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    Clinical Trial Results:
    A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer

    Summary
    EudraCT number
    		 2016-001099-31
    Trial protocol
    		 DE   ES   IT  
    Global end of trial date
    17 Jun 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    19 Jun 2022
    First version publication date
    11 Jan 2022
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    LPV results

    Trial information

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    Trial identification
    Sponsor protocol code
    I5B-MC-JGDP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03086369
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15844
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    05 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jan 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jun 2017
    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 States: 162
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Spain: 9
    Worldwide total number of subjects
    184
    EEA total number of subjects
    22
    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)
    76
    From 65 to 84 years
    108
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Completers included participants who died from any cause.

    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
    		 Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine
    Arm description
    		 Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaratumab
    Investigational medicinal product code
    Other name
    LY3012207
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of Olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of nab-paclitaxel 125 milligrams per meter square (mg/m^2) on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Arm title
    		 Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
    Arm description
    		 Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaratumab
    Investigational medicinal product code
    Other name
    LY3012207
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of Olaratumab 20 mg/kg on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of nab-paclitaxel 125mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Arm title
    		 Phase1b Expansion:Olaratumab20mg/kg+Nab-paclitaxel+Gemcitabine
    Arm description
    		 Following a protocol amendment, expansion arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaratumab
    Investigational medicinal product code
    Other name
    LY3012207
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of Olaratumab 20 mg/kg on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of nab-paclitaxel 125mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Arm title
    		 Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
    Arm description
    		 Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaratumab
    Investigational medicinal product code
    Other name
    LY3012207
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of Olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of nab-paclitaxel 125mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Arm title
    		 Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Arm description
    		 Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous infusion of placebo on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Number of subjects in period 1
    		Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b Expansion:Olaratumab20mg/kg+Nab-paclitaxel+Gemcitabine Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Started
    3
    7
    12
    82
    80
    Received at least 1 dose of study drug
    3
    7
    12
    81
    78
    Completed
    2
    7
    12
    73
    73
    Not completed
    1
    0
    0
    9
    7
         Consent withdrawn by subject
    -
    -
    -
    5
    3
         Physician decision
    -
    -
    -
    1
    2
         Progressive Disease
    -
    -
    -
    1
    1
         Lost to follow-up
    1
    -
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase1b Expansion:Olaratumab20mg/kg+Nab-paclitaxel+Gemcitabine
    Reporting group description
    		 Following a protocol amendment, expansion arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group values
    		 Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b Expansion:Olaratumab20mg/kg+Nab-paclitaxel+Gemcitabine Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Total
    Number of subjects
    		 3 7 12 82 80 184
    Age categorical
    Units: Subjects
        <=18 years
    		 0 0 0 0 0 0
        Between 18 and 65 years
    		 0 3 4 32 37 76
        >=65 years
    		 3 4 8 50 43 108
    Gender categorical
    Units: Subjects
        Female
    		 2 3 3 29 35 72
        Male
    		 1 4 9 53 45 112
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 1 7 8 16
        Not Hispanic or Latino
    		 3 7 11 74 70 165
        Unknown or Not Reported
    		 0 0 0 1 2 3
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 1 1
        Asian
    		 0 0 0 4 1 5
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 0 0 4 3 7
        White
    		 3 7 12 72 73 167
        More than one race
    		 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 2 2 4
    Region of Enrollment
    Units: Subjects
        United States
    		 1 5 7 76 73 162
        Germany
    		 1 1 5 3 3 13
        Spain
    		 1 1 0 3 4 9

    End points

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    End points reporting groups
    Reporting group title
    Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase1b Expansion:Olaratumab20mg/kg+Nab-paclitaxel+Gemcitabine
    Reporting group description
    		 Following a protocol amendment, expansion arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Primary: Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs)

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    End point title
    		 Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs) [1] [2]
    End point description
    A DLT is an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to NCI-CTCAE version 4.03: Any febrile neutropenia, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage, Grade 4 neutropenia lasting 7 days or longer, Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc., Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study). Analysis Population Description: All participants in phase 1b who received at least one dose of Olaratumab.
    End point type
    Primary
    End point timeframe
    Cycle 1 (Up to 28 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics were planned for this endpoint.
    [2] - 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: This outcome is specific to phase 1b arms only.
    End point values
    		 Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b Expansion:Olaratumab20mg/kg+Nab-paclitaxel+Gemcitabine
    Number of subjects analysed
    3
    7
    12
    Units: participants
    0
    0
    0
    No statistical analyses for this end point

    Primary: Phase 2: Overall Survival (OS)

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    End point title
    		 Phase 2: Overall Survival (OS) [3]
    End point description
    OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any patient who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study. Analysis Population Description (APD): All randomized participants in phase 2 (including the censored participants). Number of participants censored in Olaratumab+Nab-paclitaxel+Gemcitabine=26, Placebo+Nab-paclitaxel+Gemcitabine=21.
    End point type
    Primary
    End point timeframe
    Baseline to Date of Death from Any Cause (Up To 29 Months)
    Notes
    [3] - 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: This outcome is specific to phase 2 arms only.
    End point values
    		 Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects analysed
    82
    80
    Units: Months
        median (confidence interval 95%)
    9.10 (7.49 to 14.09)
    10.81 (8.51 to 14.75)
    Statistical analysis title
    		 Phase 2: Overall Survival (OS)
    Comparison groups
    Phase 2: Placebo + Nab-paclitaxel + Gemcitabine v Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7902
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.054
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.728
         upper limit
    		 1.527

    Secondary: Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab

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    End point title
    		 Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab [4]
    End point description
    PK: Cmin of olaratumab APD: All participants in phase 1b/2 who received at least one dose of Olaratumab and had evaluable PK data. 9999 = N/A = Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15
    Notes
    [4] - 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: This outcome was analysed in phase 1b/2 arms that received Olaratumab drug.
    End point values
    		 Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b Expansion:Olaratumab20mg/kg+Nab-paclitaxel+Gemcitabine Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
    Number of subjects analysed
    3
    5 [5]
    9
    66 [6]
    Units: micrograms per milliliter (μg/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1 (Day 1)
    128 ± 36
    86.3 ± 90
    87.8 ± 91
    112 ± 40
        Cycle 1 (Day 15)
    78.7 ± 42
    172 ± 76
    101 ± 36
    94.7 ± 62
        Cycle 3 (Day 1)
    204 ± 13
    9999 ± 9999
    173 ± 33
    147 ± 38
        Cycle 3 (Day 15)
    159 ± 17
    9999 ± 9999
    101 ± 37
    106 ± 68
    Notes
    [5] - Cycle 3 (Day 1)=1; Individual value : 184 μg/mL Cycle 3 (Day 15)=1; Individual value : 99.7 μg/mL
    [6] - Cycle 1 (Day 1)=61 Cycle 3 (Day 1)=51 Cycle 3 (Day 15)=44
    No statistical analyses for this end point

    Secondary: Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies

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    End point title
    		 Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies [7]
    End point description
    Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies. APD: All randomized participants in phase 2 who received at least one dose of Olaratumab and had evaluable immunogenicity data.
    End point type
    Secondary
    End point timeframe
    Baseline through Follow-up (Up To 29 Months)
    Notes
    [7] - 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: This outcome was analysed in phase 2 arms that received Olaratumab drug.
    End point values
    		 Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
    Number of subjects analysed
    81
    Units: participants
    0
    No statistical analyses for this end point

    Secondary: Phase 1b: Overall Survival (OS)

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    End point title
    		 Phase 1b: Overall Survival (OS) [8]
    End point description
    OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study. APD: Zero participants analysed as data was not collected. OS was not measured in phase 1b.
    End point type
    Secondary
    End point timeframe
    Baseline to Date of Death from Any Cause (Approximately 9 Months)
    Notes
    [8] - 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: This outcome is specific to phase 1b arms only.
    End point values
    		 Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b Expansion:Olaratumab20mg/kg+Nab-paclitaxel+Gemcitabine
    Number of subjects analysed
    0 [9]
    0 [10]
    0 [11]
    Units: Months
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [9] - Zero participants analysed as data was not collected. OS was not measured in phase 1b.
    [10] - Zero participants analysed as data was not collected. OS was not measured in phase 1b.
    [11] - Zero participants analysed as data was not collected. OS was not measured in phase 1b.
    No statistical analyses for this end point

    Secondary: Phase 2: Progression-Free Survival (PFS)

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    End point title
    		 Phase 2: Progression-Free Survival (PFS) [12]
    End point description
    PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause in the absence of progressive disease (PD). Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits. APD: All randomized participants in phase 2 (including the censored participants). Number of participants censored in Olaratumab+Nab-paclitaxel+Gemcitabine=24, Placebo+Nab-paclitaxel+Gemcitabine=26.
    End point type
    Secondary
    End point timeframe
    Baseline to Disease Progression or Death (Up To 26 Months)
    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: This outcome is specific to phase 1b arms only.
    End point values
    		 Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects analysed
    82
    80
    Units: Months
        median (confidence interval 95%)
    5.55 (4.14 to 7.0)
    6.41 (5.42 to 7.98)
    Statistical analysis title
    		 Phase 2: Progression-Free Survival (PFS)
    Comparison groups
    Phase 2: Placebo + Nab-paclitaxel + Gemcitabine v Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3771
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.192
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.806
         upper limit
    		 1.764

    Secondary: Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

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    End point title
    		 Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
    End point description
    ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. APD: All participants in phase 1b/2.
    End point type
    Secondary
    End point timeframe
    Baseline through Disease Progression or Death (Up To 26 Months)
    End point values
    		 Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b Expansion:Olaratumab20mg/kg+Nab-paclitaxel+Gemcitabine Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects analysed
    3
    7
    12
    82
    80
    Units: Percentage of participants
        number (not applicable)
    33.3
    14.3
    0
    30.5
    33.8
    No statistical analyses for this end point

    Secondary: Phase 1b/2: Duration of Response (DoR)

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    End point title
    		 Phase 1b/2: Duration of Response (DoR)
    End point description
    DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. APD: All participants in phase 1b/2 who had CR or PR responses. For phase 1b cohort expansion arm, there were no participants with CR or PR responses to evaluate DoR, hence, zero participants analysed. 9999 = N/A = Median and 95% Confidence Interval couldn't be calculated as there was only one participant.
    End point type
    Secondary
    End point timeframe
    From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
    End point values
    		 Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b Expansion:Olaratumab20mg/kg+Nab-paclitaxel+Gemcitabine Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects analysed
    1 [13]
    1 [14]
    0 [15]
    25
    27
    Units: Months
        median (confidence interval 95%)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    ( to )
    5.55 (2.63 to 9.23)
    5.55 (3.84 to 7.26)
    Notes
    [13] - Individual value reported: 6.24 months.
    [14] - Individual value reported: 3.68 months.
    [15] - There were no participants with CR or PR responses to evaluate DoR, thus, zero participants analysed
    No statistical analyses for this end point

    Secondary: Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"

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    End point title
    		 Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" [16]
    End point description
    The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered. APD: All randomized participants in phase 2 who had baseline and at least one post-baseline assessment.
    End point type
    Secondary
    End point timeframe
    Baseline through Follow-up (Up To 21 Months)
    Notes
    [16] - 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: This outcome is specific to phase 2 arms only.
    End point values
    		 Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects analysed
    51 [17]
    47
    Units: Months
        median (confidence interval 95%)
    14.13 (5.19 to 9999)
    6.11 (2.04 to 9.95)
    Notes
    [17] - 9999 = N/A = There were not enough events to estimate the upper confidence limit.
    Statistical analysis title
    		 Phase 2: TWP
    Comparison groups
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine v Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.175
         upper limit
    		 0.872

    Secondary: Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.

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    End point title
    		 Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. [18]
    End point description
    The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems. APD: All randomized participants in phase 2 who had baseline and at least one post-baseline assessment. 9999=N/A=Not enough events to estimate the median/upper confidence limit, as applicable.
    End point type
    Secondary
    End point timeframe
    Baseline through Follow-up (Up To 21 Months)
    Notes
    [18] - 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: This outcome is specific to phase 2 arms only.
    End point values
    		 Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects analysed
    68 [19]
    66 [20]
    Units: Months
    median (confidence interval 95%)
        Appetite loss
    9999 (2.79 to 9999)
    2.86 (1.94 to 9999)
        Constipation
    9999 (2.76 to 9999)
    9999 (1.94 to 9999)
        Diarrhoea
    2.79 (1.87 to 9999)
    1.97 (1.91 to 9999)
        Dyspnoea
    2.79 (2.10 to 9999)
    3.12 (2.07 to 9999)
        Fatigue
    1.87 (1.05 to 2.33)
    1.87 (1.12 to 2.07)
        Financial difficulties
    9999 (2.37 to 9999)
    9999 (2.79 to 9999)
        Insomnia
    3.19 (2.10 to 9999)
    9999 (2.83 to 9999)
        Nausea and vomiting
    3.19 (2.10 to 9999)
    2.86 (1.97 to 9999)
        Pain
    9999 (2.76 to 9999)
    3.25 (2.04 to 9999)
    Notes
    [19] - Appetite loss=57 Constipation/Pain=64 Dysp/Fatigue/Nausea&vomit=66 Financial diff=65 Insomnia=60
    [20] - Appetite loss/Insomnia=60 Constipation=59 Diarrhoea=62 Fatigue=64 Financial diff=61 Pain=58
    Statistical analysis title
    		 Phase 2:Time to First Worsening of Symptom Burden
    Statistical analysis description
    Appetite loss
    Comparison groups
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine v Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 = 0.288
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.718
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.392
         upper limit
    		 1.317
    Notes
    [21] - Appetite loss
    Statistical analysis title
    		 Phase 2:Time to First Worsening of Symptom Burden
    Statistical analysis description
    Constipation
    Comparison groups
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine v Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [22]
    P-value
    		 = 0.442
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.788
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.423
         upper limit
    		 1.468
    Notes
    [22] - Constipation
    Statistical analysis title
    		 Phase 2:Time to First Worsening of Symptom Burden
    Statistical analysis description
    Diarrhoea
    Comparison groups
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine v Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [23]
    P-value
    		 = 0.883
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.037
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.612
         upper limit
    		 1.755
    Notes
    [23] - Diarrhoea
    Statistical analysis title
    		 Phase 2:Time to First Worsening of Symptom Burden
    Statistical analysis description
    Dyspnoea
    Comparison groups
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine v Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [24]
    P-value
    		 = 0.803
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.933
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.532
         upper limit
    		 1.636
    Notes
    [24] - Dyspnoea
    Statistical analysis title
    		 Phase 2:Time to First Worsening of Symptom Burden
    Statistical analysis description
    Fatigue
    Comparison groups
    Phase 2: Placebo + Nab-paclitaxel + Gemcitabine v Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [25]
    P-value
    		 = 0.805
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.053
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.675
         upper limit
    		 1.645
    Notes
    [25] - Fatigue
    Statistical analysis title
    		 Phase 2:Time to First Worsening of Symptom Burden
    Statistical analysis description
    Financial difficulties
    Comparison groups
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine v Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [26]
    P-value
    		 = 0.465
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.784
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 1.464
    Notes
    [26] - Financial difficulties
    Statistical analysis title
    		 Phase 2:Time to First Worsening of Symptom Burden
    Statistical analysis description
    Insomnia
    Comparison groups
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine v Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [27]
    P-value
    		 = 0.231
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.457
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.787
         upper limit
    		 2.698
    Notes
    [27] - Insomnia
    Statistical analysis title
    		 Phase 2:Time to First Worsening of Symptom Burden
    Statistical analysis description
    Nausea and vomiting
    Comparison groups
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine v Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [28]
    P-value
    		 = 0.748
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.914
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.532
         upper limit
    		 1.57
    Notes
    [28] - Nausea and vomiting
    Statistical analysis title
    		 Phase 2:Time to First Worsening of Symptom Burden
    Statistical analysis description
    Pain
    Comparison groups
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine v Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [29]
    P-value
    		 = 0.875
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.947
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.491
         upper limit
    		 1.827
    Notes
    [29] - Pain

    Secondary: Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)

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    End point title
    		 Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) [30]
    End point description
    The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status. APD: All randomized participants in phase 2 who completed EQ-5D-5L.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1, Cycle 7 Day 1
    Notes
    [30] - 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: This outcome is specific to phase 2 arms only.
    End point values
    		 Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Number of subjects analysed
    70 [31]
    70 [32]
    Units: score on a scale
    arithmetic mean (standard deviation)
        Index Value [Cycle 1 (Day1)]
    0.8 ± 0.2
    0.8 ± 0.2
        Index Value [Cycle 7 (Day1)]
    0.8 ± 0.1
    0.8 ± 0.2
        VAS Score [Cycle 1 (Day1)]
    70.1 ± 21.7
    69.7 ± 20.4
        VAS Score [Cycle 7 (Day1)]
    71.7 ± 20.2
    73.2 ± 22.5
    Notes
    [31] - Cycle 1 (Day1)=Index Value=69 Cycle 7 (Day1)=Index Value=22, VAS Score=23
    [32] - Cycle 7 (Day1)=Index Value, VAS Score=33
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Follow-up (Up To 29 Months)
    Adverse event reporting additional description
    All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nabpaclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
    Reporting group description
    		 Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Phase1bExpansion:Olaratumab20mg/kg+Nabpaclitaxel+ Gemcitabine
    Reporting group description
    		 Following a protocol amendment, expansion arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.

    Serious adverse events
    		 Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Phase1bExpansion:Olaratumab20mg/kg+Nabpaclitaxel+ Gemcitabine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 7 (42.86%)
    3 / 3 (100.00%)
    50 / 81 (61.73%)
    41 / 78 (52.56%)
    8 / 12 (66.67%)
         number of deaths (all causes)
    7
    2
    60
    63
    12
         number of deaths resulting from adverse events
    1
    1
    8
    4
    0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypertension
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    abdominal cavity drainage
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chills
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fatigue
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral swelling
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    5 / 81 (6.17%)
    4 / 78 (5.13%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    4 / 5
    1 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cough
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oropharyngeal pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    4 / 81 (4.94%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    pulmonary oedema
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary thrombosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    Psychiatric disorders
    confusional state
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    depression
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mental status changes
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    blood bilirubin increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    platelet count decreased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    anastomotic ulcer
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    drain site complication
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hip fracture
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lumbar vertebral fracture
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    2 / 78 (2.56%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardio-respiratory arrest
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Nervous system disorders
    cerebrovascular accident
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    2 / 78 (2.56%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    embolic stroke
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    epilepsy
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ischaemic cerebral infarction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    leukoencephalopathy
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    memory impairment
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    presyncope
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    seizure
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    subarachnoid haemorrhage
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    disseminated intravascular coagulation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    amaurosis fugax
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal distension
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    abdominal pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ascites
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    duodenal obstruction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    duodenal stenosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    duodenal ulcer
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastritis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    4 / 81 (4.94%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal necrosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haematemesis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intestinal perforation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    melaena
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 2
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    obstruction gastric
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatic cyst
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    proctitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    3 / 3
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    biliary obstruction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholangitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholestasis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    portal vein thrombosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    pruritus
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    flank pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myositis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    bacteraemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    biliary tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    covid-19
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    clostridium difficile colitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colonic abscess
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    device related bacteraemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    device related infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    enterocolitis infectious
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    escherichia urinary tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    influenza
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    kidney infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    liver abscess
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peritonitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumocystis jirovecii pneumonia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    8 / 78 (10.26%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 9
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia klebsiella
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    postoperative wound infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    7 / 81 (8.64%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 7
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    septic shock
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    2 / 81 (2.47%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wound infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyperglycaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyperkalaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypoglycaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vitamin b12 deficiency
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Phase1bExpansion:Olaratumab20mg/kg+Nabpaclitaxel+ Gemcitabine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    3 / 3 (100.00%)
    79 / 81 (97.53%)
    78 / 78 (100.00%)
    12 / 12 (100.00%)
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    3 / 81 (3.70%)
    4 / 78 (5.13%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    3
    4
    2
    embolism
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    5 / 81 (6.17%)
    2 / 78 (2.56%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    5
    2
    1
    hypertension
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    7 / 81 (8.64%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    14
    6
    0
    hypotension
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    14 / 81 (17.28%)
    6 / 78 (7.69%)
    2 / 12 (16.67%)
         occurrences all number
    1
    1
    18
    7
    2
    lymphoedema
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    1
    Surgical and medical procedures
    central venous catheterisation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    dental implantation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    pancreatic pseudocyst drainage
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    11 / 81 (13.58%)
    10 / 78 (12.82%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    12
    18
    2
    chills
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    8 / 81 (9.88%)
    12 / 78 (15.38%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    10
    17
    1
    fatigue
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 7 (42.86%)
    2 / 3 (66.67%)
    53 / 81 (65.43%)
    44 / 78 (56.41%)
    9 / 12 (75.00%)
         occurrences all number
    4
    10
    74
    84
    19
    general physical health deterioration
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    influenza like illness
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    3 / 81 (3.70%)
    5 / 78 (6.41%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    3
    14
    0
    mucosal inflammation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    2 / 81 (2.47%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    3
    0
    0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    3 / 78 (3.85%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    4
    1
    oedema peripheral
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 3 (66.67%)
    25 / 81 (30.86%)
    28 / 78 (35.90%)
    5 / 12 (41.67%)
         occurrences all number
    0
    4
    43
    44
    8
    pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    4
    0
    pyrexia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    20 / 81 (24.69%)
    21 / 78 (26.92%)
    1 / 12 (8.33%)
         occurrences all number
    2
    0
    30
    28
    1
    Immune system disorders
    allergy to arthropod bite
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    seasonal allergy
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Reproductive system and breast disorders
    vulvovaginal pruritus
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed [1]
    0 / 3 (0.00%)
    1 / 2 (50.00%)
    0 / 29 (0.00%)
    0 / 35 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    13 / 81 (16.05%)
    10 / 78 (12.82%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    14
    10
    0
    dyspnoea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    14 / 81 (17.28%)
    13 / 78 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    2
    0
    17
    25
    1
    epistaxis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    4 / 81 (4.94%)
    8 / 78 (10.26%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    4
    10
    0
    nasal congestion
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    4
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    4
    0
    productive cough
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    4 / 78 (5.13%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    4
    1
    pulmonary embolism
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    4 / 81 (4.94%)
    4 / 78 (5.13%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    4
    4
    1
    rhinorrhoea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Psychiatric disorders
    agitation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    anxiety
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    5 / 81 (6.17%)
    8 / 78 (10.26%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    5
    11
    1
    confusional state
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    2 / 78 (2.56%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    2
    2
    delirium
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    depression
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    7 / 81 (8.64%)
    5 / 78 (6.41%)
    2 / 12 (16.67%)
         occurrences all number
    1
    0
    9
    7
    2
    insomnia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    10 / 81 (12.35%)
    11 / 78 (14.10%)
    2 / 12 (16.67%)
         occurrences all number
    1
    0
    11
    13
    3
    restlessness
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Investigations
    activated partial thromboplastin time prolonged
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    4 / 81 (4.94%)
    5 / 78 (6.41%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    4
    6
    0
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    13 / 81 (16.05%)
    14 / 78 (17.95%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    28
    26
    0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    15 / 81 (18.52%)
    13 / 78 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    38
    20
    1
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    8 / 81 (9.88%)
    9 / 78 (11.54%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    23
    20
    0
    blood bilirubin increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    8 / 81 (9.88%)
    9 / 78 (11.54%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    12
    11
    0
    blood creatinine increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    3 / 81 (3.70%)
    5 / 78 (6.41%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    4
    10
    0
    blood potassium decreased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    3 / 81 (3.70%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    13
    0
    1
    liver function test increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    lymphocyte count decreased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    12 / 81 (14.81%)
    7 / 78 (8.97%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    88
    34
    3
    neutrophil count decreased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 7 (42.86%)
    2 / 3 (66.67%)
    31 / 81 (38.27%)
    25 / 78 (32.05%)
    4 / 12 (33.33%)
         occurrences all number
    15
    4
    184
    128
    11
    platelet count decreased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 3 (33.33%)
    29 / 81 (35.80%)
    31 / 78 (39.74%)
    3 / 12 (25.00%)
         occurrences all number
    3
    3
    134
    106
    9
    troponin increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    weight decreased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    23 / 81 (28.40%)
    9 / 78 (11.54%)
    2 / 12 (16.67%)
         occurrences all number
    1
    1
    36
    14
    2
    white blood cell count decreased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    23 / 81 (28.40%)
    16 / 78 (20.51%)
    3 / 12 (25.00%)
         occurrences all number
    2
    0
    127
    92
    5
    Injury, poisoning and procedural complications
    ankle fracture
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    fall
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    3 / 81 (3.70%)
    6 / 78 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    0
    3
    4
    6
    1
    incisional hernia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    infusion related reaction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    skin abrasion
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    3 / 81 (3.70%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    3
    0
    1
    skin laceration
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    4 / 81 (4.94%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    4
    1
    1
    sinus bradycardia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    tachycardia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    2 / 78 (2.56%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    3
    3
    1
    Nervous system disorders
    balance disorder
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    cognitive disorder
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    1
    dizziness
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    20 / 81 (24.69%)
    21 / 78 (26.92%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    26
    30
    0
    dysgeusia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    8 / 81 (9.88%)
    13 / 78 (16.67%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    11
    15
    1
    formication
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    headache
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    6 / 81 (7.41%)
    10 / 78 (12.82%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    9
    11
    1
    memory impairment
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    3 / 81 (3.70%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    4
    4
    0
    neuropathy peripheral
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    18 / 81 (22.22%)
    12 / 78 (15.38%)
    3 / 12 (25.00%)
         occurrences all number
    0
    3
    36
    23
    9
    neurotoxicity
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    paraesthesia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    3 / 78 (3.85%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    3
    5
    1
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    15 / 81 (18.52%)
    17 / 78 (21.79%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    29
    30
    0
    polyneuropathy
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    presyncope
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    restless legs syndrome
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    2
    0
    syncope
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    3 / 81 (3.70%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    3
    1
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 3 (66.67%)
    46 / 81 (56.79%)
    45 / 78 (57.69%)
    5 / 12 (41.67%)
         occurrences all number
    7
    8
    186
    165
    9
    iron deficiency anaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    2 / 78 (2.56%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    2
    1
    neutropenia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    20 / 81 (24.69%)
    16 / 78 (20.51%)
    3 / 12 (25.00%)
         occurrences all number
    2
    13
    53
    70
    6
    thrombocytopenia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 3 (66.67%)
    7 / 81 (8.64%)
    12 / 78 (15.38%)
    5 / 12 (41.67%)
         occurrences all number
    3
    5
    19
    93
    6
    Eye disorders
    dry eye
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    1 / 81 (1.23%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    2
    0
    eye haemorrhage
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    eye swelling
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    0
    1
    ocular hyperaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    vision blurred
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    6 / 81 (7.41%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    6
    2
    0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    2 / 78 (2.56%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    3
    1
    abdominal distension
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    4 / 81 (4.94%)
    4 / 78 (5.13%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    5
    5
    1
    abdominal pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    15 / 81 (18.52%)
    16 / 78 (20.51%)
    6 / 12 (50.00%)
         occurrences all number
    1
    0
    21
    22
    12
    ascites
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    5 / 81 (6.17%)
    5 / 78 (6.41%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    6
    7
    0
    constipation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    4 / 7 (57.14%)
    2 / 3 (66.67%)
    22 / 81 (27.16%)
    30 / 78 (38.46%)
    4 / 12 (33.33%)
         occurrences all number
    4
    2
    26
    31
    5
    diarrhoea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 3 (66.67%)
    40 / 81 (49.38%)
    30 / 78 (38.46%)
    7 / 12 (58.33%)
         occurrences all number
    1
    4
    72
    58
    9
    dyspepsia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    3 / 81 (3.70%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    3
    5
    0
    dysphagia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    4 / 78 (5.13%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    4
    1
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    4 / 78 (5.13%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    6
    2
    haemorrhoidal haemorrhage
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    1
    1
    haemorrhoids
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    0
    1
    lip swelling
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    2
    nausea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 3 (33.33%)
    33 / 81 (40.74%)
    39 / 78 (50.00%)
    6 / 12 (50.00%)
         occurrences all number
    3
    1
    46
    62
    15
    paraesthesia oral
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    stomatitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    9 / 81 (11.11%)
    9 / 78 (11.54%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    11
    11
    1
    vomiting
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    19 / 81 (23.46%)
    19 / 78 (24.36%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    26
    23
    4
    Hepatobiliary disorders
    bile duct stenosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    28 / 81 (34.57%)
    16 / 78 (20.51%)
    6 / 12 (50.00%)
         occurrences all number
    0
    1
    34
    21
    7
    dermatitis acneiform
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    2 / 78 (2.56%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    2
    1
    dermatitis allergic
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    erythema
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    1
    0
    0
    2
    erythema multiforme
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    hyperhidrosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    1
    1
    nail disorder
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    1
    1
    pruritus
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    5 / 81 (6.17%)
    5 / 78 (6.41%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    5
    5
    0
    rash
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    6 / 81 (7.41%)
    13 / 78 (16.67%)
    3 / 12 (25.00%)
         occurrences all number
    0
    0
    9
    22
    4
    rash maculo-papular
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    4 / 81 (4.94%)
    7 / 78 (8.97%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    6
    8
    1
    skin burning sensation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    skin lesion
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    urticaria
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 81 (1.23%)
    0 / 78 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    4
    0
    2
    Renal and urinary disorders
    chronic kidney disease
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    dysuria
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    2 / 78 (2.56%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    2
    1
    pollakiuria
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    urinary tract obstruction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 3 (33.33%)
    2 / 81 (2.47%)
    7 / 78 (8.97%)
    0 / 12 (0.00%)
         occurrences all number
    2
    2
    3
    9
    0
    back pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    6 / 81 (7.41%)
    11 / 78 (14.10%)
    2 / 12 (16.67%)
         occurrences all number
    1
    0
    6
    13
    2
    joint effusion
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    muscle spasms
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    4 / 78 (5.13%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    2
    5
    3
    muscular weakness
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    11 / 81 (13.58%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    14
    5
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    1 / 81 (1.23%)
    1 / 78 (1.28%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    2
    1
    0
    myalgia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    8 / 81 (9.88%)
    8 / 78 (10.26%)
    1 / 12 (8.33%)
         occurrences all number
    2
    0
    8
    12
    1
    pain in extremity
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    9 / 81 (11.11%)
    6 / 78 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    10
    11
    1
    spinal pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    cellulitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    4 / 81 (4.94%)
    3 / 78 (3.85%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    4
    8
    3
    erysipelas
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 81 (2.47%)
    1 / 78 (1.28%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    2
    1
    pneumonia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    6 / 81 (7.41%)
    5 / 78 (6.41%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    7
    5
    0
    postoperative wound infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    sinusitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    2 / 81 (2.47%)
    3 / 78 (3.85%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    2
    3
    0
    skin infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    3 / 81 (3.70%)
    2 / 78 (2.56%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    7
    5
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    3 / 81 (3.70%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    3
    4
    0
    urinary tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    3 / 81 (3.70%)
    8 / 78 (10.26%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    3
    16
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    22 / 81 (27.16%)
    24 / 78 (30.77%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    26
    37
    1
    dehydration
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 3 (33.33%)
    14 / 81 (17.28%)
    15 / 78 (19.23%)
    1 / 12 (8.33%)
         occurrences all number
    2
    1
    20
    30
    1
    hyperglycaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    5 / 81 (6.17%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    5
    10
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    hypoalbuminaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    13 / 81 (16.05%)
    4 / 78 (5.13%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    60
    7
    0
    hypocalcaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    10 / 81 (12.35%)
    3 / 78 (3.85%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    13
    3
    0
    hypokalaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    19 / 81 (23.46%)
    17 / 78 (21.79%)
    3 / 12 (25.00%)
         occurrences all number
    1
    0
    40
    31
    4
    hypomagnesaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    16 / 81 (19.75%)
    12 / 78 (15.38%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    27
    20
    1
    hyponatraemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 3 (0.00%)
    15 / 81 (18.52%)
    6 / 78 (7.69%)
    3 / 12 (25.00%)
         occurrences all number
    3
    0
    41
    11
    4
    vitamin d deficiency
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 81 (0.00%)
    0 / 78 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    0
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: There are gender specific adverse events occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Dec 2016
    Amendment (a) updated the Phase 1b design to enroll participants in the Days 1, 8 and 15 cohort first, and begin enrollment in the Days 1 and 15 dosing cohorts if the Days 1, 8 and 15 cohort is not tolerable. In addition, the design was changed to add a cohort expansion to ensure an appropriate number of participants (12 to 15 participants) are evaluated for safety in Phase 1b at the highest tolerated dose.
    27 Feb 2017
    Amendment (b) revised the definition of DLT based on Food and Drug Administration (FDA) feedback to include toxicities related to the combination of olaratumab plus gemcitabine and nab-paclitaxel.
    04 Dec 2017
    -Amendment (c) addresses several requests from FDA including language urging caution when administering nab-paclitaxel with CYP2C8 or CYP3A4 inhibitors or inducers as well as further details regarding the sample size justification. -In addition, the amendment adjusts the study entry criteria-related prior therapies, DLT wordings, participant's dose re-escalatation after dose reduction, schedule and timing of PROs in the follow-up periods (both long-term and shortterm), plans for the Phase 2 interim analysis and the Internal Assessment Committee (IAC) and several administrative items to provide clarity or correct errors.
    10 Dec 2018
    -Amendment D updates the protocol to include dose and schedule of olaratumab to be administered in the Phase 2 part, based on the results of the Phase 1b part of study JGDP. -This amendment also formalizes a change from an IAC (internal assessment committee) to an IDMC (independent data monitoring committee) for the Phase 2 part of the study.
    20 Mar 2019
    Amendment (e) updates the protocol to include screening criteria for Immunoglobulin E (IgE) antibodies against galactose-α-1-3-galactose (α-gal) and premedication requirements.

    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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