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A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03535194
Collaborator
(none)
1,484
Enrollment
178
Locations
5
Arms
23.3
Actual Duration (Months)
8.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1484 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2
Actual Study Start Date :
Jun 26, 2018
Actual Primary Completion Date :
Mar 5, 2020
Actual Study Completion Date :
Jun 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 250mg Q4W/250mg Q8W Mirikizumab

Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.

Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828

    		•
    Experimental: 250mg Q4W/125mg Q8W Mirikizumab

    Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.

    Drug: Mirikizumab
    Administered SC
    Other Names:
  • LY3074828

    		•
    Experimental: Placebo/250mg Mirikizumab

    Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.

    Drug: Mirikizumab
    Administered SC
    Other Names:
  • LY3074828

    • Drug: Placebo
    Administered SC
    Active Comparator: 300mg Secukinumab

    Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.

    Drug: Secukinumab
    Administered SC
    Experimental: Japan GPP/EP

    Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.

    Drug: Mirikizumab
    Administered SC
    Other Names:
  • LY3074828

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline [Week 16]

      The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

    2. Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline [Week 16]

      PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).

    Secondary Outcome Measures

    1. Percentage of Participants Achieving a 75% Improvement in PASI 75 [Week 16]

      PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).

    2. Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement [Week 16]

      The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.

    3. Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline [Week 16]

      PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.

    4. Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5 [Week 16]

      The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.

    5. Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline [Baseline, Week 16]

      The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.

    6. Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline [Baseline, Week 16]

      The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).

    7. Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline [Baseline, Week 16]

      The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).

    8. Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) [Baseline, Week 16]

      SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.

    9. Change From Baseline on the SF-36 Mental Component Summary (MCS) [Baseline, Week 16]

      SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.

    10. Percentage of Participants Achieving Patient's Global Assessment (PatGA) of Disease Severity of (0,1) With at Least a 2-point Improvement From Baseline in Patients With a Baseline PatGA ≥2 [Week 16]

      The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.

    11. Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores [Baseline, Week 16]

      The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.

    12. Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11. [Baseline, Week 16]

      QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms.

    13. Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab [Week 16]

      Minimum observed serum Ctrough,ss of mirikizumab

    14. Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority) [Week 16]

      The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

    15. Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority) [Week 16]

      PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participant must have chronic plaque psoriasis for at least 6 months.
    Exclusion Criteria:

    • Participant must not be breastfeeding or nursing woman.

    • Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months.

    • Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study.

    • Participant must not have any other skin conditions (excluding psoriasis).

    • Participant must not have previous exposure to Cosentyx and any other biologic therapy targeting IL-17 (including Taltz).

    • Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8 weeks.

    • Participant must not have previous exposure to any biologic therapy targeting IL-23 (including Stelara).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 Bakersfield Dermatology and Skin Cancer Medical Group Bakersfield California United States 93309
    3 David Stoll, M.D. Beverly Hills California United States 90212
    4 California Dermatology and Clinical Research Institute Encinitas California United States 92024
    5 Tien Q. Nguyen, MD inc. DBA First OC Dermatology Fountain Valley California United States 92708
    6 Keck School of Medicine University of Southern California Los Angeles California United States 90033
    7 Dermatology Clinical Trials Newport Beach California United States 92660
    8 San Luis Dermatology & Laser Clinic, Inc San Luis Obispo California United States 93405
    9 Clinical Science Institute Santa Monica California United States 90404
    10 Park Avenue Dermatology Orange Park Florida United States 32073
    11 Dermatologic Surgery Specialists, PC Macon Georgia United States 31217
    12 Medaphase Inc Newnan Georgia United States 30263
    13 Meridian Clinical Research Savannah Georgia United States 31406
    14 Treasure Valley Dermatology Boise Idaho United States 83713
    15 University Dermatology Darien Illinois United States 60561
    16 Arlington Dermatology Rolling Meadows Illinois United States 60008
    17 Dawes Fretzin Clinical Research Indianapolis Indiana United States 46250
    18 The Indiana Clinical Trials Center, PC Plainfield Indiana United States 46168
    19 The South Bend Clinic South Bend Indiana United States 46617
    20 Dermatology Specialist Louisville Kentucky United States 40241
    21 DelRicht Research Baton Rouge Louisiana United States 70809
    22 Dermatology and Skin Cancer Specialists Rockville Maryland United States 20850
    23 Lawrence J Green, M.D, LLC Rockville Maryland United States 20850
    24 ORA, Inc Andover Massachusetts United States 01810
    25 Central Dermatology PC Saint Louis Missouri United States 63117
    26 Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey United States 08520
    27 Mount Sinai School of Medicine Dermatology Clinical Trials New York New York United States 10029
    28 PMG Research of Cary, LLC Cary North Carolina United States 27511
    29 University of North Carolina Dermatology and Skin Cancer Cen Chapel Hill North Carolina United States 27516
    30 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
    31 Bexley Dermatology Research Bexley Ohio United States 43209
    32 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    33 Wright State Physicians Dermatology Fairborn Ohio United States 46435
    34 Oregon Dermatology and Research Center Portland Oregon United States 97210
    35 Oregon Health and Science University Portland Oregon United States 97239
    36 Clinical Partners LLC Johnston Rhode Island United States 02919
    37 Modern Research Associates PLLC Dallas Texas United States 75231
    38 Austin Institute for Clinical Research, Inc. Pflugerville Texas United States 78660
    39 Texas Dermatology and Laser Specialists San Antonio Texas United States 78218
    40 Jordan Valley Dermatology Center West Jordan Utah United States 84088
    41 Virginia Clinical Research Norfolk Virginia United States 23502
    42 Dermatology Associates Seattle Washington United States 98101
    43 CEDIC-Centro de Investigaciones Clinicas Caba Buenos Aires Argentina C1425DES
    44 Centro de Investigaciones Metabólicas (CINME) Buenos Aires Argentina C1027AAP
    45 Buenos Aires Skin Ciudad Autonoma Buenos Aires Argentina C1055AA0
    46 Instituto de Neumonología y Dermatología Ciudad Autonoma Buenos Aires Argentina C1425BEA
    47 Psoriahue Medicina Interdisciplinaria Ciudad Autonoma Buenos Aires Argentina C1425DKG
    48 Clinica Adventista de Belgrano Ciudad Autonoma Buenos Aires Argentina C1430EGF
    49 Halitus Instituto Médico Ciudad Autonoma de Buenos Aire Argentina C1122AAF
    50 Parra Dermatología Mendoza Argentina 5500
    51 Woden Dermatology Phillip Australian Capital Territory Australia 2606
    52 Veracity Clinical Research Pty Ltd Woolloongabba Queensland Australia 4102
    53 Clinical Trials SA Pty Ltd Adelaide South Australia Australia 5073
    54 Skin and Cancer Foundation Inc. Carlton Victoria Australia 3053
    55 Fremantle Dermatology Perth Western Australia Australia 6160
    56 Stratica Medical Edmonton Alberta Canada T5K 1X3
    57 Dr. Chih-ho Hong Medical Inc. Surrey British Columbia Canada V3R 6A7
    58 Eastern Canada Cutaneous Research Assoicates Ltd Halifax Nova Scotia Canada B3H1Z2
    59 The Guenther Dermatology Research Centre London Ontario Canada N6A 3H7
    60 Lynderm Research Inc Markham Ontario Canada L3P1X2
    61 SKiN Centre for Dermatology Peterborough Ontario Canada K9J 5K2
    62 K. Papp Clinical Research Inc Waterloo Ontario Canada N2J 1C4
    63 Innovaderm Research Inc Montreal Quebec Canada H2X 2V1
    64 Clintrial, s.r.o. Praha 10 Hl. M. Praha Czechia 100 00
    65 Fakultni nemocnice Kralovske Vinohrady Praha 10 Hl. M. Praha Czechia 100 34
    66 Fakultni Nemocnice U svate Anny Brno Jihomoravský Kraj Czechia 656 91
    67 Kozni ambulance Kutna Hora, s.r.o. Kutna Hora Středočeský Kraj Czechia 28430
    68 Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Usti nad Labem Ustecký Kraj Czechia 40113
    69 Kozni oddeleni Novy Jicin Czechia 741 01
    70 CHU Dupuytren 2 Limoges Cedex France 87042
    71 CHU de Bordeaux Hopital Saint Andre Bordeaux Cedex France 33075
    72 CH du Mans - Pavillon Claude Monet Le Mans Cedex 1 France 72037
    73 Cabinet Médical Martigues France 13500
    74 Hopital Saint Eloi Montpellier France 34295
    75 CHU de Nice Hopital de L'Archet Nice cedex 3 France 06202
    76 Chu de Rouen Hopital Charles Nicolle Rouen cedex France 76036
    77 Hopital Larrey Toulouse cedex 9 France 31059
    78 Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg Germany 69120
    79 Hautarztpraxis Dr. Leitz und Kollegen Stuttgart Baden-Württemberg Germany 70178
    80 Universitätsklinikum Tübingen Tübingen Baden-Württemberg Germany 72076
    81 Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH Darmstadt Hessen Germany 64283
    82 Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Frankfurt am Main Hessen Germany 60590
    83 Dermatologisches Zentrum Osnabrück Nord Bramsche Niedersachsen Germany 49565
    84 Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude Buxtehude Niedersachsen Germany 21614
    85 Fachklinik Bad Bentheim Bad Bentheim Nordrhein-Westfalen Germany 48455
    86 Universitätsklinikum Schleswig-Holstein Kiel Schleswig-Holstein Germany 24105
    87 Universitätsklinikum Schleswig-Holstein Lübeck Schleswig-Holstein Germany 23538
    88 Klin. Forschung Berlin-Mitte GmbH Berlin Germany 10117
    89 Rothhaar Studien GmbH Berlin Germany 10783
    90 TFS Trial Form Support GmbH Hamburg Germany 20537
    91 Bacs-Kiskun Megyei Korhaz Kecskemet Bacs-Kiskun Hungary 6000
    92 Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika Debrecen Hajdu-Bihar Hungary 4032
    93 Trial Pharma Kft. Puspokladany Hajdu-Bihar Hungary 4150
    94 Allergo-Derm Bakos Kft Szolnok Jasz-Nagykun-Szolnok Hungary 5000
    95 UNO Medical Trials Kft. Budapest Hungary 1135
    96 Ambrozia Kft. Budapest Hungary 1238
    97 Oroshaza Varosi Onkormanyzat Korhaza Oroshaza Hungary 5900
    98 MedMare Bt Veszprem Hungary 8200
    99 Haemek Medical Center- Dermatology Afula Israel 1834111
    100 Soroka Medical Center Beer Sheva Israel 8410101
    101 Rambam Medical Center Haifa Israel 3525408
    102 Rabin Medical Center Petach Tikva Israel 4941492
    103 Sheba Medical Center Ramat Gan Israel 5265601
    104 Tel Aviv Sourasky Medical Center Tel Aviv Israel 6423906
    105 Istituto Clinico Humanitas Rozzano Milano Italy 20089
    106 Policlinico Univ. Agostino Gemelli Roma Rome Italy 00168
    107 Presidio Ospedaliero Firenze Centro Piero Palagi Firenze Italy 50125
    108 Policlinico di Tor Vergata Roma Italy 00133
    109 Nagoya City University Hospital Nagoya Aichi Japan 467-8602
    110 Juntendo Urayasu Hospital Urayasu Chiba Japan 279-0021
    111 Kurume University Hospital Kurume Fukuoka Japan 830 0011
    112 Gunma University Hosptial Maebashi Gunma Japan 371-8511
    113 Asahikawa Medical College Hospital Asahikawa Hokkaido Japan 078-8510
    114 Tokyo Medical University Ibaraki Medical Center Inashiki-gun Ibaraki Japan 300-0395
    115 Tokai University Hospital Isehara Kanagawa Japan 259-1193
    116 Kyoto Prefectural University of Medicine Kyoto-shi Kyoto Japan 602-8566
    117 Mie University Hospital Tsu Mie Japan 514-8507
    118 Tohoku University Hospital Sendai Miyagi Japan 980-8574
    119 Shinshu University Hospital Matsumoto Nagano Japan 390-8621
    120 Ryukyu University Hospital Nakagami-gun Okinawa Japan 903-0215
    121 Kansai Medical University Hospital Hirakata Osaka Japan 573-1191
    122 Shiga University of Medical Science Hosptial Ohtsu-shi Shiga Japan 520-2192
    123 The University of Tokyo Hospital Bunkyo-ku Tokyo Japan 113-8655
    124 St. Lukes International Hospital Chuo-Ku Tokyo Japan 104 8560
    125 Teikyo University Hospital Itabashi-ku Tokyo Japan 173 8606
    126 Nihon University Itabashi Hospital Itabashi-ku Tokyo Japan 173-8610
    127 Showa University Hospital Shinagawa-ku Tokyo Japan 142-8666
    128 Tokyo Medical University Hospital Shinjuku-ku Tokyo Japan 160-0023
    129 Yamaguchi University Hospital Ube Yamaguchi Japan 755-8505
    130 Yamanashi Prefectural Central Hospital Kofu Yamanashi Japan 400-8506
    131 Gifu University Hospital Gifu Japan 501-1194
    132 Nagasaki University Hospital Nagaski Japan 852-8501
    133 Osaka City University Hospital Osaka Japan 545-8586
    134 Nippon Life Hospital Osaka Japan 550-0006
    135 Tokushima University Hospital Tokushima Japan 770-8503
    136 Wakayama MedicaL University Hospital Wakayama Japan 641-8510
    137 Ilsan Paik Hospital IlsanSeo-gu Goyang-si Korea, Republic of 10380
    138 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620
    139 Pusan National University Hospital Busan Korea Korea, Republic of 49241
    140 Gachon University Gil Medical Center Incheon Korea Korea, Republic of 21565
    141 Samsung Medical Center Seoul Korea Korea, Republic of 06351
    142 Korea University Guro Hospital Seoul Korea Korea, Republic of 08308
    143 Konkuk University Medical Center Seoul Korea, Republic of 05030
    144 Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    145 Chungang University Hospital Seoul Korea, Republic of 06973
    146 Severance Hospital Yonsei University Health System Seoul Korea, Republic of 120-792
    147 DermMEDICA Sp. z o.o. Wroclaw Dolnoslaskie Poland 51-318
    148 DermoDent, Centrum Medyczne Czajkowscy Osielsko Kujawsko-pomorskie Poland 86-031
    149 Dermed Centrum Medyczne Sp. z o.o. Lodz Lodzkie Poland 90-265
    150 Lubelskie Centrum Diagnostyczne Swidnik Lubelskie Poland 21-040
    151 Barbara Rewerska DIAMOND CLINIC Krakow Malopolskie Poland 31-559
    152 Centralny Szpital Kliniczny MSW Klinika Dermatologii Warszawa Mazowieckie Poland 02-507
    153 Centrum Medyczne Evimed Warszawa Mazowieckie Poland 02-625
    154 NZOZ ZDROWIE Osteo-Medic Bialystok Podlaskie Poland 15-351
    155 NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm Bialystok Podlaskie Poland 15-375
    156 Centrum Badan Klinicznych, PI House Gdansk Pomorskie Poland 80-546
    157 Centrum Medyczne Angelius Provita Katowice Slaskie Poland 40-611
    158 LASER CLINIC Specjalistyczne Gabinety Lekarskie Szczecin Zachodniopomorskie Poland 70-332
    159 Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Lodz Poland 90-242
    160 AI Centrum Medyczne Poznan Poland 61-113
    161 Santa Cruz Behavioral PSC Bayamón Puerto Rico 00961-6911
    162 Office of Dr. Samuel Sanchez PSC Caguas Puerto Rico 00727
    163 Office of Dr. Alma M. Cruz Carolina Puerto Rico 00985
    164 Ponce School of Medicine CAIMED Center Ponce Puerto Rico 00716
    165 GCM Medical Group PSC San Juan Puerto Rico 00917
    166 Hospital Marina Baixa Villajoyosa Alicante Spain 03570
    167 Hospital Germans Trias i Pujol Barcelona Badalona Spain 08916
    168 Hospital de Manises Manises Valencia Spain 46940
    169 Hospital De Basurto Bilbao Vizcaya Spain 48013
    170 Hospital del Mar Barcelona Spain 08003
    171 Hospital Reina Sofia Cordoba Spain 14004
    172 Hospital Infanta Leonor Madrid Spain 28031
    173 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    174 Hospital Universitario La Paz Madrid Spain 28046
    175 Centro de Especialidades Mollabao Pontevedra Spain 36001
    176 Hospital Universitario Virgen Macarena Sevilla Spain 41009
    177 Hospital Universitario La Fe de Valencia Valencia Spain 46026
    178 Salford Royal NHS Foundation Trust Salford Greater Manchester United Kingdom M6 8HD

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: all 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

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03535194
    Other Study ID Numbers:
    • 16504
    • I6T-MC-AMAJ
    • 2017-003286-10
    First Posted:
    May 24, 2018
    Last Update Posted:
    Mar 30, 2021
    Last Verified:
    Aug 1, 2020
    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
    Keywords provided by Eli Lilly and Company
    Interleukin-23 (IL-23)
    Additional relevant MeSH terms:
    Psoriasis
    Mirikizumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 250mg Q4W/250mg Q8W Mirikizumab 250mg Q4W/125mg Q8W Mirikizumab Placebo/250mg Mirikizumab 300mg Secukinumab Japan GPP/EP
    Arm/Group Description Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W). Participants received matching placebo to blind Secukinumab. Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab. Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period. Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
    Period Title: Induction Period
    STARTED 454 451 112 448 19
    Received at Least One Dose of Study Drug 454 450 112 448 19
    COMPLETED 443 434 104 437 19
    NOT COMPLETED 11 17 8 11 0
    Period Title: Induction Period
    STARTED 443 434 104 437 19
    COMPLETED 421 418 96 400 13
    NOT COMPLETED 22 16 8 37 6
    Period Title: Induction Period
    STARTED 38 35 18 47 8
    COMPLETED 27 21 7 23 8
    NOT COMPLETED 11 14 11 24 0

    Baseline Characteristics

    Arm/Group Title Mirikizumab 250mg Q4W/250mg Q8W 250mg Mirikizumab /125mg Q8W Placebo/250mg Mirikizumab 300mg Secukinumab Japan GPP/EP Total
    Arm/Group Description Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received placebo at weeks 1, 2, 3 to match Secukinumab. Participants received matching placebo to blind Secukinumab. Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab. Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period. Participants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection. Total of all reporting groups
    Overall Participants 454 451 112 448 19 1484
    Age, Customized (Count of Participants)
    <65
    417
    91.9%
    398
    88.2%
    103
    92%
    399
    89.1%
    14
    73.7%
    1331
    89.7%
    >=65
    37
    8.1%
    53
    11.8%
    9
    8%
    49
    10.9%
    5
    26.3%
    153
    10.3%
    Sex: Female, Male (Count of Participants)
    Female
    158
    34.8%
    140
    31%
    30
    26.8%
    137
    30.6%
    1
    5.3%
    466
    31.4%
    Male
    296
    65.2%
    311
    69%
    82
    73.2%
    311
    69.4%
    18
    94.7%
    1018
    68.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    9
    2%
    15
    3.3%
    4
    3.6%
    10
    2.2%
    0
    0%
    38
    2.6%
    Not Hispanic or Latino
    79
    17.4%
    71
    15.7%
    12
    10.7%
    72
    16.1%
    0
    0%
    234
    15.8%
    Unknown or Not Reported
    366
    80.6%
    365
    80.9%
    96
    85.7%
    366
    81.7%
    19
    100%
    1212
    81.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    2
    0.4%
    2
    0.4%
    1
    0.9%
    2
    0.4%
    0
    0%
    7
    0.5%
    Asian
    81
    17.8%
    66
    14.6%
    12
    10.7%
    70
    15.6%
    19
    100%
    248
    16.7%
    Native Hawaiian or Other Pacific Islander
    1
    0.2%
    1
    0.2%
    0
    0%
    1
    0.2%
    0
    0%
    3
    0.2%
    Black or African American
    7
    1.5%
    7
    1.6%
    2
    1.8%
    8
    1.8%
    0
    0%
    24
    1.6%
    White
    361
    79.5%
    372
    82.5%
    97
    86.6%
    365
    81.5%
    0
    0%
    1195
    80.5%
    More than one race
    2
    0.4%
    2
    0.4%
    0
    0%
    2
    0.4%
    0
    0%
    6
    0.4%
    Unknown or Not Reported
    0
    0%
    1
    0.2%
    0
    0%
    0
    0%
    0
    0%
    1
    0.1%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline
    Description The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 112 448 905
    Number (95% Confidence Interval) [percentage of participants]
    6.3
    1.4%
    76.3
    16.9%
    79.7
    71.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 73.5
    Confidence Interval (2-Sided) 95%
    68.2 to 78.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
    Description PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 112 448 905
    Number (95% Confidence Interval) [percentage of participants]
    6.3
    1.4%
    72.8
    16.1%
    74.4
    66.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 68.0
    Confidence Interval (2-Sided) 95%
    62.7 to 73.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Percentage of Participants Achieving a 75% Improvement in PASI 75
    Description PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 112 448 905
    Number (95% Confidence Interval) [percentage of participants]
    8.0
    1.8%
    89.5
    19.8%
    89.5
    79.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 81.6
    Confidence Interval (2-Sided) 95%
    76.1 to 87.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
    Description The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 112 448 905
    Number (95% Confidence Interval) [percentage of participants]
    1.8
    0.4%
    54.5
    12.1%
    53.1
    47.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 51.7
    Confidence Interval (2-Sided) 95%
    47.6 to 55.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline
    Description PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with PSS symptom score of ≥1 at baseline.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 108 414 849
    Number (95% Confidence Interval) [percentage of participants]
    1.9
    0.4%
    28.7
    6.4%
    25.0
    22.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 23.2
    Confidence Interval (2-Sided) 95%
    19.3 to 27.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5
    Description The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline DLQI Total Score ≥5.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 101 396 821
    Number (95% Confidence Interval) [percentage of participants]
    5.9
    1.3%
    60.4
    13.4%
    59.6
    53.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 53.5
    Confidence Interval (2-Sided) 95%
    47.7 to 59.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
    Description The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had palmoplantar involvement at baseline.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 18 84 191
    Least Squares Mean (Standard Error) [Score on a scale]
    -1.33
    (1.030)
    -5.79
    (0.541)
    -6.28
    (0.383)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -4.94
    Confidence Interval (2-Sided) 95%
    -7.01 to -2.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.050
    Estimation Comments
    8. Secondary Outcome
    Title Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
    Description The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had scalp Involvement at baseline.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 90 387 789
    Least Squares Mean (Standard Error) [Score on a scale]
    -3.62
    (0.676)
    -18.22
    (0.365)
    -18.78
    (0.286)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -15.15
    Confidence Interval (2-Sided) 95%
    -16.51 to -13.80
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.692
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
    Description The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had Nail Psoriasis involvement at baseline.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 54 235 492
    Least Squares Mean (Standard Error) [Score on a scale]
    0.20
    (1.494)
    -11.24
    (0.774)
    -9.38
    (0.580)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -9.59
    Confidence Interval (2-Sided) 95%
    -12.63 to -6.55
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.550
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
    Description SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 112 448 905
    Least Squares Mean (Standard Error) [Score on a scale]
    0.57
    (0.633)
    4.38
    (0.358)
    4.03
    (0.291)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 3.46
    Confidence Interval (2-Sided) 95%
    2.20 to 4.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.642
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline on the SF-36 Mental Component Summary (MCS)
    Description SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 112 448 905
    Least Squares Mean (Standard Error) [Score on a scale]
    0.50
    (0.701)
    4.21
    (0.398)
    4.45
    (0.321)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value 3.96
    Confidence Interval (2-Sided) 95%
    2.56 to 5.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.711
    Estimation Comments
    12. Secondary Outcome
    Title Percentage of Participants Achieving Patient's Global Assessment (PatGA) of Disease Severity of (0,1) With at Least a 2-point Improvement From Baseline in Patients With a Baseline PatGA ≥2
    Description The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with non missing baseline PatGA >=2 data.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 110 433 883
    Number (95% Confidence Interval) [percentage of participants]
    7.3
    1.6%
    71.8
    15.9%
    72.3
    64.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 65.0
    Confidence Interval (2-Sided) 95%
    59.3 to 70.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores
    Description The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline employment status of yes.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 84 320 617
    Absenteeism
    -0.48
    (1.753)
    -2.48
    (0.995)
    -2.20
    (0.844)
    Presenteeism
    -3.36
    (2.104)
    -18.95
    (1.204)
    -18.95
    (1.020)
    Overall work impairment
    -2.77
    (2.448)
    -18.49
    (1.401)
    -19.21
    (1.187)
    Impairment in Activities Performed Outside of Work
    -5.86
    (1.847)
    -25.71
    (1.061)
    -24.17
    (0.885)
    14. Secondary Outcome
    Title Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11.
    Description QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All participants who had a baseline QIDS-SR16 total score >=11.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 5 44 93
    Least Squares Mean (Standard Error) [score on a scale]
    -4.79
    (2.266)
    -5.10
    (0.935)
    -5.28
    (0.733)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.826
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LSMean Difference
    Estimated Value -0.50
    Confidence Interval (2-Sided) 95%
    -4.96 to 3.96
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.255
    Estimation Comments
    15. Secondary Outcome
    Title Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab
    Description Minimum observed serum Ctrough,ss of mirikizumab
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable PK samples.
    Arm/Group Title Mirikizumab 250mg Q4W
    Arm/Group Description Participants received 250mg Mirikizumab once every four weeks by subcutaneous injection.
    Measure Participants 809
    Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter (ug/mL)]
    2.40
    (112)
    16. Secondary Outcome
    Title Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority)
    Description The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 112 448 905
    Number (95% Confidence Interval) [percentage of participants]
    6.3
    1.4%
    76.3
    16.9%
    79.7
    71.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 300mg Secukinumab, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Non-Inferiority
    Comments 10% non-inferiority margin was used.
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 3.3
    Confidence Interval (2-Sided) 95%
    -1.4 to 7.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority)
    Description PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Placebo 300mg Secukinumab 250mg Q4W Mirikizumab
    Arm/Group Description Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.
    Measure Participants 112 448 905
    Number (95% Confidence Interval) [percentage of participants]
    6.3
    1.4%
    72.8
    16.1%
    74.4
    66.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 300mg Secukinumab, 250mg Q4W Mirikizumab
    Comments
    Type of Statistical Test Non-Inferiority
    Comments 10% non-inferiority margin was used.
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 1.6
    Confidence Interval (2-Sided) 95%
    -3.4 to 6.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Up to 64 weeks
    Adverse Event Reporting Description
    Arm/Group Title Placebo / Induction Period 300mg Secukinumab / Induction Period 250mg Mirikizumab Q4W / Induction Period 250mg Mirikizumab Q4W - Japan GPP/EP / Induction Period 300mg Secukinumab/Maintenance Period 125mg Mirikizumab Q8W / Maintenance Period 250mg Mirikizumab Q8W / Maintenance Period 250mg Mirikizumab / Maintenance Period 250mg Mirikizumab Q8W - Japan GPP/EP / Maintenance Period Placebo / Follow-up Period 300mg Secukinumab / Follow-up Period 250mg Mirikizumab Q4W / Follow-up Period 250mg Mirikizumab Q4W - Japan GPP/EP / Follow-up Period 250mg Mirikizumab Q4W/125mg Mirikizumab Q8W / Follow-up Period 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W / Follow-up Period Placebo/250mg Mirikizumab / Follow-up Period 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W - Japan GPP/EP / Follow-up Period 300mg Secukinumab /300mg Secukinumab / Follow-up Period
    Arm/Group Description Participants received matching placebo by subcutaneous injection in induction period. Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period. Participants received 250 Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period. Participants received 250mg Mirikizumab Q4Wby subcutaneous injection in induction period. Participants received 300mg Secukinumab Q4W by subcutaneous injection from week 16 to 52 in maintenance period. Participants received 125mg Mirikizumab once every eight weeks (Q8W) by subcutaneous injection in maintenance period. Participants received 250mg Mirikizumab once every eight weeks (Q8W) by subcutaneous injection in maintenance period. Participants received 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 by subcutaneous injection in maintenance period. Participants received 250mg Q8W by subcutaneous injection in maintenance period Participants did not receive any intervention in post- treatment follow-up period. Participants did not receive any intervention in post- treatment follow-up period Participants did not receive any intervention in post- treatment follow-up period Participants did not receive any intervention in post- treatment follow-up period Participants did not receive any intervention in post- treatment follow-up period Participants did not receive any intervention in post- treatment follow-up period Participants did not receive any intervention in post- treatment follow-up period Participants did not receive any intervention in post- treatment follow-up period Participants did not receive any intervention in post- treatment follow-up period
    All Cause Mortality
    Placebo / Induction Period 300mg Secukinumab / Induction Period 250mg Mirikizumab Q4W / Induction Period 250mg Mirikizumab Q4W - Japan GPP/EP / Induction Period 300mg Secukinumab/Maintenance Period 125mg Mirikizumab Q8W / Maintenance Period 250mg Mirikizumab Q8W / Maintenance Period 250mg Mirikizumab / Maintenance Period 250mg Mirikizumab Q8W - Japan GPP/EP / Maintenance Period Placebo / Follow-up Period 300mg Secukinumab / Follow-up Period 250mg Mirikizumab Q4W / Follow-up Period 250mg Mirikizumab Q4W - Japan GPP/EP / Follow-up Period 250mg Mirikizumab Q4W/125mg Mirikizumab Q8W / Follow-up Period 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W / Follow-up Period Placebo/250mg Mirikizumab / Follow-up Period 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W - Japan GPP/EP / Follow-up Period 300mg Secukinumab /300mg Secukinumab / Follow-up Period
    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 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 0/112 (0%) 0/448 (0%) 1/904 (0.1%) 0/19 (0%) 0/437 (0%) 0/434 (0%) 0/443 (0%) 0/104 (0%) 0/18 (0%) 0/4 (0%) 0/4 (0%) 0/9 (0%) 0/1 (0%) 0/29 (0%) 0/35 (0%) 0/14 (0%) 0/6 (0%) 0/43 (0%)
    Serious Adverse Events
    Placebo / Induction Period 300mg Secukinumab / Induction Period 250mg Mirikizumab Q4W / Induction Period 250mg Mirikizumab Q4W - Japan GPP/EP / Induction Period 300mg Secukinumab/Maintenance Period 125mg Mirikizumab Q8W / Maintenance Period 250mg Mirikizumab Q8W / Maintenance Period 250mg Mirikizumab / Maintenance Period 250mg Mirikizumab Q8W - Japan GPP/EP / Maintenance Period Placebo / Follow-up Period 300mg Secukinumab / Follow-up Period 250mg Mirikizumab Q4W / Follow-up Period 250mg Mirikizumab Q4W - Japan GPP/EP / Follow-up Period 250mg Mirikizumab Q4W/125mg Mirikizumab Q8W / Follow-up Period 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W / Follow-up Period Placebo/250mg Mirikizumab / Follow-up Period 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W - Japan GPP/EP / Follow-up Period 300mg Secukinumab /300mg Secukinumab / Follow-up Period
    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 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 0/112 (0%) 11/448 (2.5%) 15/904 (1.7%) 2/19 (10.5%) 15/437 (3.4%) 13/434 (3%) 10/443 (2.3%) 0/104 (0%) 3/18 (16.7%) 0/4 (0%) 0/4 (0%) 0/9 (0%) 0/1 (0%) 3/29 (10.3%) 0/35 (0%) 0/14 (0%) 0/6 (0%) 0/43 (0%)
    Cardiac disorders
    Acute myocardial infarction 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Angina pectoris 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 1/19 (5.3%) 1 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Atrial fibrillation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Atrial flutter 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Congestive cardiomyopathy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Coronary artery disease 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Myocardial infarction 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ear and labyrinth disorders
    Hypoacusis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eye disorders
    Cataract 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastrointestinal disorders
    Crohn's disease 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Diarrhoea 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Enlarged uvula 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Incarcerated inguinal hernia 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Inguinal hernia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Irritable bowel syndrome 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 1/19 (5.3%) 2 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pancreatitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pancreatitis acute 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 2 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Umbilical hernia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    General disorders
    Chest pain 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hepatobiliary disorders
    Cholecystitis acute 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Immune system disorders
    Anaphylactic shock 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Infections and infestations
    Anal abscess 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Appendicitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cellulitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Diverticulitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Erysipelas 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Meningitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pneumonia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pyelonephritis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sinusitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Wound infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injury, poisoning and procedural complications
    Concussion 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Fibula fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Incisional hernia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Meniscus injury 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pulmonary contusion 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Radius fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Road traffic accident 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin laceration 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Spinal compression fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tibia fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Investigations
    Liver function test abnormal 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Musculoskeletal and connective tissue disorders
    Enthesopathy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Intervertebral disc protrusion 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Osteoarthritis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Symphysiolysis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gallbladder cancer 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Haemangioma of skin 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lung adenocarcinoma 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lung adenocarcinoma stage i 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Malignant melanoma 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Non-small cell lung cancer stage iv 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Prostate cancer 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nervous system disorders
    Cerebral infarction 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ischaemic stroke 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Monoplegia 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nerve compression 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sacral radiculopathy 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Psychiatric disorders
    Bipolar disorder 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Depression 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Renal and urinary disorders
    Nephrolithiasis 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin and subcutaneous tissue disorders
    Psoriasis 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pustular psoriasis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Surgical and medical procedures
    Gender reassignment therapy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hernia repair 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Mammoplasty 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tenotomy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vascular disorders
    Hypertension 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo / Induction Period 300mg Secukinumab / Induction Period 250mg Mirikizumab Q4W / Induction Period 250mg Mirikizumab Q4W - Japan GPP/EP / Induction Period 300mg Secukinumab/Maintenance Period 125mg Mirikizumab Q8W / Maintenance Period 250mg Mirikizumab Q8W / Maintenance Period 250mg Mirikizumab / Maintenance Period 250mg Mirikizumab Q8W - Japan GPP/EP / Maintenance Period Placebo / Follow-up Period 300mg Secukinumab / Follow-up Period 250mg Mirikizumab Q4W / Follow-up Period 250mg Mirikizumab Q4W - Japan GPP/EP / Follow-up Period 250mg Mirikizumab Q4W/125mg Mirikizumab Q8W / Follow-up Period 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W / Follow-up Period Placebo/250mg Mirikizumab / Follow-up Period 250mg Mirikizumab Q4W/250mg Mirikizumab Q8W - Japan GPP/EP / Follow-up Period 300mg Secukinumab /300mg Secukinumab / Follow-up Period
    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 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 68/112 (60.7%) 257/448 (57.4%) 520/904 (57.5%) 14/19 (73.7%) 292/437 (66.8%) 271/434 (62.4%) 282/443 (63.7%) 0/104 (0%) 14/18 (77.8%) 0/4 (0%) 0/4 (0%) 1/9 (11.1%) 1/1 (100%) 3/29 (10.3%) 6/35 (17.1%) 4/14 (28.6%) 2/6 (33.3%) 7/43 (16.3%)
    Blood and lymphatic system disorders
    Anaemia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eosinophilia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Iron deficiency anaemia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Leukocytosis 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Leukopenia 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lymphadenitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lymphadenopathy 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lymphopenia 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Neutropenia 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Neutrophilia 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Thrombocytopenia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cardiac disorders
    Angina pectoris 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Atrial fibrillation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Coronary artery disease 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Palpitations 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sinus tachycardia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tachycardia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ventricular extrasystoles 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Congenital, familial and genetic disorders
    Distichiasis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ear and labyrinth disorders
    Auditory disorder 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cerumen impaction 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ear discomfort 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ear disorder 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ear pain 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ear swelling 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypoacusis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 3 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tinnitus 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vertigo 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 1/19 (5.3%) 1 1/437 (0.2%) 1 0/434 (0%) 0 2/443 (0.5%) 4 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vertigo positional 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Endocrine disorders
    Adrenal insufficiency 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Goitre 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypothyroidism 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eye disorders
    Blepharitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cataract 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Chalazion 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Conjunctival haemorrhage 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Conjunctivitis allergic 0/112 (0%) 0 3/448 (0.7%) 3 2/904 (0.2%) 2 0/19 (0%) 0 3/437 (0.7%) 3 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Corneal disorder 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dry eye 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Erythema of eyelid 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eye haemorrhage 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eye irritation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eye pain 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eye pruritus 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 1/19 (5.3%) 1 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eyelid oedema 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypermetropia 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Meibomianitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Posterior capsule opacification 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vision blurred 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort 0/112 (0%) 0 3/448 (0.7%) 3 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 4/443 (0.9%) 5 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Abdominal distension 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Abdominal pain 2/112 (1.8%) 2 2/448 (0.4%) 2 5/904 (0.6%) 5 0/19 (0%) 0 2/437 (0.5%) 9 4/434 (0.9%) 4 5/443 (1.1%) 6 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Abdominal pain lower 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Abdominal pain upper 1/112 (0.9%) 1 2/448 (0.4%) 2 2/904 (0.2%) 2 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Abdominal tenderness 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Acquired oesophageal web 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Anal fissure 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Aphthous ulcer 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 3/437 (0.7%) 3 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Chilaiditi's syndrome 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Chronic gastritis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Constipation 0/112 (0%) 0 2/448 (0.4%) 2 4/904 (0.4%) 4 2/19 (10.5%) 2 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Crohn's disease 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dental caries 0/112 (0%) 0 0/448 (0%) 0 3/904 (0.3%) 3 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Diarrhoea 2/112 (1.8%) 2 17/448 (3.8%) 37 17/904 (1.9%) 19 1/19 (5.3%) 1 5/437 (1.1%) 27 6/434 (1.4%) 6 9/443 (2%) 10 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Diverticulum intestinal 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/43 (0%) 0
    Dry mouth 0/112 (0%) 0 0/448 (0%) 0 3/904 (0.3%) 3 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Duodenitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dyspepsia 0/112 (0%) 0 3/448 (0.7%) 4 6/904 (0.7%) 8 0/19 (0%) 0 0/437 (0%) 0 4/434 (0.9%) 4 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dysphagia 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Enlarged uvula 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Enteritis 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Faeces soft 0/112 (0%) 0 1/448 (0.2%) 2 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Flatulence 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Food poisoning 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Frequent bowel movements 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastric disorder 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastric polyps 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastritis 1/112 (0.9%) 1 2/448 (0.4%) 7 3/904 (0.3%) 3 0/19 (0%) 0 2/437 (0.5%) 10 3/434 (0.7%) 3 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastrolithiasis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastrooesophageal reflux disease 0/112 (0%) 0 2/448 (0.4%) 2 2/904 (0.2%) 2 0/19 (0%) 0 1/437 (0.2%) 1 2/434 (0.5%) 2 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastrooesophageal sphincter insufficiency 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gingival bleeding 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gingival pain 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Glossitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Haematochezia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Haemorrhoidal haemorrhage 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Haemorrhoids 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hiatus hernia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Inflammatory bowel disease 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Inguinal hernia 1/112 (0.9%) 1 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Intestinal polyp 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Irritable bowel syndrome 1/112 (0.9%) 1 0/448 (0%) 0 0/904 (0%) 0 1/19 (5.3%) 2 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 1/1 (100%) 1 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Large intestine polyp 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Loose tooth 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lumbar hernia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nausea 1/112 (0.9%) 1 1/448 (0.2%) 1 10/904 (1.1%) 10 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 3/443 (0.7%) 3 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Odynophagia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Oral pain 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Paraesthesia oral 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Peptic ulcer 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Saliva altered 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Stomatitis 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tongue discolouration 1/112 (0.9%) 1 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Toothache 1/112 (0.9%) 4 4/448 (0.9%) 4 8/904 (0.9%) 10 0/19 (0%) 0 5/437 (1.1%) 6 2/434 (0.5%) 4 7/443 (1.6%) 8 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Traumatic occlusion 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Umbilical hernia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vomiting 1/112 (0.9%) 1 3/448 (0.7%) 3 4/904 (0.4%) 4 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    General disorders
    Asthenia 1/112 (0.9%) 1 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 1/437 (0.2%) 1 4/434 (0.9%) 4 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Chest discomfort 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Chest pain 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cyst 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dehiscence 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Discomfort 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Fatigue 1/112 (0.9%) 1 6/448 (1.3%) 6 15/904 (1.7%) 16 0/19 (0%) 0 4/437 (0.9%) 5 6/434 (1.4%) 6 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    General physical health deterioration 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Granuloma 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Inflammation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Influenza like illness 0/112 (0%) 0 1/448 (0.2%) 1 5/904 (0.6%) 5 0/19 (0%) 0 4/437 (0.9%) 5 5/434 (1.2%) 6 6/443 (1.4%) 6 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site bruising 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site discomfort 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site erythema 0/112 (0%) 0 2/448 (0.4%) 4 13/904 (1.4%) 27 0/19 (0%) 0 0/437 (0%) 0 4/434 (0.9%) 6 3/443 (0.7%) 7 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site haematoma 2/112 (1.8%) 2 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site haemorrhage 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site hypersensitivity 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site induration 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site inflammation 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site oedema 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 2 0/19 (0%) 0 0/437 (0%) 0 3/434 (0.7%) 4 1/443 (0.2%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site pain 4/112 (3.6%) 28 1/448 (0.2%) 6 21/904 (2.3%) 109 0/19 (0%) 0 3/437 (0.7%) 11 8/434 (1.8%) 38 4/443 (0.9%) 28 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site papule 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site paraesthesia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site pruritus 0/112 (0%) 0 0/448 (0%) 0 5/904 (0.6%) 8 0/19 (0%) 0 0/437 (0%) 0 4/434 (0.9%) 8 3/443 (0.7%) 6 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site reaction 1/112 (0.9%) 1 4/448 (0.9%) 7 26/904 (2.9%) 64 1/19 (5.3%) 2 3/437 (0.7%) 4 14/434 (3.2%) 24 14/443 (3.2%) 35 0/104 (0%) 0 2/18 (11.1%) 5 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injection site swelling 0/112 (0%) 0 2/448 (0.4%) 2 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Malaise 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Non-cardiac chest pain 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Oedema 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Oedema peripheral 1/112 (0.9%) 1 1/448 (0.2%) 1 3/904 (0.3%) 3 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pain 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 4/443 (0.9%) 4 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Peripheral swelling 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pyrexia 0/112 (0%) 0 1/448 (0.2%) 1 6/904 (0.7%) 6 0/19 (0%) 0 3/437 (0.7%) 4 4/434 (0.9%) 4 3/443 (0.7%) 4 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Swelling face 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tenderness 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Xerosis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hepatobiliary disorders
    Biliary dilatation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cholelithiasis 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Drug-induced liver injury 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hepatic fibrosis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hepatic function abnormal 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hepatic pain 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hepatic steatosis 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 2/437 (0.5%) 2 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pneumobilia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Immune system disorders
    Allergy to arthropod bite 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Food allergy 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypersensitivity 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Multiple allergies 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rubber sensitivity 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Seasonal allergy 0/112 (0%) 0 1/448 (0.2%) 1 2/904 (0.2%) 2 0/19 (0%) 0 3/437 (0.7%) 4 3/434 (0.7%) 3 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Selective igg subclass deficiency 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Infections and infestations
    Abdominal hernia infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Abscess 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Abscess jaw 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Abscess limb 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Acarodermatitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Anal abscess 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Asymptomatic bacteriuria 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Bacterial vaginosis 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Body tinea 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 1/19 (5.3%) 1 2/437 (0.5%) 2 1/434 (0.2%) 1 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Bronchitis 1/112 (0.9%) 1 4/448 (0.9%) 4 14/904 (1.5%) 14 0/19 (0%) 0 8/437 (1.8%) 8 9/434 (2.1%) 10 9/443 (2%) 9 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Bronchitis viral 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Candida infection 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cellulitis 0/112 (0%) 0 0/448 (0%) 0 5/904 (0.6%) 5 0/19 (0%) 0 3/437 (0.7%) 3 2/434 (0.5%) 2 1/443 (0.2%) 1 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Chronic sinusitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Conjunctivitis 0/112 (0%) 0 3/448 (0.7%) 3 3/904 (0.3%) 3 0/19 (0%) 0 8/437 (1.8%) 9 4/434 (0.9%) 4 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cystitis 0/112 (0%) 0 0/448 (0%) 0 4/904 (0.4%) 4 0/19 (0%) 0 2/437 (0.5%) 2 3/434 (0.7%) 3 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Demodicidosis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dermatophytosis 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Diverticulitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ear infection 0/112 (0%) 0 1/448 (0.2%) 1 3/904 (0.3%) 3 0/19 (0%) 0 4/437 (0.9%) 4 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ear infection bacterial 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Empyema 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 1/19 (5.3%) 1 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Enteritis infectious 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Epididymitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Erysipelas 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Erythema infectiosum 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Erythrasma 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eye infection 1/112 (0.9%) 1 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Folliculitis 1/112 (0.9%) 1 2/448 (0.4%) 3 3/904 (0.3%) 3 0/19 (0%) 0 6/437 (1.4%) 6 4/434 (0.9%) 4 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Fungal infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Fungal skin infection 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Furuncle 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 5/437 (1.1%) 6 1/434 (0.2%) 1 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastroenteritis 2/112 (1.8%) 2 3/448 (0.7%) 3 11/904 (1.2%) 11 1/19 (5.3%) 1 10/437 (2.3%) 10 9/434 (2.1%) 9 7/443 (1.6%) 7 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastroenteritis viral 1/112 (0.9%) 1 2/448 (0.4%) 2 5/904 (0.6%) 5 0/19 (0%) 0 3/437 (0.7%) 3 4/434 (0.9%) 4 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gastrointestinal infection 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Genital candidiasis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Genital herpes simplex 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Genital infection female 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gingivitis 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Groin infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Helicobacter gastritis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 3/434 (0.7%) 3 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Helicobacter infection 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Herpes simplex 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 2/443 (0.5%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Herpes zoster 0/112 (0%) 0 1/448 (0.2%) 1 3/904 (0.3%) 3 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hordeolum 1/112 (0.9%) 1 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Impetigo 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 5/437 (1.1%) 5 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Infected dermal cyst 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Influenza 1/112 (0.9%) 1 7/448 (1.6%) 7 10/904 (1.1%) 10 0/19 (0%) 0 2/437 (0.5%) 3 5/434 (1.2%) 5 5/443 (1.1%) 5 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Kidney infection 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Labyrinthitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 3 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Laryngitis 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Localised infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lyme disease 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Mastitis 1/112 (0.9%) 1 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Mastoiditis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Molluscum contagiosum 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/43 (0%) 0
    Mycoplasma infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Myringitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nasopharyngitis 18/112 (16.1%) 22 55/448 (12.3%) 71 144/904 (15.9%) 168 4/19 (21.1%) 5 61/437 (14%) 81 60/434 (13.8%) 73 67/443 (15.1%) 82 0/104 (0%) 0 4/18 (22.2%) 4 0/4 (0%) 0 0/4 (0%) 0 1/9 (11.1%) 1 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 2/6 (33.3%) 2 2/43 (4.7%) 2
    Onychomycosis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Oral candidiasis 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 3/437 (0.7%) 3 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Oral fungal infection 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Oral herpes 0/112 (0%) 0 6/448 (1.3%) 6 5/904 (0.6%) 5 0/19 (0%) 0 4/437 (0.9%) 4 3/434 (0.7%) 5 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1 1/14 (7.1%) 1 0/6 (0%) 0 0/43 (0%) 0
    Otitis externa 0/112 (0%) 0 2/448 (0.4%) 2 1/904 (0.1%) 1 0/19 (0%) 0 7/437 (1.6%) 8 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/43 (0%) 0
    Otitis media 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 1/19 (5.3%) 1 2/437 (0.5%) 3 2/434 (0.5%) 2 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/43 (0%) 0
    Otitis media acute 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Parasitic gastroenteritis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Paronychia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Periodontitis 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pharyngitis 1/112 (0.9%) 1 9/448 (2%) 9 7/904 (0.8%) 7 0/19 (0%) 0 13/437 (3%) 16 6/434 (1.4%) 7 4/443 (0.9%) 6 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pharyngitis bacterial 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pharyngitis streptococcal 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pharyngotonsillitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pneumonia 0/112 (0%) 0 1/448 (0.2%) 1 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Postoperative wound infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pulpitis dental 0/112 (0%) 0 1/448 (0.2%) 1 2/904 (0.2%) 2 0/19 (0%) 0 4/437 (0.9%) 4 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pyoderma 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Respiratory tract infection 1/112 (0.9%) 1 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rhinitis 1/112 (0.9%) 1 6/448 (1.3%) 6 16/904 (1.8%) 16 0/19 (0%) 0 2/437 (0.5%) 2 5/434 (1.2%) 6 5/443 (1.1%) 5 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sinusitis 0/112 (0%) 0 4/448 (0.9%) 5 11/904 (1.2%) 11 0/19 (0%) 0 6/437 (1.4%) 6 7/434 (1.6%) 7 7/443 (1.6%) 7 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sinusitis bacterial 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin bacterial infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin candida 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin infection 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Staphylococcal abscess 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Staphylococcal infection 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Staphylococcal skin infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Subcutaneous abscess 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Syphilis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tinea cruris 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tinea infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tinea pedis 0/112 (0%) 0 5/448 (1.1%) 5 7/904 (0.8%) 7 1/19 (5.3%) 1 3/437 (0.7%) 3 2/434 (0.5%) 4 5/443 (1.1%) 5 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tinea versicolour 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 3/434 (0.7%) 3 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tonsillitis 1/112 (0.9%) 1 6/448 (1.3%) 6 6/904 (0.7%) 8 0/19 (0%) 0 8/437 (1.8%) 8 2/434 (0.5%) 2 3/443 (0.7%) 4 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tonsillitis bacterial 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tooth abscess 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 3/437 (0.7%) 3 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tooth infection 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Upper respiratory tract infection 4/112 (3.6%) 5 39/448 (8.7%) 46 53/904 (5.9%) 64 1/19 (5.3%) 2 35/437 (8%) 46 30/434 (6.9%) 40 29/443 (6.5%) 36 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Upper respiratory tract infection bacterial 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Urinary tract infection 0/112 (0%) 0 6/448 (1.3%) 6 1/904 (0.1%) 1 0/19 (0%) 0 5/437 (1.1%) 5 3/434 (0.7%) 3 5/443 (1.1%) 6 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vaginal infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Viral infection 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 3 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Viral pharyngitis 0/112 (0%) 0 3/448 (0.7%) 3 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Viral sinusitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Viral upper respiratory tract infection 0/112 (0%) 0 1/448 (0.2%) 1 9/904 (1%) 9 0/19 (0%) 0 1/437 (0.2%) 1 3/434 (0.7%) 3 5/443 (1.1%) 5 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vulvovaginal candidiasis 0/112 (0%) 0 1/448 (0.2%) 3 4/904 (0.4%) 4 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vulvovaginal mycotic infection 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 2 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Wound infection 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injury, poisoning and procedural complications
    Arthropod bite 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 2/443 (0.5%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Arthropod sting 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Chemical burn 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Concussion 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Contusion 1/112 (0.9%) 1 2/448 (0.4%) 2 3/904 (0.3%) 3 0/19 (0%) 0 5/437 (1.1%) 5 4/434 (0.9%) 4 2/443 (0.5%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Craniocerebral injury 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Epicondylitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 1/14 (7.1%) 1 0/6 (0%) 0 0/43 (0%) 0
    Eye contusion 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eye injury 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Face injury 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Fall 0/112 (0%) 0 0/448 (0%) 0 6/904 (0.7%) 6 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Foot fracture 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hand fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Head injury 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Heat stroke 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Humerus fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Injury corneal 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Joint dislocation 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Joint injury 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 2/434 (0.5%) 2 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ligament injury 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ligament sprain 0/112 (0%) 0 1/448 (0.2%) 1 6/904 (0.7%) 6 0/19 (0%) 0 1/437 (0.2%) 1 5/434 (1.2%) 7 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Limb crushing injury 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Limb fracture 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Limb injury 0/112 (0%) 0 1/448 (0.2%) 2 4/904 (0.4%) 4 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 3/443 (0.7%) 3 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lower limb fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Mallet finger 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Meniscus injury 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Multiple injuries 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Muscle injury 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Muscle rupture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Muscle strain 0/112 (0%) 0 0/448 (0%) 0 7/904 (0.8%) 8 0/19 (0%) 0 0/437 (0%) 0 4/434 (0.9%) 4 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Patella fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Post-traumatic neck syndrome 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Post-traumatic pain 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Procedural pain 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Radius fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rib fracture 0/112 (0%) 0 1/448 (0.2%) 1 2/904 (0.2%) 2 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Road traffic accident 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Scratch 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin abrasion 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin injury 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin laceration 2/112 (1.8%) 2 1/448 (0.2%) 1 2/904 (0.2%) 3 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin wound 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sternal injury 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tendon rupture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Thermal burn 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tooth fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Traumatic haematoma 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Traumatic ulcer 1/112 (0.9%) 1 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Upper limb fracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Wound 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 3 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Wrist fracture 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Investigations
    Alanine aminotransferase increased 0/112 (0%) 0 3/448 (0.7%) 4 1/904 (0.1%) 1 0/19 (0%) 0 3/437 (0.7%) 4 2/434 (0.5%) 2 4/443 (0.9%) 4 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Anti-actin antibody positive 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Aspartate aminotransferase increased 0/112 (0%) 0 2/448 (0.4%) 3 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 1/434 (0.2%) 1 5/443 (1.1%) 5 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Aspiration joint 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Biopsy skin 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/43 (0%) 0
    Blood bilirubin increased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood cholesterol increased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood creatine increased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood creatine phosphokinase abnormal 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood creatine phosphokinase increased 0/112 (0%) 0 2/448 (0.4%) 2 12/904 (1.3%) 12 0/19 (0%) 0 3/437 (0.7%) 3 7/434 (1.6%) 8 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood creatinine increased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood glucose increased 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood iron decreased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood potassium increased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood pressure increased 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 2 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood thyroid stimulating hormone decreased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood triglycerides increased 0/112 (0%) 0 2/448 (0.4%) 2 1/904 (0.1%) 1 0/19 (0%) 0 4/437 (0.9%) 4 0/434 (0%) 0 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blood uric acid increased 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Body temperature increased 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Female sex hormone level abnormal 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Fibrin d dimer increased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gamma-glutamyltransferase abnormal 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gamma-glutamyltransferase increased 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 3 2/434 (0.5%) 2 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Haemoglobin increased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hepatic enzyme increased 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hepatitis e virus test positive 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Liver function test abnormal 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Liver function test increased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lymph node palpable 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lymphocyte count decreased 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lymphocyte morphology abnormal 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Mammogram 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Neutrophil count decreased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Neutrophil count increased 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Occult blood 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Panendoscopy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Platelet count decreased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Platelet count increased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Prostatic specific antigen increased 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Protein urine present 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Red blood cell count decreased 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Transaminases increased 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Very low density lipoprotein increased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vitamin d decreased 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Weight decreased 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 1/437 (0.2%) 1 3/434 (0.7%) 3 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 1/6 (16.7%) 1 0/43 (0%) 0
    Weight increased 0/112 (0%) 0 1/448 (0.2%) 1 2/904 (0.2%) 3 0/19 (0%) 0 3/437 (0.7%) 3 4/434 (0.9%) 4 4/443 (0.9%) 4 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    White blood cell count decreased 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    White blood cell count increased 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Metabolism and nutrition disorders
    Cachexia 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Decreased appetite 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Diabetes mellitus 0/112 (0%) 0 3/448 (0.7%) 3 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dyslipidaemia 0/112 (0%) 0 1/448 (0.2%) 1 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Food craving 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Gout 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypercholesterolaemia 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 3 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hyperglycaemia 1/112 (0.9%) 1 3/448 (0.7%) 3 3/904 (0.3%) 3 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hyperlipidaemia 0/112 (0%) 0 1/448 (0.2%) 1 2/904 (0.2%) 2 0/19 (0%) 0 3/437 (0.7%) 3 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypertriglyceridaemia 0/112 (0%) 0 0/448 (0%) 0 4/904 (0.4%) 5 0/19 (0%) 0 2/437 (0.5%) 2 1/434 (0.2%) 1 2/443 (0.5%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hyperuricaemia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 3/437 (0.7%) 3 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypocholesterolaemia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypokalaemia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Increased appetite 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Iron deficiency 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Metabolic syndrome 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Obesity 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Polydipsia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Type 2 diabetes mellitus 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vitamin d deficiency 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/112 (2.7%) 5 5/448 (1.1%) 5 20/904 (2.2%) 25 0/19 (0%) 0 8/437 (1.8%) 9 18/434 (4.1%) 19 13/443 (2.9%) 17 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Arthritis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 1/19 (5.3%) 1 0/437 (0%) 0 0/434 (0%) 0 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Back pain 5/112 (4.5%) 5 3/448 (0.7%) 4 22/904 (2.4%) 22 0/19 (0%) 0 13/437 (3%) 14 19/434 (4.4%) 19 19/443 (4.3%) 22 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Bone pain 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Bursitis 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Chondrocalcinosis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Connective tissue disorder 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Enthesopathy 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Exostosis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Facet joint syndrome 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Flank pain 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Foot deformity 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Inclusion body myositis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Intervertebral disc degeneration 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Intervertebral disc protrusion 0/112 (0%) 0 1/448 (0.2%) 1 3/904 (0.3%) 3 0/19 (0%) 0 2/437 (0.5%) 2 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Joint swelling 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Muscle contracture 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Muscle spasms 0/112 (0%) 0 1/448 (0.2%) 1 3/904 (0.3%) 3 0/19 (0%) 0 2/437 (0.5%) 4 3/434 (0.7%) 3 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Muscle tightness 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Muscular weakness 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Musculoskeletal chest pain 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 3/434 (0.7%) 4 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Musculoskeletal discomfort 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Musculoskeletal pain 0/112 (0%) 0 3/448 (0.7%) 4 8/904 (0.9%) 8 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 7/443 (1.6%) 7 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Musculoskeletal stiffness 1/112 (0.9%) 1 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Myalgia 0/112 (0%) 0 2/448 (0.4%) 3 10/904 (1.1%) 10 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Myositis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Neck pain 0/112 (0%) 0 1/448 (0.2%) 1 5/904 (0.6%) 5 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Osteitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Osteoarthritis 2/112 (1.8%) 2 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 2/437 (0.5%) 3 5/434 (1.2%) 5 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pain in extremity 0/112 (0%) 0 2/448 (0.4%) 2 6/904 (0.7%) 6 0/19 (0%) 0 3/437 (0.7%) 3 5/434 (1.2%) 5 8/443 (1.8%) 8 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Periarthritis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Polyarthritis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Psoriatic arthropathy 2/112 (1.8%) 2 2/448 (0.4%) 2 2/904 (0.2%) 2 1/19 (5.3%) 1 3/437 (0.7%) 3 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rotator cuff syndrome 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Spinal osteoarthritis 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Spinal pain 0/112 (0%) 0 1/448 (0.2%) 3 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Synovial cyst 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Synovitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tendonitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 4/443 (0.9%) 4 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tenosynovitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 4/437 (0.9%) 4 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tenosynovitis stenosans 0/112 (0%) 0 1/448 (0.2%) 2 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Trigger finger 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    B-cell lymphoma 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Basal cell carcinoma 0/112 (0%) 0 2/448 (0.4%) 2 3/904 (0.3%) 4 0/19 (0%) 0 1/437 (0.2%) 1 2/434 (0.5%) 2 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dysplastic naevus 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lentigo maligna 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lip neoplasm malignant stage unspecified 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lipoma 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lung adenocarcinoma stage i 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lymphoma 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Melanocytic naevus 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Neoplasm 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Neoplasm skin 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Oral fibroma 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Prostate cancer 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Seborrhoeic keratosis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin papilloma 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Squamous cell carcinoma 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Uterine leiomyoma 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nervous system disorders
    Burning sensation 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Carpal tunnel syndrome 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 1/19 (5.3%) 1 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cervicobrachial syndrome 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 1/35 (2.9%) 1 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Disturbance in attention 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dizziness 2/112 (1.8%) 2 0/448 (0%) 0 9/904 (1%) 10 1/19 (5.3%) 1 1/437 (0.2%) 1 1/434 (0.2%) 1 2/443 (0.5%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dysaesthesia 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dysgeusia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Facial paralysis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Headache 4/112 (3.6%) 4 24/448 (5.4%) 27 44/904 (4.9%) 63 0/19 (0%) 0 9/437 (2.1%) 14 16/434 (3.7%) 20 19/443 (4.3%) 38 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypertonia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypoaesthesia 1/112 (0.9%) 1 0/448 (0%) 0 3/904 (0.3%) 3 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Loss of consciousness 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Migraine 0/112 (0%) 0 1/448 (0.2%) 5 2/904 (0.2%) 3 0/19 (0%) 0 2/437 (0.5%) 4 2/434 (0.5%) 2 4/443 (0.9%) 4 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nerve compression 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Neuralgia 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Notalgia paraesthetica 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Paraesthesia 1/112 (0.9%) 2 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Presyncope 1/112 (0.9%) 1 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sciatica 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Senile dementia 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sinus headache 1/112 (0.9%) 1 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Somnolence 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Syncope 0/112 (0%) 0 1/448 (0.2%) 1 2/904 (0.2%) 2 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Taste disorder 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tension headache 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Trigeminal neuralgia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Product Issues
    Device breakage 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Device physical property issue 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Psychiatric disorders
    Abnormal dreams 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Acute stress disorder 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Adjustment disorder with depressed mood 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Alcoholic psychosis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Anxiety 1/112 (0.9%) 1 0/448 (0%) 0 3/904 (0.3%) 4 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Anxiety disorder 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Attention deficit hyperactivity disorder 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Burnout syndrome 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Depressed mood 2/112 (1.8%) 2 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Depression 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Insomnia 1/112 (0.9%) 1 1/448 (0.2%) 1 1/904 (0.1%) 1 1/19 (5.3%) 1 0/437 (0%) 0 1/434 (0.2%) 1 2/443 (0.5%) 9 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Irritability 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Libido decreased 1/112 (0.9%) 1 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Loss of libido 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Mood altered 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Panic attack 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sleep disorder 0/112 (0%) 0 0/448 (0%) 0 4/904 (0.4%) 6 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Social anxiety disorder 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Stress 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Calculus urinary 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dysuria 0/112 (0%) 0 1/448 (0.2%) 1 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Haematuria 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Micturition urgency 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nephrolithiasis 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 2/437 (0.5%) 2 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Nocturia 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pollakiuria 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Renal colic 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Renal failure 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Reproductive system and breast disorders
    Amenorrhoea 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Balanoposthitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Benign prostatic hyperplasia 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 3/437 (0.7%) 3 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Breast calcifications 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Breast mass 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Breast pain 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dysmenorrhoea 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 4/443 (0.9%) 10 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ectropion of cervix 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Erectile dysfunction 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Menstruation irregular 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Metrorrhagia 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Oligospermia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ovarian cyst 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Penile erythema 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pruritus genital 1/112 (0.9%) 1 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Testicular pain 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vaginal haemorrhage 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vulvovaginal dryness 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vulvovaginal pruritus 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/112 (0%) 0 2/448 (0.4%) 2 3/904 (0.3%) 5 0/19 (0%) 0 3/437 (0.7%) 3 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Bronchial hyperreactivity 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Chronic obstructive pulmonary disease 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cough 4/112 (3.6%) 4 7/448 (1.6%) 7 13/904 (1.4%) 13 0/19 (0%) 0 12/437 (2.7%) 14 7/434 (1.6%) 9 5/443 (1.1%) 6 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 2/35 (5.7%) 2 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dysphonia 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dyspnoea 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Epistaxis 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypoxia 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Interstitial lung disease 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Laryngeal pain 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lower respiratory tract congestion 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nasal congestion 0/112 (0%) 0 2/448 (0.4%) 2 6/904 (0.7%) 6 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 1/443 (0.2%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nasal discomfort 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nasal polyps 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nasal septum deviation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Oropharyngeal pain 2/112 (1.8%) 2 11/448 (2.5%) 12 7/904 (0.8%) 7 0/19 (0%) 0 4/437 (0.9%) 6 4/434 (0.9%) 4 11/443 (2.5%) 11 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Paranasal sinus discomfort 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pharyngeal erythema 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Productive cough 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pulmonary embolism 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 1/19 (5.3%) 1 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pulmonary mass 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Respiratory disorder 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Respiratory distress 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rhinitis allergic 0/112 (0%) 0 2/448 (0.4%) 2 4/904 (0.4%) 4 0/19 (0%) 0 6/437 (1.4%) 6 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rhinorrhoea 1/112 (0.9%) 1 1/448 (0.2%) 1 3/904 (0.3%) 4 0/19 (0%) 0 3/437 (0.7%) 4 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sinus congestion 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sleep apnoea syndrome 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sneezing 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Throat tightness 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Upper respiratory tract inflammation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin and subcutaneous tissue disorders
    Acanthosis nigricans 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Acne 1/112 (0.9%) 1 1/448 (0.2%) 1 6/904 (0.7%) 6 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Actinic keratosis 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 4 0/19 (0%) 0 2/437 (0.5%) 4 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Alopecia 0/112 (0%) 0 1/448 (0.2%) 1 2/904 (0.2%) 2 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Alopecia areata 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Angioedema 0/112 (0%) 0 2/448 (0.4%) 3 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Asteatosis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Blister 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dermal cyst 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dermatitis 0/112 (0%) 0 3/448 (0.7%) 3 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dermatitis allergic 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dermatitis contact 0/112 (0%) 0 4/448 (0.9%) 4 5/904 (0.6%) 5 0/19 (0%) 0 5/437 (1.1%) 5 5/434 (1.2%) 5 9/443 (2%) 9 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 1/29 (3.4%) 1 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Drug eruption 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 1/19 (5.3%) 1 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dry skin 0/112 (0%) 0 2/448 (0.4%) 2 3/904 (0.3%) 3 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dyshidrotic eczema 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ecchymosis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 2/443 (0.5%) 2 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eczema 0/112 (0%) 0 3/448 (0.7%) 3 11/904 (1.2%) 14 1/19 (5.3%) 1 10/437 (2.3%) 11 6/434 (1.4%) 6 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eczema asteatotic 0/112 (0%) 0 2/448 (0.4%) 2 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Eczema nummular 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Erythema 0/112 (0%) 0 0/448 (0%) 0 3/904 (0.3%) 3 0/19 (0%) 0 2/437 (0.5%) 3 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Granuloma annulare 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hand dermatitis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hyperhidrosis 0/112 (0%) 0 0/448 (0%) 0 3/904 (0.3%) 3 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Ingrown hair 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Intertrigo 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 1/437 (0.2%) 1 2/434 (0.5%) 2 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Keratosis pilaris 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lentigo 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Leukoplakia 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lichen planus 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lichen sclerosus 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Macule 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Miliaria 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Myxoid cyst 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nail psoriasis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Night sweats 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Onychoclasis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pain of skin 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Papule 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Papulopustular rosacea 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Petechiae 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Photodermatosis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Photosensitivity reaction 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pityriasis rosea 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pityriasis rubra pilaris 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Polymorphic light eruption 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Post inflammatory pigmentation change 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Prurigo 0/112 (0%) 0 1/448 (0.2%) 1 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pruritus 2/112 (1.8%) 4 4/448 (0.9%) 4 22/904 (2.4%) 22 2/19 (10.5%) 2 8/437 (1.8%) 8 2/434 (0.5%) 2 4/443 (0.9%) 5 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Pruritus allergic 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Psoriasis 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Purpura 1/112 (0.9%) 1 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rash 0/112 (0%) 0 3/448 (0.7%) 3 1/904 (0.1%) 1 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rash papular 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rash pruritic 1/112 (0.9%) 1 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rash vesicular 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rosacea 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Seborrhoea 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Seborrhoeic dermatitis 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 3/443 (0.7%) 3 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Sensitive skin 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin atrophy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin fissures 0/112 (0%) 0 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin mass 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin ulcer 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Solar dermatitis 1/112 (0.9%) 1 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Toxic skin eruption 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Urticaria 0/112 (0%) 0 1/448 (0.2%) 1 8/904 (0.9%) 10 0/19 (0%) 0 2/437 (0.5%) 2 3/434 (0.7%) 3 4/443 (0.9%) 4 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 1/9 (11.1%) 1 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Urticaria cholinergic 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Urticaria chronic 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Xeroderma 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Social circumstances
    Menopause 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Stress at work 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Surgical and medical procedures
    Abscess drainage 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Antiviral prophylaxis 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 3 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Bile duct stent insertion 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Cataract operation 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 2/443 (0.5%) 4 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cervix cryotherapy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Cholangiostomy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 1/43 (2.3%) 1
    Cholecystectomy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 2/434 (0.5%) 2 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dental care 0/112 (0%) 0 2/448 (0.4%) 2 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dental implantation 1/112 (0.9%) 1 0/448 (0%) 0 1/904 (0.1%) 2 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Dental prosthesis placement 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Endodontic procedure 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Female sterilisation 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Foot operation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hernia repair 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Infusion 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Intestinal polypectomy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Joint surgery 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lens extraction 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 1/18 (5.6%) 1 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Limb operation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Lipoma excision 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Mass excision 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Meniscus removal 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Nephrostomy 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Percutaneous coronary intervention 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 1/19 (5.3%) 2 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Phlebectomy 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rehabilitation therapy 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Removal of foreign body 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Rotator cuff repair 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Shoulder operation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Skin neoplasm excision 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Tooth extraction 1/112 (0.9%) 1 0/448 (0%) 0 2/904 (0.2%) 2 0/19 (0%) 0 2/437 (0.5%) 2 2/434 (0.5%) 2 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Varicose vein operation 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Vascular disorders
    Arteriosclerosis 0/112 (0%) 0 1/448 (0.2%) 1 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Deep vein thrombosis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Essential hypertension 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Haemorrhage 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 1/443 (0.2%) 1 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hot flush 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypertension 4/112 (3.6%) 4 9/448 (2%) 9 24/904 (2.7%) 25 0/19 (0%) 0 9/437 (2.1%) 9 8/434 (1.8%) 8 8/443 (1.8%) 8 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Hypotension 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Orthostatic hypotension 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Peripheral venous disease 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Phlebitis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Raynaud's phenomenon 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Thrombophlebitis superficial 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 0/437 (0%) 0 1/434 (0.2%) 1 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Varicose vein 0/112 (0%) 0 0/448 (0%) 0 0/904 (0%) 0 0/19 (0%) 0 1/437 (0.2%) 1 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    Venous thrombosis 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0
    White coat hypertension 0/112 (0%) 0 0/448 (0%) 0 1/904 (0.1%) 1 0/19 (0%) 0 0/437 (0%) 0 0/434 (0%) 0 0/443 (0%) 0 0/104 (0%) 0 0/18 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/9 (0%) 0 0/1 (0%) 0 0/29 (0%) 0 0/35 (0%) 0 0/14 (0%) 0 0/6 (0%) 0 0/43 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 8005455979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03535194
    Other Study ID Numbers:
    • 16504
    • I6T-MC-AMAJ
    • 2017-003286-10
    First Posted:
    May 24, 2018
    Last Update Posted:
    Mar 30, 2021
    Last Verified:
    Aug 1, 2020