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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects with Acute Spinal Cord Injury

    Summary
    EudraCT number
    2012-004373-80
    Trial protocol
    GB   CZ   ES   PL  
    Global end of trial date
    21 Mar 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    31 Jul 2016
    First version publication date
    31 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ASBI603
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01502631
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    IND Number: 105,377
    Sponsors
    Sponsor organisation name
    Daiichi Sankyo, Inc
    Sponsor organisation address
    399 Thornall St., Edison, New Jersey, United States, 08837
    Public contact
    Clinical Trials Information, Asubio Pharmaceuticals, Inc., +001 201368 5020, info@asubio.com
    Scientific contact
    Clinical Trials Information, Asubio Pharmaceuticals, Inc., +001 201368 5020, info@asubio.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
    21 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to determine if treatment of acute spinal cord injury (ASCI) with SUN13837, when compared with placebo, resulted in a greater improvement in measures of overall functional independence by a comparison of the difference in the final mean total Spinal Cord Independence Measure, version III (SCIM III) scores between the 2 treatment groups.
    Protection of trial subjects
    The safety assessments included adverse events, vital signs, electrocardiograms (ECGs), physical examination and clinical laboratory tests.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Jul 2012
    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
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    United States: 53
    Worldwide total number of subjects
    61
    EEA total number of subjects
    8
    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)
    57
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 69 subjects screened. Of which 65 subjects were randomized. 4 subjects were randomized but not treated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SUN13837
    Arm description
    Subjects received SUN13837 1 milligram per kilogram (mg/kg) intravenous injection once daily for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    SUN13837
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received SUN13837 1 milligram per kilogram (mg/kg) intravenous injection once daily for 28 days.

    Arm title
    Placebo
    Arm description
    Subjects received placebo intravenous injection once daily for 28 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received placebo intravenous injection once daily for 28 days.

    Number of subjects in period 1
    SUN13837 Placebo
    Started
    30
    31
    Completed
    16
    18
    Not completed
    14
    13
         Early withdrawal from study treatment
    6
    5
         Adverse event, serious fatal
    2
    3
         Subject Non-Compliant
    1
    -
         Consent withdrawn by subject
    -
    1
         Unspecified
    3
    2
         Lost to follow-up
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SUN13837
    Reporting group description
    Subjects received SUN13837 1 milligram per kilogram (mg/kg) intravenous injection once daily for 28 days.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo intravenous injection once daily for 28 days.

    Reporting group values
    SUN13837 Placebo Total
    Number of subjects
    30 31 61
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    28 29 57
        From 65-84 years
    2 2 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.9 ± 16.58 38.8 ± 17.22 -
    Gender categorical
    Units: Subjects
        Female
    4 5 9
        Male
    26 26 52

    End points

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    End points reporting groups
    Reporting group title
    SUN13837
    Reporting group description
    Subjects received SUN13837 1 milligram per kilogram (mg/kg) intravenous injection once daily for 28 days.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo intravenous injection once daily for 28 days.

    Primary: Spinal Cord Independence Measure, version III (SCIM III) Total Score at Week 16

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    End point title
    Spinal Cord Independence Measure, version III (SCIM III) Total Score at Week 16
    End point description
    The SCIM III is a comprehensive rating scale that measures the ability of subjects with spinal cord injury to perform everyday tasks. The SCIM III has 19 items that assess 3 domains: Self-Care (6 items, scores range from 0 to 20), Respiration and Sphincter Management (4 items, scores range from 0 to 40), and Mobility (9 items, scores range from 0 to 40). The total SCIM score ranges from 0 to 100. Higher value represents increase in the improvement. The Intent-to-Treat population included all randomized subjects who received at least 7 doses of study drug and had at least 1 SCIM III evaluation.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    SUN13837 Placebo
    Number of subjects analysed
    27
    28
    Units: units on a scale
        least squares mean (standard error)
    38.14 ± 4.74
    33.6 ± 4.703
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    SUN13837 v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4912
    Method
    ANCOVA
    Parameter type
    Least Square Mean
    Point estimate
    4.54
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.48
         upper limit
    15.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.524

    Secondary: Total Motor Score (TMS) of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) at Week 16

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    End point title
    Total Motor Score (TMS) of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) at Week 16
    End point description
    The TMS was the sum of the overall Upper Extremity Motor Score (UEMS) and the overall Lower Extremity Motor Score (LEMS) of ISNCSCI. The Upper Extremity Motor Score (UEMS) was defined as the sum of the motor function scores (based on the 0 to 5-point scale). A separate sum was obtained for the right and left sides (a maximum of 25 points each) and for an overall score (with a maximum score of 50). The Lower Extremity Motor Score (LEMS) was defined as the sum of the motor function scores. A separate sum was obtained for the right and left sides (a maximum of 25 points each) and for an overall score (with a maximum score of 50). Therefore, the maximum TMS score was 100. The TMS score reaches a maximum of 100 points in an individual with a fully functional spinal cord. The Intent-to-Treat population included all randomized subjects who received at least 7 doses of study drug and had at least 1 SCIM III evaluation.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    SUN13837 Placebo
    Number of subjects analysed
    27
    28
    Units: units on a scale
        least squares mean (standard error)
    16.58 ± 4.277
    14.07 ± 4.175
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v SUN13837
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6719
    Method
    ANCOVA
    Parameter type
    Least Square Mean
    Point estimate
    2.51
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.37
         upper limit
    12.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.874

    Secondary: Self-Care and Mobility Subscale Scores of Spinal Cord Independence Measure, version III (SCIM III) at Week 16

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    End point title
    Self-Care and Mobility Subscale Scores of Spinal Cord Independence Measure, version III (SCIM III) at Week 16
    End point description
    The SCIM III is a comprehensive rating scale that measures the ability of subjects with spinal cord injury to perform everyday tasks. The SCIM III has 19 items that assess 3 domains: Self-Care (6 items, scores range from 0 to 20), Respiration and Sphincter Management (4 items, scores range from 0 to 40), and Mobility (9 items, scores range from 0 to 40). The total SCIM score ranges from 0 to 100. SCIM III Self-Care subscale offered a means to evaluate upper extremity activities. Higher value represents increase in the improvement. The Intent-to-Treat population included all randomized subjects who received at least 7 doses of study drug and had at least 1 SCIM III evaluation.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    SUN13837 Placebo
    Number of subjects analysed
    27
    28
    Units: units on a scale
        least squares mean (standard error)
    18.73 ± 3.124
    15.02 ± 3.101
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    SUN13837 v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3951
    Method
    ANCOVA
    Parameter type
    Least Square Mean
    Point estimate
    3.71
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.59
         upper limit
    11.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.298

    Secondary: Number of Subjects With American Spinal Injury Association Impairment Scale (AIS) Grade - Improvement from Baseline at Final Assessment at Week 16

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    End point title
    Number of Subjects With American Spinal Injury Association Impairment Scale (AIS) Grade - Improvement from Baseline at Final Assessment at Week 16
    End point description
    Subjects were assessed for AIS based on the following grading scheme: A (complete, no motor or sensory function is preserved in the sacral levels 4 through 5), B (incomplete, sensory but no motor function is preserved below the neurological level and includes sacral levels 4 through 5), C (incomplete, motor function is preserved below the neurological level and more than half of the key muscles below the neurological level have a muscle grade of less than 3), D (incomplete, motor function preserved below the neurological level and at least half of the key muscles below the neurological level have a muscle grade of 5 or more) and E (normal). Improvement was defined as 1 or more shift toward AIS grade (B-E) from baseline. The Intent-to-Treat population included all randomized subjects who received at least 7 doses of study drug and had at least 1 SCIM III evaluation. Here, "N" is number of subjects analyzed for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    SUN13837 Placebo
    Number of subjects analysed
    27
    27
    Units: subjects
    12
    15
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    SUN13837 v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4916
    Method
    ANCOVA
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.67
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.26
         upper limit
    1.73

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From First Administration of Study Drug up to End of Study (Day 182)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    SUN13837
    Reporting group description
    Subjects received SUN13837 1 milligram per kilogram (mg/kg) intravenous injection once daily for 28 days.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo intravenous injection once daily for 28 days.

    Serious adverse events
    SUN13837 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 30 (36.67%)
    17 / 31 (54.84%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Withdrawal of life support
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Multiple myeloma
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Euthanasia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 31 (9.68%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercapnia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anuria
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyuria
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urine abnormality
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroiditis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 31 (9.68%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection pseudomonal
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection fungal
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    SUN13837 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 30 (100.00%)
    31 / 31 (100.00%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    9 / 30 (30.00%)
    8 / 31 (25.81%)
         occurrences all number
    9
    8
    Hypotension
         subjects affected / exposed
    5 / 30 (16.67%)
    6 / 31 (19.35%)
         occurrences all number
    5
    6
    Deep vein thrombosis
         subjects affected / exposed
    2 / 30 (6.67%)
    5 / 31 (16.13%)
         occurrences all number
    2
    5
    Hypertension
         subjects affected / exposed
    1 / 30 (3.33%)
    5 / 31 (16.13%)
         occurrences all number
    1
    9
    Flushing
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Neurogenic shock
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Phlebitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    3
    0
    Phlebitis superficial
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Surgical and medical procedures
    Osteosynthesis
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Sinus operation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    17 / 30 (56.67%)
    14 / 31 (45.16%)
         occurrences all number
    26
    18
    Oedema peripheral
         subjects affected / exposed
    5 / 30 (16.67%)
    4 / 31 (12.90%)
         occurrences all number
    5
    4
    Pain
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Chest pain
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    1
    4
    Catheter site inflammation
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Generalised oedema
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Medical device pain
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Oedema
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Chest discomfort
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Chills
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Hyperthermia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    3
    Impaired healing
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Implant site erosion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Irritability
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Temperature regulation disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    14 / 30 (46.67%)
    12 / 31 (38.71%)
         occurrences all number
    17
    13
    Anxiety
         subjects affected / exposed
    9 / 30 (30.00%)
    10 / 31 (32.26%)
         occurrences all number
    9
    13
    Depression
         subjects affected / exposed
    8 / 30 (26.67%)
    9 / 31 (29.03%)
         occurrences all number
    9
    9
    Agitation
         subjects affected / exposed
    5 / 30 (16.67%)
    1 / 31 (3.23%)
         occurrences all number
    5
    2
    Confusional state
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Delirium
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Adjustment disorder
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Claustrophobia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Delirium tremens
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Depressed mood
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Hallucination
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Mental status changes
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Nightmare
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Personality disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Psychotic disorder
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Restlessness
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Penis disorder
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Cervix oedema
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Epididymitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Genital burning sensation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Pelvic pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Scrotal oedema
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Vaginal discharge
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 31 (6.45%)
         occurrences all number
    6
    2
    Autonomic dysreflexia
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 31 (9.68%)
         occurrences all number
    2
    3
    Procedural pain
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 31 (3.23%)
         occurrences all number
    3
    1
    Procedural site reaction
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Muscle strain
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Wound
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Clavicle fracture
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Epicondylitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Incision site oedema
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Joint dislocation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Open wound
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    2
    Penis injury
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Post procedural oedema
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Postoperative wound complication
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Procedural haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Pseudomeningocele
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Spinal column injury
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Wound dehiscence
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Wound necrosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    7 / 30 (23.33%)
    5 / 31 (16.13%)
         occurrences all number
    7
    5
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 30 (16.67%)
    3 / 31 (9.68%)
         occurrences all number
    5
    3
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 31 (9.68%)
         occurrences all number
    5
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 31 (9.68%)
         occurrences all number
    2
    3
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 31 (9.68%)
         occurrences all number
    1
    3
    Haematocrit decreased
         subjects affected / exposed
    4 / 30 (13.33%)
    0 / 31 (0.00%)
         occurrences all number
    4
    0
    Haemoglobin decreased
         subjects affected / exposed
    4 / 30 (13.33%)
    0 / 31 (0.00%)
         occurrences all number
    4
    0
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Platelet count decreased
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Blood creatine increased
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Blood glucose increased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Body temperature increased
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    International normalised ratio increased
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Neutrophil count increased
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    4
    0
    Red blood cell count decreased
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    White blood cell count increased
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Bacterial test
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Blood albumin decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Blood bicarbonate increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Blood chloride decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Blood magnesium decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Blood sodium decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Blood urea increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Body temperature decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Chest X-ray abnormal
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Haemophilus test positive
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Heart rate decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Mean arterial pressure decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Myelocyte count increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Oxygen consumption increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Platelet count increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    White blood cells urine positive
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    5 / 30 (16.67%)
    4 / 31 (12.90%)
         occurrences all number
    5
    5
    Tachycardia
         subjects affected / exposed
    8 / 30 (26.67%)
    1 / 31 (3.23%)
         occurrences all number
    8
    1
    Atrial fibrillation
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Cardiac failure congestive
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    8 / 30 (26.67%)
    4 / 31 (12.90%)
         occurrences all number
    8
    4
    Atelectasis
         subjects affected / exposed
    5 / 30 (16.67%)
    6 / 31 (19.35%)
         occurrences all number
    5
    7
    Oropharyngeal pain
         subjects affected / exposed
    5 / 30 (16.67%)
    6 / 31 (19.35%)
         occurrences all number
    5
    7
    Respiratory failure
         subjects affected / exposed
    6 / 30 (20.00%)
    4 / 31 (12.90%)
         occurrences all number
    6
    6
    Pleural effusion
         subjects affected / exposed
    6 / 30 (20.00%)
    1 / 31 (3.23%)
         occurrences all number
    6
    1
    Pneumonia aspiration
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 31 (9.68%)
         occurrences all number
    3
    3
    Dyspnoea
         subjects affected / exposed
    1 / 30 (3.33%)
    4 / 31 (12.90%)
         occurrences all number
    2
    5
    Increased bronchial secretion
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Pulmonary oedema
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Respiratory distress
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Cough
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Hypoxia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Nasal dryness
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Aspiration
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Bronchial secretion retention
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Lung infiltration
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    3
    0
    Tachypnoea
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Acute respiratory failure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Apnoea
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Bronchospasm
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Choking
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Diaphragmatic paralysis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Haemoptysis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Hypoventilation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Pneumothorax
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Pulmonary congestion
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Respiratory acidosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Respiratory depression
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Respiratory depth decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Sinus congestion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Tracheal oedema
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    8 / 30 (26.67%)
    10 / 31 (32.26%)
         occurrences all number
    8
    13
    Anaemia
         subjects affected / exposed
    5 / 30 (16.67%)
    11 / 31 (35.48%)
         occurrences all number
    6
    11
    Haemorrhagic anaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Thrombocytopenia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Thrombocytosis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Bandaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Blood disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    2
    Eosinophilia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Nucleated red cells
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Muscle spasticity
         subjects affected / exposed
    12 / 30 (40.00%)
    9 / 31 (29.03%)
         occurrences all number
    13
    11
    Neuralgia
         subjects affected / exposed
    13 / 30 (43.33%)
    8 / 31 (25.81%)
         occurrences all number
    13
    9
    Headache
         subjects affected / exposed
    9 / 30 (30.00%)
    4 / 31 (12.90%)
         occurrences all number
    10
    5
    Dizziness
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 31 (3.23%)
         occurrences all number
    3
    1
    Dysaesthesia
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 31 (0.00%)
         occurrences all number
    3
    0
    Hypertonia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Sedation
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Spinal cord compression
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Spinal cord oedema
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    5 / 30 (16.67%)
    3 / 31 (9.68%)
         occurrences all number
    5
    3
    Diplopia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Ear pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    12 / 30 (40.00%)
    10 / 31 (32.26%)
         occurrences all number
    15
    14
    Constipation
         subjects affected / exposed
    7 / 30 (23.33%)
    11 / 31 (35.48%)
         occurrences all number
    12
    17
    Diarrhoea
         subjects affected / exposed
    6 / 30 (20.00%)
    5 / 31 (16.13%)
         occurrences all number
    7
    6
    Vomiting
         subjects affected / exposed
    5 / 30 (16.67%)
    6 / 31 (19.35%)
         occurrences all number
    7
    6
    Dysphagia
         subjects affected / exposed
    5 / 30 (16.67%)
    5 / 31 (16.13%)
         occurrences all number
    5
    6
    Ileus
         subjects affected / exposed
    6 / 30 (20.00%)
    4 / 31 (12.90%)
         occurrences all number
    6
    4
    Neurogenic bowel
         subjects affected / exposed
    4 / 30 (13.33%)
    4 / 31 (12.90%)
         occurrences all number
    4
    4
    Haemorrhoids
         subjects affected / exposed
    5 / 30 (16.67%)
    2 / 31 (6.45%)
         occurrences all number
    5
    2
    Dry mouth
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 31 (6.45%)
         occurrences all number
    3
    2
    Dyspepsia
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 31 (9.68%)
         occurrences all number
    2
    5
    Abdominal discomfort
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 31 (3.23%)
         occurrences all number
    3
    1
    Abdominal distension
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    0
    3
    Flatulence
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Abdominal pain
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Haematochezia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Oesophagitis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Abdominal pain lower
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Anal ulcer
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Anorectal discomfort
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Dental caries
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Duodenal ulcer
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Eructation
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Faeces discoloured
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Haematemesis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Ileus paralytic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Impaired gastric emptying
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Odynophagia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Proctalgia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Reflux gastritis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Neurogenic bladder
         subjects affected / exposed
    5 / 30 (16.67%)
    5 / 31 (16.13%)
         occurrences all number
    5
    5
    Haematuria
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 31 (9.68%)
         occurrences all number
    3
    3
    Urinary incontinence
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 31 (9.68%)
         occurrences all number
    1
    3
    Urinary retention
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 31 (9.68%)
         occurrences all number
    1
    5
    Bladder spasm
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Hypertonic bladder
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    1
    3
    Renal failure acute
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    0
    3
    Polyuria
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Automatic bladder
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Bladder discomfort
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Calculus bladder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Dysuria
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Glycosuria
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Leukocyturia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Micturition urgency
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Renal tubular necrosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Urethral haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Urine abnormality
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    13 / 30 (43.33%)
    13 / 31 (41.94%)
         occurrences all number
    26
    24
    Rash
         subjects affected / exposed
    9 / 30 (30.00%)
    4 / 31 (12.90%)
         occurrences all number
    10
    4
    Pruritus
         subjects affected / exposed
    3 / 30 (10.00%)
    4 / 31 (12.90%)
         occurrences all number
    4
    6
    Dry skin
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 31 (6.45%)
         occurrences all number
    3
    2
    Skin ulcer
         subjects affected / exposed
    1 / 30 (3.33%)
    4 / 31 (12.90%)
         occurrences all number
    1
    4
    Blister
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    1
    3
    Skin disorder
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    3
    1
    Dermatitis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Erythema
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Hyperkeratosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Pruritus allergic
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Skin maceration
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    10 / 30 (33.33%)
    7 / 31 (22.58%)
         occurrences all number
    13
    7
    Muscle spasms
         subjects affected / exposed
    8 / 30 (26.67%)
    6 / 31 (19.35%)
         occurrences all number
    8
    7
    Neck pain
         subjects affected / exposed
    5 / 30 (16.67%)
    4 / 31 (12.90%)
         occurrences all number
    6
    5
    Pain in extremity
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 31 (6.45%)
         occurrences all number
    3
    3
    Arthralgia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    3
    2
    Back pain
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    1
    3
    Extraskeletal ossification
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Periarthritis
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    0
    3
    Extremity contracture
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Pain in jaw
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Tendonitis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Rhabdomyolysis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Groin pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Joint contracture
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Joint effusion
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Joint range of motion decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Muscle contracture
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Myofascial pain syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Myositis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Pubic pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Torticollis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Hypothyroidism
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Hypophosphataemia
         subjects affected / exposed
    5 / 30 (16.67%)
    5 / 31 (16.13%)
         occurrences all number
    5
    5
    Hypokalaemia
         subjects affected / exposed
    3 / 30 (10.00%)
    5 / 31 (16.13%)
         occurrences all number
    5
    8
    Dehydration
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 31 (6.45%)
         occurrences all number
    4
    2
    Hyperglycaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    5 / 31 (16.13%)
         occurrences all number
    1
    5
    Hyponatraemia
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 31 (6.45%)
         occurrences all number
    4
    2
    Hypocalcaemia
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 31 (3.23%)
         occurrences all number
    3
    1
    Fluid overload
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Decreased appetite
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Fluid retention
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Cachexia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Hyperchloraemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Hypernatraemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Malnutrition
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Sodium retention
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    20 / 30 (66.67%)
    23 / 31 (74.19%)
         occurrences all number
    40
    35
    Pneumonia
         subjects affected / exposed
    7 / 30 (23.33%)
    16 / 31 (51.61%)
         occurrences all number
    8
    18
    Respiratory tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 31 (9.68%)
         occurrences all number
    2
    3
    Clostridial infection
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Candidiasis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Cystitis klebsiella
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Otitis externa
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Sinusitis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    Staphylococcal infection
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Abdominal infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Acarodermatitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Acute sinusitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Bacterial disease carrier
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Bacteriuria
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    2
    Cellulitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Fungal infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Herpes dermatitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Infected skin ulcer
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Intraspinal abscess
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Lung infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Lung infection pseudomonal
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Nail infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Onychomycosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Pneumonia bacterial
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Post procedural infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Postoperative wound infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Purulent discharge
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Sepsis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Tooth abscess
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Tracheitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Tracheobronchitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Tracheostomy infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Aug 2011
    The overall reason for the amendment was to exclude subjects with renal compromise, hepatic dysfunction, and/or hepatic impairment at screening before the first dose of study drug. - Required that subjects discontinue use of potent CYP3A4/5 inducers for the first 35 days of the study (that is, for the duration of dosing plus 5.5 times the terminal elimination phase half-life of SUN13837). - Added that concomitant administration of CYP3A substrates with a narrow therapeutic index should be avoided during the first 35 days of the study; subjects requiring such therapy should be carefully monitored. - Added that exploratory pharmacokinetic (PK) analysis of 1-benzyl-N-methylpiperidin-4-amine (BMP) (ASB 15490) was conducted. - Added that if blood ethanol concentration (if measured within 72 hours of admission) and/or anatomical length of spinal cord injury was obtained by the hospital as part of patient care, these data, along with date obtained, were to be recorded in the Electronic Case Report Form (eCRF). - Amended the statistical methods section to include multiple imputation methods for handling missing data.
    07 Nov 2012
    The overall reason for the amendment was to allow the enrollment of American Spinal Injury Association Impairment Scale grade of B and C (AIS B and C) subjects which allowed for the evaluation of SUN13837 injection in a broader population of acute spinal cord injury subjects. AIS B and C subjects were required to have a Lower Extremity Motor Score (LEMS) of 5 or less points. - Clarified that, at study entry, American Spinal Injury Association Impairment Scale grade of A (AIS A) subjects with a level of injury at cervical level 4 must have at least 1 point of motor activity within the zone of partial preservation inclusive of cervical level 5 to thoracic level 1. - The previous version of the protocol the Spinal Cord Independence Measure, Version III (SCIM III) Self-Care subscale score to confirm the clinical meaningfulness of the primary endpoint. In order to accommodate the inclusion of AIS B and C subjects, the protocol was amended to use the total SCIM III score in this analysis. - Amended the supportive and exploratory efficacy endpoints to accommodate the inclusion of AIS B and C subjects. - Amended the lower age limit to 16 years and the upper age limit to 70 years for AIS B or C subjects. - Allowed sites outside the US and Canada to participate. - Specified that details of the method of imputation were to be included in the Statistical Analysis Plan (SAP).
    02 Jun 2014
    The overall reason for the amendment was to drop the requirement that AIS B and C subject must have a LEMS score of 5 or less points. - Amended the primary objective to be based on improvement in measures of overall functional independence based on the final mean total SCIM III. - Amended secondary objectives to include the final mean SCIM III Self-Care and Mobility subscale scores. - Added new secondary objectives related to Total Motor Score (TMS) and AIS grade. - Amended the definition of the Intent to Treat (ITT) population to include SCIM III, rather than International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) assessments. - Added an additional requirement to the ITT population that a subject must have received at least 7 doses of study drug. - Amended the sample size calculation to reflect changes in the primary endpoint. Sample size was changed from 164 subjects to 70 subjects. - Changed the number of sites to 70 with approximately 52 acute centers enrolling subjects.

    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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