confidence interval 95%)
    41.3 (34.2 to 48.6)
    46.0 (38.8 to 53.4)
    Statistical analysis title
    		 Experimental Group vs Control Group
    Comparison groups
    Magrolimab + Venetoclax + Azacitidine v Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4679 [3]
    Method
    		 Stratum-adjusted Mantel-Haenszel
    Parameter type
    		 Stratified Odds Ratio
    Point estimate
    0.856
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.307
    Notes
    [3] - Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.

    Secondary: Event-Free Survival (EFS)

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    End point title
    		 Event-Free Survival (EFS)
    End point description
    EFS was defined as time from the date of randomization to the earliest date of the documented relapse from CR, treatment failure (defined as failure to achieve CR within 6 cycles of treatment), or death from any cause within the response window. CR is defined in outcome measure #2. KM estimates were used in outcome measure analysis. Analysis Population Description: Participants in the Intent-To-Treat Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    189
    189
    Units: months
        median (confidence interval 95%)
    0.0 (0.0 to 5.4)
    1.7 (0.0 to 4.5)
    Statistical analysis title
    		 Experimental Group vs Control Group
    Comparison groups
    Magrolimab + Venetoclax + Azacitidine v Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7903 [4]
    Method
    		 Stratified Log Rank
    Parameter type
    		 Stratified Hazard Ratio
    Point estimate
    0.946
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.225
    Notes
    [4] - The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.

    Secondary: Duration of CR + CRh in Participants who achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh)

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    End point title
    		 Duration of CR + CRh in Participants who achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh)
    End point description
    The duration of CR + CRh was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) or CRh within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cut off date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, duration of CR + CRh were censored at the last response assessment before the initiation of the new anti-AML therapies. CR and CRh are defined in Outcome Measure #2. Each cycle was of 28 days. Participants in the Intent-To-Treat Analysis Set who achieved CR + CRh within 6 cycles were analyzed. 9999: Upper limit of CI was not estimable due to low number of participants with events.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    90
    101
    Units: months
        median (confidence interval 95%)
    9.4 (5.9 to 9999)
    9.2 (5.8 to 9999)
    No statistical analyses for this end point

    Secondary: Duration of Complete Remission (DCR) in Participants who achieved Complete Remission (CR)

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    End point title
    		 Duration of Complete Remission (DCR) in Participants who achieved Complete Remission (CR)
    End point description
    The DCR measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cutoff date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, DCR were censored at the last response assessment before the initiation of the new anti-AML therapies. KM estimates were used in outcome measure analysis. CRMRD- and CRMRD+/unk are defined in outcome measure #2. Each cycle was of 28 days. Participants in the ITT Analysis Set who achieved CR within 6 cycle were analyzed. 9999: Upper limit of CI wasnt estimable due to low number of participants with events.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    78
    87
    Units: months
        median (confidence interval 95%)
    9.4 (6.3 to 9999)
    8.1 (5.7 to 9999)
    No statistical analyses for this end point

    Secondary: Rate of CR/CRh Without Minimal Residual Disease (CR/CRhMRD-)

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    End point title
    		 Rate of CR/CRh Without Minimal Residual Disease (CR/CRhMRD-)
    End point description
    The CR/CRhMRD- rate was the percentage of participants who achieved a CRMRD- or CRhMRD- within 6 cycles of treatment while on study prior to initiation of any new anti-AML therapy or SCT within the response assessment window of 1.6 years. Each cycle was of 28 days. KM estimates were used for outcome measure analysis. CRhMRD- : neutrophils > 0.5 x 10^9/L; platelets > 50 x 10^9/L; bone marrow blasts < 5%; MRD negative (determined using multiparameter flow cytometry with a sensitivity of < 0.1%). Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRMRD is defined in outcome measure #2. Percentages were rounded off. Analysis Population Description: Participants in the Intent-To-Treat Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    189
    189
    Units: percentage of participants
        number (confidence interval 95%)
    24.3 (18.4 to 31.1)
    22.2 (16.5 to 28.8)
    Statistical analysis title
    		 Experimental Group vs Control Group
    Comparison groups
    Magrolimab + Venetoclax + Azacitidine v Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4873 [5]
    Method
    		 Stratum-adjusted Mantel Haenszel
    Parameter type
    		 Stratified Odds Ratio
    Point estimate
    1.189
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.727
         upper limit
    		 1.945
    Notes
    [5] - Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.

    Secondary: Rate of CR Without Minimal Residual Disease (CRMRD-)

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    End point title
    		 Rate of CR Without Minimal Residual Disease (CRMRD-)
    End point description
    The CRMRD- rate was the percentage of participants who achieved a CRMRD- within 6 cycles of treatment SCT within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. CRMRD- is defined in outcome measure #2. Each cycle was of 28 days. Analysis Population Description: Participants in the Intent-To-Treat Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    189
    189
    Units: percentage of participants
        number (confidence interval 95%)
    21.7 (16.0 to 28.3)
    20.1 (14.6 to 26.5)
    Statistical analysis title
    		 Experimental Group vs Control Group
    Comparison groups
    Magrolimab + Venetoclax + Azacitidine v Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5842 [6]
    Method
    		 Stratum-adjusted Mantel Haenszel
    Parameter type
    		 Stratified Odds Ratio
    Point estimate
    1.154
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.932
    Notes
    [6] - Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.

    Secondary: Red blood cell (RBC) Transfusion Independence Conversion Rate

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    End point title
    		 Red blood cell (RBC) Transfusion Independence Conversion Rate
    End point description
    The RBC transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no RBC or whole blood transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were RBC transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    151
    151
    Units: percentage of participants
        number (confidence interval 95%)
    51.7 (43.4 to 59.9)
    58.3 (50.0 to 66.2)
    Statistical analysis title
    		 Experimental Group vs Control Group
    Comparison groups
    Magrolimab + Venetoclax + Azacitidine v Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3003 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Stratified Odds Ratio
    Point estimate
    0.783
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.492
         upper limit
    		 1.245
    Notes
    [7] - The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).

    Secondary: Time to First Deterioration (TTD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale

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    End point title
    		 Time to First Deterioration (TTD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale
    End point description
    The TTD on the EORTC QLQ-C30 GHS/QoL scale was defined as time from the date of randomization to the time a participant experienced at least 1 threshold value deterioration from baseline or death, whichever was earlier. Questionnaire includes 30 questions resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 GHS/QoL scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). After linear transformation, all scales and single item measures range in score from 0-100. Higher score on GHS/QoL scale meant better GHS/QoL. KM estimates were used in outcome measure analysis. Participants in the Intent-To-Treat Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    189
    189
    Units: months
        median (confidence interval 95%)
    4.7 (2.3 to 6.3)
    5.1 (2.8 to 6.9)
    Statistical analysis title
    		 Experimental Group vs Control Group
    Comparison groups
    Magrolimab + Venetoclax + Azacitidine v Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5796 [8]
    Method
    		 Stratified Log Rank
    Parameter type
    		 Stratified Hazard Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.799
         upper limit
    		 1.487
    Notes
    [8] - The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.

    Secondary: Platelet Transfusion Independence Conversion Rate

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    End point title
    		 Platelet Transfusion Independence Conversion Rate
    End point description
    The platelet transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no platelet transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were platelet transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Analysis Population Description: Participants in the Intent-To-Treat Analysis Set with Platelet transfusion dependence at Baseline were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    74
    74
    Units: percentage of participants
        number (confidence interval 95%)
    48.6 (36.9 to 60.6)
    47.3 (35.6 to 59.3)
    Statistical analysis title
    		 Experimental Group vs Control Group
    Comparison groups
    Magrolimab + Venetoclax + Azacitidine v Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.579 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Stratified Odds Ratio
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 2.36
    Notes
    [9] - The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).

    Secondary: Time to First Deterioration (TTD) on the EORTC QLQ-C30 Physical Functioning Scale

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    End point title
    		 Time to First Deterioration (TTD) on the EORTC QLQ-C30 Physical Functioning Scale
    End point description
    The TTD on the EORTC QLQ-C30 physical functioning scale was defined as time from the date of randomization to the time a participant experienced at least 1 threshold value deterioration from baseline or death, whichever is earlier. Physical functioning scale is one of the five functional scales of the EORTC QLQ C30 questionnaire. After linear transformation, scale range in score from 0-100. A higher score on functional scales means better functioning and better quality of life. KM estimates were used in outcome measure analysis. Participants in the Intent-To-Treat Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    189
    189
    Units: months
        number (confidence interval 95%)
    3.0 (2.1 to 4.4)
    3.9 (2.8 to 6.9)
    Statistical analysis title
    		 Time to First Deterioration (TTD) on the EORTC QLQ
    Statistical analysis description
    -C30 Physical Functioning Scale
    Comparison groups
    Magrolimab + Venetoclax + Azacitidine v Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1026 [10]
    Method
    		 Stratified Log Rank
    Parameter type
    		 Stratified Hazard Ratio
    Point estimate
    1.271
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.948
         upper limit
    		 1.704
    Notes
    [10] - PLACEHOLDER20

    Secondary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
    End point description
    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 70 days after the study drug last dose date or the day before initiation of new anti-AML therapy including stem cell transplantation, whichever is earlier. Percentages were rounded-off. Analysis Population Description: The Safety Analysis Set included all participants who received at least 1 dose of any study treatment, with treatment assignments designated according to the actual treatment received.
    End point type
    Secondary
    End point timeframe
    First dose date up to 1.4 years plus 70 days
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    189
    184
    Units: percentage of participants
        number (not applicable)
    99.5
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Grade 3 or Higher Treatment-Emergent Laboratory Abnormalities

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    End point title
    		 Percentage of Participants Experiencing Grade 3 or Higher Treatment-Emergent Laboratory Abnormalities
    End point description
    Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 70 days or the day before the initiation of new anti-AML therapy including SCT, whichever came first, and were summarized by treatment group. Severity grades were defined by the CTCAE Version 5.0. 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-Threatening; 5 = Death. Percentages were rounded-off. Participants in the Safety Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    First dose date up to 1.4 years, plus 70 days
    End point values
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Number of subjects analysed
    189
    184
    Units: percentage of participants
        number (not applicable)
    99.5
    100
    No statistical analyses for this end point

    Secondary: Serum Concentration of Magrolimab over time

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    End point title
    		 Serum Concentration of Magrolimab over time [11]
    End point description
    The Pharmacokinetic (PK) Analysis Set included all randomized participants who took at least one dose of magrolimab and have at least 1 measurable (non - below the limit of quantitation (BLQ) numeric values) post-treatment serum concentration of magrolimab with data available for analysis.
    End point type
    Secondary
    End point timeframe
    Predose on Day 1, Day 8, Day 15, Day 29; Predose on Day 57 and 1 hour post-dose; Predose on Day 113, Day 169, Day 253, and Day 337.
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 Magrolimab + Venetoclax + Azacitidine
    Number of subjects analysed
    156
    Units: µg/mL
    arithmetic mean (standard deviation)
        D 1 Predose N=156
    0 ( 0 )
        D 8 Predose N=135
    0 ( 0 )
        D 15 Predose N=143
    291 ( 123 )
        D 29 Predose N=129
    385 ( 206 )
        D 57 Predose N=111
    503 ( 230 )
        D 57, 1 h Postdose N=103
    1060 ( 289 )
        D 113 Predose N=91
    281 ( 140 )
        D 169 Predose N=62
    274 ( 120 )
        D 253 Predose N=28
    322 ( 151 )
        D 337 Predose N=16
    298 ( 72.9 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Anti-Magrolimab Antibodies

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    End point title
    		 Percentage of Participants With Anti-Magrolimab Antibodies [12]
    End point description
    Percentages were rounded-off. Analysis Population Description: The participants in the Immunogenicity Analysis Set with available data were analyzed. The Immunogenicity Analysis Set included all randomized participants who received at least one dose of magrolimab and had at least one evaluable anti-magrolimab antibody test result.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 Magrolimab + Venetoclax + Azacitidine
    Number of subjects analysed
    166
    Units: percentage of participants
    number (not applicable)
        ADA Incidence
    2.4
    No statistical analyses for this end point

    Secondary: Maximum Levels of Serum Anti-Magrolimab Antibodies

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    End point title
    		 Maximum Levels of Serum Anti-Magrolimab Antibodies [13]
    End point description
    Analysis Population Description: Data is reported for participants in the Immunogenicity Analysis Set with quantifiable measurement for ADA for magrolimab.
    End point type
    Secondary
    End point timeframe
    Up to 1.6 years
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 Magrolimab + Venetoclax + Azacitidine
    Number of subjects analysed
    4
    Units: Titer
        arithmetic mean (standard deviation)
    40 ( 67.33 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality: Up to 1.6 years; Adverse events: 1.4 years plus 70 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Magrolimab + Venetoclax + Azacitidine
    Reporting group description
    		 Patients who received Magrolimab + Venetoclax + Azacitidine

    Reporting group title
    Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Reporting group description
    		 Patients who received magrolimab matching placebo + venetoclax + azacitidine

    Serious adverse events
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    138 / 189 (73.02%)
    134 / 184 (72.83%)
         number of deaths (all causes)
    84
    70
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 189 (0.53%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism venous
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortitis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superficial vein thrombosis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health ~ deterioration
         subjects affected / exposed
    2 / 189 (1.06%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyrexia
         subjects affected / exposed
    9 / 189 (4.76%)
    4 / 184 (2.17%)
         occurrences causally related to treatment / all
    4 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion site extravasation
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    6 / 189 (3.17%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 0
         deaths causally related to treatment / all
    1 / 4
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    3 / 189 (1.59%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary toxicity
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical condition abnormal
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    3 / 189 (1.59%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin I increased
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    6 / 189 (3.17%)
    3 / 184 (1.63%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Refractoriness to platelet ~ transfusion
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medication error
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    7 / 189 (3.70%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    8 / 8
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hip fracture
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Spinal fracture
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiogenic shock
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    2 / 189 (1.06%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    4 / 189 (2.12%)
    4 / 184 (2.17%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 189 (0.53%)
    4 / 184 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    2 / 189 (1.06%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Encephalopathy
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral microembolism
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrapyramidal disorder
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy chronic
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    8 / 189 (4.23%)
    8 / 184 (4.35%)
         occurrences causally related to treatment / all
    12 / 13
    8 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone marrow failure
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agranulocytosis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    44 / 189 (23.28%)
    47 / 184 (25.54%)
         occurrences causally related to treatment / all
    38 / 59
    39 / 62
         deaths causally related to treatment / all
    2 / 2
    1 / 2
    Haemolysis
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile bone marrow aplasia
         subjects affected / exposed
    2 / 189 (1.06%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 189 (0.53%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    5 / 189 (2.65%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    3 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterocolitis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 189 (0.53%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 189 (2.12%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 189 (0.53%)
    5 / 184 (2.72%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic hypoperfusion
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 189 (0.00%)
    3 / 184 (1.63%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Chronic kidney disease
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    5 / 189 (2.65%)
    5 / 184 (2.72%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haematuria
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    5 / 189 (2.65%)
    7 / 184 (3.80%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Pneumonia
         subjects affected / exposed
    17 / 189 (8.99%)
    15 / 184 (8.15%)
         occurrences causally related to treatment / all
    7 / 19
    2 / 16
         deaths causally related to treatment / all
    2 / 7
    0 / 4
    Covid-19
         subjects affected / exposed
    7 / 189 (3.70%)
    6 / 184 (3.26%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    7 / 189 (3.70%)
    3 / 184 (1.63%)
         occurrences causally related to treatment / all
    4 / 7
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    17 / 189 (8.99%)
    8 / 184 (4.35%)
         occurrences causally related to treatment / all
    10 / 21
    5 / 8
         deaths causally related to treatment / all
    4 / 7
    2 / 2
    Device related infection
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 189 (0.00%)
    3 / 184 (1.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 189 (0.53%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorectal infection
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    3 / 189 (1.59%)
    3 / 184 (1.63%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 189 (1.06%)
    3 / 184 (1.63%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 189 (1.06%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 189 (0.53%)
    3 / 184 (1.63%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 189 (0.00%)
    3 / 184 (1.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 189 (0.53%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Covid-19 pneumonia
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pseudomonal sepsis
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 189 (0.00%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site cellulitis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacillus bacteraemia
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematological infection
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter infection
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular device infection
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abscess of salivary gland
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion site cellulitis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral infection
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Periorbital cellulitis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Otosalpingitis
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis intestinal perforated
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial ~ viral
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stenotrophomonas sepsis
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 189 (0.53%)
    2 / 184 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    2 / 189 (1.06%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 189 (0.53%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 189 (0.00%)
    1 / 184 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 189 (0.53%)
    0 / 184 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Magrolimab + Venetoclax + Azacitidine Magrolimab Matching Placebo + Venetoclax + Azacitidine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    180 / 189 (95.24%)
    179 / 184 (97.28%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    19 / 189 (10.05%)
    19 / 184 (10.33%)
         occurrences all number
    25
    30
    Hypertension
         subjects affected / exposed
    14 / 189 (7.41%)
    16 / 184 (8.70%)
         occurrences all number
    25
    22
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    22 / 189 (11.64%)
    16 / 184 (8.70%)
         occurrences all number
    34
    22
    Pyrexia
         subjects affected / exposed
    58 / 189 (30.69%)
    51 / 184 (27.72%)
         occurrences all number
    85
    72
    Oedema peripheral
         subjects affected / exposed
    27 / 189 (14.29%)
    39 / 184 (21.20%)
         occurrences all number
    32
    45
    Fatigue
         subjects affected / exposed
    34 / 189 (17.99%)
    36 / 184 (19.57%)
         occurrences all number
    37
    44
    Injection site reaction
         subjects affected / exposed
    7 / 189 (3.70%)
    14 / 184 (7.61%)
         occurrences all number
    7
    14
    Oedema
         subjects affected / exposed
    10 / 189 (5.29%)
    1 / 184 (0.54%)
         occurrences all number
    11
    1
    Chills
         subjects affected / exposed
    14 / 189 (7.41%)
    11 / 184 (5.98%)
         occurrences all number
    18
    18
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    26 / 189 (13.76%)
    19 / 184 (10.33%)
         occurrences all number
    29
    22
    Epistaxis
         subjects affected / exposed
    15 / 189 (7.94%)
    16 / 184 (8.70%)
         occurrences all number
    17
    17
    Pleural effusion
         subjects affected / exposed
    11 / 189 (5.82%)
    9 / 184 (4.89%)
         occurrences all number
    11
    11
    Rhinorrhoea
         subjects affected / exposed
    5 / 189 (2.65%)
    14 / 184 (7.61%)
         occurrences all number
    7
    19
    Hypoxia
         subjects affected / exposed
    6 / 189 (3.17%)
    11 / 184 (5.98%)
         occurrences all number
    6
    12
    Cough
         subjects affected / exposed
    28 / 189 (14.81%)
    20 / 184 (10.87%)
         occurrences all number
    30
    22
    Oropharyngeal pain
         subjects affected / exposed
    5 / 189 (2.65%)
    15 / 184 (8.15%)
         occurrences all number
    5
    16
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    20 / 189 (10.58%)
    12 / 184 (6.52%)
         occurrences all number
    20
    14
    Anxiety
         subjects affected / exposed
    3 / 189 (1.59%)
    10 / 184 (5.43%)
         occurrences all number
    3
    10
    Delirium
         subjects affected / exposed
    3 / 189 (1.59%)
    10 / 184 (5.43%)
         occurrences all number
    3
    11
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    34 / 189 (17.99%)
    14 / 184 (7.61%)
         occurrences all number
    46
    14
    Neutrophil count decreased
         subjects affected / exposed
    51 / 189 (26.98%)
    38 / 184 (20.65%)
         occurrences all number
    170
    126
    Platelet count decreased
         subjects affected / exposed
    40 / 189 (21.16%)
    45 / 184 (24.46%)
         occurrences all number
    130
    116
    White blood cell count decreased
         subjects affected / exposed
    19 / 189 (10.05%)
    21 / 184 (11.41%)
         occurrences all number
    39
    40
    Weight decreased
         subjects affected / exposed
    20 / 189 (10.58%)
    13 / 184 (7.07%)
         occurrences all number
    26
    13
    Aspartate aminotransferase increased
         subjects affected / exposed
    17 / 189 (8.99%)
    11 / 184 (5.98%)
         occurrences all number
    21
    12
    Blood creatinine increased
         subjects affected / exposed
    12 / 189 (6.35%)
    14 / 184 (7.61%)
         occurrences all number
    21
    18
    Blood alkaline phosphatase increased
         subjects affected / exposed
    14 / 189 (7.41%)
    8 / 184 (4.35%)
         occurrences all number
    16
    8
    Alanine aminotransferase increased
         subjects affected / exposed
    15 / 189 (7.94%)
    4 / 184 (2.17%)
         occurrences all number
    18
    7
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    28 / 189 (14.81%)
    14 / 184 (7.61%)
         occurrences all number
    39
    15
    Fall
         subjects affected / exposed
    20 / 189 (10.58%)
    16 / 184 (8.70%)
         occurrences all number
    23
    23
    Contusion
         subjects affected / exposed
    12 / 189 (6.35%)
    8 / 184 (4.35%)
         occurrences all number
    12
    13
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    18 / 189 (9.52%)
    9 / 184 (4.89%)
         occurrences all number
    20
    11
    Nervous system disorders
    Headache
         subjects affected / exposed
    22 / 189 (11.64%)
    24 / 184 (13.04%)
         occurrences all number
    32
    34
    Dizziness
         subjects affected / exposed
    14 / 189 (7.41%)
    25 / 184 (13.59%)
         occurrences all number
    19
    31
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    38 / 189 (20.11%)
    31 / 184 (16.85%)
         occurrences all number
    48
    38
    Thrombocytopenia
         subjects affected / exposed
    39 / 189 (20.63%)
    47 / 184 (25.54%)
         occurrences all number
    76
    85
    Anaemia
         subjects affected / exposed
    92 / 189 (48.68%)
    63 / 184 (34.24%)
         occurrences all number
    198
    141
    Neutropenia
         subjects affected / exposed
    67 / 189 (35.45%)
    76 / 184 (41.30%)
         occurrences all number
    239
    232
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    30 / 189 (15.87%)
    39 / 184 (21.20%)
         occurrences all number
    39
    53
    Stomatitis
         subjects affected / exposed
    12 / 189 (6.35%)
    20 / 184 (10.87%)
         occurrences all number
    12
    20
    Dyspepsia
         subjects affected / exposed
    7 / 189 (3.70%)
    10 / 184 (5.43%)
         occurrences all number
    7
    12
    Abdominal pain
         subjects affected / exposed
    18 / 189 (9.52%)
    20 / 184 (10.87%)
         occurrences all number
    22
    27
    Diarrhoea
         subjects affected / exposed
    76 / 189 (40.21%)
    67 / 184 (36.41%)
         occurrences all number
    110
    92
    Nausea
         subjects affected / exposed
    66 / 189 (34.92%)
    60 / 184 (32.61%)
         occurrences all number
    86
    86
    Haemorrhoids
         subjects affected / exposed
    19 / 189 (10.05%)
    15 / 184 (8.15%)
         occurrences all number
    19
    17
    Constipation
         subjects affected / exposed
    72 / 189 (38.10%)
    76 / 184 (41.30%)
         occurrences all number
    90
    101
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    10 / 189 (5.29%)
    3 / 184 (1.63%)
         occurrences all number
    10
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    17 / 189 (8.99%)
    17 / 184 (9.24%)
         occurrences all number
    20
    17
    Rash
         subjects affected / exposed
    17 / 189 (8.99%)
    12 / 184 (6.52%)
         occurrences all number
    21
    15
    Rash maculo-papular
         subjects affected / exposed
    11 / 189 (5.82%)
    14 / 184 (7.61%)
         occurrences all number
    15
    17
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    15 / 189 (7.94%)
    5 / 184 (2.72%)
         occurrences all number
    15
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    22 / 189 (11.64%)
    22 / 184 (11.96%)
         occurrences all number
    27
    25
    Back pain
         subjects affected / exposed
    20 / 189 (10.58%)
    18 / 184 (9.78%)
         occurrences all number
    22
    20
    Pain in extremity
         subjects affected / exposed
    12 / 189 (6.35%)
    17 / 184 (9.24%)
         occurrences all number
    13
    23
    Muscular weakness
         subjects affected / exposed
    9 / 189 (4.76%)
    13 / 184 (7.07%)
         occurrences all number
    9
    17
    Infections and infestations
    Covid-19
         subjects affected / exposed
    18 / 189 (9.52%)
    22 / 184 (11.96%)
         occurrences all number
    18
    24
    Pneumonia
         subjects affected / exposed
    15 / 189 (7.94%)
    14 / 184 (7.61%)
         occurrences all number
    19
    14
    Urinary tract infection
         subjects affected / exposed
    6 / 189 (3.17%)
    11 / 184 (5.98%)
         occurrences all number
    10
    13
    Bacteraemia
         subjects affected / exposed
    5 / 189 (2.65%)
    10 / 184 (5.43%)
         occurrences all number
    5
    10
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    49 / 189 (25.93%)
    54 / 184 (29.35%)
         occurrences all number
    99
    101
    Hypophosphataemia
         subjects affected / exposed
    26 / 189 (13.76%)
    27 / 184 (14.67%)
         occurrences all number
    37
    39
    Hypomagnesaemia
         subjects affected / exposed
    23 / 189 (12.17%)
    10 / 184 (5.43%)
         occurrences all number
    40
    13
    Hypocalcaemia
         subjects affected / exposed
    15 / 189 (7.94%)
    14 / 184 (7.61%)
         occurrences all number
    21
    19
    Hyperglycaemia
         subjects affected / exposed
    10 / 189 (5.29%)
    15 / 184 (8.15%)
         occurrences all number
    10
    17
    Hyponatraemia
         subjects affected / exposed
    9 / 189 (4.76%)
    11 / 184 (5.98%)
         occurrences all number
    12
    17
    Hypoalbuminaemia
         subjects affected / exposed
    6 / 189 (3.17%)
    12 / 184 (6.52%)
         occurrences all number
    7
    18
    Decreased appetite
         subjects affected / exposed
    40 / 189 (21.16%)
    29 / 184 (15.76%)
         occurrences all number
    44
    39

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Sep 2021
    Herein was a summary of the major changes made to the original protocol dated 30 June 2021 and reflected in Amendment 1 dated 08 September 2021. The protocol had been amended primarily to: incorporate changes based on feedback from the United States (US) Food and Drug Administration (FDA) and incorporate changes based on feedback from the Medicines and Healthcare products Regulatory Agency (MHRA). To highlight the cumulative differences between the original protocol and Amendment 1 of the protocol, changes/additions were in bold italicized font and deletions were depicted with strikethrough text.
    01 Nov 2021
    Herein was a summary of the major changes made to Amendment 1 dated 08 September 2021 and reflected in Amendment 2 dated 01 November 2021. The protocol had been amended primarily to: incorporate changes based on feedback from the Voluntary Harmonization Procedure (VHP). To highlight the cumulative differences between Amendment 1 and Amendment 2 of the protocol, changes/additions were in bold italicized font and deletions were depicted with strikethrough text.
    29 Nov 2021
    The major update(s) to the protocol and related rationale were as follows: A Per-Protocol Analysis Set for the primary and key secondary efficacy endpoints had been added. Details on how the randomization list would be generated had been provided.
    30 Mar 2022
    The primary reason for this amendment was to provide additional guidance for anemia management in response to the Dear Investigator Letter dated 17 January 2022. The protocol had been updated with the following additional requirements for monitoring hemoglobin: A minimum hemoglobin threshold prior to the first 2 doses of magrolimab/placebo during treatment initiation. Post-magrolimab/placebo treatment hemoglobin monitoring after the first 2 doses of magrolimab/placebo, during treatment initiation.
    27 Jul 2022
    The primary reason for this amendment was to update the contraception requirements for female patients to align with the revised contraception recommendations in the azacitidine prescribing information dated June 2022.

    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
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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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