Clincosm LogoSign in Get a demo

A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02959190
Collaborator
(none)
311
Enrollment
44
Locations
6
Arms
30
Actual Duration (Months)
7.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
311 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 (Galcanezumab) in Japanese Patients With Migraine
Actual Study Start Date :
Feb 7, 2017
Actual Primary Completion Date :
Aug 10, 2019
Actual Study Completion Date :
Aug 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 120mg/120mg Galcanezumab - Episodic Migraine (EM)

240 milligram (loading dose) of Galcanezumab at first dosing visit followed by 120 milligram (mg) once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.

Drug: Galcanezumab
Administered SC
Other Names:
  • LY2951742

    		•
    Experimental: 240mg/240mg Galcanezumab - EM

    240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.

    Drug: Galcanezumab
    Administered SC
    Other Names:
  • LY2951742

    		•
    Experimental: Placebo/ 120mg Galcanezumab - EM

    240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.

    Drug: Galcanezumab
    Administered SC
    Other Names:
  • LY2951742

    		•
    Experimental: Placebo/ 240mg Galcanezumab - EM

    240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.

    Drug: Galcanezumab
    Administered SC
    Other Names:
  • LY2951742

    		•
    Experimental: 120mg Galcanezumab - CM

    240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.

    Drug: Galcanezumab
    Administered SC
    Other Names:
  • LY2951742

    		•
    Experimental: 240mg Galcanezumab - CM

    240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.

    Drug: Galcanezumab
    Administered SC
    Other Names:
  • LY2951742

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Up To 16 Months]

      A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Serum Concentration of Galcanezumab [Month 12: Predose]

      Serum Concentration of Galcanezumab at month 12 is reported.

    2. Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP) [Month 12: Predose]

      Plasma Concentration of total CGRP at month 12 is reported.

    3. Percentage of Participants Developing Anti-Drug Antibodies (ADA) [Month 0, 1, 2, 3, 6, 9, 12 and 16: Predose; Month 0 and 14 days Postdose]

      Treatment emergent ADA will be defined as any of the following: A negative baseline result and a positive post-baseline ADA result with a titer ≥20. This is also called treatment-induced ADA. A positive baseline result and a positive post-baseline ADA result with a ≥4-fold increase in titers (for example, baseline titer of 10 increasing to ≥40 post-baseline). This is called treatment-boosted ADA.

    4. Mean Change From Baseline in the Number of Migraine Headache Days (MHDs) [Baseline, Month 12]

      Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache (EM Participants): A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia. Migraine Headache (CM Participants) : A headache, with or without aura, of greater than or equal to (≥30) minutes duration which meets criteria A and B or meets criterion C: A and B criteria as described above and criteria C) The headache is believed by the participant to be migraine at onset and is relieved by a triptan or ergot derivative.

    5. Mean Change From Baseline in the Number of Headache Days (HDs) [Baseline, Month 12]

      A headache day is calendar day on which any type of headache occurs,(including migraine headache, probable migraine headache, and non-migraine headache).

    6. Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days [Month 12]

      Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 50% responder in a particular month is any participant who has a ≥50% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval.

    7. Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache [Baseline, Month 12]

      Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication.

    8. Mean Change From Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache [Baseline, Month 12]

      Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache: Calendar days on which headache, migraine or probable migraine occurs, requiring acute medication.

    9. Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score [Baseline, Month 12]

      The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill").

    10. Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score [Baseline, Month 12]

      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 missing 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.

    11. Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 [Baseline, Month 12]

      MSQ version 2.1 is a health status instrument,with a 4-week recall period,developed to address physical & 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 addressing 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 total raw score is computed for each domain & total score, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.

    12. Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) [Month 12]

      The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects.Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment (5 categories). Preference compared the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study" (5 categories). The side effects responses range from "significantly less side effects" to "significantly more side effects" (5 categories). Positive responses for each item were defined as follows: Satisfaction: "Very Satisfied" or "Somewhat Satisfied"; Preference: "Much Prefer Study Medication" or "Prefer Study Medication"; Side Effects: "Much-Less Side Effects" or "Less Side Effects".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN.

    • Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.

    Exclusion Criteria:

    • For Chronic Migraine participants:

    • Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.

    • Current use or prior exposure to Galcanezumab or other antibodies of calcitonin gene-related peptide (CGRP) or its receptor.

    • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.

    • History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.

    • Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chofu-shi Japan 182-0006
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fukui Japan 918 8503
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fukuoka Japan 816 0824
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Higashiosaka Japan 578-8588
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hiroshima Japan 730-0031
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ibaraki Japan 300-1206
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Iruma-Gun Japan 350-0495
    8 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. Kagawa Japan 769-0103
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kagoshima Japan 892-0842
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kagoshima Japan 892-0844
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kai-Shi Japan 400-0124
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kanoya-City Japan 893-0032
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kasaoka-shi Japan 714-0043
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kasuga-shi Japan 816-0802
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kobe Japan 658-0064
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kochi-Shi Japan 780-0051
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kochi Japan 780-8011
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kyoto Japan 600-8811
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kyoto Japan 606-0851
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Minato-Ku Japan 108-8642
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Morioka Japan 020-0034
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Morioka Japan 020-8505
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Narashino-shi Japan 275-0026
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nishinomiya Japan 663-8014
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nishinomiya Japan 663-8204
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oita Japan 870-0831
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Okayama-shi Japan 700-8557
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Osaka-Shi Japan 556-0015
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ota-ku Japan 145-0063
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ota-shi Japan 373-8585
    31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saijo-shi Japan 793-0030
    32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saitama Japan 338-8577
    33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sapporo Japan 003-0003
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sapporo Japan 060-8570
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sendai Japan
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Shibuya-ku Japan 151-0051
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Shinjuku-ku Japan 160-0017
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Shizuoka Japan 420-0853
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tachikawa-shi Japan 190-8531
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tochigi Japan 321-0207
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tochigi Japan 321-0293
    42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tokyo Japan 160-8582
    43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Yamaguchi Japan 754-0002
    44 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. Ōsaka Japan 560-0012

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02959190
    Other Study ID Numbers:
    • 16108
    • I5Q-JE-CGAP
    First Posted:
    Nov 8, 2016
    Last Update Posted:
    Sep 29, 2020
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Eli Lilly and Company
    prevention
    prophylaxis
    headache
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    Participant Flow

    Recruitment Details Episodic migraine (EM) participants rolled over from parental Study I5Q-JE-CGAN (CGAN - NCT02959177)), and chronic migraine (CM) participants were newly enrolled in this CGAP study.
    Pre-assignment Detail
    Arm/Group Title 120 mg Galcanezumab EM 240 mg Galcanezumab EM 120 mg Galcanezumab CM 240 mg Galcanezumab CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab or placebo. Participants did not receive any intervention during post-treatment follow-up phase. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab or placebo. Participants did not receive any intervention during post-treatment follow-up phase. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. Participants did not receive any intervention during post-treatment follow-up phase. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled. Participants did not receive any intervention during post-treatment follow-up phase.
    Period Title: Open Label
    STARTED 120 126 32 33
    Received at Least 1 Dose of Study Drug 120 126 32 33
    120mg/120mg Galcanezumab - EM 58 0 0 0
    240mg/240mg Galcanezumab - EM 0 62 0 0
    Placebo/ 120mg Galcanezumab - EM 62 0 0 0
    Placebo/ 240mg Galcanezumab - EM 0 64 0 0
    COMPLETED 113 110 28 27
    NOT COMPLETED 7 16 4 6
    Period Title: Open Label
    STARTED 117 120 32 32
    COMPLETED 114 119 31 32
    NOT COMPLETED 3 1 1 0

    Baseline Characteristics

    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM Total
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled. Total of all reporting groups
    Overall Participants 58 62 62 64 32 33 311
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    44.95
    (10.04)
    45.47
    (9.79)
    45.35
    (10.69)
    45.08
    (8.88)
    41.88
    (9.40)
    43.70
    (11.53)
    44.71
    (9.98)
    Sex: Female, Male (Count of Participants)
    Female
    48
    82.8%
    52
    83.9%
    51
    82.3%
    58
    90.6%
    32
    100%
    27
    81.8%
    268
    86.2%
    Male
    10
    17.2%
    10
    16.1%
    11
    17.7%
    6
    9.4%
    0
    0%
    6
    18.2%
    43
    13.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    58
    100%
    62
    100%
    62
    100%
    64
    100%
    32
    100%
    33
    100%
    311
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    58
    100%
    62
    100%
    62
    100%
    64
    100%
    32
    100%
    33
    100%
    311
    100%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    Japan
    58
    100%
    62
    100%
    62
    100%
    64
    100%
    32
    100%
    33
    100%
    311
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    Description A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
    Time Frame Up To 16 Months

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 58 62 62 64 32 33
    Any TEAE
    54
    93.1%
    56
    90.3%
    54
    87.1%
    61
    95.3%
    31
    96.9%
    29
    87.9%
    Any SAE
    2
    3.4%
    0
    0%
    2
    3.2%
    2
    3.1%
    1
    3.1%
    2
    6.1%
    2. Secondary Outcome
    Title Pharmacokinetics (PK): Serum Concentration of Galcanezumab
    Description Serum Concentration of Galcanezumab at month 12 is reported.
    Time Frame Month 12: Predose

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had evaluable galcanezumab PK data.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 56 53 58 57 28 27
    Mean (Standard Deviation) [nanogram/milliliter (ng/mL)]
    21100
    (6120)
    46000
    (15300)
    21000
    (7290)
    42200
    (12400)
    20100
    (8550)
    39600
    (13600)
    3. Secondary Outcome
    Title Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP)
    Description Plasma Concentration of total CGRP at month 12 is reported.
    Time Frame Month 12: Predose

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had measurable CGRP concentrations.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 56 53 58 57 28 27
    Mean (Standard Deviation) [ng/mL]
    4.51
    (1.26)
    5.87
    (1.45)
    4.69
    (1.45)
    5.59
    (1.45)
    4.37
    (1.40)
    5.19
    (1.52)
    4. Secondary Outcome
    Title Percentage of Participants Developing Anti-Drug Antibodies (ADA)
    Description Treatment emergent ADA will be defined as any of the following: A negative baseline result and a positive post-baseline ADA result with a titer ≥20. This is also called treatment-induced ADA. A positive baseline result and a positive post-baseline ADA result with a ≥4-fold increase in titers (for example, baseline titer of 10 increasing to ≥40 post-baseline). This is called treatment-boosted ADA.
    Time Frame Month 0, 1, 2, 3, 6, 9, 12 and 16: Predose; Month 0 and 14 days Postdose

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had evaluable immunogenicity data.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 58 62 62 64 32 33
    Number [percentage of participants]
    12.07
    20.8%
    9.68
    15.6%
    16.13
    26%
    10.94
    17.1%
    12.50
    39.1%
    18.18
    55.1%
    5. Secondary Outcome
    Title Mean Change From Baseline in the Number of Migraine Headache Days (MHDs)
    Description Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache (EM Participants): A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia. Migraine Headache (CM Participants) : A headache, with or without aura, of greater than or equal to (≥30) minutes duration which meets criteria A and B or meets criterion C: A and B criteria as described above and criteria C) The headache is believed by the participant to be migraine at onset and is relieved by a triptan or ergot derivative.
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 56 53 58 57 28 27
    Mean (Standard Deviation) [MHDs]
    -1.82
    (2.96)
    -1.49
    (4.11)
    -4.29
    (4.07)
    -3.23
    (5.81)
    -9.44
    (6.16)
    -8.97
    (8.06)
    6. Secondary Outcome
    Title Mean Change From Baseline in the Number of Headache Days (HDs)
    Description A headache day is calendar day on which any type of headache occurs,(including migraine headache, probable migraine headache, and non-migraine headache).
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 56 53 58 57 28 27
    Mean (Standard Deviation) [Headache days (HDs)]
    -2.37
    (3.62)
    -1.75
    (4.57)
    -5.04
    (4.71)
    -4.00
    (5.14)
    -9.30
    (6.83)
    -9.42
    (8.37)
    7. Secondary Outcome
    Title Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days
    Description Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 50% responder in a particular month is any participant who has a ≥50% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval.
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 47 46 55 56 28 27
    Number [Percentage of participants]
    48.9
    84.3%
    45.7
    73.7%
    52.7
    85%
    46.4
    72.5%
    35.7
    111.6%
    51.9
    157.3%
    8. Secondary Outcome
    Title Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache
    Description Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication.
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 56 53 58 57 28 27
    Mean (Standard Deviation) [MHDs with medication use]
    -1.40
    (2.54)
    -1.00
    (3.59)
    -3.87
    (3.84)
    -3.01
    (5.76)
    -8.36
    (6.29)
    -7.43
    (7.89)
    9. Secondary Outcome
    Title Mean Change From Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache
    Description Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache: Calendar days on which headache, migraine or probable migraine occurs, requiring acute medication.
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 56 53 58 57 28 27
    Mean (Standard Deviation) [MHDs and HDs with medication use]
    -1.62
    (3.21)
    -1.17
    (3.89)
    -4.47
    (4.81)
    -3.43
    (5.53)
    -8.21
    (6.84)
    -7.48
    (8.21)
    10. Secondary Outcome
    Title Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
    Description The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill").
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 56 53 58 57 28 27
    Mean (Standard Deviation) [score on a scale]
    -0.29
    (0.76)
    -0.04
    (0.76)
    -0.02
    (0.66)
    0.11
    (0.77)
    -0.07
    (1.59)
    -0.81
    (1.14)
    11. Secondary Outcome
    Title Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
    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 missing 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.
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 56 53 58 57 28 27
    Mean (Standard Deviation) [score on a scale]
    -0.38
    (8.99)
    -0.42
    (15.94)
    -8.67
    (17.39)
    -4.60
    (12.77)
    -20.71
    (32.66)
    -15.48
    (32.26)
    12. Secondary Outcome
    Title Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
    Description MSQ version 2.1 is a health status instrument,with a 4-week recall period,developed to address physical & 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 addressing 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 total raw score is computed for each domain & total score, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.
    Time Frame Baseline, Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 56 53 58 57 28 27
    Total Score
    1.02
    (8.68)
    0.38
    (11.97)
    7.51
    (10.58)
    4.56
    (11.22)
    19.23
    (12.57)
    18.31
    (15.67)
    Role Function-Restrictive Domain
    1.68
    (9.77)
    0.22
    (13.75)
    8.77
    (12.74)
    4.96
    (12.60)
    22.65
    (15.08)
    22.96
    (17.69)
    Role Function-Preventive Domain
    0.09
    (9.70)
    0.75
    (13.17)
    7.16
    (10.18)
    3.77
    (12.86)
    15.89
    (13.68)
    13.52
    (16.63)
    Emotional Function Domain
    0.71
    (10.54)
    0.25
    (11.47)
    5.06
    (11.47)
    4.68
    (12.34)
    15.71
    (13.96)
    13.83
    (17.82)
    13. Secondary Outcome
    Title Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
    Description The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects.Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment (5 categories). Preference compared the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study" (5 categories). The side effects responses range from "significantly less side effects" to "significantly more side effects" (5 categories). Positive responses for each item were defined as follows: Satisfaction: "Very Satisfied" or "Somewhat Satisfied"; Preference: "Much Prefer Study Medication" or "Prefer Study Medication"; Side Effects: "Much-Less Side Effects" or "Less Side Effects".
    Time Frame Month 12

    Outcome Measure Data

    Analysis Population Description
    All participants who were randomized and received at least 1 dose of the study drug and had month 12 PSMQ-M measurement.
    Arm/Group Title 120mg/120mg Galcanezumab - EM 240mg/240mg Galcanezumab - EM Placebo/ 120mg Galcanezumab - EM Placebo/ 240mg Galcanezumab - EM 120mg Galcanezumab - CM 240mg Galcanezumab - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
    Measure Participants 56 53 58 57 28 27
    Responder for satisfaction
    80.4
    138.6%
    73.6
    118.7%
    72.4
    116.8%
    73.7
    115.2%
    82.1
    256.6%
    74.1
    224.5%
    Responder for preference
    76.8
    132.4%
    73.6
    118.7%
    75.9
    122.4%
    75.4
    117.8%
    85.7
    267.8%
    81.5
    247%
    Responder for side effect
    78.6
    135.5%
    69.8
    112.6%
    72.4
    116.8%
    71.9
    112.3%
    82.1
    256.6%
    81.5
    247%

    Adverse Events

    Time Frame Up To 16 Months
    Adverse Event Reporting Description All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    Arm/Group Title 120mg/120mg Galcanezumab - Open-Label Treatment Phase (Ph) -EM 240mg/240mg Galcanezumab - Open-Label Treatment Ph-EM Placebo/ 120mg Galcanezumab - Open-Label Treatment - EM Placebo/ 240mg Galcanezumab - Open-Label Treatment-EM 120mg Galcanezumab - Open-Label Treatment Phase-CM 240mg Galcanezumab - Open-Label Treatment Phase-CM 120mg Galcanezumab - Post-Treatment Phase - EM 240mg Galcanezumab - Post-Treatment Phase - EM 120mg Galcanezumab - Post-Treatment Phase - CM 240mg Galcanezumab - Post-Treatment Phase - CM
    Arm/Group Description 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo. 240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo. 240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. 240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled. Participants didn't received any intervention Participants didn't received any intervention Participants didn't received any intervention Participants didn't received any intervention
    All Cause Mortality
    120mg/120mg Galcanezumab - Open-Label Treatment Phase (Ph) -EM 240mg/240mg Galcanezumab - Open-Label Treatment Ph-EM Placebo/ 120mg Galcanezumab - Open-Label Treatment - EM Placebo/ 240mg Galcanezumab - Open-Label Treatment-EM 120mg Galcanezumab - Open-Label Treatment Phase-CM 240mg Galcanezumab - Open-Label Treatment Phase-CM 120mg Galcanezumab - Post-Treatment Phase - EM 240mg Galcanezumab - Post-Treatment Phase - EM 120mg Galcanezumab - Post-Treatment Phase - CM 240mg Galcanezumab - Post-Treatment Phase - CM
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/58 (0%) 0/62 (0%) 0/62 (0%) 0/64 (0%) 0/32 (0%) 0/33 (0%) 0/117 (0%) 0/120 (0%) 0/32 (0%) 0/32 (0%)
    Serious Adverse Events
    120mg/120mg Galcanezumab - Open-Label Treatment Phase (Ph) -EM 240mg/240mg Galcanezumab - Open-Label Treatment Ph-EM Placebo/ 120mg Galcanezumab - Open-Label Treatment - EM Placebo/ 240mg Galcanezumab - Open-Label Treatment-EM 120mg Galcanezumab - Open-Label Treatment Phase-CM 240mg Galcanezumab - Open-Label Treatment Phase-CM 120mg Galcanezumab - Post-Treatment Phase - EM 240mg Galcanezumab - Post-Treatment Phase - EM 120mg Galcanezumab - Post-Treatment Phase - CM 240mg Galcanezumab - Post-Treatment Phase - CM
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/58 (3.4%) 0/62 (0%) 2/62 (3.2%) 2/64 (3.1%) 1/32 (3.1%) 2/33 (6.1%) 2/117 (1.7%) 1/120 (0.8%) 1/32 (3.1%) 1/32 (3.1%)
    Cardiac disorders
    Stress cardiomyopathy 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0
    Hepatobiliary disorders
    Cholangitis acute 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Infections and infestations
    Appendicitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 2 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Pelvic inflammatory disease 0/48 (0%) 0 0/52 (0%) 0 0/51 (0%) 0 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 1/105 (1%) 1 0/32 (0%) 0 0/26 (0%) 0
    Pneumonia 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injury, poisoning and procedural complications
    Ligament rupture 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Musculoskeletal and connective tissue disorders
    Fracture malunion 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Intervertebral disc protrusion 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Reproductive system and breast disorders
    Uterine polyp 1/48 (2.1%) 1 0/52 (0%) 0 0/51 (0%) 0 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Other (Not Including Serious) Adverse Events
    120mg/120mg Galcanezumab - Open-Label Treatment Phase (Ph) -EM 240mg/240mg Galcanezumab - Open-Label Treatment Ph-EM Placebo/ 120mg Galcanezumab - Open-Label Treatment - EM Placebo/ 240mg Galcanezumab - Open-Label Treatment-EM 120mg Galcanezumab - Open-Label Treatment Phase-CM 240mg Galcanezumab - Open-Label Treatment Phase-CM 120mg Galcanezumab - Post-Treatment Phase - EM 240mg Galcanezumab - Post-Treatment Phase - EM 120mg Galcanezumab - Post-Treatment Phase - CM 240mg Galcanezumab - Post-Treatment Phase - CM
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 54/58 (93.1%) 56/62 (90.3%) 54/62 (87.1%) 61/64 (95.3%) 31/32 (96.9%) 29/33 (87.9%) 40/117 (34.2%) 37/120 (30.8%) 10/32 (31.3%) 13/32 (40.6%)
    Blood and lymphatic system disorders
    Anaemia 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Iron deficiency anaemia 0/58 (0%) 0 0/62 (0%) 0 2/62 (3.2%) 2 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Lymphadenitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Cardiac disorders
    Angina pectoris 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Arrhythmia 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Palpitations 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Prinzmetal angina 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0
    Ear and labyrinth disorders
    Deafness 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Deafness neurosensory 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 2/33 (6.1%) 2 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Deafness transitory 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Ear discomfort 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Meniere's disease 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Sudden hearing loss 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tinnitus 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0
    Vertigo 0/58 (0%) 0 2/62 (3.2%) 2 2/62 (3.2%) 2 2/64 (3.1%) 2 0/32 (0%) 0 1/33 (3%) 2 1/117 (0.9%) 1 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Vertigo positional 0/58 (0%) 0 0/62 (0%) 0 2/62 (3.2%) 2 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Endocrine disorders
    Autoimmune thyroiditis 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hypothyroidism 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Thyroid cyst 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Eye disorders
    Asthenopia 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 2/32 (6.3%) 2 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Blepharitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 2/117 (1.7%) 2 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Conjunctival haemorrhage 1/58 (1.7%) 1 3/62 (4.8%) 3 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Conjunctivitis allergic 1/58 (1.7%) 1 1/62 (1.6%) 1 0/62 (0%) 0 4/64 (6.3%) 5 2/32 (6.3%) 2 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Dry eye 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Eye inflammation 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Eye pruritus 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Foreign body sensation in eyes 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Keratitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Ocular discomfort 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Ocular hyperaemia 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Vitreous floaters 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort 1/58 (1.7%) 1 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 4
    Abdominal pain 1/58 (1.7%) 1 2/62 (3.2%) 2 1/62 (1.6%) 2 3/64 (4.7%) 3 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Abdominal pain lower 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Abdominal pain upper 2/58 (3.4%) 2 2/62 (3.2%) 2 2/62 (3.2%) 2 6/64 (9.4%) 6 2/32 (6.3%) 2 1/33 (3%) 1 1/117 (0.9%) 1 1/120 (0.8%) 1 0/32 (0%) 0 1/32 (3.1%) 1
    Angular cheilitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Chapped lips 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Cheilitis 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Chronic gastritis 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Constipation 5/58 (8.6%) 6 2/62 (3.2%) 2 3/62 (4.8%) 3 1/64 (1.6%) 1 2/32 (6.3%) 2 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Dental caries 3/58 (5.2%) 3 3/62 (4.8%) 3 7/62 (11.3%) 7 5/64 (7.8%) 5 2/32 (6.3%) 2 2/33 (6.1%) 2 2/117 (1.7%) 2 1/120 (0.8%) 1 1/32 (3.1%) 1 0/32 (0%) 0
    Dental cyst 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 2 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Diarrhoea 1/58 (1.7%) 1 2/62 (3.2%) 2 3/62 (4.8%) 3 2/64 (3.1%) 2 4/32 (12.5%) 4 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Enteritis 0/58 (0%) 0 1/62 (1.6%) 2 0/62 (0%) 0 1/64 (1.6%) 2 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Enterocolitis 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Erosive oesophagitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Gastric polyps 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Gastritis 0/58 (0%) 0 3/62 (4.8%) 3 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Gastroduodenal ulcer 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Gastrointestinal disorder 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Gastrooesophageal reflux disease 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Haemorrhoids 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hiatus hernia 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hyperaesthesia teeth 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Irritable bowel syndrome 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Large intestine polyp 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Lip erosion 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Nausea 3/58 (5.2%) 3 2/62 (3.2%) 2 2/62 (3.2%) 3 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Oesophageal discomfort 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Periodontal disease 1/58 (1.7%) 1 1/62 (1.6%) 1 1/62 (1.6%) 1 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Stomatitis 2/58 (3.4%) 2 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 1/33 (3%) 1 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tooth impacted 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tooth loss 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Toothache 1/58 (1.7%) 1 1/62 (1.6%) 1 3/62 (4.8%) 4 2/64 (3.1%) 3 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Vomiting 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    General disorders
    Asthenia 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 2 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Chest pain 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Chills 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Discomfort 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Fatigue 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 1/32 (3.1%) 2 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Feeling abnormal 1/58 (1.7%) 1 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0
    Hangover 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 5 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site bruising 1/58 (1.7%) 1 1/62 (1.6%) 1 0/62 (0%) 0 2/64 (3.1%) 2 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site eczema 0/58 (0%) 0 1/62 (1.6%) 2 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site erythema 11/58 (19%) 37 15/62 (24.2%) 66 11/62 (17.7%) 53 16/64 (25%) 50 3/32 (9.4%) 4 3/33 (9.1%) 15 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site haemorrhage 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site hypoaesthesia 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site induration 3/58 (5.2%) 3 2/62 (3.2%) 3 2/62 (3.2%) 6 7/64 (10.9%) 10 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site inflammation 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site mass 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 2/64 (3.1%) 7 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site pain 1/58 (1.7%) 2 3/62 (4.8%) 7 4/62 (6.5%) 5 11/64 (17.2%) 31 2/32 (6.3%) 2 3/33 (9.1%) 6 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site pruritus 7/58 (12.1%) 26 9/62 (14.5%) 22 10/62 (16.1%) 33 17/64 (26.6%) 68 5/32 (15.6%) 9 4/33 (12.1%) 18 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site rash 0/58 (0%) 0 1/62 (1.6%) 2 0/62 (0%) 0 3/64 (4.7%) 13 1/32 (3.1%) 1 1/33 (3%) 5 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site reaction 0/58 (0%) 0 0/62 (0%) 0 2/62 (3.2%) 2 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site swelling 6/58 (10.3%) 17 5/62 (8.1%) 12 4/62 (6.5%) 12 7/64 (10.9%) 17 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site urticaria 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injection site warmth 1/58 (1.7%) 1 0/62 (0%) 0 2/62 (3.2%) 2 2/64 (3.1%) 2 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injury associated with device 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Malaise 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 1/64 (1.6%) 1 0/32 (0%) 0 2/33 (6.1%) 2 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Non-cardiac chest pain 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Oedema 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Pyrexia 1/58 (1.7%) 1 2/62 (3.2%) 5 1/62 (1.6%) 3 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 2/120 (1.7%) 2 0/32 (0%) 0 0/32 (0%) 0
    Swelling 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Thirst 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hepatobiliary disorders
    Gallbladder polyp 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hepatic function abnormal 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hepatic steatosis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Non-alcoholic steatohepatitis 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Immune system disorders
    Sarcoidosis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Seasonal allergy 1/58 (1.7%) 1 1/62 (1.6%) 1 2/62 (3.2%) 2 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 1/32 (3.1%) 1
    Infections and infestations
    Acute sinusitis 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Adenoviral conjunctivitis 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Adenovirus infection 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Bronchitis 1/58 (1.7%) 1 0/62 (0%) 0 1/62 (1.6%) 1 1/64 (1.6%) 1 1/32 (3.1%) 2 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Cellulitis 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Chronic sinusitis 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Conjunctivitis 2/58 (3.4%) 2 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Cystitis 2/58 (3.4%) 2 0/62 (0%) 0 2/62 (3.2%) 2 4/64 (6.3%) 6 2/32 (6.3%) 2 4/33 (12.1%) 5 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Cystitis bacterial 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Dermatophytosis 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Folliculitis 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Gastroenteritis 4/58 (6.9%) 4 5/62 (8.1%) 6 2/62 (3.2%) 2 1/64 (1.6%) 1 2/32 (6.3%) 2 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 1/32 (3.1%) 1 1/32 (3.1%) 1
    Gastroenteritis norovirus 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Gastroenteritis viral 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Genital herpes 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Gingivitis 4/58 (6.9%) 4 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Helicobacter infection 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Herpes dermatitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Herpes zoster 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 1/64 (1.6%) 1 1/32 (3.1%) 1 1/33 (3%) 1 1/117 (0.9%) 1 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Hordeolum 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 1/32 (3.1%) 1 1/33 (3%) 1 2/117 (1.7%) 2 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Influenza 5/58 (8.6%) 5 11/62 (17.7%) 11 8/62 (12.9%) 8 5/64 (7.8%) 5 4/32 (12.5%) 4 2/33 (6.1%) 2 1/117 (0.9%) 1 2/120 (1.7%) 2 0/32 (0%) 0 0/32 (0%) 0
    Laryngitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Nasopharyngitis 27/58 (46.6%) 44 29/62 (46.8%) 45 25/62 (40.3%) 44 32/64 (50%) 48 13/32 (40.6%) 19 16/33 (48.5%) 23 9/117 (7.7%) 10 8/120 (6.7%) 8 2/32 (6.3%) 2 2/32 (6.3%) 3
    Oral herpes 2/58 (3.4%) 4 1/62 (1.6%) 1 2/62 (3.2%) 2 1/64 (1.6%) 1 0/32 (0%) 0 2/33 (6.1%) 2 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Otitis externa 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 2 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Otitis media 0/58 (0%) 0 2/62 (3.2%) 2 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Pelvic inflammatory disease 0/48 (0%) 0 0/52 (0%) 0 0/51 (0%) 0 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 1/105 (1%) 1 0/32 (0%) 0 0/26 (0%) 0
    Periodontitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 2/33 (6.1%) 2 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Pharyngitis 2/58 (3.4%) 3 0/62 (0%) 0 2/62 (3.2%) 3 1/64 (1.6%) 1 2/32 (6.3%) 2 0/33 (0%) 0 2/117 (1.7%) 2 1/120 (0.8%) 1 0/32 (0%) 0 1/32 (3.1%) 1
    Pneumonia 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Pulpitis dental 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 2/64 (3.1%) 2 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Pyelitis 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Rhinitis 1/58 (1.7%) 1 1/62 (1.6%) 1 0/62 (0%) 0 2/64 (3.1%) 2 1/32 (3.1%) 2 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Sinusitis 2/58 (3.4%) 2 1/62 (1.6%) 1 0/62 (0%) 0 1/64 (1.6%) 1 1/32 (3.1%) 2 0/33 (0%) 0 1/117 (0.9%) 2 2/120 (1.7%) 2 0/32 (0%) 0 0/32 (0%) 0
    Streptococcal infection 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tinea pedis 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tonsillitis 0/58 (0%) 0 1/62 (1.6%) 2 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 2 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Urinary tract infection 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Vaginal infection 1/48 (2.1%) 1 0/52 (0%) 0 0/51 (0%) 0 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Viral tonsillitis 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Vulvovaginal candidiasis 0/48 (0%) 0 1/52 (1.9%) 1 0/51 (0%) 0 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 1/96 (1%) 1 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Injury, poisoning and procedural complications
    Animal bite 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Arthropod bite 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Arthropod sting 2/58 (3.4%) 2 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Avulsion fracture 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Bite 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Bone contusion 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Comminuted fracture 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Contusion 1/58 (1.7%) 1 1/62 (1.6%) 1 2/62 (3.2%) 2 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Epicondylitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Foot fracture 1/58 (1.7%) 1 1/62 (1.6%) 1 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hand fracture 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Head injury 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Heat illness 2/58 (3.4%) 2 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Heat stroke 0/58 (0%) 0 0/62 (0%) 0 2/62 (3.2%) 2 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Injury 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Joint dislocation 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Joint injury 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Ligament injury 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Ligament rupture 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Ligament sprain 2/58 (3.4%) 2 2/62 (3.2%) 2 1/62 (1.6%) 1 2/64 (3.1%) 2 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Lower limb fracture 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Meniscus injury 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Muscle injury 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Muscle strain 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Procedural pain 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 1/32 (3.1%) 1
    Spinal column injury 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Spinal fracture 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Stress fracture 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Sunburn 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Thermal burn 1/58 (1.7%) 1 0/62 (0%) 0 1/62 (1.6%) 1 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tooth fracture 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tooth injury 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Wound 1/58 (1.7%) 1 1/62 (1.6%) 1 0/62 (0%) 0 3/64 (4.7%) 3 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Investigations
    Alanine aminotransferase increased 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Anti-cyclic citrullinated peptide antibody positive 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Blood creatine phosphokinase increased 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Blood uric acid increased 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Heart rate increased 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Liver function test abnormal 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Liver function test increased 1/58 (1.7%) 1 0/62 (0%) 0 2/62 (3.2%) 2 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Platelet count increased 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Urine ketone body present 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0
    Iron deficiency 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Type 2 diabetes mellitus 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/58 (1.7%) 1 0/62 (0%) 0 1/62 (1.6%) 2 2/64 (3.1%) 2 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Arthropathy 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Back pain 2/58 (3.4%) 2 6/62 (9.7%) 6 2/62 (3.2%) 2 4/64 (6.3%) 5 1/32 (3.1%) 1 2/33 (6.1%) 2 1/117 (0.9%) 1 2/120 (1.7%) 2 0/32 (0%) 0 0/32 (0%) 0
    Flank pain 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Fracture malunion 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 2 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Intervertebral disc protrusion 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Limb discomfort 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Lumbar spinal stenosis 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Musculoskeletal chest pain 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Musculoskeletal pain 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Musculoskeletal stiffness 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 2/32 (6.3%) 2 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Myalgia 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Myofascial pain syndrome 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Neck pain 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 2/64 (3.1%) 2 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Nodal osteoarthritis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Osteoarthritis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Pain in extremity 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 1/64 (1.6%) 1 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Periarthritis 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Plantar fasciitis 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Spondylitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0
    Spondylolisthesis 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Synovial cyst 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Temporomandibular joint syndrome 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tendonitis 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tenosynovitis 1/58 (1.7%) 1 0/62 (0%) 0 2/62 (3.2%) 2 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Skin papilloma 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Uterine leiomyoma 2/48 (4.2%) 2 0/52 (0%) 0 0/51 (0%) 0 1/58 (1.7%) 1 1/32 (3.1%) 1 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Nervous system disorders
    Amnesia 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Carpal tunnel syndrome 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Cerebral arteriosclerosis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Cervical radiculopathy 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Cervicobrachial syndrome 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Dizziness 2/58 (3.4%) 2 0/62 (0%) 0 2/62 (3.2%) 2 3/64 (4.7%) 3 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Dysgeusia 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Head discomfort 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Hyperaesthesia 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hypoaesthesia 0/58 (0%) 0 1/62 (1.6%) 2 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Intracranial aneurysm 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Migraine 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Neuropathy peripheral 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Occipital neuralgia 0/58 (0%) 0 1/62 (1.6%) 2 1/62 (1.6%) 1 1/64 (1.6%) 1 0/32 (0%) 0 1/33 (3%) 1 1/117 (0.9%) 1 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Sciatica 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Sensory disturbance 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 1/32 (3.1%) 1 0/32 (0%) 0
    Somnolence 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Syncope 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Taste disorder 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tension headache 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Thunderclap headache 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy 0/48 (0%) 0 0/52 (0%) 0 0/51 (0%) 0 1/58 (1.7%) 1 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Psychiatric disorders
    Anxiety 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Anxiety disorder 1/58 (1.7%) 1 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Frustration tolerance decreased 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Insomnia 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 1/64 (1.6%) 1 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Middle insomnia 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Sleep disorder 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Stress 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Renal and urinary disorders
    Calculus urinary 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Hypertonic bladder 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Pollakiuria 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Renal impairment 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Reproductive system and breast disorders
    Adenomyosis 1/48 (2.1%) 1 0/52 (0%) 0 0/51 (0%) 0 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Cervical dysplasia 1/48 (2.1%) 1 0/52 (0%) 0 0/51 (0%) 0 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Cervical polyp 0/48 (0%) 0 0/52 (0%) 0 0/51 (0%) 0 1/58 (1.7%) 1 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Dysmenorrhoea 1/48 (2.1%) 1 1/52 (1.9%) 1 0/51 (0%) 0 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 1/96 (1%) 1 1/105 (1%) 1 0/32 (0%) 0 0/26 (0%) 0
    Endometriosis 1/48 (2.1%) 1 0/52 (0%) 0 0/51 (0%) 0 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Menopausal disorder 0/48 (0%) 0 1/52 (1.9%) 1 0/51 (0%) 0 1/58 (1.7%) 1 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Menopausal symptoms 1/48 (2.1%) 1 0/52 (0%) 0 0/51 (0%) 0 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 1/105 (1%) 1 0/32 (0%) 0 0/26 (0%) 0
    Menorrhagia 0/48 (0%) 0 0/52 (0%) 0 1/51 (2%) 1 0/58 (0%) 0 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Menstruation irregular 0/48 (0%) 0 0/52 (0%) 0 0/51 (0%) 0 1/58 (1.7%) 1 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Metrorrhagia 1/48 (2.1%) 1 1/52 (1.9%) 1 0/51 (0%) 0 2/58 (3.4%) 3 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 1/105 (1%) 1 1/32 (3.1%) 1 0/26 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Allergic bronchitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Asthma 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 3/64 (4.7%) 4 0/32 (0%) 0 3/33 (9.1%) 3 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Choking sensation 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Cough 0/58 (0%) 0 0/62 (0%) 0 2/62 (3.2%) 2 2/64 (3.1%) 3 2/32 (6.3%) 2 1/33 (3%) 1 1/117 (0.9%) 1 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Epistaxis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hyperventilation 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Oropharyngeal pain 1/58 (1.7%) 1 2/62 (3.2%) 2 2/62 (3.2%) 2 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Productive cough 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Rhinitis allergic 1/58 (1.7%) 1 1/62 (1.6%) 1 0/62 (0%) 0 1/64 (1.6%) 1 2/32 (6.3%) 2 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Upper respiratory tract inflammation 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Alopecia 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Asteatosis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Blister 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Cold urticaria 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 2 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Dermal cyst 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Dermatitis 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Dermatitis atopic 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Dermatitis contact 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 3 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Dry skin 1/58 (1.7%) 1 1/62 (1.6%) 1 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Dyshidrotic eczema 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Eczema 2/58 (3.4%) 2 2/62 (3.2%) 2 1/62 (1.6%) 1 3/64 (4.7%) 4 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 1/32 (3.1%) 1 0/32 (0%) 0
    Eczema asteatotic 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Eczema nummular 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Erythema annulare 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Haemorrhage subcutaneous 0/58 (0%) 0 1/62 (1.6%) 2 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hand dermatitis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Hyperkeratosis 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Ingrowing nail 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Miliaria 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Nail bed bleeding 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Onychalgia 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Onychomadesis 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Pruritus 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Rash 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Rash pruritic 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Seborrhoeic dermatitis 1/58 (1.7%) 2 0/62 (0%) 0 1/62 (1.6%) 1 1/64 (1.6%) 3 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Urticaria 1/58 (1.7%) 5 4/62 (6.5%) 4 3/62 (4.8%) 3 1/64 (1.6%) 1 3/32 (9.4%) 3 1/33 (3%) 1 1/117 (0.9%) 1 3/120 (2.5%) 3 0/32 (0%) 0 0/32 (0%) 0
    Urticaria chronic 0/58 (0%) 0 1/62 (1.6%) 1 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Urticaria thermal 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Surgical and medical procedures
    Appendicectomy 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 1/33 (3%) 1 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Bone graft 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Cervical polypectomy 0/48 (0%) 0 0/52 (0%) 0 0/51 (0%) 0 1/58 (1.7%) 1 0/32 (0%) 0 0/27 (0%) 0 0/96 (0%) 0 0/105 (0%) 0 0/32 (0%) 0 0/26 (0%) 0
    Cholecystectomy 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Endodontic procedure 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Haemorrhoid operation 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Intervertebral disc operation 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Ligament operation 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Lipectomy 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Mastectomy 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Polypectomy 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Removal of foreign body 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 1/120 (0.8%) 1 0/32 (0%) 0 0/32 (0%) 0
    Sinus operation 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 1/32 (3.1%) 1
    Skin cyst excision 0/58 (0%) 0 0/62 (0%) 0 0/62 (0%) 0 1/64 (1.6%) 1 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tendon sheath incision 0/58 (0%) 0 0/62 (0%) 0 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Tooth extraction 0/58 (0%) 0 1/62 (1.6%) 1 1/62 (1.6%) 1 2/64 (3.1%) 2 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Wisdom teeth removal 1/58 (1.7%) 1 0/62 (0%) 0 0/62 (0%) 0 0/64 (0%) 0 1/32 (3.1%) 1 0/33 (0%) 0 0/117 (0%) 0 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0
    Vascular disorders
    Hypertension 0/58 (0%) 0 2/62 (3.2%) 2 1/62 (1.6%) 1 0/64 (0%) 0 0/32 (0%) 0 0/33 (0%) 0 1/117 (0.9%) 1 0/120 (0%) 0 0/32 (0%) 0 0/32 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The sponsor can review the study result with PIs prior to public release and can embargo a communication about it until the public release by the contract with Investigator sites.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02959190
    Other Study ID Numbers:
    • 16108
    • I5Q-JE-CGAP
    First Posted:
    Nov 8, 2016
    Last Update Posted:
    Sep 29, 2020
    Last Verified:
    Aug 1, 2019