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    Clinical Trial Results:
    A randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke

    Summary
    EudraCT number
    		 2008-000622-40
    Trial protocol
    		 NL   HU   AT   DE   FR   ES   EE  
    Global end of trial date
    07 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2016
    First version publication date
    25 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    12402A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00790920
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark,
    Public contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    H. Lundbeck A/S, H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.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
    24 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of desmoteplase 90 µg/kg versus placebo in terms of favourable outcome at Day 90 in patients with acute ischemic stroke.
    Protection of trial subjects
    The nature of the illness often implies impairment to understand and /or consent to participate in a study in the acute setting. Hence, consenting procedures, normally done by the patient and/or his/her legal representative, were extended to include consent by an impartial witness, a proxy (a relative), or a study-independent physician. However, this was only allowed under the conditions listed in the protocol and if allowed by local law and regulations and approved by the relevant ethics committee or IRB
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Jan 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Spain: 54
    Country: Number of subjects enrolled
    Austria: 25
    Country: Number of subjects enrolled
    Estonia: 25
    Country: Number of subjects enrolled
    France: 35
    Country: Number of subjects enrolled
    Germany: 27
    Country: Number of subjects enrolled
    Switzerland: 3
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Hong Kong: 17
    Country: Number of subjects enrolled
    India: 31
    Country: Number of subjects enrolled
    Korea, Republic of: 52
    Country: Number of subjects enrolled
    Philippines: 3
    Country: Number of subjects enrolled
    Singapore: 8
    Country: Number of subjects enrolled
    Thailand: 56
    Country: Number of subjects enrolled
    Taiwan: 50
    Country: Number of subjects enrolled
    Vietnam: 72
    Worldwide total number of subjects
    492
    EEA total number of subjects
    181
    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)
    175
    From 65 to 84 years
    308
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening for patients with occlusion or high-grade stenosis of the proximal cerebral arteries, and excluded patients with intracranial haemorrhage (ICH), signs of extensive infarct core, or subacute infarction.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Desmoteplase
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desmoteplase
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Desmoteplase 90 μg/kg single bolus within 3-9 hours after the onset of stroke symptoms

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single bolus within 3-9 hours after the onset of stroke symptoms

    Number of subjects in period 1 [1]
    		Desmoteplase Placebo
    Started
    240
    238
    Completed
    200
    205
    Not completed
    40
    33
         Adverse event, serious fatal
    23
    22
         Consent withdrawn by subject
    8
    2
         administrative or other reasons
    1
    3
         Lost to follow-up
    8
    4
         Protocol deviation
    -
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 492 patients were randomised (245 and 247 to placebo and treatment, respectively) However, only 478 (238 and 240 to placebo and treatment, respectively) were actually treated

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Desmoteplase
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Desmoteplase Placebo Total
    Number of subjects
    		 240 238 478
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 85 85 170
        From 65-84 years
    		 150 149 299
        85 years and over
    		 5 4 9
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67 ± 14.1 67.7 ± 13.2 -
    Gender categorical
    Units: Subjects
        Female
    		 125 112 237
        Male
    		 115 126 241
    Race
    Units: Subjects
        White
    		 99 95 194
        Black or african american
    		 2 1 3
        Asian
    		 138 142 280
        Other
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Desmoteplase
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Modified Rankin Scale Score

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    End point title
    		 Modified Rankin Scale Score
    End point description
    mRS response (score of 0 to 2) at Day 90 The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient’s function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke.
    End point type
    Primary
    End point timeframe
    90 days
    End point values
    		 Desmoteplase Placebo
    Number of subjects analysed
    236
    237
    Units: Score (%)
        number (not applicable)
    51.3
    49.8
    Statistical analysis title
    		 mRS response (score 0 to 2) at Day 90
    Comparison groups
    Placebo v Desmoteplase
    Number of subjects included in analysis
    473
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.81

    Secondary: National Institutes of Health Stroke Scale (NIHSS) score

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    End point title
    		 National Institutes of Health Stroke Scale (NIHSS) score
    End point description
    The NIHSS is a clinician-rated, 15-item scale designed to assess the severity of stroke-related neurological deficits: level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect. Each item is rated on a 3-, 4-, or 5- point scale ranging from 0 (normal) to the maximum score (extremely severe symptoms). The total score of the 15 items ranges from 0 to 42, where lower scores indicate less impairment.9
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Desmoteplase Placebo
    Number of subjects analysed
    236
    237
    Units: score (%)
        number (not applicable)
    61.9
    56.1
    Statistical analysis title
    		 National Institutes of Health Stroke Scale (NIHSS)
    Comparison groups
    Desmoteplase v Placebo
    Number of subjects included in analysis
    473
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.9

    Secondary: mRS & NIHSS Response

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    End point title
    		 mRS & NIHSS Response
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Desmoteplase Placebo
    Number of subjects analysed
    236
    237
    Units: Score (%)
        number (not applicable)
    45.8
    42.2
    Statistical analysis title
    		 mRS & NIHSS
    Comparison groups
    Desmoteplase v Placebo
    Number of subjects included in analysis
    473
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.93

    Secondary: Modified Ranking Scale Score (using the ordinal scale)

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    End point title
    		 Modified Ranking Scale Score (using the ordinal scale)
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Desmoteplase Placebo
    Number of subjects analysed
    236
    237
    Units: Score
        least squares mean (standard error)
    2.46 ± 0.15
    2.65 ± 0.15
    Statistical analysis title
    		 mRS Scores at Day 90
    Comparison groups
    Placebo v Desmoteplase
    Number of subjects included in analysis
    473
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.74
    Notes
    [1] - Ordinal logistic regression

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose to follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Desmoteplase
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Desmoteplase Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    64 / 240 (26.67%)
    69 / 238 (28.99%)
         number of deaths (all causes)
    24
    23
         number of deaths resulting from adverse events
    6
    7
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholangiocarcinoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric cancer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ovarian cancer metastatic
    alternative assessment type: Non-systematic
         subjects affected / exposed [1]
    0 / 125 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 240 (0.83%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodynamic instability
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Withdrawal of life support
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Catheter site haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Sudden death
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 240 (0.83%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia aspiration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 240 (2.50%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Pneumothorax
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 240 (1.25%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Psychiatric disorders
    Anxiety disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Haemoglobin decreased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 240 (1.25%)
    5 / 238 (2.10%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Cardiac disorders
    Acute coronary syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    3 / 238 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Atrial fibrillation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 240 (1.25%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac discomfort
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Cardiac failure congestive
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Congestive cardiomyopathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac thrombus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sick sinus syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (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
    Altered state of consciousness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basilar artery thrombosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain oedema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 240 (1.25%)
    6 / 238 (2.52%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 6
         deaths causally related to treatment / all
    1 / 2
    1 / 3
    Cerebral artery occlusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 240 (2.08%)
    4 / 238 (1.68%)
         occurrences causally related to treatment / all
    5 / 5
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    3 / 3
    Cerebral infarction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 240 (0.83%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 240 (1.25%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Hydrocephalus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic transformation stroke
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 240 (1.25%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial pressure increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 240 (0.83%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ischaemic stroke
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 240 (2.08%)
    5 / 238 (2.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological decompensation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    3 / 238 (1.26%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudobulbar palsy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stroke in evolution
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 240 (1.25%)
    8 / 238 (3.36%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 8
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Subarachnoid haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery occlusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    3 / 238 (1.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia macrocytic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia of chronic disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diaphragmatic hernia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric polyps
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric ulcer haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival bleeding
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 240 (0.83%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prerenal failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal failure acute
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 240 (0.83%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Musculoskeletal and connective tissue disorders
    Spondylolisthesis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis infectious
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endocarditis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 240 (1.25%)
    3 / 238 (1.26%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Pneumonia bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    5 / 238 (2.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia escherichia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 240 (0.83%)
    2 / 238 (0.84%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Septic shock
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 240 (1.25%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Staphylococcal sepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 240 (0.42%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 240 (0.83%)
    0 / 238 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 240 (0.00%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This Adverse Event only apply to women
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Desmoteplase Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    182 / 240 (75.83%)
    173 / 238 (72.69%)
    Investigations
    Nih stroke scale score increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 240 (5.42%)
    11 / 238 (4.62%)
         occurrences all number
    13
    12
    Vascular disorders
    Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    29 / 240 (12.08%)
    20 / 238 (8.40%)
         occurrences all number
    32
    20
    Cardiac disorders
    Atrial fibrillation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    18 / 240 (7.50%)
    18 / 238 (7.56%)
         occurrences all number
    18
    19
    Nervous system disorders
    Haemorrhagic transformation stroke
    alternative assessment type: Non-systematic
         subjects affected / exposed
    14 / 240 (5.83%)
    16 / 238 (6.72%)
         occurrences all number
    14
    17
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    37 / 240 (15.42%)
    34 / 238 (14.29%)
         occurrences all number
    39
    39
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    29 / 240 (12.08%)
    20 / 238 (8.40%)
         occurrences all number
    30
    23
    Gastrointestinal disorders
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    61 / 240 (25.42%)
    66 / 238 (27.73%)
         occurrences all number
    62
    70
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 240 (6.25%)
    14 / 238 (5.88%)
         occurrences all number
    16
    14
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    15 / 240 (6.25%)
    9 / 238 (3.78%)
         occurrences all number
    15
    9
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    21 / 240 (8.75%)
    24 / 238 (10.08%)
         occurrences all number
    21
    26
    Psychiatric disorders
    Anxiety
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 240 (4.58%)
    13 / 238 (5.46%)
         occurrences all number
    11
    13
    Depressive symptom
    alternative assessment type: Non-systematic
         subjects affected / exposed
    22 / 240 (9.17%)
    17 / 238 (7.14%)
         occurrences all number
    22
    17
    Insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    22 / 240 (9.17%)
    21 / 238 (8.82%)
         occurrences all number
    22
    22
    Renal and urinary disorders
    Haematuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    27 / 240 (11.25%)
    27 / 238 (11.34%)
         occurrences all number
    28
    27
    Infections and infestations
    Pneumonia bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 240 (5.42%)
    8 / 238 (3.36%)
         occurrences all number
    14
    8
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    30 / 240 (12.50%)
    29 / 238 (12.18%)
         occurrences all number
    33
    30
    Urinary tract infection bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    17 / 240 (7.08%)
    24 / 238 (10.08%)
         occurrences all number
    20
    24
    Metabolism and nutrition disorders
    Hypokalaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    35 / 240 (14.58%)
    28 / 238 (11.76%)
         occurrences all number
    36
    30

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2009
    The statistical design of the study was modified in order to align with the twin-study (12649A; DIAS-4). The original design was changed to a fixed-sample design, including an interim futility analysis without adjusting the significance level in the final analysis. With the fixed design, a two-sided test at the 0.05 level of significance was used. The sample size was increased to 400 treated patients in order to be able to detect a smaller effect size of 13% (38% desmoteplase responders versus 25% placebo responders) instead of 15%. The following was added: hierarchical ordering of endpoints, identification of the full-analysis set (FAS) as the primary analysis set, sensitivity analyses.
    09 May 2012
    Post-follow-up visits, up to 2 years after IMP administration, were added to explore the long-term antibody response and safety profile. Also, long-term assessments of living arrangements, quality of life, and a measure of resource utilisation were added. The timing of the post-dose ECG was moved from 24 hours after IMP administration to within 4 hours after IMP administration, as this was closer to the peak plasma concentration. Central reading of the ECGs was added. Exclusion criteria were clarified
    21 Sep 2012
    The total number of patients planned was increased from 400 to 480, to preserve the risk of a type II error at an acceptable level, as a review of blinded data showed that the overall percentage of responders in the study was higher than anticipated.
    18 Oct 2013
    Additional analyses of the primary and secondary endpoints were added to investigate the subgroup of patients with a baseline NIHSS score of 8-24. Analysis of the mRS using ordinal logistic regression was moved from the exploratory analysis to the secondary analysis. Subgroup analyses investigating the relationship between time from stroke onset to treatment and clinical outcome were added.

    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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