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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults with Treatment-Resistant Migraine - The CONQUER Study

    Summary
    EudraCT number
    		 2018-000600-42
    Trial protocol
    		 FR   DE   ES   CZ   BE   NL   HU   DK   GB  
    Global end of trial date
    19 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jul 2020
    First version publication date
    05 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I5Q-MC-CGAW
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03559257
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16670
    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
    19 Sep 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.
    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
    31 Jul 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 56
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    United States: 90
    Country: Number of subjects enrolled
    Belgium: 27
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    Czech Republic: 109
    Country: Number of subjects enrolled
    France: 30
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    Japan: 42
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 28
    Country: Number of subjects enrolled
    Netherlands: 20
    Worldwide total number of subjects
    462
    EEA total number of subjects
    291
    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)
    433
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Total 463 participants were randomized and 462 participants received at least one dose of study drug. one participant was screen failure.

    Pre-assignment
    Screening details
    		 NA

    Period 1
    Period 1 title
    Double Blind Treatment 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
    		 Participants received matching placebo every month for three months by subcutaneous (SC) injection.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received matching placebo every month for three months by SC injection.

    Arm title
    		 Galcanezumab 120mg
    Arm description
    		 Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received initial loading dose of 240 milligrams (mg) of Galcanezumab followed by 120mg Galcanezumab every month for two months by SC injection.

    Number of subjects in period 1
    		Placebo Galcanezumab 120mg
    Started
    230
    232
    Completed
    226
    225
    Not completed
    4
    7
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    -
    1
         Lack of efficacy
    1
    1
         Protocol deviation
    1
    4
    Period 2
    Period 2 title
    Open-label Treatment Period
    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
    		 Galcanezumab 120mg
    Arm description
    		 Participants received initial loading dose of 240mg galcanezumab followed by 120mg every month for two months during open label treatment phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received initial loading dose of 240mg Galcanezumab followed by 120mg every month for two months during open label treatment phase by subcutaneous injection.

    Arm title
    		 Galcanezumab 120mg
    Arm description
    		 Participants received 120mg of galcanezumab every month for three months by subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Galcanezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 120mg of Galcanezumab every month for three months during open label treatment period by subcutaneous injection.

    Number of subjects in period 2 [1]
    		Galcanezumab 120mg Galcanezumab 120mg
    Started
    225
    224
    Completed
    215
    217
    Not completed
    10
    7
         Consent withdrawn by subject
    3
    -
         Physician decision
    -
    1
         Adverse event, non-fatal
    1
    4
         Lost to follow-up
    1
    -
         Lack of efficacy
    3
    2
         Protocol deviation
    2
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One participant in placebo group who completed double blind period has withdrawn from the study. One participant in Galcanezumab group who completed double blind period had discontinued due to AE.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo every month for three months by subcutaneous (SC) injection.

    Reporting group title
    Galcanezumab 120mg
    Reporting group description
    		 Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.

    Reporting group values
    		 Placebo Galcanezumab 120mg Total
    Number of subjects
    		 230 232 462
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.67 ± 12.33 45.87 ± 11.34 -
    Gender categorical
    Units: Subjects
        Female
    		 202 195 397
        Male
    		 28 37 65
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 16 15 31
        Not Hispanic or Latino
    		 174 172 346
        Unknown or Not Reported
    		 40 45 85
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 35 37 72
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Black or African American
    		 2 3 5
        White
    		 182 183 365
        More than one race
    		 3 0 3
        Unknown or Not Reported
    		 7 8 15
    Monthly Migraine Headache Days
    Units: Days
        arithmetic mean (standard deviation)
    		 13.01 ± 5.73 13.44 ± 6.08 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo every month for three months by subcutaneous (SC) injection.

    Reporting group title
    Galcanezumab 120mg
    Reporting group description
    		 Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
    Reporting group title
    Galcanezumab 120mg
    Reporting group description
    		 Participants received initial loading dose of 240mg galcanezumab followed by 120mg every month for two months during open label treatment phase.

    Reporting group title
    Galcanezumab 120mg
    Reporting group description
    		 Participants received 120mg of galcanezumab every month for three months by subcutaneous injection.

    Primary: Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days

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    End point title
    		 Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days
    End point description
    Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Primary
    End point timeframe
    Baseline, Month 1 through Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    228
    230
    Units: Days
        least squares mean (standard error)
    -1.02 ± 0.32
    -4.14 ± 0.32
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Galcanezumab 120mg v Placebo
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -3.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.92
         upper limit
    		 -2.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.41

    Secondary: Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days in Participants with Episodic Migraine

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    End point title
    		 Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days in Participants with Episodic Migraine
    End point description
    MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. APD: All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    132
    137
    Units: Days
        least squares mean (standard error)
    -0.31 ± 0.34
    -2.88 ± 0.34
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -2.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.41
         upper limit
    		 -1.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.43

    Secondary: Percentage of Participants with ≥50% Reduction from Baseline in Monthly Migraine Headache Days

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    End point title
    		 Percentage of Participants with ≥50% Reduction from Baseline in Monthly Migraine Headache Days
    End point description
    MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. APD: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    228
    230
    Units: Percentage of Participants
        number (confidence interval 95%)
    13.3 (10.2 to 17.3)
    37.7 (32.9 to 42.8)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.935
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.719
         upper limit
    		 5.693

    Secondary: Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days

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    End point title
    		 Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days
    End point description
    MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. APD: All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    132
    137
    Units: Percentage of Participants
        number (confidence interval 95%)
    17.1 (12.7 to 22.7)
    41.8 (35.7 to 48.1)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Pseudo likelihood-based repeated measure
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.481
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.252
         upper limit
    		 5.381

    Secondary: Mean Change from Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)

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    End point title
    		 Mean Change from Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
    End point description
    MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3 APD: All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    222
    223
    Units: score on a scale
        least squares mean (standard error)
    10.86 ± 1.34
    23.21 ± 1.35
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    445
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    12.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.19
         upper limit
    		 15.87
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.7
    Notes
    [1] - LS Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.

    Secondary: Mean Change from Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) in Participants with Episodic Migraine

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    End point title
    		 Mean Change from Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) in Participants with Episodic Migraine
    End point description
    MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3 APD: All randomized episodic migraine participants who received at least one dose of study drug and had a post baseline value at Month 3.
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    127
    135
    Units: score on a scale
        least squares mean (standard error)
    11.88 ± 1.80
    23.39 ± 1.79
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    11.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.14
         upper limit
    		 15.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.22
    Notes
    [2] - LS Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.

    Secondary: Percentage of Participants With Episodic Migraine with ≥75% Reduction from Baseline in Monthly Migraine Headache Days

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    End point title
    		 Percentage of Participants With Episodic Migraine with ≥75% Reduction from Baseline in Monthly Migraine Headache Days
    End point description
    MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. APD: All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    132
    137
    Units: Percentage of Participants
        number (confidence interval 95%)
    3.7 (1.6 to 8.2)
    18.4 (13.9 to 23.9)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 Pseudo likelihood-based repeated measure
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.878
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.374
         upper limit
    		 14.554

    Secondary: Percentage of Participants With Episodic Migraine With 100% Reduction From Baseline in Monthly Migraine Headache Days

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    End point title
    		 Percentage of Participants With Episodic Migraine With 100% Reduction From Baseline in Monthly Migraine Headache Days
    End point description
    MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. APD: All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    132
    137
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.00 (0.00 to 0.00)
    7.7 (4.7 to 12.3)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Pseudo likelihood-based repeated measure
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    999.999
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 548.706
         upper limit
    		 999.999
    Notes
    [3] - Estimated value and upper bound are >999.999

    Secondary: Percentage of Participants with ≥75% Reduction from Baseline in Monthly Migraine Headache Days

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    End point title
    		 Percentage of Participants with ≥75% Reduction from Baseline in Monthly Migraine Headache Days
    End point description
    MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. APD: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    228
    230
    Units: Percentage of Participants
        number (confidence interval 95%)
    3.3 (1.7 to 6.3)
    14.5 (10.9 to 19.0)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 pseudo likelihood-based repeated measure
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.012
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.352
         upper limit
    		 10.679

    Secondary: Percentage of Participants with 100% Reduction from Baseline in Monthly Migraine Headache Days

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    End point title
    		 Percentage of Participants with 100% Reduction from Baseline in Monthly Migraine Headache Days
    End point description
    MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD APD: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    228
    230
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.000 (0.000 to 0.000)
    4.9 (2.8 to 8.6)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Pseudo likelihood-based repeated measure
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    999.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 999.99
         upper limit
    		 999.99
    Notes
    [4] - Point estimate, upper limit and lower limit are >999.99

    Secondary: Overall Mean Change from Baseline in the Number of Monthly Days with Acute Headache Medication Use

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    End point title
    		 Overall Mean Change from Baseline in the Number of Monthly Days with Acute Headache Medication Use
    End point description
    Overall mean is derived from the average of months 1 to 3 from Mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. APD: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    228
    230
    Units: Days
        least squares mean (standard error)
    -0.80 ± 0.31
    -4.19 ± 0.32
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.14
         upper limit
    		 -2.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.38

    Secondary: Overall Mean Change from Baseline in the Number of Monthly Headache Days

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    End point title
    		 Overall Mean Change from Baseline in the Number of Monthly Headache Days
    End point description
    Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache). Overall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. APD: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1 through Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    228
    230
    Units: Days
        least squares mean (standard error)
    -1.05 ± 0.36
    -4.18 ± 0.35
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -3.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.96
         upper limit
    		 -2.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.42

    Secondary: Mean Change from Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score

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    End point title
    		 Mean Change from Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score
    End point description
    The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missed or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LS mean was calculated using analysis of covariance (ANCOVA) with last observation carried forward (LOCF), with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. APD: All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    225
    228
    Units: score on a scale
        least squares mean (standard error)
    -3.295 ± 3.2834
    -21.097 ± 3.3164
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    453
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean Change from Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4)

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    End point title
    		 Mean Change from Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4)
    End point description
    MIBS-4 is a self-administered scale that measures the burden related to headache in the time between attacks. The instrument consists of 4 items that address disruption at work and school, diminished family and social life, difficulty planning, and emotional difficulty. The questionnaire specifically asks about the effect of the disease over the past 4 weeks on days without a headache attack. Response options include: don't know/not applicable (0), never (0), rarely (1), some of the time (2), much of the time (3), or most or all of the time (3). Each responses associated numerical score are summed across all 4 items resulting in a total score ranging from 0 to 12, and the level of interictal burden being categorized into the following: 0 for none, 1-2 mild, 3-4 moderate, and >5 severe. LS mean was calculated using MMRM model with fixed effects of treatment, pooled country, baseline migraine frequency category, month, treatment by month as fixed effects.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3 APD: All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    222
    223
    Units: score on a scale
        least squares mean (standard error)
    -0.78 ± 0.21
    -1.83 ± 0.21
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    445
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.58
         upper limit
    		 -0.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.27

    Secondary: Mean Change from Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI)

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    End point title
    		 Mean Change from Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI)
    End point description
    The WPAI Questionnaire is a patient-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores are calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores are calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3 APD: All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    225
    227
    Units: score on a scale
    least squares mean (standard error)
        Activity Impairment (n = 225,227)
    -8.644 ± 1.9195
    -20.713 ± 1.9537
        Absenteeism (n = 145, 148)
    -2.900 ± 1.2436
    -4.224 ± 1.2929
        Presenteeism (n = 141, 147)
    -2.564 ± 2.3222
    -12.504 ± 2.3705
        Work Impairment (n = 145, 148)
    -3.457 ± 2.4098
    -14.307 ± 2.5148
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Activity Impairment.
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [5] - Activitiy Impairment.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Absenteeism.
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.388
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [6] - Absenteeism.
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Presenteeism.
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.0004
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [7] - Presenteeism.
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Work Impairment.
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.0003
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [8] - Work Impairment.

    Secondary: Mean Change from Baseline in the Patient Global Impression of Severity (PGI-S)

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    End point title
    		 Mean Change from Baseline in the Patient Global Impression of Severity (PGI-S)
    End point description
    The PGI-S is a patient-rated instrument that measures illness severity. For this study, the patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" The PGI-S includes a range of possible responses, from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. APD: All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    225
    228
    Units: score on a scale
        least squares mean (standard error)
    -0.283 ± 0.0863
    -0.664 ± 0.0873
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    453
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean Change from Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (US)

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    End point title
    		 Mean Change from Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (US)
    End point description
    EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the US algorithm (-0.109 to 1). A higher score indicates better health state. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. APD: All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    225
    227
    Units: score on a scale
        least squares mean (standard error)
    -0.002 ± 0.0079
    0.013 ± 0.0080
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1267
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean Change from Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (UK)

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    End point title
    		 Mean Change from Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (UK)
    End point description
    EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the UK algorithm (-0.594 to 1). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. APD: All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    225
    227
    Units: score on a scale
        least squares mean (standard error)
    -0.001 ± 0.0109
    0.017 ± 0.0110
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.163
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean Change from Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - VAS Score

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    End point title
    		 Mean Change from Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - VAS Score
    End point description
    EQ-5D-5L is a 2-part questionnaire that assesses general health status 'today'. . The second part is assessed using a visual analog scale (VAS) on which the patient rates their perceived health state, ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. APD: All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3
    End point values
    		 Placebo Galcanezumab 120mg
    Number of subjects analysed
    225
    227
    Units: mm
        least squares mean (standard error)
    -0.086 ± 1.2916
    3.376 ± 1.3080
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Galcanezumab 120mg
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0277
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I5Q-MC-CGAW
    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
    		 -

    Reporting group title
    Galcanezumab 120mg - Double-Blind Treatment Phase
    Reporting group description
    		 -

    Reporting group title
    Placebo/Galcanezumab 120mg - Open-Label Treatment Phase
    Reporting group description
    		 -

    Reporting group title
    Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase Placebo/Galcanezumab 120mg - Open-Label Treatment Phase Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 230 (0.87%)
    2 / 232 (0.86%)
    6 / 225 (2.67%)
    3 / 224 (1.34%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    arthropod bite
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 232 (0.00%)
    1 / 225 (0.44%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    injury
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 232 (0.00%)
    1 / 225 (0.44%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lower limb fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 232 (0.00%)
    0 / 225 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    behcet's syndrome
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 232 (0.00%)
    0 / 225 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    hemiplegia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 232 (0.00%)
    1 / 225 (0.44%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 232 (0.00%)
    0 / 225 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 232 (0.00%)
    1 / 225 (0.44%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    haemorrhoids
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 232 (0.43%)
    0 / 225 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    inguinal hernia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 232 (0.00%)
    1 / 225 (0.44%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    ovarian cyst ruptured
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [1]
    0 / 202 (0.00%)
    0 / 195 (0.00%)
    0 / 197 (0.00%)
    1 / 187 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    pulmonary embolism
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 232 (0.00%)
    1 / 225 (0.44%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    pneumonia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 232 (0.00%)
    0 / 225 (0.00%)
    1 / 224 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tonsillitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 232 (0.43%)
    0 / 225 (0.00%)
    0 / 224 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 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 to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo - Double-Blind Treatment Phase Galcanezumab 120mg - Double-Blind Treatment Phase Placebo/Galcanezumab 120mg - Open-Label Treatment Phase Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 230 (13.48%)
    21 / 232 (9.05%)
    19 / 225 (8.44%)
    13 / 224 (5.80%)
    General disorders and administration site conditions
    injection site pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    13 / 230 (5.65%)
    5 / 232 (2.16%)
    11 / 225 (4.89%)
    5 / 224 (2.23%)
         occurrences all number
    30
    7
    19
    7
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    21 / 230 (9.13%)
    16 / 232 (6.90%)
    11 / 225 (4.89%)
    8 / 224 (3.57%)
         occurrences all number
    24
    17
    11
    9

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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