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    Clinical Trial Results:
    A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody IMC-3G3 Plus Mitoxantrone Plus Prednisone or Mitoxantrone Plus Prednisone in Metastatic Castration-Refractory Prostate Cancer Following Disease Progression or Intolerance on Docetaxel-based Chemotherapy

    Summary
    EudraCT number
    		 2009-018015-11
    Trial protocol
    		 DE   BE   ES   CZ   IT   HU  
    Global end of trial date
    01 Oct 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Apr 2018
    First version publication date
    04 Dec 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Update to FDS needed for results.

    Trial information

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    Trial identification
    Sponsor protocol code
    I5B-IE-JGDD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01204710
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial number: 13938
    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, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon-Fri 9 am - 5 pm, 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
    01 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a study evaluating the safety and efficacy of the monoclonal antibody olaratumab plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory prostate cancer following disease progression or intolerance on docetaxel-based chemotherapy.
    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
    06 Oct 2010
    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
    Hungary: 16
    Country: Number of subjects enrolled
    Czech Republic: 7
    Country: Number of subjects enrolled
    Spain: 29
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Italy: 17
    Worldwide total number of subjects
    123
    EEA total number of subjects
    123
    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)
    36
    From 65 to 84 years
    87
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A participant was considered to have completed the study if he or she experienced progressive disease (PD) or had died.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Olaratumab (IMC-3G3) + Mitoxantrone
    Arm description
    		 15 milligrams per kilogram (mg/kg) olaratumab was administered intravenously (IV) on Days 1 and 8 of each 21-day cycle, followed by 12 milligrams per square meter (mg/m²) mitoxantrone IV on Day 1 of each 21-day cycle with 5 milligrams (mg) prednisone orally (PO) twice daily (BID) on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²). After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaratumab
    Investigational medicinal product code
    Other name
    IMC-3G3, LY3012207
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15 milligrams per kilogram (mg/kg) olaratumab was administered intravenously (IV) on Days 1 and 8 of each 21-day cycle, followed by 12 milligrams per square meter (mg/m²) mitoxantrone IV on Day 1 of each 21-day cycle with 5 milligrams (mg) prednisone orally (PO) twice daily (BID) on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²). After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met.

    Investigational medicinal product name
    Mitoxantrone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²).

    Arm title
    		 Mitoxantrone
    Arm description
    		 12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²). PO BID on each day. Participants received treatment until withdrawal criteria were met.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mitoxantrone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²).

    Number of subjects in period 1
    		Olaratumab (IMC-3G3) + Mitoxantrone Mitoxantrone
    Started
    63
    60
    Received ≥1 dose of study drug
    62
    59
    Completed
    49
    47
    Not completed
    14
    13
         Consent withdrawn by subject
    6
    5
         Physician decision
    3
    2
         Moved and Followed for Survival
    -
    1
         Adverse event, non-fatal
    4
    2
         Sponsor Decision
    -
    1
         Lost to follow-up
    1
    -
         Worsening of General condition
    -
    1
         Entry criteria not met
    -
    1
    Period 2
    Period 2 title
    Optional Olaratumab Monotherapy
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Optional Olaratumab Monotherapy
    Arm description
    		 Participants who experienced PD had the option to receive olaratumab monotherapy treatment. 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met. These participants are a subset of the control arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaratumab
    Investigational medicinal product code
    Other name
    IMC-3G3, LY3012207
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15 milligrams per kilogram (mg/kg) olaratumab was administered intravenously (IV) on Days 1 and 8 of each 21-day cycle

    Number of subjects in period 2 [1]
    		Optional Olaratumab Monotherapy
    Started
    19
    Completed
    16
    Not completed
    3
         Consent withdrawn by subject
    1
         Physician decision
    1
         Olaratumab Intolerance
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Olaratumab follow-on treatment was optional for participants in mitoxantrone group only who had PD. Among 43 participants who experienced PD, 19 received olaratumab follow-on treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Olaratumab (IMC-3G3) + Mitoxantrone
    Reporting group description
    		 15 milligrams per kilogram (mg/kg) olaratumab was administered intravenously (IV) on Days 1 and 8 of each 21-day cycle, followed by 12 milligrams per square meter (mg/m²) mitoxantrone IV on Day 1 of each 21-day cycle with 5 milligrams (mg) prednisone orally (PO) twice daily (BID) on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²). After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met.

    Reporting group title
    Mitoxantrone
    Reporting group description
    		 12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²). PO BID on each day. Participants received treatment until withdrawal criteria were met.

    Reporting group values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Mitoxantrone Total
    Number of subjects
    		 63 60 123
    Age Categorical
    Units: participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 20 16 36
        >=65 years
    		 43 44 87
    Gender, Male/Female
    Units: participants
        Female
    		 0 0 0
        Male
    		 63 60 123
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 3 5
        Not Hispanic or Latino
    		 61 57 118
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 63 59 122
        More than one race
    		 0 1 1
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Hungary
    		 6 10 16
        Czech Republic
    		 5 2 7
        Spain
    		 17 12 29
        Poland
    		 11 6 17
        Belgium
    		 3 3 6
        Germany
    		 15 16 31
        Italy
    		 6 11 17

    End points

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    End points reporting groups
    Reporting group title
    Olaratumab (IMC-3G3) + Mitoxantrone
    Reporting group description
    		 15 milligrams per kilogram (mg/kg) olaratumab was administered intravenously (IV) on Days 1 and 8 of each 21-day cycle, followed by 12 milligrams per square meter (mg/m²) mitoxantrone IV on Day 1 of each 21-day cycle with 5 milligrams (mg) prednisone orally (PO) twice daily (BID) on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²). After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met.

    Reporting group title
    Mitoxantrone
    Reporting group description
    		 12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²). PO BID on each day. Participants received treatment until withdrawal criteria were met.
    Reporting group title
    Optional Olaratumab Monotherapy
    Reporting group description
    		 Participants who experienced PD had the option to receive olaratumab monotherapy treatment. 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met. These participants are a subset of the control arm.

    Subject analysis set title
    Optional Olaratumab Monotherapy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who experienced PD had the option to receive olaratumab monotherapy treatment. 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone

    Subject analysis set title
    PFS Olaratumab + Mitoxantrone (LE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had CTC counts at baseline in the Olaratumab + Mitoxantrone arm. Low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 mL. PFS is measured from randomization to the earliest date of the following events: PD according to RECIST criteria v. 1.1, is a ≥20% increase in the sum diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 mm, the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy, PFS was censored at their last tumor assessment.

    Subject analysis set title
    PFS Olaratumab + Mitoxantrone (HE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had CTC counts at baseline in the Olaratumab + Mitoxantrone arm. High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL). PFS is measured from randomization to the earliest date of the following events: PD according to RECIST criteria v. 1.1, is a ≥20% increase in the sum diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 mm, the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy, PFS was censored at their last tumor assessment.

    Subject analysis set title
    OS Olaratumab + Mitoxantrone (LE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had CTC counts at baseline in the Olaratumab + Mitoxantrone arm. LE of CTC was defined as having CTC counts <5 cells/7.5 mL.

    Subject analysis set title
    OS Olaratumab + Mitoxantrone (HE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had CTC counts at baseline in the Olaratumab + Mitoxantrone arm. HE of CTC was defined as having CTC counts ≥5 cells/7.5 mL

    Subject analysis set title
    PFS Mitoxantrone (HE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had CTC counts at baseline in the Olaratumab + Mitoxantrone arm. High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL).

    Subject analysis set title
    PFS Mitoxantrone (LE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had CTC counts at baseline in the Olaratumab + Mitoxantrone arm. Low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 milliliter (mL).

    Subject analysis set title
    OS Mitoxantrone (HE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had CTC counts at baseline in the Olaratumab + Mitoxantrone arm. High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL).

    Subject analysis set title
    OS Mitoxantrone (LE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomized participants who had CTC counts at baseline in the Olaratumab + Mitoxantrone arm. Low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 milliliter (mL).

    Primary: Progression-Free survival (PFS)

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    End point title
    		 Progression-Free survival (PFS)
    End point description
    PFS is measured from randomization to the earliest date of the following events: PD according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1, is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy or were lost to follow-up, PFS was censored at their last tumor assessment.
    End point type
    Primary
    End point timeframe
    Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
    End point values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Mitoxantrone
    Number of subjects analysed
    62 [1]
    59 [2]
    Units: months
        median (confidence interval 95%)
    2.3 (2.2 to 2.8)
    2.4 (2.2 to 3.8)
    Notes
    [1] - All randomized participants who received ≥1 dose of study drug.
    [2] - All randomized participants who received ≥1 dose of study drug.
    Statistical analysis title
    		 Statistical Analysis for Progression-Free Survival
    Comparison groups
    Olaratumab (IMC-3G3) + Mitoxantrone v Mitoxantrone
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2201 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.9
    Notes
    [3] - Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    OS was defined as the time from the date of randomization to the date of death from any cause. If the participants were alive at the end of the follow-up period or were lost to follow-up, OS time was censored on the last date the participant was known to be alive.
    End point type
    Secondary
    End point timeframe
    Randomization to Death Due to Any Cause Up to 36 Months
    End point values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Mitoxantrone
    Number of subjects analysed
    62 [4]
    59 [5]
    Units: months
        median (confidence interval 95%)
    14.2 (12.2 to 16)
    12.8 (8.1 to 16.4)
    Notes
    [4] - All randomized participants who received ≥1 dose of study drug.
    [5] - All randomized participants who received ≥1 dose of study drug.
    Statistical analysis title
    		 Statistical Analysis for Overall Survival
    Comparison groups
    Mitoxantrone v Olaratumab (IMC-3G3) + Mitoxantrone
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7291 [6]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.61
    Notes
    [6] - Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.

    Secondary: Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) [Objective Response Rate (ORR)]

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    End point title
    		 Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) [Objective Response Rate (ORR)]
    End point description
    Best response is categorized using the RECIST v1.1 guidelines. CR is the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is a ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the pretreatment sum diameter. Percentage of participants = (number of participants who had CR or PR) / (number of participants treated) * 100.
    End point type
    Secondary
    End point timeframe
    Randomization to Objective PD or Death Up to 23 Months
    End point values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Mitoxantrone
    Number of subjects analysed
    30 [7]
    32 [8]
    Units: percentage of participants
        number (confidence interval 95%)
    10 (3.5 to 25.6)
    3.1 (0.6 to 15.7)
    Notes
    [7] - All randomized participants who received at least ≥1 dose of study drug and had measurable disease.
    [8] - All randomized participants who received at least ≥1 dose of study drug and had measurable disease.
    Statistical analysis title
    		 Statistical Analysis for Best Overall Response
    Comparison groups
    Mitoxantrone v Olaratumab (IMC-3G3) + Mitoxantrone
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3465
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Percentage of participants with a ≥50% decrease in Prostate Specific Androgen (PSA) from pretreatment to any time

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    End point title
    		 Percentage of participants with a ≥50% decrease in Prostate Specific Androgen (PSA) from pretreatment to any time
    End point description
    Decrease in PSA ≥50% from pretreatment required confirmation no less than 3 weeks after the initial suggestion of response and occurring prior to documentation of PD. Percentage of participants = (number of participants who had ≥50% decrease in PSA at any time) / (number of participants treated) * 100.
    End point type
    Secondary
    End point timeframe
    Pretreatment to PD Up to 23 Months
    End point values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Mitoxantrone
    Number of subjects analysed
    62 [9]
    59
    Units: percentage of participants
        number (confidence interval 95%)
    22.6 (14 to 34.4)
    18.6 (10.7 to 30.4)
    Notes
    [9] - All randomized participants who received ≥1 dose of study drug.
    Statistical analysis title
    		 Statistical Analysis for ≥50% Decrease in PSA
    Comparison groups
    Mitoxantrone v Olaratumab (IMC-3G3) + Mitoxantrone
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6571
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12

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    End point title
    		 Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12
    End point description
    Percentage of participants = (number of participants who had ≥30% decrease in PSA at Week 12) / (number of participants treated) * 100.
    End point type
    Secondary
    End point timeframe
    Pretreatment through Week 12
    End point values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Mitoxantrone
    Number of subjects analysed
    62 [10]
    59 [11]
    Units: percentage of participants
        number (confidence interval 95%)
    22.6 (14 to 34.4)
    16.9 (9.5 to 28.5)
    Notes
    [10] - All randomized participants who received ≥1 dose of study drug.
    [11] - All randomized participants who received ≥1 dose of study drug.
    Statistical analysis title
    		 Statistical Analysis for ≥30% Decrease in PSA
    Comparison groups
    Mitoxantrone v Olaratumab (IMC-3G3) + Mitoxantrone
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4986
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE)

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    End point title
    		 Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE)
    End point description
    Data presented are the number of participants who experienced serious adverse events (SAEs) and other nonserious adverse events (AEs). For participants in mitoxantrone group who had PD and chose optional IMC-3G3 follow-on treatment, the baseline was defined as the last assessment prior to the start of the olaratumab treatment. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.
    End point type
    Secondary
    End point timeframe
    From Start of Treatment Through Study Completion Up to 36 months
    End point values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Optional Olaratumab Monotherapy Mitoxantrone
    Number of subjects analysed
    62 [12]
    19 [13]
    59
    Units: participants
    number (not applicable)
        SAEs
    26
    6
    21
        AEs
    52
    15
    51
    Notes
    [12] - All randomized participants who received at least 1 dose of study drug.
    [13] - All randomized participants who received at least 1 dose of study drug.
    No statistical analyses for this end point

    Secondary: PFS based on baseline Circulating Tumor Cells (CTC) counts

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    End point title
    		 PFS based on baseline Circulating Tumor Cells (CTC) counts
    End point description
    High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL) and low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 mL. PFS is measured from randomization to the earliest date of the following events: PD according to RECIST criteria v. 1.1, is a ≥20% increase in the sum diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 mm, the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause.
    End point type
    Secondary
    End point timeframe
    Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
    End point values
    		 PFS Olaratumab + Mitoxantrone (LE) PFS Olaratumab + Mitoxantrone (HE) PFS Mitoxantrone (HE) PFS Mitoxantrone (LE)
    Number of subjects analysed
    21 [14]
    32 [15]
    32 [16]
    18 [17]
    Units: months
        median (confidence interval 95%)
    2.38 (2.14 to 7.20)
    2.32 (2.10 to 2.79)
    2.23 (2.10 to 2.40)
    4.91 (2.40 to 11.73)
    Notes
    [14] - Low expression CTC counts
    [15] - High expression CTC counts
    [16] - High expression CTC counts
    [17] - Low expression CTC counts
    No statistical analyses for this end point

    Secondary: OS Based on Baseline CTC Counts

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    End point title
    		 OS Based on Baseline CTC Counts
    End point description
    HE of CTC was defined as having CTC counts ≥5 cells/7.5 mL and LE of CTC was defined as having CTC counts <5 cells/7.5 mL. OS was defined as the time from the date of randomization to the date of death from any cause.
    End point type
    Secondary
    End point timeframe
    Randomization to Death Due to Any Cause Up to 36 Months
    End point values
    		 OS Olaratumab + Mitoxantrone (LE) OS Olaratumab + Mitoxantrone (HE) OS Mitoxantrone (HE) OS Mitoxantrone (LE)
    Number of subjects analysed
    21 [18]
    32 [19]
    32 [20]
    18 [21]
    Units: months
        median (confidence interval 95%)
    16.49 (9.13 to 28.12)
    12.85 (7.10 to 15.18)
    8.10 (5.82 to 13.14)
    23.00 (11.93 to 9999)
    Notes
    [18] - Low expression CTC counts
    [19] - High expression CTC counts
    [20] - High expression CTC counts
    [21] - Low expression CTC counts. Upper limit not estimable due survivor function falls above 0.5 line.
    No statistical analyses for this end point

    Secondary: Number of participants with negative platelet-Derived growth factor receptor alpha (PDGFRα) protein expression by immunohistochemistry (IHC)

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    End point title
    		 Number of participants with negative platelet-Derived growth factor receptor alpha (PDGFRα) protein expression by immunohistochemistry (IHC)
    End point description
    PDGFRα protein expression (pretreatment) by IHC was assessed in tumor cells, and was provided as a dichotomous variable with “positive” and “negative” expression. “Positive” corresponds to weak intensity membranous staining comprising greater than 30% of the tumor and/or moderate to strong intensity membranous staining comprising greater than 5% of the tumor. “Negative” corresponds to staining that does not meet these requirements.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Mitoxantrone
    Number of subjects analysed
    14 [22]
    9 [23]
    Units: participants
        number (not applicable)
    14
    9
    Notes
    [22] - All randomized participants who had tissue specimens from the initial diagnosis for PDGFRα.
    [23] - All randomized participants who had tissue specimens from the initial diagnosis for PDGFRα.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Olaratumab Antibody Assessment (immunogenicity)

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    End point title
    		 Percentage of Participants with Anti-Olaratumab Antibody Assessment (immunogenicity)
    End point description
    Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
    End point type
    Secondary
    End point timeframe
    From Start of Treatment up to 9 Months
    End point values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Mitoxantrone
    Number of subjects analysed
    52 [24]
    11 [25]
    Units: percent of participants
        number (not applicable)
    3.8
    0
    Notes
    [24] - All randomized participants who had evaluable baseline and evaluable post-baseline antibody data.
    [25] - All randomized participants who had evaluable baseline and evaluable post-baseline antibody data.
    No statistical analyses for this end point

    Secondary: Maximum concentration (Cmax) of Olaratumab cycles 1, 2 and 3

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    End point title
    		 Maximum concentration (Cmax) of Olaratumab cycles 1, 2 and 3
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycles 1, 2 and 3, and Day 8 of Cycles 1 and 3 (21-day cycle)
    End point values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Mitoxantrone
    Number of subjects analysed
    0 [26]
    0 [27]
    Units: number
        number (not applicable)
    Notes
    [26] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [27] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    No statistical analyses for this end point

    Other pre-specified: Number of participants who died during study

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    End point title
    		 Number of participants who died during study
    End point description
    End point type
    Other pre-specified
    End point timeframe
    From Start of Treatment through Study Completion up to 36 Months
    End point values
    		 Olaratumab (IMC-3G3) + Mitoxantrone Optional Olaratumab Monotherapy Mitoxantrone
    Number of subjects analysed
    62 [28]
    19 [29]
    59 [30]
    Units: participants
    number (not applicable)
        Due to PD
    43
    12
    27
        Due to AEs
    4
    1
    3
        Due to Other reasons
    3
    1
    2
    Notes
    [28] - All randomized participants who received ≥1 dose of study drug.
    [29] - All randomized participants who received ≥1 dose of study drug.
    [30] - All randomized participants who received ≥1 dose of study drug.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I5B-IE-JGDD
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Olaratumab + Mitoxantrone
    Reporting group description
    		 -

    Reporting group title
    Mitoxantrone
    Reporting group description
    		 -

    Reporting group title
    Optional Olaratumab Monotherapy
    Reporting group description
    		 Participants who experienced PD had the option to receive olaratumab monotherapy treatment.15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met. These participants are a subset of the control arm.

    Serious adverse events
    		 Olaratumab + Mitoxantrone Mitoxantrone Optional Olaratumab Monotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 62 (41.94%)
    21 / 59 (35.59%)
    6 / 19 (31.58%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    circulatory collapse
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    deep vein thrombosis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    fatigue
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    general physical health deterioration
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    localised oedema
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    multi-organ failure
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    oedema peripheral
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    anaphylactic reaction
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    anaphylactic shock
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hypersensitivity
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    pleural effusion
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pulmonary infarction
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    alcoholism
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    general physical condition abnormal
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    cystitis radiation
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    incorrect dose administered
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    subdural haematoma
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    atrial flutter
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    cardiac failure chronic
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    congestive cardiomyopathy
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    myocardial ischaemia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebral haemorrhage
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    depressed level of consciousness
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    facial paresis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    muscle spasticity
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    paraparesis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    paraplegia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    spinal cord compression
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 59 (3.39%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    agranulocytosis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    anaemia of malignant disease
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    anaemia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    5 / 62 (8.06%)
    4 / 59 (6.78%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    leukopenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 59 (3.39%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    neutropenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pancytopenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    periodontitis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    hydronephrosis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    renal failure acute
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    urinary tract obstruction
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    bone pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    muscular weakness
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pain in extremity
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    bronchopneumonia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    erysipelas
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis escherichia coli
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    rectal abscess
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    respiratory tract infection
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    septic shock
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    urosepsis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    cachexia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Olaratumab + Mitoxantrone Mitoxantrone Optional Olaratumab Monotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 62 (83.87%)
    51 / 59 (86.44%)
    15 / 19 (78.95%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    5 / 62 (8.06%)
    2 / 59 (3.39%)
    0 / 19 (0.00%)
         occurrences all number
    7
    6
    0
    hypotension
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences all number
    0
    3
    0
    thrombosis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    18 / 62 (29.03%)
    13 / 59 (22.03%)
    5 / 19 (26.32%)
         occurrences all number
    39
    23
    5
    fatigue
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    11 / 62 (17.74%)
    11 / 59 (18.64%)
    3 / 19 (15.79%)
         occurrences all number
    11
    13
    3
    infusion related reaction
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 59 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    1
    0
    3
    oedema peripheral
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    6 / 62 (9.68%)
    4 / 59 (6.78%)
    1 / 19 (5.26%)
         occurrences all number
    8
    4
    1
    pyrexia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    4 / 62 (6.45%)
    7 / 59 (11.86%)
    1 / 19 (5.26%)
         occurrences all number
    8
    7
    1
    Reproductive system and breast disorders
    pelvic pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 59 (3.39%)
    2 / 19 (10.53%)
         occurrences all number
    3
    2
    2
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    4 / 62 (6.45%)
    6 / 59 (10.17%)
    0 / 19 (0.00%)
         occurrences all number
    4
    6
    0
    dyspnoea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    4 / 62 (6.45%)
    4 / 59 (6.78%)
    1 / 19 (5.26%)
         occurrences all number
    4
    5
    1
    pleural effusion
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences all number
    2
    2
    1
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 59 (3.39%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    1
    depression
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1
    1
    Investigations
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    1
    ejection fraction decreased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences all number
    1
    3
    0
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences all number
    2
    5
    0
    weight decreased
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    5 / 59 (8.47%)
    0 / 19 (0.00%)
         occurrences all number
    2
    6
    0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences all number
    3
    4
    0
    dysgeusia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences all number
    2
    4
    0
    headache
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    4 / 62 (6.45%)
    5 / 59 (8.47%)
    1 / 19 (5.26%)
         occurrences all number
    6
    17
    1
    paraesthesia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences all number
    1
    3
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    17 / 62 (27.42%)
    15 / 59 (25.42%)
    3 / 19 (15.79%)
         occurrences all number
    41
    33
    4
    leukopenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    9 / 62 (14.52%)
    8 / 59 (13.56%)
    0 / 19 (0.00%)
         occurrences all number
    25
    13
    0
    neutropenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    19 / 62 (30.65%)
    11 / 59 (18.64%)
    0 / 19 (0.00%)
         occurrences all number
    44
    28
    0
    thrombocytopenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    8 / 62 (12.90%)
    6 / 59 (10.17%)
    1 / 19 (5.26%)
         occurrences all number
    19
    17
    1
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    4 / 59 (6.78%)
    0 / 19 (0.00%)
         occurrences all number
    2
    6
    0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 59 (3.39%)
    1 / 19 (5.26%)
         occurrences all number
    2
    3
    1
    abdominal pain upper
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences all number
    0
    4
    0
    cheilitis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    constipation
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    5 / 62 (8.06%)
    11 / 59 (18.64%)
    3 / 19 (15.79%)
         occurrences all number
    6
    14
    4
    diarrhoea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    12 / 62 (19.35%)
    7 / 59 (11.86%)
    0 / 19 (0.00%)
         occurrences all number
    15
    8
    0
    dyspepsia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    5 / 59 (8.47%)
    0 / 19 (0.00%)
         occurrences all number
    0
    6
    0
    dysphagia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1
    haemorrhoidal haemorrhage
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    nausea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    15 / 62 (24.19%)
    14 / 59 (23.73%)
    2 / 19 (10.53%)
         occurrences all number
    19
    19
    2
    vomiting
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    5 / 62 (8.06%)
    3 / 59 (5.08%)
    1 / 19 (5.26%)
         occurrences all number
    5
    3
    1
    Skin and subcutaneous tissue disorders
    hypoaesthesia facial
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    rash
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 59 (3.39%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    2
    skin disorder
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    haematuria
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    4 / 59 (6.78%)
    0 / 19 (0.00%)
         occurrences all number
    3
    5
    0
    pollakiuria
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    2
    urinary incontinence
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    4 / 59 (6.78%)
    0 / 19 (0.00%)
         occurrences all number
    1
    4
    0
    urinary retention
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    0
    4
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    7 / 62 (11.29%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences all number
    7
    6
    0
    back pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    6 / 62 (9.68%)
    7 / 59 (11.86%)
    2 / 19 (10.53%)
         occurrences all number
    8
    8
    2
    bone pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    7 / 62 (11.29%)
    5 / 59 (8.47%)
    1 / 19 (5.26%)
         occurrences all number
    10
    5
    1
    flank pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    1
    muscle atrophy
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    muscle spasms
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    4 / 62 (6.45%)
    1 / 59 (1.69%)
    0 / 19 (0.00%)
         occurrences all number
    5
    1
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    4 / 59 (6.78%)
    2 / 19 (10.53%)
         occurrences all number
    1
    4
    2
    pain in extremity
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    7 / 62 (11.29%)
    3 / 59 (5.08%)
    0 / 19 (0.00%)
         occurrences all number
    7
    4
    0
    Infections and infestations
    urinary tract infection
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences all number
    2
    2
    1
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    11 / 62 (17.74%)
    6 / 59 (10.17%)
    3 / 19 (15.79%)
         occurrences all number
    15
    10
    5
    hypokalaemia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    1
    hypovitaminosis
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 59 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    vitamin b12 deficiency
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 59 (1.69%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Sep 2010
    Protocol Version 2.0 dated 28-Sep-2010. Changes from Version 1.0 • Updated to reflect new data— the 39-week toxicology study in monkeys—that was presentedin the updated Investigator’s Brochure (V5.1) • Added updated patient disposition and safety information for all clinical IMC-3G3 studies presented the updated Investigator’s Brochure (V5.1) • Body surface area to be measured only on Day 1 for patients with scheduled mitoxantrone administration • Per request by the German Health Authority, a description of the independent data monitoring committee (IDMC) provided in-text • Various administrative changes for further clarity

    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.
    Efficacy analysis for the follow-on treatment is exploratory, therefore, efficacy analysis for follow-on treatment are not included in this clinical trial results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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