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    Clinical Trial Results:
    A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen with Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas with Actinic Keratosis on Face/Scalp and Trunk/Extremities

    Summary
    EudraCT number
    		 2012-002863-88
    Trial protocol
    		 ES   IT  
    Global end of trial date
    22 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0041-64
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01787383
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark,
    Public contact
    Clinical trial Disclosure Manager , LEO Pharma A/S, + 45 44945888, ctr.disclosure@leo-pharma.com
    Scientific contact
    Clinical trial Disclosure Manager , LEO Pharma A/S, + 45 44945888, ctr.disclosure@leo-pharma.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
    22 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face or scalp and the other located on trunk or extremities) are treated with ingenol mebutate gel.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 124
    Country: Number of subjects enrolled
    Spain: 75
    Worldwide total number of subjects
    199
    EEA total number of subjects
    199
    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)
    21
    From 65 to 84 years
    155
    85 years and over
    23

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In the clinical study protocol 200 subjects were planned to be enrolled and 199 subjects were acutally enrolled and randomised.

    Pre-assignment period milestones
    Number of subjects started
    		 199
    Number of subjects completed
    		 199

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ingenol Mebutate Gel Simultaneous Treatment
    Arm description
    		 Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ingenol mebutate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.

    Arm title
    		 Ingenol Mebutate Gel Sequential Treatment
    Arm description
    		 Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ingenol mebutate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.

    Number of subjects in period 1
    		Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Started
    101
    98
    Completed
    92
    76
    Not completed
    9
    22
         Voluntary
    -
    8
         Afraid skin reactions
    -
    2
         More than 8 AK
    -
    1
         Adverse event, non-fatal
    2
    1
         Personal reason
    -
    1
         Treatment area over 25 square centimeters
    2
    1
         Wrong kit number used
    2
    5
         Treatment area under 25 square centimeters
    2
    -
         Lost to follow-up
    -
    3
         Wrong study treatment used
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ingenol Mebutate Gel Simultaneous Treatment
    Reporting group description
    		 Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.

    Reporting group title
    Ingenol Mebutate Gel Sequential Treatment
    Reporting group description
    		 Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.

    Reporting group values
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment Total
    Number of subjects
    		 101 98 199
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 9 21
        From 65-84 years
    		 78 77 155
        85 years and over
    		 11 12 23
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 74.4 (43 to 94) 74.5 (48 to 92) -
    Gender categorical
    Units: Subjects
        Female
    		 13 18 31
        Male
    		 88 80 168

    End points

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    End points reporting groups
    Reporting group title
    Ingenol Mebutate Gel Simultaneous Treatment
    Reporting group description
    		 Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.

    Reporting group title
    Ingenol Mebutate Gel Sequential Treatment
    Reporting group description
    		 Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.

    Primary: Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area

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    End point title
    		 Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area
    End point description
    Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.
    End point type
    Primary
    End point timeframe
    3 days after each treatment of each selected treatement area
    End point values
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Number of subjects analysed
    101
    98
    Units: Local Skin Reaction (LSR) Score
        arithmetic mean (standard deviation)
    10.4 ± 5.1
    9.7 ± 4.5
    Statistical analysis title
    		 Comparison groups
    Comparison groups
    Ingenol Mebutate Gel Simultaneous Treatment v Ingenol Mebutate Gel Sequential Treatment
    Number of subjects included in analysis
    199
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.13
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment

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    End point title
    		 Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment
    End point description
    Complete clearance of Aktinic Keratosis lesions (AKs) analysed in each separate treatment area and presented by treatment regimen
    End point type
    Secondary
    End point timeframe
    8 weeks after treatment
    End point values
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Number of subjects analysed
    101
    98
    Units: Complete clearance
        number (not applicable)
    52.7
    46.9
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Ingenol Mebutate Gel Simultaneous Treatment v Ingenol Mebutate Gel Sequential Treatment
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.34
    Method
    		 Regression, Logistic
    Confidence interval

    Secondary: Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment

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    End point title
    		 Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment
    End point description
    Partial clearance of Actinic Keratosis lesions (AKs) in each separate treatement area defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment, was analysed in each separate treatment area and presented by treatment regimen
    End point type
    Secondary
    End point timeframe
    8 weeks after treatment
    End point values
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Number of subjects analysed
    101
    98
    Units: Partial Clearance of AKs
        number (not applicable)
    76.6
    68.1
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Ingenol Mebutate Gel Simultaneous Treatment v Ingenol Mebutate Gel Sequential Treatment
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.088
    Method
    		 Regression, Logistic
    Confidence interval

    Secondary: Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment

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    End point title
    		 Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment
    End point description
    Percent reduction in number of Actinic Keratosis lesions (AKs) in each separate treatment area, analysed in each separate treatment area and presented by treatment regimen
    End point type
    Secondary
    End point timeframe
    8 weeks after treatment
    End point values
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Number of subjects analysed
    101
    98
    Units: Percent Reduction in Number of AKs
        arithmetic mean (standard deviation)
    83.4 ± 22
    79.1 ± 26.7
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Ingenol Mebutate Gel Simultaneous Treatment v Ingenol Mebutate Gel Sequential Treatment
    Number of subjects included in analysis
    199
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.2
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Effectiveness Satisfaction Questionniarre for Medication (TSQM)

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    End point title
    		 Effectiveness Satisfaction Questionniarre for Medication (TSQM)
    End point description
    Effectiveness of TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived effectiveness of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome)
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Number of subjects analysed
    90
    73
    Units: Units on a scale
        arithmetic mean (standard deviation)
    63.1 ± 23.4
    66.4 ± 21.4
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Ingenol Mebutate Gel Simultaneous Treatment v Ingenol Mebutate Gel Sequential Treatment
    Number of subjects included in analysis
    163
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.38
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Side Effects of TSQM

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    End point title
    		 Side Effects of TSQM
    End point description
    Side Effects of TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived side effects of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Number of subjects analysed
    90
    73
    Units: Units on a scale
        arithmetic mean (standard deviation)
    93.1 ± 18.4
    96.1 ± 16.4
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Ingenol Mebutate Gel Simultaneous Treatment v Ingenol Mebutate Gel Sequential Treatment
    Number of subjects included in analysis
    163
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.033
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Global Satisfaction TSQM

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    End point title
    		 Global Satisfaction TSQM
    End point description
    Global Satisfaction TSQM After a Treatment Cycle of 8 weeks. Measurement of the perceived overall satisfaction with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Number of subjects analysed
    82
    72
    Units: Units on a scale
        arithmetic mean (standard deviation)
    64.6 ± 19
    67.4 ± 20.3
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Ingenol Mebutate Gel Sequential Treatment v Ingenol Mebutate Gel Simultaneous Treatment
    Number of subjects included in analysis
    154
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.37
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Convenience of TSQM

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    End point title
    		 Convenience of TSQM
    End point description
    Convenience TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived convenience with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Number of subjects analysed
    83
    73
    Units: Units on a scale
        arithmetic mean (standard deviation)
    73.7 ± 14.6
    74.7 ± 18.1
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Ingenol Mebutate Gel Simultaneous Treatment v Ingenol Mebutate Gel Sequential Treatment
    Number of subjects included in analysis
    156
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.66
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    8 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Ingenol Mebutate Gel Simultaneous Treatment
    Reporting group description
    		 Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.

    Reporting group title
    Ingenol Mebutate Gel Sequential Treatment
    Reporting group description
    		 Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.

    Serious adverse events
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 101 (2.97%)
    4 / 98 (4.08%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign renal neoplasm
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 98 (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
    Amnesia
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         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
    Skin ulcer
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         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: 0%
    Non-serious adverse events
    		 Ingenol Mebutate Gel Simultaneous Treatment Ingenol Mebutate Gel Sequential Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 101 (20.79%)
    19 / 98 (19.39%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
    Additional description: non-serious as occured outside the treatment area
         subjects affected / exposed
    3 / 101 (2.97%)
    3 / 98 (3.06%)
         occurrences all number
    3
    3
    Squamous cell carcinoma of skin
    Additional description: non-serious as occured outside the treatment area
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 98 (1.02%)
         occurrences all number
    2
    2
    Malignant melanoma
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Application site burn
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Fall
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 101 (4.95%)
    2 / 98 (2.04%)
         occurrences all number
    5
    3
    Loss of consciousness
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site pruritus
         subjects affected / exposed
    8 / 101 (7.92%)
    1 / 98 (1.02%)
         occurrences all number
    9
    1
    Application site pain
         subjects affected / exposed
    5 / 101 (4.95%)
    1 / 98 (1.02%)
         occurrences all number
    6
    1
    Feeling cold
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Eyelid oedema
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Scotoma
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Subcutaneous nodule
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 98 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 98 (1.02%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 98 (1.02%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jun 2013
    One protocol amendment (see Appendix 1.1) was issued 5-Jun-2013, mainly issuing changes in trial administrative structure. In addition, the protocol appendix named “Treatment Satisfaction Questionnaire for Medication” (English version – version 1.4) used in the LP0041-64 clinical study protocol version 1 (dated 15-Oct-2012) was not complete and was thus updated to contain all questionnaire questions required.

    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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