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    Clinical Trial Results:
    Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer – Cachexia (NSCLC-C): A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients with NSCLC-C

    Summary
    EudraCT number
    		 2010-023648-34
    Trial protocol
    		 BE   NL   ES   DE   CZ   IT   SI   HU   PL  
    Global end of trial date
    22 Oct 2014

    Results information
    Results version number
    		 v1
    This version publication date
    15 Sep 2016
    First version publication date
    15 Sep 2016
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    HT-ANAM-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Other : ROMANA 1
    Sponsors
    Sponsor organisation name
    Helsinn Therapeutics (US), Inc.
    Sponsor organisation address
    170 Wood Avenue South, 5th Floor, Iselin, NJ, United States, 08830
    Public contact
    Richard K. Bourne, Ph.D., Helsinn Therapeutics (US), Inc., +1 732-603-2852, richard.bourne@helsinn.com
    Scientific contact
    Richard K. Bourne, Ph.D., Helsinn Therapeutics (US), Inc., +1 732-603-2852, richard.bourne@helsinn.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
    04 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To evaluate the effect of Anamorelin HCl on lean body mass (LBM) as measured by dual energy X-ray absorptiometry (DXA) 2. To evaluate the effect of Anamorelin HCl on muscle strength as measured by handgrip strength (HGS)
    Protection of trial subjects
    The study was designed and monitored in accordance with Sponsor procedures, which comply with the ethical principles of Good Clinical Practice (GCP) as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Jun 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 12
    Country: Number of subjects enrolled
    Serbia: 13
    Country: Number of subjects enrolled
    Ukraine: 199
    Country: Number of subjects enrolled
    Belarus: 24
    Country: Number of subjects enrolled
    United States: 37
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 74
    Country: Number of subjects enrolled
    Slovenia: 9
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Czech Republic: 27
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Italy: 14
    Worldwide total number of subjects
    484
    EEA total number of subjects
    184
    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)
    320
    From 65 to 84 years
    164
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Approximately 477 patients with advanced NSCLC-C (defined as unresectable Stage III and Stage IV and a weight loss of ≥ 5% body weight within 6 months prior to screening or a screening body mass index [BMI] < 20 kg/m2) were to be randomized 2:1 to anamorelin HCl 100 mg or placebo.

    Pre-assignment
    Screening details
    		 Central randomization stratified patients by geographic region, by chemotherapy and/or radiation therapy status and by weight loss over prior 6 months.

    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
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablets.

    Arm title
    		 Anamorelin HCl
    Arm description
    		 Active drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anamorelin HCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.

    Number of subjects in period 1
    		Placebo Anamorelin HCl
    Started
    161
    323
    Completed
    121
    231
    Not completed
    40
    92
         Unrelated AE
    3
    12
         Lost to follow-up
    -
    1
         Death
    20
    38
         Other
    7
    8
         Study drug-related AE
    -
    1
         Withdrawal by patient
    10
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Anamorelin HCl
    Reporting group description
    		 Active drug

    Reporting group values
    		 Placebo Anamorelin HCl Total
    Number of subjects
    		 161 323 484
    Age categorical
    Units: Subjects
        ≤ 65 years
    		 105 215 320
        > 65 years
    		 56 108 164
    Gender categorical
    Units: Subjects
        Female
    		 40 76 116
        Male
    		 121 247 368
    Race
    Units: Subjects
        White
    		 159 319 478
        Black or African American
    		 0 1 1
        Asian
    		 0 1 1
        Missing
    		 2 2 4
    Geographic region
    Units: Subjects
        North America
    		 17 35 52
        West Europe
    		 62 122 184
        East Europe + Russia
    		 82 166 248
        Australia
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Anamorelin HCl
    Reporting group description
    		 Active drug

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Population included all randomized patients.

    Subject analysis set title
    MITT Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The MITT Population included all randomized patients who received any study drug and for whom at least 1 post-baseline co-primary efficacy variable (LBM or HGS) observation was obtained.

    Primary: Change in Lean Body Mass

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    End point title
    		 Change in Lean Body Mass
    End point description
    Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
    End point type
    Primary
    End point timeframe
    Change in Lean Body Mass from Baseline Over 12 Weeks
    End point values
    		 Placebo Anamorelin HCl
    Number of subjects analysed
    158
    316
    Units: kg
        median (confidence interval 95%)
    -0.47 (-1 to 0.21)
    0.99 (0.61 to 1.36)
    Statistical analysis title
    		 LBM statistical analysis
    Comparison groups
    Placebo v Anamorelin HCl
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Primary: Change in Handgrip Strength

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    End point title
    		 Change in Handgrip Strength
    End point description
    Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
    End point type
    Primary
    End point timeframe
    Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks
    End point values
    		 Placebo Anamorelin HCl
    Number of subjects analysed
    158
    316
    Units: kg
        median (confidence interval 95%)
    -1.58 (-2.99 to -1.14)
    -1.1 (-1.69 to -0.4)
    Statistical analysis title
    		 HGS statistical analysis
    Comparison groups
    Placebo v Anamorelin HCl
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1475
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Change in FAACT A/CS Domain Score

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    End point title
    		 Change in FAACT A/CS Domain Score
    End point description
    Change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) 12-item Additional Concerns Subscale (A/CS) domain score from baseline overall (i.e., over 12 weeks) for the MITT Population.
    End point type
    Secondary
    End point timeframe
    Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks
    End point values
    		 Placebo Anamorelin HCl
    Number of subjects analysed
    141
    282
    Units: score
        least squares mean (standard error)
    1.92 ( 0.805 )
    4.12 ( 0.752 )
    Statistical analysis title
    		 FAACT A/CS statistical analysis
    Comparison groups
    Placebo v Anamorelin HCl
    Number of subjects included in analysis
    423
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in FACIT-F Fatigue Domain Score

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    End point title
    		 Change in FACIT-F Fatigue Domain Score
    End point description
    Change in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) domain score from baseline overall (i.e., over 12 weeks) for the MITT Population.
    End point type
    Secondary
    End point timeframe
    Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks
    End point values
    		 Placebo Anamorelin HCl
    Number of subjects analysed
    140
    280
    Units: score
        least squares mean (standard error)
    -1.19 ( 0.933 )
    0.26 ( 0.886 )
    Statistical analysis title
    		 FACIT-F statistical analysis
    Comparison groups
    Placebo v Anamorelin HCl
    Number of subjects included in analysis
    420
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0544
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in Body Weight

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    End point title
    		 Change in Body Weight
    End point description
    Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.
    End point type
    Secondary
    End point timeframe
    Change in Body Weight from Baseline Over 12 Weeks
    End point values
    		 Placebo Anamorelin HCl
    Number of subjects analysed
    141
    283
    Units: kg
        least squares mean (standard error)
    0.14 ( 0.363 )
    2.2 ( 0.326 )
    Statistical analysis title
    		 BW statistical analysis
    Comparison groups
    Placebo v Anamorelin HCl
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events that occurred during the clinical trial, commenced with the first dose of study drug through the 28 day post-treatment follow-up visit.
    Adverse event reporting additional description
    Adverse events that occurred following the signature of the informed consent, but prior to the first dose of study drug were not reported as adverse events in this trial. The adverse event reporting period also ended if the patient began an alternative therapy within 28 days of the last administration of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Anamorelin HCl
    Reporting group description
    		 -

    Reporting group title
    Total: Placebo and Anamorelin HCl
    Reporting group description
    		 TEAEs were defined as AEs with an onset date on or after the first dose date of the extension trial study drug and up to and including 7 days post-last dose date of the extension trial study drug.

    Serious adverse events
    		 Placebo Anamorelin HCl Total: Placebo and Anamorelin HCl
    Total subjects affected by serious adverse events
         subjects affected / exposed
    48 / 161 (29.81%)
    82 / 320 (25.63%)
    130 / 481 (27.03%)
         number of deaths (all causes)
    30
    59
    89
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm progression
         subjects affected / exposed
    12 / 161 (7.45%)
    24 / 320 (7.50%)
    36 / 481 (7.48%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 24
    0 / 36
         deaths causally related to treatment / all
    0 / 12
    0 / 24
    0 / 36
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iliac artery occlusion
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inferior vena caval occlusion
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 161 (0.62%)
    2 / 320 (0.63%)
    3 / 481 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    General physical health deterioration
         subjects affected / exposed
    1 / 161 (0.62%)
    3 / 320 (0.94%)
    4 / 481 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    Pain
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 320 (0.31%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 320 (0.31%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    3 / 161 (1.86%)
    4 / 320 (1.25%)
    7 / 481 (1.46%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 161 (0.00%)
    3 / 320 (0.94%)
    3 / 481 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 161 (0.62%)
    3 / 320 (0.94%)
    4 / 481 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    Dyspnoea
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 320 (0.00%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 320 (0.00%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    Bronchopulmonary hemorrhage
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Haemoptysis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Epistaxis
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 320 (0.63%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    1 / 161 (0.62%)
    2 / 320 (0.63%)
    3 / 481 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 320 (0.00%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    Myocardial infarction
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Atrial flutter
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 161 (1.86%)
    5 / 320 (1.56%)
    8 / 481 (1.66%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 161 (1.86%)
    0 / 320 (0.00%)
    3 / 481 (0.62%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 161 (0.62%)
    2 / 320 (0.63%)
    3 / 481 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 161 (0.62%)
    3 / 320 (0.94%)
    4 / 481 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    3 / 161 (1.86%)
    1 / 320 (0.31%)
    4 / 481 (0.83%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 320 (0.31%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal ulcer
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 320 (0.31%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 320 (0.31%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 320 (0.63%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary tract obstruction
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 320 (0.31%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    4 / 161 (2.48%)
    4 / 320 (1.25%)
    8 / 481 (1.66%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    Cellulitis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 320 (0.31%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 320 (0.00%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 320 (0.63%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    Oral candidiasis
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 161 (0.00%)
    3 / 320 (0.94%)
    3 / 481 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    2 / 161 (1.24%)
    0 / 320 (0.00%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 320 (0.31%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 320 (0.31%)
    1 / 481 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 320 (0.63%)
    2 / 481 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Anamorelin HCl Total: Placebo and Anamorelin HCl
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    84 / 161 (52.17%)
    182 / 320 (56.88%)
    266 / 481 (55.30%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    14 / 161 (8.70%)
    50 / 320 (15.63%)
    64 / 481 (13.31%)
         occurrences all number
    20
    78
    98
    Aspartate aminotransferase increased
         subjects affected / exposed
    15 / 161 (9.32%)
    37 / 320 (11.56%)
    52 / 481 (10.81%)
         occurrences all number
    21
    52
    73
    Blood alkaline phosphatase increased
         subjects affected / exposed
    10 / 161 (6.21%)
    34 / 320 (10.63%)
    44 / 481 (9.15%)
         occurrences all number
    14
    40
    54
    Platelet count decreased
         subjects affected / exposed
    10 / 161 (6.21%)
    14 / 320 (4.38%)
    24 / 481 (4.99%)
         occurrences all number
    16
    30
    46
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    66 / 161 (40.99%)
    119 / 320 (37.19%)
    185 / 481 (38.46%)
         occurrences all number
    114
    179
    293
    Leukopenia
         subjects affected / exposed
    10 / 161 (6.21%)
    16 / 320 (5.00%)
    26 / 481 (5.41%)
         occurrences all number
    10
    17
    27
    Neutropenia
         subjects affected / exposed
    22 / 161 (13.66%)
    28 / 320 (8.75%)
    50 / 481 (10.40%)
         occurrences all number
    34
    34
    68
    Thrombocytopenia
         subjects affected / exposed
    23 / 161 (14.29%)
    29 / 320 (9.06%)
    52 / 481 (10.81%)
         occurrences all number
    34
    42
    76
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    9 / 161 (5.59%)
    19 / 320 (5.94%)
    28 / 481 (5.82%)
         occurrences all number
    10
    23
    33
    Fatigue
         subjects affected / exposed
    13 / 161 (8.07%)
    25 / 320 (7.81%)
    38 / 481 (7.90%)
         occurrences all number
    15
    28
    43
    Pyrexia
         subjects affected / exposed
    1 / 161 (0.62%)
    15 / 320 (4.69%)
    16 / 481 (3.33%)
         occurrences all number
    1
    16
    17
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 161 (5.59%)
    17 / 320 (5.31%)
    26 / 481 (5.41%)
         occurrences all number
    9
    21
    30
    Nausea
         subjects affected / exposed
    15 / 161 (9.32%)
    29 / 320 (9.06%)
    44 / 481 (9.15%)
         occurrences all number
    21
    44
    65
    Vomiting
         subjects affected / exposed
    8 / 161 (4.97%)
    25 / 320 (7.81%)
    33 / 481 (6.86%)
         occurrences all number
    8
    27
    35
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 161 (4.97%)
    14 / 320 (4.38%)
    22 / 481 (4.57%)
         occurrences all number
    9
    14
    23
    Dyspnoea
         subjects affected / exposed
    11 / 161 (6.83%)
    19 / 320 (5.94%)
    30 / 481 (6.24%)
         occurrences all number
    13
    24
    37
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 161 (4.97%)
    13 / 320 (4.06%)
    22 / 481 (4.57%)
         occurrences all number
    8
    15
    23
    Hyperglycaemia
         subjects affected / exposed
    10 / 161 (6.21%)
    35 / 320 (10.94%)
    45 / 481 (9.36%)
         occurrences all number
    11
    41
    52

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2012
    Protocol amendment.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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