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    Clinical Trial Results:
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 with a Long-Term Open-Label Extension in Patients with Chronic Cluster Headache

    Summary
    EudraCT number
    		 2014-005429-11
    Trial protocol
    		 GB   DE   ES   DK   FI   BE   FR   NL   GR   IT  
    Global end of trial date
    14 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2020
    First version publication date
    30 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I5Q-MC-CGAM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02438826
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15781
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    14 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Netherlands: 10
    Country: Number of subjects enrolled
    Belgium: 32
    Country: Number of subjects enrolled
    United States: 33
    Country: Number of subjects enrolled
    Finland: 4
    Country: Number of subjects enrolled
    Denmark: 9
    Country: Number of subjects enrolled
    Italy: 31
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    France: 40
    Country: Number of subjects enrolled
    Germany: 42
    Country: Number of subjects enrolled
    Spain: 11
    Worldwide total number of subjects
    237
    EEA total number of subjects
    196
    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)
    236
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Available

    Pre-assignment
    Screening details
    		 Study consists of a 12-week double-blind treatment phase; an optional 1-year open-label treatment phase; and a 16-week post-treatment phase (washout).

    Period 1
    Period 1 title
    Double-Blind Treatment (DBT) Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 subcutaneous injections of placebo administered once a month for 3 months.

    Arm title
    		 Galcanezumab 300 mg
    Arm description
    		 Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab 300 mg
    Investigational medicinal product code
    Other name
    LY2951742
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg of galcanezumab administered as subcutaneous injection for 3 months.

    Number of subjects in period 1
    		Placebo Galcanezumab 300 mg
    Started
    123
    117
    Received at Least 1 Dose of Study Drug
    120
    117
    Completed
    117
    113
    Not completed
    6
    4
         Consent withdrawn by subject
    1
    1
         Screen Failure
    2
    -
         Adverse event, non-fatal
    1
    1
         Protocol deviation
    1
    2
         Lack of efficacy
    1
    -
    Period 2
    Period 2 title
    Received at least 1 dose (DBT) - Period1
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 subcutaneous injections of placebo administered once a month for 3 months.

    Arm title
    		 Galcanezumab 300 mg
    Arm description
    		 Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab 300 mg
    Investigational medicinal product code
    Other name
    LY2951742
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg of galcanezumab administered as subcutaneous injection for 3 months.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Participants must have completed the double-blind phase to enter the optional open-label phase. One placebo treated participant chose not to enter the open-label phase.
    Number of subjects in period 2
    		Placebo Galcanezumab 300 mg
    Started
    120
    117
    Completed
    117
    113
    Not completed
    3
    4
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    1
         Lack of efficacy
    1
    -
         Protocol deviation
    -
    2
    Period 3
    Period 3 title
    Open-Label Treatment Phase-Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo/GMB 300 mg
    Arm description
    		 Participants from placebo group received 300 mg of galcanezumab (GMB) by subcutaneous injection every 30 days, for up to a total of 12 administrations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab 300 mg
    Investigational medicinal product code
    Other name
    LY2951742
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg of galcanezumab administered as subcutaneous injections every 30 days, for up to a total of 12 administrations.

    Arm title
    		 GMB 300 mg/GMB 300 mg
    Arm description
    		 Participants from galcanezumab group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab 300 mg
    Investigational medicinal product code
    Other name
    LY2951742
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg of galcanezumab administered as subcutaneous injections every 30 days, for up to a total of 12 administrations.

    Number of subjects in period 3
    		Placebo/GMB 300 mg GMB 300 mg/GMB 300 mg
    Started
    116
    113
    Completed
    72
    80
    Not completed
    44
    33
         Consent withdrawn by subject
    6
    7
         Adverse event, non-fatal
    11
    6
         Lost to follow-up
    -
    2
         Lack of efficacy
    27
    18
    Period 4
    Period 4 title
    Post-Treatment Phase-Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo/GMB 300 mg (Open-Label Treatment Phase)
    Arm description
    		 Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 GMB 300 mg/GMB 300 mg (Open-Label Treatment Phase)
    Arm description
    		 Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo (Double-Blind Treatment Phase)
    Arm description
    		 Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Galcanezumab 300 mg (Double-Blind Treatment Phase)
    Arm description
    		 Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Placebo/GMB 300 mg (Open-Label Treatment Phase) GMB 300 mg/GMB 300 mg (Open-Label Treatment Phase) Placebo (Double-Blind Treatment Phase) Galcanezumab 300 mg (Double-Blind Treatment Phase)
    Started
    93
    93
    2
    4
    Completed
    84
    92
    2
    4
    Not completed
    9
    1
    0
    0
         Physician decision
    1
    -
    -
    -
         Consent withdrawn by subject
    1
    1
    -
    -
         Adverse event, non-fatal
    3
    -
    -
    -
         Lack of efficacy
    4
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once a month by subcutaneous (SC) injection for 3 months.

    Reporting group title
    Galcanezumab 300 mg
    Reporting group description
    		 Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.

    Reporting group values
    		 Placebo Galcanezumab 300 mg Total
    Number of subjects
    		 120 117
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.38 ± 10.81 45.62 ± 11.03 -
    Gender categorical
    Units: Subjects
        Female
    		 34 31 65
        Male
    		 86 86 172
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 15 18 33
        Not Hispanic or Latino
    		 87 81 168
        Unknown or Not Reported
    		 18 18 36
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 1 1 2
        White
    		 101 99 200
        More than one race
    		 18 17 35
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Greece
    		 0 1 1
        Canada
    		 4 4 8
        Netherlands
    		 5 5 10
        Belgium
    		 16 16 32
        United States
    		 15 18 33
        Finland
    		 2 2 4
        Denmark
    		 5 4 9
        Italy
    		 17 14 31
        United Kingdom
    		 8 8 16
        France
    		 20 20 40
        Germany
    		 22 20 42
        Spain
    		 6 5 11
    Weekly Cluster Headache Attacks
    Units: cluster headache attacks per week
        arithmetic mean (standard deviation)
    		 18.47 ± 10.66 19.18 ± 9.82 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once a month by subcutaneous (SC) injection for 3 months.

    Reporting group title
    Galcanezumab 300 mg
    Reporting group description
    		 Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo once a month by subcutaneous (SC) injection for 3 months.

    Reporting group title
    Galcanezumab 300 mg
    Reporting group description
    		 Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
    Reporting group title
    Placebo/GMB 300 mg
    Reporting group description
    		 Participants from placebo group received 300 mg of galcanezumab (GMB) by subcutaneous injection every 30 days, for up to a total of 12 administrations.

    Reporting group title
    GMB 300 mg/GMB 300 mg
    Reporting group description
    		 Participants from galcanezumab group received 300 mg of galcanezumab by subcutaneous injection every 30 days, for up to a total of 12 administrations.
    Reporting group title
    Placebo/GMB 300 mg (Open-Label Treatment Phase)
    Reporting group description
    		 Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.

    Reporting group title
    GMB 300 mg/GMB 300 mg (Open-Label Treatment Phase)
    Reporting group description
    		 Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.

    Reporting group title
    Placebo (Double-Blind Treatment Phase)
    Reporting group description
    		 Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.

    Reporting group title
    Galcanezumab 300 mg (Double-Blind Treatment Phase)
    Reporting group description
    		 Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.

    Primary: Overall Mean Change from Baseline in Weekly Cluster Headache Attack Frequency

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    End point title
    		 Overall Mean Change from Baseline in Weekly Cluster Headache Attack Frequency
    End point description
    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug, and had baseline and at least one post baseline value.
    End point type
    Primary
    End point timeframe
    Baseline, Week 1 through Week 12
    End point values
    		 Placebo Galcanezumab 300 mg
    Number of subjects analysed
    120
    117
    Units: cluster headache attacks per week
        least squares mean (standard error)
    -4.59 ± 0.79
    -5.38 ± 0.81
    Statistical analysis title
    		 Cluster Headache Attack Frequency
    Comparison groups
    Placebo v Galcanezumab 300 mg
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.334 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.77
         upper limit
    		 1.17
    Notes
    [1] - Cui, Hung, Wang (CHW) procedure applied

    Secondary: Percentage of Participants with a 50% or Greater Reduction from Baseline in the Weekly Number of Cluster Headache Attacks

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    End point title
    		 Percentage of Participants with a 50% or Greater Reduction from Baseline in the Weekly Number of Cluster Headache Attacks
    End point description
    A 50% responder is any participant who has a ≥50% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval: Weeks 1/2, Weeks 3/4, Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects. APD: All randomized participants who received at least 1 dose of study drug, and had baseline and at least 1 post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 through Week 12
    End point values
    		 Placebo Galcanezumab 300 mg
    Number of subjects analysed
    120
    117
    Units: percentage of participants
        arithmetic mean (standard error)
    27.1 ± 3.5
    32.6 ± 3.8
    Statistical analysis title
    		 50% Greater Reduction in Cluster Headache Attacks
    Comparison groups
    Placebo v Galcanezumab 300 mg
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.297
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 2.028
    Notes
    [2] - Cui, Hung, Wang (CHW) procedure applied

    Secondary: Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks

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    End point title
    		 Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
    End point description
    Sustained Response is defined as a 50% or greater reduction in the weekly cluster attack frequency from baseline to Weeks 3/4 and maintained at Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Percentage of participants with a sustained response was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex, verapamil use and baseline value. APD: All randomized participants who received at least 1 dose of study drug, had a baseline, and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 3 through Week 12
    End point values
    		 Placebo Galcanezumab 300 mg
    Number of subjects analysed
    120
    117
    Units: percentage of participants
        number (not applicable)
    17.50
    16.24
    Statistical analysis title
    		 Sustained Response of Cluster Headache Attacks
    Comparison groups
    Placebo v Galcanezumab 300 mg
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.946 [3]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [3] - Chui, Hung, Wang (CHW) procedure applied)

    Secondary: Percentage of Participants with a 30% Reduction in the Weekly Number of Cluster Headache Attacks

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    End point title
    		 Percentage of Participants with a 30% Reduction in the Weekly Number of Cluster Headache Attacks
    End point description
    A 30% responder is any participant who has a ≥30% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval. Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects. APD: All randomized participants who received at least 1 dose of study drug, and had baseline and at least 1 post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 through Week 12
    End point values
    		 Placebo Galcanezumab 300 mg
    Number of subjects analysed
    120
    117
    Units: percentage of participants
        arithmetic mean (standard error)
    39.0 ± 3.9
    49.1 ± 4.1
    Statistical analysis title
    		 30% Reduction in Weekly Cluster Headache Attacks
    Comparison groups
    Placebo v Galcanezumab 300 mg
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.057
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.987
         upper limit
    		 2.309

    Secondary: Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)

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    End point title
    		 Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
    End point description
    PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects. APD: All randomized participants who received at least one dose of study drug and had PGI-I measurement at Week 4.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Placebo Galcanezumab 300 mg
    Number of subjects analysed
    92
    88
    Units: percentage of participants
        number (not applicable)
    19.4
    21.5
    Statistical analysis title
    		 Patient Global Impression of Improvement (PGI-I)
    Comparison groups
    Placebo v Galcanezumab 300 mg
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.713
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.141
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.563
         upper limit
    		 2.314

    Secondary: Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)

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    End point title
    		 Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
    End point description
    PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects. APD: All randomized participants who received at least one dose of study drug and had PGI-I measurement at Week 8.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Placebo Galcanezumab 300 mg
    Number of subjects analysed
    97
    86
    Units: percentage of participants
        number (not applicable)
    32.0
    32.1
    Statistical analysis title
    		 Patient Global Impression of Improvement (PGI-I)
    Comparison groups
    Placebo v Galcanezumab 300 mg
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.979
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.008
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.548
         upper limit
    		 1.856

    Secondary: Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)

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    End point title
    		 Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
    End point description
    PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects. APD: All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 12.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo Galcanezumab 300 mg
    Number of subjects analysed
    95
    95
    Units: percentage of participants
        number (not applicable)
    35.6
    30.4
    Statistical analysis title
    		 Patient Global Impression of Improvement (PGI-I)
    Comparison groups
    Placebo v Galcanezumab 300 mg
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.437
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.788
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.431
         upper limit
    		 1.44

    Secondary: Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
    End point description
    C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. APD: All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
    End point type
    Secondary
    End point timeframe
    Week 1 through Week 12
    End point values
    		 Placebo Galcanezumab 300 mg
    Number of subjects analysed
    119
    116
    Units: percentage of participants
        number (not applicable)
    5.04
    4.31
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
    End point description
    C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. APD: All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
    End point type
    Secondary
    End point timeframe
    Week 1 through Week 12
    End point values
    		 Placebo Galcanezumab 300 mg
    Number of subjects analysed
    119
    116
    Units: percentage of participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)

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    End point title
    		 Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)
    End point description
    Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20. APD: All randomized participants who received at least one dose of study drug and had non-missing baseline ADA result, and at least one non-missing post baseline ADA result.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 through Week 12
    End point values
    		 Placebo Galcanezumab 300 mg
    Number of subjects analysed
    115
    113
    Units: percentage of participants
        number (not applicable)
    0
    0.88
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Serum Concentration of Galcanezumab

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    End point title
    		 Pharmacokinetics (PK): Serum Concentration of Galcanezumab
    End point description
    Pharmacokinetics (PK): Serum Concentration of Galcanezumab APD: All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 2.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Galcanezumab 300 mg
    Number of subjects analysed
    90
    Units: nanogram per milliliter
        arithmetic mean (standard deviation)
    30600 ± 10700
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Serum Concentration of Galcanezumab

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    End point title
    		 Pharmacokinetics (PK): Serum Concentration of Galcanezumab
    End point description
    Pharmacokinetics (PK): Serum Concentration of Galcanezumab APD: All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 4.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Galcanezumab 300 mg
    Number of subjects analysed
    96
    Units: nanogram per milliliter
        arithmetic mean (standard deviation)
    20200 ± 6780
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Serum Concentration of Galcanezumab

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    End point title
    		 Pharmacokinetics (PK): Serum Concentration of Galcanezumab
    End point description
    Pharmacokinetics (PK): Serum Concentration of Galcanezumab APD: All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 8.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Galcanezumab 300 mg
    Number of subjects analysed
    94
    Units: nanogram per milliliter
        arithmetic mean (standard deviation)
    29700 ± 11500
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Serum Concentration of Galcanezumab

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    End point title
    		 Pharmacokinetics (PK): Serum Concentration of Galcanezumab
    End point description
    Pharmacokinetics (PK): Serum Concentration of Galcanezumab APD: All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 12.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Galcanezumab 300 mg
    Number of subjects analysed
    96
    Units: nanogram per milliliter
        arithmetic mean (standard deviation)
    31100 ± 11900
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 1 Year 7 Months
    Adverse event reporting additional description
    All randomized participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo - Double-Blind Treatment Phase
    Reporting group description
    		 Participants received placebo once a month by subcutaneous (SC) injection for 3 months.

    Reporting group title
    Galcanezumab 300mg - Double-Blind Treatment Phase
    Reporting group description
    		 Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.

    Reporting group title
    Placebo/Galcanezumab 300mg - Open-Label Treatment Phase
    Reporting group description
    		 Participants from placebo group received galcanezumab (GMB) as three 100 mg subcutaneous injections every 30 days, for up to a total of 12 administrations.

    Reporting group title
    Galcanezumab 300mg/Galcanezumab 300mg - Open-Label Treatment
    Reporting group description
    		 Participants from galcanezumab group received galcanezumab as three 100 mg subcutaneous injections every 30 days, for up to a total of 12 administrations.

    Reporting group title
    Placebo - Follow-up Phase
    Reporting group description
    		 Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.

    Reporting group title
    Galcanezumab 300mg - Follow-up Phase
    Reporting group description
    		 Participants from double blind treatment group entered this phase, they have not received any intervention during this post-treatment period.

    Reporting group title
    Placebo/Galcanezumab 300mg - Follow-up Phase
    Reporting group description
    		 Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.

    Reporting group title
    Galcanezumab 300mg/Galcanezumab 300mg - Follow-up Phase
    Reporting group description
    		 Participants from Open-Label Treatment Phase entered this phase, they have not received any intervention during this post-treatment period.

    Serious adverse events
    		 Placebo - Double-Blind Treatment Phase Galcanezumab 300mg - Double-Blind Treatment Phase Placebo/Galcanezumab 300mg - Open-Label Treatment Phase Galcanezumab 300mg/Galcanezumab 300mg - Open-Label Treatment Placebo - Follow-up Phase Galcanezumab 300mg - Follow-up Phase Placebo/Galcanezumab 300mg - Follow-up Phase Galcanezumab 300mg/Galcanezumab 300mg - Follow-up Phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 120 (2.50%)
    2 / 117 (1.71%)
    11 / 116 (9.48%)
    10 / 113 (8.85%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    5 / 93 (5.38%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    breast cancer stage iii
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colon neoplasm
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metastasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pituitary tumour
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    arthrodesis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    injection site urticaria
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    pregnancy of partner
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    depression
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    extradural haematoma
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    kidney rupture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    palpitations
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebral ischaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cluster headache
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    2 / 113 (1.77%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    reversible cerebral vasoconstriction syndrome
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    amaurosis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    constipation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    melaena
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    ureterolithiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    rhabdomyolysis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    helicobacter gastritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rectal abscess
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection bacterial
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo - Double-Blind Treatment Phase Galcanezumab 300mg - Double-Blind Treatment Phase Placebo/Galcanezumab 300mg - Open-Label Treatment Phase Galcanezumab 300mg/Galcanezumab 300mg - Open-Label Treatment Placebo - Follow-up Phase Galcanezumab 300mg - Follow-up Phase Placebo/Galcanezumab 300mg - Follow-up Phase Galcanezumab 300mg/Galcanezumab 300mg - Follow-up Phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 120 (50.00%)
    68 / 117 (58.12%)
    69 / 116 (59.48%)
    72 / 113 (63.72%)
    1 / 2 (50.00%)
    2 / 4 (50.00%)
    18 / 93 (19.35%)
    16 / 93 (17.20%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 120 (2.50%)
    2 / 117 (1.71%)
    2 / 116 (1.72%)
    4 / 113 (3.54%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 93 (1.08%)
    0 / 93 (0.00%)
         occurrences all number
    3
    2
    2
    4
    0
    0
    1
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 117 (0.85%)
    2 / 116 (1.72%)
    2 / 113 (1.77%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    2 / 93 (2.15%)
    1 / 93 (1.08%)
         occurrences all number
    1
    4
    2
    2
    0
    0
    2
    1
    chest pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    0
    3
    0
    0
    0
    0
    fatigue
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    7 / 120 (5.83%)
    5 / 117 (4.27%)
    6 / 116 (5.17%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    9
    5
    6
    3
    0
    0
    0
    0
    influenza like illness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    5 / 117 (4.27%)
    4 / 116 (3.45%)
    4 / 113 (3.54%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    1
    8
    4
    6
    0
    0
    0
    1
    injection site erythema
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    8 / 117 (6.84%)
    5 / 116 (4.31%)
    2 / 113 (1.77%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    11
    6
    7
    0
    0
    0
    0
    injection site pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    11 / 120 (9.17%)
    14 / 117 (11.97%)
    16 / 116 (13.79%)
    8 / 113 (7.08%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    15
    32
    32
    14
    0
    0
    0
    0
    injection site pruritus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    7 / 117 (5.98%)
    5 / 116 (4.31%)
    2 / 113 (1.77%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    10
    7
    10
    0
    0
    0
    0
    injection site reaction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 117 (0.85%)
    8 / 116 (6.90%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    0
    2
    20
    0
    0
    0
    0
    0
    injection site swelling
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 117 (0.85%)
    1 / 116 (0.86%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    1
    1
    4
    0
    0
    0
    0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    2 / 117 (1.71%)
    1 / 116 (0.86%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 93 (1.08%)
    0 / 93 (0.00%)
         occurrences all number
    0
    7
    1
    3
    0
    0
    1
    0
    pyrexia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    3 / 117 (2.56%)
    2 / 116 (1.72%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    3
    2
    4
    0
    0
    0
    0
    Immune system disorders
    seasonal allergy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    0
    0
    1
    4
    0
    0
    0
    0
    Reproductive system and breast disorders
    dysmenorrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [1]
    0 / 34 (0.00%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
    0 / 29 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    menstrual disorder
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [2]
    0 / 34 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    ovarian cyst
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [3]
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 29 (3.45%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    uterine haemorrhage
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [4]
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 25 (4.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    4 / 113 (3.54%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    2 / 93 (2.15%)
    1 / 93 (1.08%)
         occurrences all number
    1
    0
    1
    4
    0
    1
    2
    1
    depression
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    5 / 116 (4.31%)
    2 / 113 (1.77%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    2 / 93 (2.15%)
    0 / 93 (0.00%)
         occurrences all number
    0
    0
    6
    2
    1
    0
    2
    0
    insomnia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 120 (3.33%)
    1 / 117 (0.85%)
    2 / 116 (1.72%)
    6 / 113 (5.31%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 93 (1.08%)
    0 / 93 (0.00%)
         occurrences all number
    4
    1
    4
    6
    0
    0
    1
    0
    Investigations
    weight increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 117 (0.85%)
    3 / 116 (2.59%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    2 / 93 (2.15%)
    0 / 93 (0.00%)
         occurrences all number
    1
    1
    3
    1
    0
    0
    2
    0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    0
    3
    0
    0
    0
    0
    ligament sprain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    1
    3
    0
    0
    0
    0
    Cardiac disorders
    palpitations
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 120 (2.50%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    2 / 113 (1.77%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 93 (1.08%)
    0 / 93 (0.00%)
         occurrences all number
    3
    0
    0
    2
    0
    0
    1
    0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    6 / 120 (5.00%)
    5 / 117 (4.27%)
    4 / 116 (3.45%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 93 (1.08%)
    0 / 93 (0.00%)
         occurrences all number
    7
    5
    5
    4
    0
    0
    1
    0
    headache
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 120 (3.33%)
    2 / 117 (1.71%)
    2 / 116 (1.72%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    2 / 93 (2.15%)
    0 / 93 (0.00%)
         occurrences all number
    5
    3
    2
    6
    0
    0
    2
    0
    Ear and labyrinth disorders
    tinnitus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    3 / 117 (2.56%)
    1 / 116 (0.86%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    3
    1
    1
    0
    0
    0
    0
    vertigo
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 120 (2.50%)
    1 / 117 (0.85%)
    0 / 116 (0.00%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    4
    1
    0
    1
    0
    0
    0
    0
    Eye disorders
    visual impairment
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 117 (0.00%)
    3 / 116 (2.59%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    3
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 120 (2.50%)
    2 / 117 (1.71%)
    2 / 116 (1.72%)
    4 / 113 (3.54%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    3
    2
    2
    4
    0
    0
    0
    0
    constipation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 120 (1.67%)
    2 / 117 (1.71%)
    6 / 116 (5.17%)
    4 / 113 (3.54%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 93 (1.08%)
    2 / 93 (2.15%)
         occurrences all number
    2
    2
    8
    4
    0
    0
    1
    2
    diarrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    6 / 120 (5.00%)
    1 / 117 (0.85%)
    5 / 116 (4.31%)
    4 / 113 (3.54%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    2 / 93 (2.15%)
         occurrences all number
    6
    1
    6
    4
    0
    0
    0
    2
    nausea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    6 / 120 (5.00%)
    6 / 117 (5.13%)
    3 / 116 (2.59%)
    2 / 113 (1.77%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 93 (1.08%)
    0 / 93 (0.00%)
         occurrences all number
    8
    7
    3
    2
    0
    0
    4
    0
    vomiting
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 120 (2.50%)
    3 / 117 (2.56%)
    2 / 116 (1.72%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    4
    3
    2
    1
    0
    0
    0
    1
    Renal and urinary disorders
    haematuria
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    nephrolithiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 117 (0.00%)
    1 / 116 (0.86%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    1
    0
    0
    Endocrine disorders
    thyroid mass
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    0 / 113 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 120 (3.33%)
    0 / 117 (0.00%)
    5 / 116 (4.31%)
    6 / 113 (5.31%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 93 (1.08%)
    1 / 93 (1.08%)
         occurrences all number
    4
    0
    6
    6
    0
    0
    1
    1
    back pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    5 / 117 (4.27%)
    4 / 116 (3.45%)
    10 / 113 (8.85%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    2 / 93 (2.15%)
         occurrences all number
    1
    5
    4
    12
    0
    0
    0
    2
    bursitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 117 (0.00%)
    0 / 116 (0.00%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    0
    myalgia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 120 (2.50%)
    3 / 117 (2.56%)
    4 / 116 (3.45%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    3
    3
    5
    1
    0
    0
    0
    0
    neck pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 117 (0.00%)
    2 / 116 (1.72%)
    2 / 113 (1.77%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    2 / 93 (2.15%)
    2 / 93 (2.15%)
         occurrences all number
    1
    0
    2
    2
    0
    0
    2
    2
    pain in extremity
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    4 / 117 (3.42%)
    3 / 116 (2.59%)
    2 / 113 (1.77%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    2
    4
    3
    2
    0
    0
    0
    1
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    2 / 117 (1.71%)
    4 / 116 (3.45%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 93 (1.08%)
    1 / 93 (1.08%)
         occurrences all number
    1
    2
    5
    3
    0
    0
    1
    1
    gastroenteritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 120 (0.83%)
    3 / 117 (2.56%)
    3 / 116 (2.59%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    2 / 93 (2.15%)
    1 / 93 (1.08%)
         occurrences all number
    1
    3
    3
    1
    0
    0
    2
    1
    influenza
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 120 (2.50%)
    2 / 117 (1.71%)
    8 / 116 (6.90%)
    5 / 113 (4.42%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    4 / 93 (4.30%)
    0 / 93 (0.00%)
         occurrences all number
    4
    2
    8
    5
    0
    0
    4
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    15 / 120 (12.50%)
    12 / 117 (10.26%)
    14 / 116 (12.07%)
    17 / 113 (15.04%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    3 / 93 (3.23%)
    2 / 93 (2.15%)
         occurrences all number
    16
    13
    19
    24
    0
    0
    3
    2
    sinusitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 120 (1.67%)
    1 / 117 (0.85%)
    3 / 116 (2.59%)
    6 / 113 (5.31%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    2
    1
    3
    6
    0
    0
    0
    0
    tracheitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 117 (0.85%)
    3 / 116 (2.59%)
    1 / 113 (0.88%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    4
    1
    0
    0
    0
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 120 (1.67%)
    1 / 117 (0.85%)
    2 / 116 (1.72%)
    5 / 113 (4.42%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    2
    1
    2
    5
    0
    0
    0
    0
    urinary tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 120 (0.00%)
    2 / 117 (1.71%)
    1 / 116 (0.86%)
    3 / 113 (2.65%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 93 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    0
    2
    1
    3
    0
    0
    0
    0
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [5]
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
    0 / 29 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Mar 2015
    Protocol (a) 1) Updated planned duration of treatment. 2) Updated primary endpoint duration. 3) Updated Inclusion and Exclusion Criteria.
    22 Dec 2015
    Protocol (b) -Added rescreening details (Inclusion Criteria 3).
    10 Feb 2017
    Protocol (c) -Updated rescreening details (Inclusion Criterion 3b and Exclusion Criterion 24d).
    28 Mar 2018
    Protocol (d): 1) Duration of primary analysis was changed from Week 3/4 to 12-Week. 2) Updated blinding information.

    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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