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    Clinical Trial Results:
    A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients (TRIUMPH)

    Summary
    EudraCT number
    		 2004-000646-20
    Trial protocol
    		 SE   IE   GB   IT  
    Global end of trial date
    27 Dec 2005

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2017
    First version publication date
    06 Jan 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C04-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00112983
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alexion Pharmaceuticals Incorporated
    Sponsor organisation address
    100 College Street , New Haven, CT, United States, 06510
    Public contact
    European Clinical Trial Information, Alexion Europe SAS, +33 1 47 10 06 06, clinicaltrials.eu@alexion.com
    Scientific contact
    European Clinical Trial Information, Alexion Europe SAS, +33 1 47 10 06 06, clinicaltrials.eu@alexion.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 Jul 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Dec 2005
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2005
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of eculizumab in transfusion-dependent patients with haemolytic paroxysmal haemoglobinuria (PNH).
    Protection of trial subjects
    Patients must have been vaccinated for Neisseria meningitidis 14 days prior to randomisation.
    Background therapy
    		 No background therapy used.
    Evidence for comparator
    		 This was a randomised, double-blind, placebo-controlled, multicenter study. The use of a placebo-controlled group was deemed appropriate for this trial because the standard of care applicable at the time of study initiation for PNH (eg, transfusions or other symptomatic treatment measures) was permitted to be used in conjunction with proposed study therapy. Thus, patients were not placed at undue risk and patients may have benefited by increased monitoring of physical signs and symptoms during the study.
    Actual start date of recruitment
    27 Aug 2004
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    United States: 33
    Country: Number of subjects enrolled
    Ireland: 4
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Canada: 2
    Worldwide total number of subjects
    109
    EEA total number of subjects
    66
    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)
    100
    From 65 to 84 years
    8
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 34 clinical sites in the United States, Canada, Australia, Belgium, France, Germany, Ireland, Italy, Netherlands, Sweden, and the United Kingdom participated in this study, and randomly assigned treatment to study patients.

    Pre-assignment
    Screening details
    		 Transfusion-dependent haemolytic PNH patients who met all of the selection criteria defined for the screening period, were eligible to enter a 13-wk observation period. 114 patients were screened, 109 patients were enrolled into the observation period, 88 patients were randomized to receive either eculizumab or placebo.

    Pre-assignment period milestones
    Number of subjects started
    		 109
    Number of subjects completed
    		 87

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Did not meet entry criteria for observation period: 1
    Reason: Number of subjects
    		 Did not meet entry criteria for treatment phase: 20
    Reason: Number of subjects
    		 Randomized in error: 1
    Period 1
    Period 1 title
    Treatment Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer, Assessor
    Blinding implementation details
    The double-blind was maintained by using identical investigational product kits and labels for investigational product and placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 eculizumab
    Arm description
    		 Patients randomly assigned to treatment with eculizumab received 600 mg of eculizumab once a week for 4 weeks, followed by 900 mg of eculizumab 1 week later for 1 dose, then 900 mg of eculizumab every 2 weeks for 21 weeks, for a total of 26 weeks of treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    eculizumab
    Investigational medicinal product code
    eculizumab
    Other name
    Soliris
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    600 mg of eculizumab once a week for 4 weeks, followed by 900 mg of eculizumab 1 week later for 1 dose, then 900 mg of eculizumab every 2 weeks for 21 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Patients randomly assigned to treatment with placebo received 1 dose of placebo once a week for 5 weeks, then 1 dose every 2 weeks for 21 weeks, for a total of 26 weeks of treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 dose of placebo once a week for 5 weeks, then 1 dose every 2 weeks for 21 weeks

    Number of subjects in period 1 [1]
    		eculizumab Placebo
    Started
    43
    44
    Completed
    41
    34
    Not completed
    2
    10
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -
         Lack of efficacy
    -
    10
    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: A total of 114 patients were screened, 109 patients were enrolled in the observation period, and 87 entered treatment phase (treatment period). The baseline period was considered to be at time of entry into the actual treatment period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    eculizumab
    Reporting group description
    		 Patients randomly assigned to treatment with eculizumab received 600 mg of eculizumab once a week for 4 weeks, followed by 900 mg of eculizumab 1 week later for 1 dose, then 900 mg of eculizumab every 2 weeks for 21 weeks, for a total of 26 weeks of treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomly assigned to treatment with placebo received 1 dose of placebo once a week for 5 weeks, then 1 dose every 2 weeks for 21 weeks, for a total of 26 weeks of treatment.

    Reporting group values
    		 eculizumab Placebo Total
    Number of subjects
    		 43 44 87
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 37 42 79
        From 65-84 years
    		 5 2 7
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.1 ( 15.47 ) 38.4 ( 13.38 ) -
    Gender categorical
    Units: Subjects
        Female
    		 23 29 52
        Male
    		 20 15 35
    Race
    Units: Subjects
        Asian
    		 1 1 2
        Unknown or Not Reported
    		 1 1 2
        Caucasian
    		 37 41 78
        Black
    		 4 0 4
        Hispanic
    		 0 1 1
    Blood type
    Units: Subjects
        A-
    		 5 1 6
        A+
    		 11 20 31
        B-
    		 2 0 2
        B+
    		 3 5 8
        AB+
    		 2 2 4
        O-
    		 4 6 10
        O+
    		 16 10 26
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 74.9 ( 11.69 ) 72.8 ( 14.04 ) -
    Height
    Units: centimeters
        arithmetic mean (standard deviation)
    		 170.4 ( 9.37 ) 169.7 ( 8.89 ) -
    Haemoglobin concentrations prior to transfusion
    Units: gram(s)/decilitre
        median (inter-quartile range (Q1-Q3))
    		 8.1 (7.3 to 8.5) 7.8 (7.2 to 8.6) -
    Haemoglobin concentrations post-transfusion
    Units: gram(s)/decilitre
        median (inter-quartile range (Q1-Q3))
    		 10.8 (9.6 to 11.1) 9.3 (8.5 to 9.8) -
    Number of red blood cells units transfused
    Units: gram(s)/decilitre
        median (inter-quartile range (Q1-Q3))
    		 18 (12 to 24) 17 (13.5 to 25) -

    End points

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    End points reporting groups
    Reporting group title
    eculizumab
    Reporting group description
    		 Patients randomly assigned to treatment with eculizumab received 600 mg of eculizumab once a week for 4 weeks, followed by 900 mg of eculizumab 1 week later for 1 dose, then 900 mg of eculizumab every 2 weeks for 21 weeks, for a total of 26 weeks of treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomly assigned to treatment with placebo received 1 dose of placebo once a week for 5 weeks, then 1 dose every 2 weeks for 21 weeks, for a total of 26 weeks of treatment.

    Primary: Haemoglobin stabilisation

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    End point title
    		 Haemoglobin stabilisation
    End point description
    Haemoglobin stabilisation and the number of units of packed red blood cells (RBCs) transfused during the treatment phase of the study were defined as co-primary endpoints. For the haemoglobin stabilisation endpoint, patients who dropped out of the study or were transfused above their set points during the treatment phase were treated as not achieving haemoglobin stabilisation.
    End point type
    Primary
    End point timeframe
    Through 26 weeks
    End point values
    		 eculizumab Placebo
    Number of subjects analysed
    43
    44
    Units: Subjects
        Overall (n=87)
    21
    0
        4 - 14 units (n=30)
    12
    0
        15 - 25 units (n=35)
    5
    0
        > 25 units (n=22)
    4
    0
    Statistical analysis title
    		 Statistics for haemoglobin stabilisation
    Statistical analysis description
    The analysis was based on the intent-to-treat population.
    Comparison groups
    eculizumab v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Difference between proportions
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 0.64

    Primary: Number of units of packed RBCs transfused

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    End point title
    		 Number of units of packed RBCs transfused
    End point description
    Haemoglobin stabilisation and the number of units of packed red blood cells (RBCs) transfused during the treatment phase of the study were defined as co-primary endpoints.
    End point type
    Primary
    End point timeframe
    Through 26 weeks
    End point values
    		 eculizumab Placebo
    Number of subjects analysed
    43
    44
    Units: number of PRBC units transfused
    arithmetic mean (standard error)
        Overall
    3 ( 0.67 )
    11 ( 0.83 )
        4 - 14 units
    0.4 ( 0.29 )
    6.7 ( 0.72 )
        15 - 25 units
    4.2 ( 1.14 )
    10.8 ( 1.17 )
        > 25 units
    4.5 ( 1.59 )
    17 ( 1.04 )
    Statistical analysis title
    		 Analysis 1 for number of packed RBC units
    Statistical analysis description
    For the number of units of packed RBCs transfused, each patient’s units of packed RBCs transfused after randomization to 26 weeks were calculated. For those patients who discontinued study drug, but remained in the study, their actual transfusion records were used to calculate units; for those patients who have transfusion(s), but dropped out of the study prior to 26 wks, the number of units were prorated.
    Comparison groups
    eculizumab v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Difference between means
    Point estimate
    -8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 -5.9

    Secondary: Transfusion Avoidance

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    End point title
    		 Transfusion Avoidance
    End point description
    Proportion of patients achieving transfusion avoidance.
    End point type
    Secondary
    End point timeframe
    Through 26 weeks
    End point values
    		 eculizumab Placebo
    Number of subjects analysed
    43
    44
    Units: subjects
        Overall
    22
    0
        4 - 14 units
    12
    0
        15 -25 units
    6
    0
        > 25 units
    4
    0
    Statistical analysis title
    		 Statistical analysis 1 for transfusion avoidance.
    Statistical analysis description
    The analysis of the secondary endpoint of transfusion avoidance was carried out using the 2-sided Fisher exact test. As a sensitivity analysis, those patients who dropped out of the study during the treatment phase prior to having a transfusion were classified as not requiring a transfusion.
    Comparison groups
    eculizumab v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Haemolysis (as assessed by LDH)

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    End point title
    		 Haemolysis (as assessed by LDH)
    End point description
    A quantitative assessment of chronic haemolysis was obtained by calculating the AUC for LDH from Baseline to Week 26.
    End point type
    Secondary
    End point timeframe
    Through 26 weeks
    End point values
    		 eculizumab Placebo
    Number of subjects analysed
    43
    44
    Units: Decrease of LDH AUC levels
    arithmetic mean (standard error)
        Overall
    81141 ( 17626.59 )
    429874.1 ( 21704.31 )
        4 - 14 units
    103760.6 ( 49309.63 )
    391388.7 ( 32020.39 )
        15- 25 units
    58670.4 ( 3364.68 )
    444075.6 ( 37304.47 )
        > 25 units
    85019.5 ( 16790.79 )
    459115.5 ( 44197.34 )
    Statistical analysis title
    		 Statistical analysis 1 for AUC for LDH
    Statistical analysis description
    The AUC of LDH from baseline to 26 weeks was calculated for each patient. For those patients with missing LDH values, the last observation carry forward method was used to impute missing values.
    Comparison groups
    eculizumab v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wilcoxon Rank-Sum test
    Confidence interval

    Secondary: Levels of fatigue

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    End point title
    		 Levels of fatigue
    End point description
    The Quality-of-Life (QoL) instrument FACIT-Fatigue scale version 4 was utilised to collect QoL data. The scoring guideline for the FACIT-Fatigue scale version 4 instrument was used to calculate the QoL score; per the corresponding scoring guideline, scores can range from 0 to 52, with higher scores indicating improvement in fatigue. A minimally important difference was defined as a change of 4 or more points at 26 weeks (Visit 18).
    End point type
    Secondary
    End point timeframe
    Through 26 weeks
    End point values
    		 eculizumab Placebo
    Number of subjects analysed
    43
    44
    Units: QoL score
    arithmetic mean (standard error)
        Baseline
    36.7 ( 1.6 )
    34.3 ( 1.88 )
        Change from baseline at Wk 3
    4.2 ( 1.13 )
    -1.9 ( 1.9 )
        Change from baseline at Wk 12
    4.6 ( 1.22 )
    -3.1 ( 1.52 )
        Change from baseline at Wk 20
    4.8 ( 1.56 )
    -2.2 ( 1.91 )
        Change from baseline at Wk 26
    6.4 ( 1.19 )
    -4 ( 1.71 )
    Statistical analysis title
    		 Analysis for the FACIT-Fatigue scale
    Statistical analysis description
    The FACIT-Fatigue scale was scored according to published scoring guideline for this instrument. The main hypothesis was that eculizumab would provide a statistically significant increase in patients’ scale score compared with placebo.
    Comparison groups
    eculizumab v Placebo
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.01
    Method
    		 Wilcoxon’s rank sum test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Information regarding AEs was collected from the time the patient signed the informed consent form up to 30 days after the last dose of investigational product was administered.
    Adverse event reporting additional description
    At every visits, patients were asked a standard non-leading question to elicit any changes in their medical well-being including inquiry about any hospitalization, accidents and new/changed concomitant medication regimens. AEs were documented from any data collected (e.g. laboratory values, physical examination findings, ECG changes, etc.)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7
    Reporting groups
    Reporting group title
    eculizumab
    Reporting group description
    		 Patients randomized to this group received 600 mg of eculizumab IV once a week for 4 doses, followed by 900 mg eculizumab IV 1 week later for 1 dose, and 900 mg eculizumab IV every 2 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomized to this group received matching placebo IV once a week for 5 doses, then once every 2 weeks

    Serious adverse events
    		 eculizumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 43 (9.30%)
    9 / 44 (20.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolysis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paroxysmal nocturnal haemoglobinuria
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (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
    Cellulitis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central line infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Folliculitis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 44 (2.27%)
         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: 5%
    Non-serious adverse events
    		 eculizumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 43 (100.00%)
    40 / 44 (90.91%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 44 (6.82%)
         occurrences all number
    1
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 43 (44.19%)
    12 / 44 (27.27%)
         occurrences all number
    27
    33
    Dizziness
         subjects affected / exposed
    2 / 43 (4.65%)
    5 / 44 (11.36%)
         occurrences all number
    2
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 43 (11.63%)
    1 / 44 (2.27%)
         occurrences all number
    13
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 43 (0.00%)
    4 / 44 (9.09%)
         occurrences all number
    0
    4
    Paroxysmal nocturnal haemoglobinuria
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 44 (6.82%)
         occurrences all number
    1
    5
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 44 (6.82%)
         occurrences all number
    1
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 43 (16.28%)
    5 / 44 (11.36%)
         occurrences all number
    8
    7
    Diarrhoea
         subjects affected / exposed
    4 / 43 (9.30%)
    5 / 44 (11.36%)
         occurrences all number
    6
    5
    Abdominal pain
         subjects affected / exposed
    2 / 43 (4.65%)
    5 / 44 (11.36%)
         occurrences all number
    2
    6
    Vomiting
         subjects affected / exposed
    2 / 43 (4.65%)
    5 / 44 (11.36%)
         occurrences all number
    2
    6
    Constipation
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 44 (4.55%)
         occurrences all number
    3
    2
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 43 (11.63%)
    4 / 44 (9.09%)
         occurrences all number
    6
    5
    Pharyngolaryngeal pain
         subjects affected / exposed
    3 / 43 (6.98%)
    4 / 44 (9.09%)
         occurrences all number
    3
    4
    Dyspnoea
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 44 (6.82%)
         occurrences all number
    3
    3
    Rash
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 44 (6.82%)
         occurrences all number
    1
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 44 (6.82%)
         occurrences all number
    1
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    8 / 43 (18.60%)
    4 / 44 (9.09%)
         occurrences all number
    9
    7
    Arthralgia
         subjects affected / exposed
    3 / 43 (6.98%)
    5 / 44 (11.36%)
         occurrences all number
    4
    6
    Myalgia
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 44 (2.27%)
         occurrences all number
    3
    1
    Pain in extremity
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 44 (2.27%)
         occurrences all number
    5
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 43 (23.26%)
    8 / 44 (18.18%)
         occurrences all number
    11
    11
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 43 (13.95%)
    10 / 44 (22.73%)
         occurrences all number
    6
    14
    Sinusitis
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 44 (6.82%)
         occurrences all number
    4
    3
    Viral infection
         subjects affected / exposed
    1 / 43 (2.33%)
    5 / 44 (11.36%)
         occurrences all number
    1
    5
    Urinary tract infection
         subjects affected / exposed
    1 / 43 (2.33%)
    4 / 44 (9.09%)
         occurrences all number
    1
    5
    Respiratory tract infection
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 44 (2.27%)
         occurrences all number
    4
    3
    Herpes simplex
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25833956
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