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    Clinical Trial Results:
    Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.

    Summary
    EudraCT number
    		 2015-005443-14
    Trial protocol
    		 DE   DK   SE   HU   CZ   PL   BG  
    Global end of trial date
    05 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Aug 2020
    First version publication date
    29 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NGAM-08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02638207
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 14096
    Sponsors
    Sponsor organisation name
    Octapharma Pharmazeutika Produktionsges.m.b.H.
    Sponsor organisation address
    Oberlaaer Strasse 235, Vienna, Austria, 1100
    Public contact
    Global Clinical Project Manager, Octapharma Pharmazeutika Produktionsges.m.b.H., 43 610321716, clinical.department@octapharma.com
    Scientific contact
    Global Clinical Project Manager, Octapharma Pharmazeutika Produktionsges.m.b.H., 43 610321716, clinical.department@octapharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Jan 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary: To provide confirmatory data on the effect of 1.0 g/kg NewGam every three weeks in patients with active CIDP based on the percentage of responders at Week 24, which should corroborate the existing evidence on efficacy of IGIV in CIDP as known from published literature.
    Protection of trial subjects
    The study described herein is conducted in accordance with the ethical principles of the Declaration of Helsinki, and ICH-GCP (Note for Guidance CPMP/ICH/135/95), and national regulatory requirements. Inclusion and exclusion criteria were carefully defined in order to protect subjects from contraindications, interactions with other medication and risk factors associated with the investigational medicinal product. Throughout the study safety was assessed, such as of monitoring of AEs, SAEs, vital signs and concomitant medication.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Aug 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
    Ukraine: 41
    Country: Number of subjects enrolled
    Bulgaria: 4
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Czech Republic: 17
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Poland: 14
    Country: Number of subjects enrolled
    Romania: 39
    Country: Number of subjects enrolled
    Russian Federation: 22
    Worldwide total number of subjects
    142
    EEA total number of subjects
    78
    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)
    97
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with documented diagnosis of chronic inflammatory demyelinating poly(radiculo)neuropathy (ProCID Study) were screened according to predefined in- and exclusion criteria.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    In the event of medical emergency, the investigator was able to unblind a patient immediately by accessing the IWRS system.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 0.5 g/kg NewGam
    Arm description
    		 All patients received a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    NewGam
    Investigational medicinal product code
    Other name
    Panzyga
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients received a loading dose of 2.0 g/kg NewGam (administered over 2 consecutive days), followed by 7 infusions of the maintenance dose the patient has been randomized to (i.e., 0.5, 1.0 or 2.0 g/kg NewGam), also administered over 2 consecutive days every 3 weeks (±4 days). The same volumes and infusion rates were used regardless of the randomized group, with supplementation with an authorized 0.9% w/v isotonic sodium chloride solution as appropriate to maintain the blinding. There was the option of rescue treatment with two consecutive blinded infusions of 2.0 g/kg NewGam at 3-week intervals (±4 days) for all patients in the 0.5 and 1.0 g/kg NewGam arms who were either stable at Week 6 or deteriorated after Week 3 and before Week 18.

    Arm title
    		 1.0 g/kg NewGam
    Arm description
    		 All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (1.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    NewGam
    Investigational medicinal product code
    Other name
    Panzyga
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients received a loading dose of 2.0 g/kg NewGam (administered over 2 consecutive days), followed by 7 infusions of the maintenance dose the patient has been randomized to (i.e., 0.5, 1.0 or 2.0 g/kg NewGam), also administered over 2 consecutive days every 3 weeks (±4 days). The same volumes and infusion rates were used regardless of the randomized group, with supplementation with an authorized 0.9% w/v isotonic sodium chloride solution as appropriate to maintain the blinding. There was the option of rescue treatment with two consecutive blinded infusions of 2.0 g/kg NewGam at 3-week intervals (±4 days) for all patients in the 0.5 and 1.0 g/kg NewGam arms who were either stable at Week 6 or deteriorated after Week 3 and before Week 18.

    Arm title
    		 2.0 g/kg NewGam
    Arm description
    		 All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (2.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    NewGam
    Investigational medicinal product code
    Other name
    Panzyga
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients received a loading dose of 2.0 g/kg NewGam (administered over 2 consecutive days), followed by 7 infusions of the maintenance dose the patient has been randomized to (i.e., 0.5, 1.0 or 2.0 g/kg NewGam), also administered over 2 consecutive days every 3 weeks (±4 days). The same volumes and infusion rates were used regardless of the randomized group, with supplementation with an authorized 0.9% w/v isotonic sodium chloride solution as appropriate to maintain the blinding. There was the option of rescue treatment with two consecutive blinded infusions of 2.0 g/kg NewGam at 3-week intervals (±4 days) for all patients in the 0.5 and 1.0 g/kg NewGam arms who were either stable at Week 6 or deteriorated after Week 3 and before Week 18.

    Number of subjects in period 1
    		0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Started
    35
    69
    38
    Completed
    28
    61
    34
    Not completed
    7
    8
    4
         Adverse event, non-fatal
    3
    2
    1
         Patient Decision
    3
    3
    1
         Administrative reasons
    -
    -
    1
         Safety Reasons
    -
    1
    1
         other
    1
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 142 142
    Age categorical
    Units: Subjects
        18-64 years
    		 97 97
        65-83 Years
    		 45 45
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 55.84 (18 to 83) -
    Gender categorical
    Units: Subjects
        Female
    		 58 58
        Male
    		 84 84

    End points

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    End points reporting groups
    Reporting group title
    0.5 g/kg NewGam
    Reporting group description
    		 All patients received a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).

    Reporting group title
    1.0 g/kg NewGam
    Reporting group description
    		 All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (1.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).

    Reporting group title
    2.0 g/kg NewGam
    Reporting group description
    		 All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (2.0g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).

    Primary: Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score in the 1.0 g/kg Group

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    End point title
    		 Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score in the 1.0 g/kg Group [1]
    End point description
    Efficacy - Proportion of responders in the 1.0 g/kg NewGam arm at Week 24 (Termination Visit) relative to baseline (Week 0). A responder being defined as a patient with a decrease of at least 1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score (a scale from 0 to 10, from healthy to unable to make any purposeful movements with arms and/or legs)
    End point type
    Primary
    End point timeframe
    at week 24
    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: Primary endpoint was evaluated by comparing the lower limit of the 95% Wilson-Score CI for the percentage of responders on the adjusted INCAT disability scale in the 1.0 g/kg dose group with a predefined threshold of 42%. The response rates in the alternative dose groups were compared descriptively to the 1.0 g/kg treatment group, and the CIs for the differences were presented. Descriptive summaries are presented for each of the primary, secondary and exploratory variables.
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    34
    69
    36
    Units: Responders
    22
    55
    33
    No statistical analyses for this end point

    Secondary: Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score in the 0.5 g/kg and 2.0 g/kg Group

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    End point title
    		 Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score in the 0.5 g/kg and 2.0 g/kg Group
    End point description
    Proportion of responders in the 0.5 g/kg and 2.0 g/kg NewGam arms at Week 24 relative to baseline compared to the 1.0 g/kg arm, based on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score.
    End point type
    Secondary
    End point timeframe
    at week 24
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    34
    69
    36
    Units: Responders
    22
    55
    33
    No statistical analyses for this end point

    Secondary: Grip Strength Score

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    End point title
    		 Grip Strength Score
    End point description
    Proportion of responders in the 0.5 g/kg and 2.0 g/kg NewGam arms at Week 24 relative to Baseline at Week 0 compared to the 1.0 g/kg arm, based on the grip strength (Martin Vigorimeter) using the previously published minimum clinically important difference (MCID) cut-off of 8 kPa .
    End point type
    Secondary
    End point timeframe
    at Week 24
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    34
    69
    36
    Units: Responders
    19
    45
    30
    No statistical analyses for this end point

    Secondary: Inflammatory Rasch-built Overall Disability Scale (I-RODS Score)

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    End point title
    		 Inflammatory Rasch-built Overall Disability Scale (I-RODS Score)
    End point description
    Proportion of responders in the 0.5 g/kg and 2.0 g/kg NewGam arms at Week 24 relative to Baseline at Week 0 compared to the 1.0 g/kg arm, based on the I-RODS scores using the MCID concept related to the varying standard errors (MCID-SE).
    End point type
    Secondary
    End point timeframe
    at Week 24
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    34
    69
    36
    Units: Responders
    13
    38
    26
    No statistical analyses for this end point

    Secondary: Worsening in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score

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    End point title
    		 Worsening in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
    End point description
    Time to first confirmed worsening on the adjusted INCAT disability scale by at least 1 point from the value at Baseline (Week 0)
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: days
    Notes
    [2] - No patients with worsening in this group, analysis not possible.
    [3] - Only 1 patient with worsening thus an analysis of the time to first worsening was not possible.
    [4] - No patients with worsening in this group, analysis not possible
    No statistical analyses for this end point

    Secondary: Mean Change in Grip Strength

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    End point title
    		 Mean Change in Grip Strength
    End point description
    Mean change from baseline (Week 0) to Termination Visit in grip strength of both hands (assessed by Martin vigorimeter).
    End point type
    Secondary
    End point timeframe
    Termination Visit
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    34
    69
    36
    Units: kPa
    arithmetic mean (standard deviation)
        Dominant Hand
    23.91 ± 25.290
    19.38 ± 20.377
    26.06 ± 25.030
        Non-dominant Hand
    23.94 ± 24.600
    17.43 ± 19.916
    24.53 ± 22.247
    No statistical analyses for this end point

    Secondary: Inflammatory Rasch-built Overall Disability Scale (I-RODS)

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    End point title
    		 Inflammatory Rasch-built Overall Disability Scale (I-RODS)
    End point description
    Mean change from baseline (Week 0) to Termination Visit in Inflammatory Rasch-built overall disability sum score (I-RODS using the concept of MCID-SE as recently reported) and number of improvers.
    End point type
    Secondary
    End point timeframe
    Termination Visit
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    34
    69
    36
    Units: Score
        arithmetic mean (standard deviation)
    11.38 ± 12.485
    10.32 ± 10.836
    13.86 ± 11.981
    No statistical analyses for this end point

    Secondary: Motor Nerves

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    End point title
    		 Motor Nerves
    End point description
    Mean change from baseline (Week 0) to Termination Visit in sum of the distal evoked amplitude of 4 right sided and 4 left sided motor nerves (peroneal, tibial, ulnar and median).
    End point type
    Secondary
    End point timeframe
    Termination Visit
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    34
    68
    36
    Units: mV
        arithmetic mean (standard deviation)
    2.16 ± 6.332
    2.69 ± 6.688
    3.93 ± 9.298
    No statistical analyses for this end point

    Secondary: Mean Change in Pain Intensity Numerical Rating Scale (PI-NRS Scale)

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    End point title
    		 Mean Change in Pain Intensity Numerical Rating Scale (PI-NRS Scale)
    End point description
    Mean change from baseline (Week 0) to Termination Visit in Pain Intensity Numeric Rating Scale (PI-NRS)
    End point type
    Secondary
    End point timeframe
    Termination Visit
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    34
    69
    36
    Units: Score
        arithmetic mean (standard deviation)
    -2.29 ± 3.040
    -2.19 ± 2.907
    -2.17 ± 3.256
    No statistical analyses for this end point

    Secondary: Worsening on the Inflammatory Rasch-built Overall Disability Scale (I-RODS Scale)

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    End point title
    		 Worsening on the Inflammatory Rasch-built Overall Disability Scale (I-RODS Scale)
    End point description
    Time to first confirmed worsening on the I-RODS scale.
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: days
    Notes
    [5] - Only 1 patient with worsening , thus an analysis of the time to first worsening was not possible.
    [6] - Only 2 patients with worsening , thus an analysis of the time to first worsening was not possible.
    [7] - No patients with worsening in this group, analysis not possible.
    No statistical analyses for this end point

    Secondary: 1 Point Decrease in the INCAT Disability Score

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    End point title
    		 1 Point Decrease in the INCAT Disability Score
    End point description
    Time to 1 point decrease (improvement of disability) in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score.
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    34
    69
    36
    Units: days
        median (confidence interval 95%)
    22.0 (22.0 to 24.0)
    26.0 (22.0 to 43.0)
    23.0 (22.0 to 43.0)
    No statistical analyses for this end point

    Secondary: Decrease in Inflammatory Rasch-built Overall Disability Scale (I-RODS Scale)

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    End point title
    		 Decrease in Inflammatory Rasch-built Overall Disability Scale (I-RODS Scale)
    End point description
    Time to decrease in Inflammatory Rasch-built overall disability scale (I-RODS) scores.
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 0.5 g/kg NewGam 1.0 g/kg NewGam 2.0 g/kg NewGam
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    Units: days
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [8] - No patients with worsening thus an analysis of the time to first worsening was not possible.
    [9] - Only 1 patient with worsening thus an analysis of the time to first worsening was not possible.
    [10] - No patients with worsening thus an analysis of the time to first worsening was not possible
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the whole study from week 0 up to week 24 (end of study visit)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Safety Population
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 142 (4.23%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Meningioma
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Deafness unilateral
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Encephalitis
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Osteomyelitis
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    88 / 142 (61.97%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    9 / 142 (6.34%)
         occurrences all number
    14
    Body temperature increased
         subjects affected / exposed
    9 / 142 (6.34%)
         occurrences all number
    12
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    5 / 142 (3.52%)
         occurrences all number
    5
    Heart rate decreased
         subjects affected / exposed
    3 / 142 (2.11%)
         occurrences all number
    3
    Transaminases increased
         subjects affected / exposed
    3 / 142 (2.11%)
         occurrences all number
    3
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    3
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 142 (2.11%)
         occurrences all number
    3
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    4 / 142 (2.82%)
         occurrences all number
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 142 (13.38%)
         occurrences all number
    26
    Somnolence
         subjects affected / exposed
    3 / 142 (2.11%)
         occurrences all number
    4
    Tension headache
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    7
    Dizziness
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    11 / 142 (7.75%)
         occurrences all number
    13
    Chills
         subjects affected / exposed
    7 / 142 (4.93%)
         occurrences all number
    8
    Influenza like illness
         subjects affected / exposed
    3 / 142 (2.11%)
         occurrences all number
    3
    Asthenia
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    2
    Chest pain
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    6 / 142 (4.23%)
         occurrences all number
    7
    Anaemia
         subjects affected / exposed
    3 / 142 (2.11%)
         occurrences all number
    4
    Thrombocytopenia
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 142 (3.52%)
         occurrences all number
    8
    Diarrhoea
         subjects affected / exposed
    4 / 142 (2.82%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    13 / 142 (9.15%)
         occurrences all number
    19
    Skin exfoliation
         subjects affected / exposed
    4 / 142 (2.82%)
         occurrences all number
    5
    Urticaria
         subjects affected / exposed
    3 / 142 (2.11%)
         occurrences all number
    4
    Rash
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    6
    Pruritus
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    3
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 142 (1.41%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 142 (4.23%)
         occurrences all number
    6
    Pain in extremity
         subjects affected / exposed
    3 / 142 (2.11%)
         occurrences all number
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 142 (3.52%)
         occurrences all number
    5
    Respiratory tract infection viral
         subjects affected / exposed
    4 / 142 (2.82%)
         occurrences all number
    4
    Urinary tract infection
         subjects affected / exposed
    4 / 142 (2.82%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jun 2018
    Amendment 2: -addition of an upper limit for age of patients of <80 years to inclusion criteria; -addition of ‘severe’ to exclusion criterion regarding hypersensitivity to blood products -material of infusion bags (ethylene vinyl acetate) deleted and period of storage of infusion bags reduced from 72 to 24 hours -PGIC assessment at Screening deleted -viral testing added at Visit 2 (in addition to the screening sample)

    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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