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    Clinical Trial Results:
    A Phase 2, Open-label, Multicenter Study to Assess Safety and Efficacy of Second/Third-line Treatment with nab®-Paclitaxel1 (ABI-007) in Combination with Epigenetic Modifying Therapy of CC-486, or Immunotherapy of Durvalumab (MEDI4736), or as Monotherapy in Subjects with Advanced Non-small Cell Lung Cancer (NSCLC): ABOUND.2L+

    Summary
    EudraCT number
    		 2014-001105-41
    Trial protocol
    		 ES   IT   DE   FR  
    Global end of trial date
    17 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Aug 2024
    First version publication date
    31 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABI-007-NSCL-006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    26 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess efficacy and safety of: o nab-paclitaxel in combination with epigenetic modifying therapy of CC-486, o nab-paclitaxel in combination with immunotherapy of durvalumab, o and nab-paclitaxel monotherapy
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jan 2015
    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: 46
    Country: Number of subjects enrolled
    United States: 32
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Spain: 103
    Country: Number of subjects enrolled
    Canada: 8
    Worldwide total number of subjects
    240
    EEA total number of subjects
    154
    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)
    123
    From 65 to 84 years
    117
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Eligible participants included those with advanced non-small cell lung cancer who had received no more than one prior containing chemotherapy regimen. Immunotherapy as a prior line of treatment was allowed. Randomization was stratified by eastern cooperative oncology group performance status, gender and the smoking status of the participant.

    Period 1
    Period 1 title
    Pre-treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nab-Paclitaxel + CC-486
    Arm description
    		 Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m^2 over 30 minutes on Days 8 and 15

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    CC-486
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg on Days 1 to 14 of each 21-day cycle

    Arm title
    		 Nab-Paclitaxel + Durvalumab
    Arm description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1125 mg/m^2 over 1 hour on Day 15 of each 21-day cycle

    Investigational medicinal product name
    Nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m^2 over 30 minutes on Days 1 and 8

    Arm title
    		 Nab-Paclitaxel
    Arm description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m^2 over 30 minutes on Days 1 and 8

    Number of subjects in period 1
    		Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel
    Started
    81
    79
    80
    Completed
    79
    78
    79
    Not completed
    2
    1
    1
         Other reasons
    2
    1
    1
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nab-Paclitaxel + CC-486
    Arm description
    		 Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    CC-486
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg on Days 1 to 14 of each 21-day cycle

    Investigational medicinal product name
    Nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m^2 over 30 minutes on Days 8 and 15

    Arm title
    		 Nab-Paclitaxel + Durvalumab
    Arm description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m^2 over 30 minutes on Days 1 and 8

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    MEDI4736
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1125 mg/m^2 over 1 hour on Day 15 of each 21-day cycle

    Arm title
    		 Nab-Paclitaxel
    Arm description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m^2 over 30 minutes on Days 1 and 8

    Number of subjects in period 2
    		Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel
    Started
    79
    78
    79
    Entered Extension Phase
    0
    4
    0
    Completed
    0
    0
    0
    Not completed
    79
    78
    79
         Adverse event, serious fatal
    1
    13
    2
         Consent withdrawn by subject
    11
    6
    4
         Adverse event, non-fatal
    8
    8
    9
         Progressive Disease
    42
    40
    47
         Other reasons
    8
    7
    7
         Symptomatic Deterioration
    9
    4
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nab-Paclitaxel + CC-486
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Reporting group title
    Nab-Paclitaxel + Durvalumab
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Reporting group title
    Nab-Paclitaxel
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Reporting group values
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel Total
    Number of subjects
    		 81 79 80 240
    Age categorical
    Units:
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.0 ( 9.00 ) 62.7 ( 10.74 ) 62.6 ( 9.58 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 31 25 30 86
        Male
    		 50 54 50 154
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 2 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 1 2 3
        White
    		 67 77 63 207
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 14 1 13 28
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 6 3 10
        Not Hispanic or Latino
    		 67 73 66 206
        Unknown or Not Reported
    		 13 0 11 24

    End points

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    End points reporting groups
    Reporting group title
    Nab-Paclitaxel + CC-486
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Reporting group title
    Nab-Paclitaxel + Durvalumab
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Reporting group title
    Nab-Paclitaxel
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
    Reporting group title
    Nab-Paclitaxel + CC-486
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Reporting group title
    Nab-Paclitaxel + Durvalumab
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8. Durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Reporting group title
    Nab-Paclitaxel
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Primary: Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator

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    End point title
    		 Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator
    End point description
    Progression-free survival was defined as the time in months from the date of randomization/assignment to the date of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria documented by computed tomography (CT) scan, not including symptomatic deterioration, or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. Participants who did not have disease progression and had not died, regardless of whether they were discontinued from treatment, were censored at the date of last tumor assessment, on or prior to the clinical cut-off date that the participant was progression free. Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions from nadir.
    End point type
    Primary
    End point timeframe
    From date of first dose of IP to DP; up to data cut-off date of 30 August (Aug) 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 December (Dec) 2017 for Durva + nab-paclitaxel; participants were followed for PFS for up to 18 months
    End point values
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel
    Number of subjects analysed
    81
    79
    80
    Units: months
        median (confidence interval 95%)
    3.2 (2.30 to 4.30)
    4.5 (3.45 to 5.88)
    4.2 (2.79 to 5.06)
    Statistical analysis title
    		 Hazard Ratio (HR)
    Statistical analysis description
    Based on stratified Cox proportional hazards regression model.
    Comparison groups
    Nab-Paclitaxel + CC-486 v Nab-Paclitaxel
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.94

    Secondary: Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria

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    End point title
    		 Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria
    End point description
    Disease control rate was defined as the percentage of participants who had a CR, PR or SD during the course of the study, according to RECIST version 1.1 criteria, as evaluated by the investigator. RECIST Version 1.1 criteria is defined as follows: - Complete Response is the disappearance of all target lesions; - Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. Responses were evaluated every 6 weeks.
    End point type
    Secondary
    End point timeframe
    Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
    End point values
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel
    Number of subjects analysed
    81
    79
    80
    Units: Percentage of Participants
        number (confidence interval 95%)
    65.4 (54.0 to 75.7)
    70.9 (59.6 to 80.6)
    67.5 (56.1 to 77.6)
    Statistical analysis title
    		 Disease Control Rate Ratio
    Comparison groups
    Nab-Paclitaxel + CC-486 v Nab-Paclitaxel
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Disease Control Rate Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.778
         upper limit
    		 1.207

    Secondary: Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria

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    End point title
    		 Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria
    End point description
    Overall Response was defined as percentage of participants who achieved a radiologic confirmed complete response or partial response according to RECIST V 1.1 criteria and compared with baseline among all tumor assessments, where baseline was the last CT obtained prior to or on Day 1 of treatment. Per RECIST V 1.1 criteria, a CR is defined as a disappearance of all target lesions; a PR is defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline. Responses were evaluated every 6 weeks.
    End point type
    Secondary
    End point timeframe
    Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
    End point values
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel
    Number of subjects analysed
    81
    79
    80
    Units: percentage of participants
        number (confidence interval 95%)
    13.6 (7.0 to 23.0)
    27.8 (18.3 to 39.1)
    16.3 (8.9 to 26.2)
    Statistical analysis title
    		 Overall Response Rate Ratio
    Comparison groups
    Nab-Paclitaxel + CC-486 v Nab-Paclitaxel
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Overall Response Rate Ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.398
         upper limit
    		 1.754

    Secondary: Kaplan Meier Estimate of Overall Survival (OS)

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    End point title
    		 Kaplan Meier Estimate of Overall Survival (OS)
    End point description
    Overall survival was defined as the time in months between randomization/treatment assignment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact. 99999=NA
    End point type
    Secondary
    End point timeframe
    Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; participants were followed for overall survival up to 30 months
    End point values
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel
    Number of subjects analysed
    81
    79
    80
    Units: Months
        median (confidence interval 95%)
    8.1 (6.64 to 11.86)
    10.1 (7.75 to 99999)
    17.0 (8.21 to 99999)
    Statistical analysis title
    		 Hazard Ratio (HR)
    Statistical analysis description
    Based on stratified Cox proportional hazards regression model.
    Comparison groups
    Nab-Paclitaxel + CC-486 v Nab-Paclitaxel
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 2.57

    Secondary: Number of Participants with Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period
    End point description
    TEAEs were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP for Arms A and C or up to 90 days after the last dose for Arm B, and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.
    End point type
    Secondary
    End point timeframe
    TEAEs were collected up to 4 weeks after receiving last dose of IP for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 354 weeks
    End point values
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel
    Number of subjects analysed
    79
    78
    79
    Units: Participants
        TEAE
    79
    78
    78
        Serious TEAE
    30
    44
    30
        Grade (GR) 3/4 TEAE
    48
    57
    47
        Grade 3 or Higher
    49
    59
    47
        Treatment Related TEAE
    74
    72
    68
        Treatment Related Serious TEAE
    11
    20
    5
        Treatment Related GR 3 or Higher TEAE
    32
    36
    25
        TEAE With Action to Reduce/Interrupt IP
    49
    59
    38
        Treatment-Related to Reduce or Interrupt IP
    36
    36
    27
        TEAE with Action Taken to Withdraw IP
    8
    11
    9
        Drug Related TEAE with Action Taken to Withdraw IP
    6
    10
    9
        TEAE with Fatal Outcome
    4
    12
    3
        Treatment Related TEAE with Fatal Outcome
    0
    4
    1
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Discontinued Study Treatment

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    End point title
    		 Percentage of Participants Who Discontinued Study Treatment
    End point description
    The discontinuation rate was defined as the percentage of participants who had study drug discontinued and was assessed throughout the conduct of the study.
    End point type
    Secondary
    End point timeframe
    Up to 30 Aug 2017 for CC-486 + nab-paclitaxel and 26 Nov 2019 for nab-paclitaxe and 20 Jul 2023 for Durva + nab-paclitaxel (up to 445 weeks)
    End point values
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel
    Number of subjects analysed
    79
    78
    79
    Units: percentage of participants
        number (not applicable)
    100.00
    100.00
    100.00
    No statistical analyses for this end point

    Secondary: Dose Intensity Per Week of nab-Paclitaxel

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    End point title
    		 Dose Intensity Per Week of nab-Paclitaxel
    End point description
    Dose intensity was the cumulative dose divided by the dosing period in weeks.
    End point type
    Secondary
    End point timeframe
    Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
    End point values
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel
    Number of subjects analysed
    79
    78
    79
    Units: mg/m^2/week
        arithmetic mean (standard deviation)
    54.73 ( 11.390 )
    57.18 ( 13.605 )
    58.61 ( 14.893 )
    No statistical analyses for this end point

    Secondary: Dose Intensity Per Week of CC-486

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    End point title
    		 Dose Intensity Per Week of CC-486
    End point description
    Dose intensity was the cumulative dose divided by the dosing period in weeks.
    End point type
    Secondary
    End point timeframe
    Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
    End point values
    		 Nab-Paclitaxel + CC-486
    Number of subjects analysed
    79
    Units: mg/ week
        arithmetic mean (standard deviation)
    716.66 ( 220.945 )
    No statistical analyses for this end point

    Secondary: Dose Intensity Per Week of Durvalumab

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    End point title
    		 Dose Intensity Per Week of Durvalumab
    End point description
    Dose intensity was the cumulative dose divided by the dosing period in weeks).
    End point type
    Secondary
    End point timeframe
    Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
    End point values
    		 Nab-Paclitaxel + Durvalumab
    Number of subjects analysed
    77
    Units: mg/week
        arithmetic mean (standard deviation)
    279.96 ( 97.304 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Study Drug Dose Reductions

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    End point title
    		 Percentage of Participants With Study Drug Dose Reductions
    End point description
    A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events or toxicities. 00000= 0 participants analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 16 Jan 2017 for CC-486 + nab-paclitaxel and up to 26 Nov 2019 for nab-paclitaxel and Durva + nab-paclitaxel (up to 255 weeks)
    End point values
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel + Durvalumab Nab-Paclitaxel
    Number of subjects analysed
    79
    78
    79
    Units: Percentage of Participants
    number (not applicable)
        Nab-Paclitaxel
    10.1
    14.1
    10.1
        CC-486
    20.3
    00000
    00000
        Durvalumab (Reductions Not Allowed per Protocol)
    00000
    0.0
    00000
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs and NSAEs were collected up to 4 weeks post last dose of nab-paclitaxel and CC-486+nab-paclitaxel and up to 90 days post last dose of Durva+nab-paclitaxel (Up to 354 weeks). Deaths are from their first dose to study completion (Up to 449 weeks).
    Adverse event reporting additional description
    The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Nab-Paclitaxel + CC-486
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15. CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Reporting group title
    Nab-Paclitaxel
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Reporting group title
    Nab-Paclitaxel + Durvalumab
    Reporting group description
    		 Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8. Durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.

    Serious adverse events
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel Nab-Paclitaxel + Durvalumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 79 (37.97%)
    30 / 79 (37.97%)
    44 / 78 (56.41%)
         number of deaths (all causes)
    61
    49
    48
         number of deaths resulting from adverse events
    5
    3
    12
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to meninges
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 79 (1.27%)
    2 / 78 (2.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Performance status decreased
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Sudden death
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 79 (3.80%)
    1 / 79 (1.27%)
    2 / 78 (2.56%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    4 / 79 (5.06%)
    4 / 79 (5.06%)
    2 / 78 (2.56%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 79 (2.53%)
    4 / 79 (5.06%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    3 / 79 (3.80%)
    1 / 79 (1.27%)
    3 / 78 (3.85%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    2 / 78 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    2 / 78 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    Respiratory distress
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    3 / 78 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood sodium decreased
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Postoperative fever
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Paraparesis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 79 (2.53%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    2 / 78 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal vasculitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Flatulence
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 79 (1.27%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 79 (1.27%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal obstruction
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocutaneous fistula
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis microscopic
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anuria
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    3 / 78 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Lung infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    2 / 78 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 79 (1.27%)
    3 / 78 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 79 (6.33%)
    3 / 79 (3.80%)
    9 / 78 (11.54%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 3
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    2 / 78 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    2 / 78 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 79 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic alkalosis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nab-Paclitaxel + CC-486 Nab-Paclitaxel Nab-Paclitaxel + Durvalumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 79 (97.47%)
    75 / 79 (94.94%)
    75 / 78 (96.15%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    2 / 79 (2.53%)
    4 / 79 (5.06%)
    9 / 78 (11.54%)
         occurrences all number
    2
    4
    9
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 79 (2.53%)
    4 / 79 (5.06%)
    4 / 78 (5.13%)
         occurrences all number
    2
    4
    6
    Flushing
         subjects affected / exposed
    1 / 79 (1.27%)
    4 / 79 (5.06%)
    0 / 78 (0.00%)
         occurrences all number
    1
    4
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    10 / 79 (12.66%)
    7 / 79 (8.86%)
    13 / 78 (16.67%)
         occurrences all number
    12
    7
    19
    Oedema peripheral
         subjects affected / exposed
    12 / 79 (15.19%)
    15 / 79 (18.99%)
    13 / 78 (16.67%)
         occurrences all number
    12
    16
    14
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 79 (3.80%)
    5 / 79 (6.33%)
    6 / 78 (7.69%)
         occurrences all number
    3
    6
    8
    General physical health deterioration
         subjects affected / exposed
    4 / 79 (5.06%)
    1 / 79 (1.27%)
    4 / 78 (5.13%)
         occurrences all number
    4
    1
    4
    Fatigue
         subjects affected / exposed
    24 / 79 (30.38%)
    23 / 79 (29.11%)
    22 / 78 (28.21%)
         occurrences all number
    27
    28
    31
    Chills
         subjects affected / exposed
    0 / 79 (0.00%)
    4 / 79 (5.06%)
    2 / 78 (2.56%)
         occurrences all number
    0
    5
    3
    Asthenia
         subjects affected / exposed
    26 / 79 (32.91%)
    25 / 79 (31.65%)
    36 / 78 (46.15%)
         occurrences all number
    36
    31
    49
    Respiratory, thoracic and mediastinal disorders
    Productive cough
         subjects affected / exposed
    3 / 79 (3.80%)
    5 / 79 (6.33%)
    11 / 78 (14.10%)
         occurrences all number
    4
    5
    15
    Pleural effusion
         subjects affected / exposed
    6 / 79 (7.59%)
    1 / 79 (1.27%)
    2 / 78 (2.56%)
         occurrences all number
    7
    2
    2
    Haemoptysis
         subjects affected / exposed
    4 / 79 (5.06%)
    6 / 79 (7.59%)
    6 / 78 (7.69%)
         occurrences all number
    5
    6
    11
    Epistaxis
         subjects affected / exposed
    3 / 79 (3.80%)
    7 / 79 (8.86%)
    5 / 78 (6.41%)
         occurrences all number
    3
    9
    6
    Dyspnoea
         subjects affected / exposed
    16 / 79 (20.25%)
    22 / 79 (27.85%)
    23 / 78 (29.49%)
         occurrences all number
    19
    25
    27
    Cough
         subjects affected / exposed
    16 / 79 (20.25%)
    23 / 79 (29.11%)
    22 / 78 (28.21%)
         occurrences all number
    19
    30
    35
    Rhinorrhoea
         subjects affected / exposed
    2 / 79 (2.53%)
    3 / 79 (3.80%)
    4 / 78 (5.13%)
         occurrences all number
    2
    3
    4
    Pulmonary embolism
         subjects affected / exposed
    7 / 79 (8.86%)
    2 / 79 (2.53%)
    2 / 78 (2.56%)
         occurrences all number
    7
    2
    2
    Pneumonitis
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 79 (1.27%)
    5 / 78 (6.41%)
         occurrences all number
    1
    1
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    9 / 79 (11.39%)
    8 / 79 (10.13%)
    5 / 78 (6.41%)
         occurrences all number
    10
    8
    5
    Depressed mood
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    4 / 78 (5.13%)
         occurrences all number
    0
    1
    4
    Anxiety
         subjects affected / exposed
    5 / 79 (6.33%)
    4 / 79 (5.06%)
    2 / 78 (2.56%)
         occurrences all number
    5
    4
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 79 (0.00%)
    4 / 78 (5.13%)
         occurrences all number
    2
    0
    4
    Blood creatinine increased
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    5 / 78 (6.41%)
         occurrences all number
    0
    1
    9
    Neutrophil count decreased
         subjects affected / exposed
    5 / 79 (6.33%)
    4 / 79 (5.06%)
    0 / 78 (0.00%)
         occurrences all number
    7
    12
    0
    Weight decreased
         subjects affected / exposed
    9 / 79 (11.39%)
    5 / 79 (6.33%)
    3 / 78 (3.85%)
         occurrences all number
    9
    5
    3
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    19 / 79 (24.05%)
    22 / 79 (27.85%)
    25 / 78 (32.05%)
         occurrences all number
    22
    30
    33
    Dizziness
         subjects affected / exposed
    8 / 79 (10.13%)
    9 / 79 (11.39%)
    6 / 78 (7.69%)
         occurrences all number
    9
    10
    7
    Headache
         subjects affected / exposed
    9 / 79 (11.39%)
    10 / 79 (12.66%)
    10 / 78 (12.82%)
         occurrences all number
    10
    11
    15
    Paraesthesia
         subjects affected / exposed
    10 / 79 (12.66%)
    3 / 79 (3.80%)
    2 / 78 (2.56%)
         occurrences all number
    12
    4
    2
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 79 (0.00%)
    5 / 79 (6.33%)
    3 / 78 (3.85%)
         occurrences all number
    0
    5
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    12 / 79 (15.19%)
    24 / 79 (30.38%)
    27 / 78 (34.62%)
         occurrences all number
    13
    39
    49
    Neutropenia
         subjects affected / exposed
    15 / 79 (18.99%)
    10 / 79 (12.66%)
    14 / 78 (17.95%)
         occurrences all number
    42
    39
    32
    Leukopenia
         subjects affected / exposed
    5 / 79 (6.33%)
    3 / 79 (3.80%)
    1 / 78 (1.28%)
         occurrences all number
    9
    4
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    4 / 79 (5.06%)
    3 / 79 (3.80%)
    2 / 78 (2.56%)
         occurrences all number
    5
    3
    2
    Eye disorders
    Vision blurred
         subjects affected / exposed
    4 / 79 (5.06%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    4
    0
    1
    Gastrointestinal disorders
    Stomatitis
         subjects affected / exposed
    8 / 79 (10.13%)
    8 / 79 (10.13%)
    6 / 78 (7.69%)
         occurrences all number
    10
    10
    11
    Nausea
         subjects affected / exposed
    45 / 79 (56.96%)
    20 / 79 (25.32%)
    19 / 78 (24.36%)
         occurrences all number
    64
    25
    27
    Haemorrhoids
         subjects affected / exposed
    4 / 79 (5.06%)
    0 / 79 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    5
    0
    1
    Dyspepsia
         subjects affected / exposed
    5 / 79 (6.33%)
    6 / 79 (7.59%)
    5 / 78 (6.41%)
         occurrences all number
    5
    7
    5
    Diarrhoea
         subjects affected / exposed
    33 / 79 (41.77%)
    20 / 79 (25.32%)
    30 / 78 (38.46%)
         occurrences all number
    54
    39
    47
    Constipation
         subjects affected / exposed
    32 / 79 (40.51%)
    26 / 79 (32.91%)
    21 / 78 (26.92%)
         occurrences all number
    45
    33
    30
    Abdominal pain
         subjects affected / exposed
    7 / 79 (8.86%)
    8 / 79 (10.13%)
    3 / 78 (3.85%)
         occurrences all number
    8
    9
    6
    Abdominal pain upper
         subjects affected / exposed
    3 / 79 (3.80%)
    2 / 79 (2.53%)
    5 / 78 (6.41%)
         occurrences all number
    3
    2
    6
    Vomiting
         subjects affected / exposed
    42 / 79 (53.16%)
    18 / 79 (22.78%)
    10 / 78 (12.82%)
         occurrences all number
    73
    25
    13
    Skin and subcutaneous tissue disorders
    Rash erythematous
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    4 / 78 (5.13%)
         occurrences all number
    0
    0
    5
    Dry skin
         subjects affected / exposed
    6 / 79 (7.59%)
    3 / 79 (3.80%)
    3 / 78 (3.85%)
         occurrences all number
    7
    4
    4
    Alopecia
         subjects affected / exposed
    25 / 79 (31.65%)
    21 / 79 (26.58%)
    26 / 78 (33.33%)
         occurrences all number
    26
    22
    26
    Rash
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 79 (1.27%)
    4 / 78 (5.13%)
         occurrences all number
    0
    1
    5
    Pruritus
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 79 (1.27%)
    6 / 78 (7.69%)
         occurrences all number
    2
    1
    9
    Pruritus generalised
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 79 (2.53%)
    5 / 78 (6.41%)
         occurrences all number
    2
    2
    5
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 79 (0.00%)
    6 / 78 (7.69%)
         occurrences all number
    0
    0
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 79 (13.92%)
    14 / 79 (17.72%)
    10 / 78 (12.82%)
         occurrences all number
    14
    17
    13
    Back pain
         subjects affected / exposed
    4 / 79 (5.06%)
    7 / 79 (8.86%)
    10 / 78 (12.82%)
         occurrences all number
    4
    9
    11
    Muscle spasms
         subjects affected / exposed
    5 / 79 (6.33%)
    3 / 79 (3.80%)
    2 / 78 (2.56%)
         occurrences all number
    5
    3
    3
    Muscular weakness
         subjects affected / exposed
    4 / 79 (5.06%)
    1 / 79 (1.27%)
    1 / 78 (1.28%)
         occurrences all number
    4
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    3 / 79 (3.80%)
    1 / 79 (1.27%)
    5 / 78 (6.41%)
         occurrences all number
    3
    1
    6
    Musculoskeletal pain
         subjects affected / exposed
    7 / 79 (8.86%)
    5 / 79 (6.33%)
    8 / 78 (10.26%)
         occurrences all number
    8
    5
    8
    Myalgia
         subjects affected / exposed
    9 / 79 (11.39%)
    7 / 79 (8.86%)
    5 / 78 (6.41%)
         occurrences all number
    9
    8
    5
    Neck pain
         subjects affected / exposed
    0 / 79 (0.00%)
    7 / 79 (8.86%)
    4 / 78 (5.13%)
         occurrences all number
    0
    7
    4
    Pain in extremity
         subjects affected / exposed
    6 / 79 (7.59%)
    8 / 79 (10.13%)
    4 / 78 (5.13%)
         occurrences all number
    6
    9
    5
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 79 (3.80%)
    8 / 79 (10.13%)
    21 / 78 (26.92%)
         occurrences all number
    4
    9
    40
    Respiratory tract infection
         subjects affected / exposed
    2 / 79 (2.53%)
    4 / 79 (5.06%)
    10 / 78 (12.82%)
         occurrences all number
    2
    4
    14
    Oral candidiasis
         subjects affected / exposed
    5 / 79 (6.33%)
    4 / 79 (5.06%)
    3 / 78 (3.85%)
         occurrences all number
    8
    4
    4
    Nasopharyngitis
         subjects affected / exposed
    5 / 79 (6.33%)
    5 / 79 (6.33%)
    4 / 78 (5.13%)
         occurrences all number
    7
    6
    4
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 79 (1.27%)
    3 / 79 (3.80%)
    12 / 78 (15.38%)
         occurrences all number
    1
    5
    15
    Bronchitis
         subjects affected / exposed
    2 / 79 (2.53%)
    4 / 79 (5.06%)
    2 / 78 (2.56%)
         occurrences all number
    2
    4
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 79 (2.53%)
    4 / 79 (5.06%)
    10 / 78 (12.82%)
         occurrences all number
    2
    4
    18
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    27 / 79 (34.18%)
    24 / 79 (30.38%)
    27 / 78 (34.62%)
         occurrences all number
    34
    29
    28
    Hypomagnesaemia
         subjects affected / exposed
    2 / 79 (2.53%)
    6 / 79 (7.59%)
    5 / 78 (6.41%)
         occurrences all number
    2
    9
    8
    Hyponatraemia
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 79 (2.53%)
    5 / 78 (6.41%)
         occurrences all number
    1
    2
    5
    Hypophosphataemia
         subjects affected / exposed
    3 / 79 (3.80%)
    4 / 79 (5.06%)
    2 / 78 (2.56%)
         occurrences all number
    3
    5
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2014
    A
    18 Jul 2014
    A
    14 Apr 2016
    A
    31 May 2016
    SA
    09 Dec 2016
    A
    02 Mar 2018
    A
    26 Jul 2019
    A
    04 Dec 2019
    A
    28 Dec 2020
    A

    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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