A Long-term Study to Evaluate Safety and Maintenance of T... | NCT03556202 | Trialant
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Studies A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3) NCT03556202 Show options United States Argentina Australia Canada Czechia France Germany Hungary Israel Italy Japan Mexico Poland Puerto Rico Russia South Korea Spain Taiwan United Kingdom
Obsolete or Duplicate NCT IDs Not provided
ID Type Description Link I6T-MC-AMAH Other Identifier Eli Lilly and Company 2017-003299-30 EudraCT Number
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3
Eli Lilly and Company INDUSTRY
Overall Recruitment Status or Expanded Access Status Terminated
The study was terminated due to a strategic business decision made by the Sponsor.
First Submission Date that Met QC Criteria Jun 4, 2018
Results First Submitted Date Feb 3, 2023
Results First Submitted that Met QC Criteria Mar 17, 2023
Results First Posted Date Mar 21, 2023 Actual
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Mar 17, 2023
Responsible Party, by Official Title Sponsor
Eli Lilly and Company INDUSTRY
Has Data Monitoring Committee (DMC) Yes
Pediatric Postmarket Surveillance of a Device Product Not provided
The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.
IL-23 Interleukin-23 Psoriasis Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names 125 Milligram (mg) Mirikizumab Q8W Experimental Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
250 mg Mirikizumab Q8W Excluding Secukinumab Experimental Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ)
Secukinumab/250 mg Mirikizumab Q8W Experimental Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Name Type Description Arm Group Labels Other Names Mirikizumab Drug 125 Milligram (mg) Mirikizumab Q8W 250 mg Mirikizumab Q8W Excluding Secukinumab Secukinumab/250 mg Mirikizumab Q8W
Measure Description Time Frame Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1 The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO 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. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.
Week 104 Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90 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. 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).
Week 104
Measure Description Time Frame Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) 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. 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).
Inclusion Criteria:
Participant must have completed the last visit of an eligible study period of originating study.
Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential.
Exclusion Criteria:
Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study.
Participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant.
Accepts Healthy Volunteers No
Name Affiliation Role 1-877-CTLILLY (1-877-285-4559) or Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company Study Director
Facility Status City State ZIP Country Contacts University of Alabama at Birmingham Birmingham Alabama 35233 United States Zenith Research, Inc.
PubMed Identifier Type Citation Retractions Derived Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.
Label URL A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
Available IPD Information Not provided
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Participants who completed an originating study: I6T-MC-AMAF (NCT02899988), I6T-MC-AMAK (NCT03482011) and I6T-MC-AMAJ (NCT03535194) were eligible for enrollment into study AMAH.
ID Title Description FG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
FG001 250 mg Mirikizumab Q8W Excluding Secukinumab
Title Milestones Reasons Not Completed Extension Treatment Period Type Comment Milestone Data STARTED
Baseline Analysis Population Description
No data available
No data is available for this block.
Document Has No Statistical Analysis Plan (SAP) Not provided
Uploaded Document Information Type Includes Protocol Includes SAP Includes ICF Document Label Document Date Document Uploaded Date Document File Name Prot Yes No No Study Protocol Nov 15, 2018 Jan 31, 2023
Estimated Results First Submitted Date Not provided
Non-Randomized
Intervention Model Description Not provided
Initially double-blind (until original, pivotal studies AMAK [NCT03482011] and AMAJ [NCT03535194] are locked and unblinded), then open-label.
Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline 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 sign score of 0 (no signs) to 30 (worst imaginable signs) will be reported.
Week 104
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 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". 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.
Week 104
Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline The PPASI 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.
Baseline, Week 104
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline 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).
Baseline, Week 104
Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline 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).
Baseline, Week 104
California Dermatology & Clinical Research Institute Encinitas California 92024 United States
First OC Dermatology Fountain Valley California 92708 United States
Keck School of Medicine University of Southern California Los Angeles California 90033 United States
Dermatology Clinical Trials Newport Beach California 92660-7831 United States
San Luis Dermatology & Laser Clinic San Luis Obispo California 93405 United States
Clinical Science Institute Santa Monica California 90404 United States
Univ of Connecticut Farmington Connecticut 06030-2840 United States
Florida Academic Centers Research and Education, LLC Coral Gables Florida 33134 United States
Renstar Medical Research Ocala Florida 34470 United States
Park Avenue Dermatology Orange Park Florida 32073 United States
ForCare Clinical Research Tampa Florida 33613-1244 United States
Dermatologic Surgery Specialists, PC Macon Georgia 31217 United States
Meridian Clinical Research Savannah Georgia 31406 United States
Advanced Clinical Research LLC Meridian Idaho 83642 United States
University Dermatology Darien Illinois 60561 United States
Arlington Dermatology Rolling Meadows Illinois 60008 United States
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana 46250 United States
The Indiana Clinical Trials Center Plainfield Indiana 46168 United States
The South Bend Clinic Center for Research South Bend Indiana 46617 United States
Forefront Research Louisville Kentucky 40241 United States
DelRicht Research Baton Rouge Louisiana 70809 United States
Dermatology and Skin Cancer Specialists Rockville Maryland 20850 United States
Lawrence J Green, M.D, LLC Rockville Maryland 20850 United States
ORA, Inc Andover Massachusetts 01810 United States
Central Dermatology PC St Louis Missouri 63117 United States
Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey 08520 United States
Mount Sinai School of Medicine Dermatology Clinical Trials New York New York 10029 United States
PMG Research of Cary, LLC Cary North Carolina 27518 United States
University of North Carolina Dermatology and Skin Cancer Cen Chapel Hill North Carolina 27516 United States
PMG Research of Wilmington Wilmington North Carolina 28411 United States
Bexley Dermatology Research Bexley Ohio 43209 United States
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 United States
Wright State Univ School of Medicine Fairborn Ohio 45324 United States
Oregon Dermatology and Research Center Portland Oregon 97210 United States
Oregon Medical Research Center Portland Oregon 97223 United States
Oregon Health and Science University Portland Oregon 97239 United States
The Pennsylvania Centre for Dermatology, LLC Exton Pennsylvania 19341 United States
Clinical Partners, LLC Johnston Rhode Island 02919 United States
Modern Research Associates Dallas Texas 75231 United States
Austin Institute for Clinical Research Pflugerville Texas 78660 United States
Texas Dermatology and Laser Specialists San Antonio Texas 78218 United States
University of Utah Murray Utah 84107 United States
Virginia Clinical Research, Inc. Norfolk Virginia 23502 United States
Dermatology Associates Seattle Washington 98101 United States
MultiCare Good Samaritan Hospital Tacoma Washington 98405 United States
Dermatology CABA Buenos Aires C1060ABN Argentina
Instituto de Neumonología Y Dermatología Capital Federal Buenos Aires 1425 Argentina
Psoriahue Ciudad Autonoma de Buenos Aire Buenos Aires C1425DKG Argentina
Buenos Aires Skin Buenos Aires Ciudad Autónoma de Buenos Aire 1055 Argentina
Clinica Adventista Belgrano CABA Ciudad Autónoma de Buenos Aire C1430EGF Argentina
Centro de Investigaciones Metabólicas (CINME) Buenos Aires C1027AAP Argentina
Halitus Instituto Médico Ciudad Autonoma de Buenos Aire C1122AAF Argentina
Parra Dermatología Mendoza 5500 Argentina
Woden Dermatology Phillip Australian Capital Territory 2606 Australia
Veracity Clinical Research Pty Ltd Woolloongabba Queensland 4102 Australia
Clinical Trials SA Pty Ltd Adelaide South Australia 5073 Australia
Skin Health Institute Inc. Carlton Victoria 3053 Australia
Fremantle Dermatology Perth Western Australia 6160 Australia
Kirk Barber Research Calgary Alberta T2G 1B1 Canada
Alberta DermaSurgery Centre Edmonton Alberta T6G 1C3 Canada
Dr. Chih-ho Hong Medical Inc. Surrey British Columbia V3R 6A7 Canada
Eastern Canada Cutaneous Research Assoicates Ltd Halifax Nova Scotia B3H1Z2 Canada
Guenther Research Inc. London Ontario N6A 3H7 Canada
Lynderm Research Inc. Markham Ontario L3P1X2 Canada
SKiN Centre for Dermatology Peterborough Ontario K9J 5K2 Canada
K. Papp Clinical Research Waterloo Ontario N2J 1C4 Canada
Innovaderm Research Inc Montreal Quebec H2X 2V1 Canada
Kožní ambulance Kutná Hora, s.r.o. Kutná Hora Central Bohemia 28401 Czechia
Fakultni nemocnice Kralovske Vinohrady Prague Hl. M. Praha 100 34 Czechia
Nemocnice AGEL Novy Jicin a.s. Nový Jičín Moravian-Silesian Region 741 01 Czechia
Clintrial s.r.o. Prague Praha 10 100 00 Czechia
Fakultni Nemocnice U svate Anny Brno South Moravian 656 91 Czechia
Etická komise Krajské zdravotní, a.s. - Masarykovy nemocnice v Ústí nad Labem, o.z. Ústí nad Labem Ustecký Kraj 40113 Czechia
CHU Dupuytren 2 Limoges Cedex 87042 France
CHU de Bordeaux Hop St ANDRE Bordeaux Gironde 33075 France
CH du Mans - Pavillon Claude Monet Le Mans 72037 France
Cabinet Médical Martigues 13500 France
Hopital Saint Eloi Montpellier 34295 France
CHU de Nice Hopital de L'Archet Nice 06202 France
CHU Charles Nicolle in Rouen Rouen 76036 France
Hopital Larrey Toulouse 31059 France
Universitätsklinikum Heidelberg Heidelberg Baden-Wurttemberg 69120 Germany
Hautarztpraxis Dr. Leitz Stuttgart Baden-Wurttemberg 70178 Germany
Universitätsklinikum Tübingen Tübingen Baden-Wurttemberg 72076 Germany
Dermatologische Gemeinschaftspraxis Mahlow Mahlow Brandenburg 15831 Germany
Rosenpark Research GmbH Darmstadt Hesse 64283 Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Frankfurt am Main Hesse 60590 Germany
Fachklinik Bad Bentheim Bad Bentheim Lower Saxony 48455 Germany
Dermatologisches Zentrum Osnabrück Nord Bramsche Lower Saxony 49565 Germany
Elbe Klinikum Buxtehude Buxtehude Lower Saxony 21614 Germany
Universitätsklinikum Münster Münster North Rhine-Westphalia 48149 Germany
Hautarztpraxis Dr. Gerlach Dresden Saxony 01097 Germany
Universitätsklinikum Schleswig-Holstein Kiel Schleswig-Holstein 24105 Germany
Universitätsklinikum Schleswig-Holstein Lübeck Schleswig-Holstein 23538 Germany
Charité Campus Virchow-Klinikum Berlin 10117 Germany
Klin. Forschung Berlin-Mitte GmbH Berlin 10117 Germany
Rothhaar Studien Berlin 10783 Germany
ISA GmbH Berlin 10789 Germany
Universitaetsklinikum Hamburg-Eppendorf Hamburg 20246 Germany
TFS Trial Form Support GmbH Hamburg 20537 Germany
Clinical Research Hamburg GmbH Hamburg 22143 Germany
Oroshaza Varosi Onkormanyzat Korhaza Orosháza Bekes County 5900 Hungary
Bacs-Kiskun Megyei Korhaz Kecskemét Bács-Kiskun county 6000 Hungary
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika Debrecen Hajdú-Bihar 4032 Hungary
Allergo-Derm Bakos Kft Szolnok Jász-Nagykun-Szolnok 5000 Hungary
Medmare Bt Veszprém Veszprém City 8200 Hungary
Uno Medical Trials Kft. Budapest 1152 Hungary
Ambrozia Kft. Budapest 1238 Hungary
Haemek Medical Center- Dermatology Afula 1834111 Israel
Soroka Medical Center Beersheba 8410101 Israel
Rambam Medical Center Haifa 3525408 Israel
Rabin Medical Center Petah Tikva 4941492 Israel
Sheba Medical Center Ramat Gan 5265601 Israel
Tel Aviv Sourasky Medical Center Tel Aviv 6423906 Israel
Policlinico Gemelli - Università Cattolica del Sacro Cuore Rome Lazio 00168 Italy
Istituto Clinico Humanitas Rozzano Milano 20089 Italy
Presidio Ospedaliero Firenze Centro Piero Palagi Florence 50125 Italy
Policlinico di Tor Vergata Roma 00133 Italy
Nagoya City University Hospital Nagoya Aichi-ken 467-8602 Japan
Toho University School of Medicine, Sakura Hospital Sakura Chiba 285-8741 Japan
Juntendo Urayasu Hospital Urayasu Chiba 279-0021 Japan
Kurume University Hospital Kurume Fukuoka 830-0011 Japan
Gunma University Hosptial Maebashi Gunma 371-8511 Japan
Asahikawa Medical College Hospital Asahikawa Hokkaido 078-8510 Japan
Takagi Dermatology Obihiro Hokkaido 080-0013 Japan
Tokyo Medical University Ibaraki Medical Center Inashiki Ibaraki 300-0332 Japan
Tokai University Hospital- Isehara Campus Isehara Kanagawa 259-1143 Japan
Kanto Rosai Hospital Kawasaki Kanagawa 211-8510 Japan
Yokohama City University Hospital Yokohama Kanagawa 236-0004 Japan
Mie University Hospital Tsu Mie-ken 514-8507 Japan
Tohoku University Hospital Sendai Miyagi 980-8574 Japan
Shinshu University Hospital Matsumoto Nagano 390-8621 Japan
Ryukyu University Hospital Nakagami-gun Okinawa 903-0215 Japan
Kansai Medical University Hospital Hirakata Osaka 573-1191 Japan
Kume Clinic Nishi-ku Sakai-shi Osaka 593 8324 Japan
Shiga University of Medical Science Hosptial Ōtsu Shiga 520-2192 Japan
Shimane University Hospital Izumo Shimane 693-0021 Japan
The University of Tokyo Hospital Bunkyo-ku Tokyo 113-8655 Japan
Tokyo Medical University Hachioji Medical Center Hachiōji Tokyo 193-0998 Japan
Teikyo University Hospital Itabashi-ku Tokyo 173 8606 Japan
Nihon University Itabashi Hospital Itabashi-ku Tokyo 173-8610 Japan
NTT Medical Center Tokyo Shinagawa-KU Tokyo 141-8625 Japan
Showa University Hospital Shinagawa Tokyo 142-8555 Japan
Tokyo Medical University Hospital Shinjuku-ku Tokyo 160-0023 Japan
Seibo Hospital Shinjuku-ku Tokyo 161-8521 Japan
Takaokashi Shirasaki Dermatology Clinic Takaoka Toyama 933-0871 Japan
Yamaguchi University Hospital Ube Yamaguchi 755-8505 Japan
Yamanashi Prefectural Central Hospital Kofu Yamanashi 400-8506 Japan
Gifu University Hospital Gifu 501-1194 Japan
Kyoto Furitsu Medical University Hospital Kyoto 602-8566 Japan
Nagasaki University Hospital Nagasaki 852-8501 Japan
Osaka City University Hospital Osaka 545-8586 Japan
Nippon Life Hospital Osaka 550-0006 Japan
Tokushima University Hospital Tokushima 770-8503 Japan
St. Luke's International Hospital Tokyo 104-8560 Japan
Wakayama Medical University Hospital Wakayama 641-0012 Japan
Centro Medico del Angel Mexicali Estado de Baja California 21100 Mexico
Grupo Clinico CATEI Sociedad Civil Guadalajara Jalisco 44657 Mexico
Hospital de Jesus I.A.P. Mexico City Mexico City 06090 Mexico
Clinica De Enfermedades Cronicas y Procedimientos Especiales Morelia Michoacán 58249 Mexico
B&B Investigaciones Medicas, SC Mazatlán Sinaloa 82140 Mexico
Köhler & Milstein Research Mérida Yucatán 97070 Mexico
RM Pharma Specialists S.A. de C.V. Distrito Federal 3100 Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C Durango 34000 Mexico
Ai Centrum Medyczne Sp. Z O.O. Sp.K. Poznan Greater Poland Voivodeship 61-113 Poland
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c. Osielsko Kuyavian-Pomeranian Voivodeship 86-031 Poland
Diamond Clinic Krakow Lesser Poland Voivodeship 31-559 Poland
dermMedica Sp. z o.o. Wroclaw Lower Silesian Voivodeship 51-318 Poland
Lubelskie Centrum Diagnostyczne Świdnik Lublin Voivodeship 21-040 Poland
Centrum Medyczne AMED Warsaw Masovian Voivodeship 01-518 Poland
Centrum Medyczne Evimed Warsaw Masovian Voivodeship 02-625 Poland
NZOZ ZDROWIE Osteo-Medic Bialystok Podlaskie Voivodeship 15-351 Poland
NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm Bialystok Podlaskie Voivodeship 15-375 Poland
Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomeranian Voivodeship 80-546 Poland
Centrum Medyczne Angelius Provita Katowice Silesian Voivodeship 40-611 Poland
LASER CLINIC Specjalistyczne Gabinety Lekarskie Szczecin West Pomeranian Voivodeship 70-332 Poland
Centralny Szpital Kliniczny MSW Klinika Dermatologii Warsaw 02-507 Poland
Dermed Centrum Medyczne Sp. z o.o. Lodz Łódź Voivodeship 90-265 Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna Lodz Łódź Voivodeship Poland
Dr. Samuel Sanchez PSC Caguas PR 00727 Puerto Rico
Office of Dr. Alma M. Cruz Carolina PR 00985 Puerto Rico
Ponce School of Medicine CAIMED Center Ponce PR 00716 Puerto Rico
GCM Medical Group, PSC - Hato Rey Site San Juan PR 00917 Puerto Rico
Santa Cruz Behavioral PSC Bayamón 00961-6911 Puerto Rico
GBUZ Clinical dermatology and venereological dispensary Krasnodar Krasnodarskiy Kray 350020 Russia
State scientific centre for dermatovenerology and cosmetolog Moscow 107076 Russia
SPb SBHI Skin-venerologic dispensary #10 Saint Petersburg 194021 Russia
GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation' Smolensk 214000 Russia
Tver State Medical University Tver' 170100 Russia
Bucheon St. Mary's Hospital Bucheon-si Gyeonggi-do 14647 South Korea
Ilsan Paik Hospital Goyang-si Gyeonggi-do 10380 South Korea
Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do 13620 South Korea
CHA Bundang Medical Center, CHA University Sungnam-si Gyeonggi-do 13496 South Korea
Ajou University Hospital Suwon Gyeonggi-do 16499 South Korea
Pusan National University Hospital Busan Korea 49241 South Korea
Chungnam National University Hospital Daejeon Korea 35015 South Korea
Chonnam National University Hospital Gwangju Korea 61469 South Korea
Gachon University Gil Hospital Incheon Korea 21565 South Korea
Kyung Hee University Hospital Seoul Korea 02447 South Korea
Hanyang University Medical Center Seoul Korea 04763 South Korea
Seoul St. Mary's Hospital Seoul Korea 06591 South Korea
Samsung Medical Center Seoul Seoul-teukbyeolsi [Seoul] 6351 South Korea
Korea University Guro Hospital Seoul Seoul-teukbyeolsi [Seoul] 8308 South Korea
Ulsan University Hospital Ulsan Ulsan-Kwangyǒkshi 44033 South Korea
Severance Hospital, Yonsei University Health System Seoul 03722 South Korea
Konkuk University Medical Center Seoul 05030 South Korea
Chungang University Hospital Seoul 06973 South Korea
Hospital Marina Baixa Villajoyosa Alicante 03570 Spain
Hospital Germans Trias i Pujol Barcelona Badalona 08916 Spain
Hospital de Manises Manises Valencia 46940 Spain
Hospital De Basurto Bilbao Vizcaya 48013 Spain
Hospital del Mar Barcelona 08003 Spain
Hospital Reina Sofia Córdoba 14004 Spain
Hospital Infanta Leonor Madrid 28031 Spain
Hospital Universitario Ramón y Cajal Madrid 28034 Spain
Hospital Universitario La Paz Madrid 28046 Spain
Centro de Especialidades Mollabao Pontevedra 36001 Spain
Hospital Universitario Virgen Macarena Seville 41009 Spain
Hospital Universitario La Fe de Valencia Valencia 46026 Spain
National Taiwan University Hospital - Hsinchu branch Hsinchu 300 Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch Kaohsiung City 83301 Taiwan
Taipei Medical University Shuang Ho Hospital New Taipei City 23561 Taiwan
Chung Shan Medical University Hospital Taichung 40201 Taiwan
National Cheng-Kung Uni. Hosp. Tainan 70403 Taiwan
National Taiwan University Hospital Taipei 10048 Taiwan
Chang Gung Memorial Hospital - Linkou Taoyuan Hsien 10508 Taiwan
Salford Royal NHS Foundation Trust Salford Greater Manchester M6 8HD United Kingdom
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
FG002 Secukinumab/250 mg Mirikizumab Q8W Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
FG000 527 subjects FG001 1020 subjects FG002 389 subjects Received at Least One Dose of Study Drug FG000 527 subjects FG001 1020 subjects FG002 389 subjects
From AMAF FG000 35 subjects FG001 132 subjects FG002 0 subjects
From AMAK FG000 83 subjects FG001 390 subjects FG002 0 subjects
From AMAJ FG000 409 subjects FG001 498 subjects FG002 389 subjects
COMPLETED FG000 0 subjects FG001 0 subjects FG002 0 subjects
NOT COMPLETED FG000 527 subjects FG001 1020 subjects FG002 389 subjects
Type Comment Reasons Adverse Event FG000 18 subjects FG001 14 subjects FG002 9 subjects Death FG000 2 subjects FG001 6 subjects FG002 0 subjects Lack of Efficacy FG000 5 subjects FG001 12 subjects FG002 18 subjects Lost to Follow-up FG000 9 subjects FG001 20 subjects FG002 2 subjects Pregnancy FG000 2 subjects FG001 4 subjects FG002 3 subjects Study Terminated by Sponsor FG000 469 subjects FG001 907 subjects FG002 331 subjects Withdrawal by Subject FG000 22 subjects FG001 47 subjects FG002 22 subjects Due to Exclusion Criteria of AMAJ study FG000 0 subjects FG001 0 subjects FG002 1 subjects Physician Decision FG000 0 subjects FG001 8 subjects FG002 2 subjects Protocol Violation FG000 0 subjects FG001 1 subjects FG002 1 subjects Sponsor Decision FG000 0 subjects FG001 1 subjects FG002 0 subjects
Follow-Up Period (12 Weeks) Type Comment Milestone Data STARTED FG000 453 subjects Participants were assigned to this arm during follow-up period. FG001 861 subjects Participants were assigned to this arm during follow-up period. FG002 333 subjects Participants were assigned to this arm during follow-up period. COMPLETED FG000 0 subjects FG001 0 subjects FG002 0 subjects NOT COMPLETED FG000 453 subjects FG001 861 subjects FG002 333 subjects
Type Comment Reasons Adverse Event FG000 11 subjects FG001 11 subjects FG002 8 subjects Death
All randomized participants.
ID Title Description BG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered SC Q8W.
BG001 250 mg Mirikizumab Q8W Excluding Secukinumab Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
BG002 Secukinumab/250 mg Mirikizumab Q8W Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
BG003 Total Total of all reporting groups
Units Counts Participants BG000 527 BG001 1020 BG002 389 BG003 1936
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Continuous Mean Standard Deviation years Title Denominators Categories Title Measurements BG000 47.90 ± 13.81 BG001 47.00 ± 12.87 BG002 46.50 ± 14.41 BG003
Sex: Female, Male Count of Participants Participants No Title Denominators Categories
Ethnicity (NIH/OMB) Count of Participants Participants No Title Denominators Categories Title Measurements Hispanic or Latino
Race (NIH/OMB) Count of Participants Participants No Title Denominators Categories Title Measurements American Indian or Alaska Native
Region of Enrollment Count of Participants Participants No Title Denominators Categories Argentina
Type Title Description Population Description Reporting Status Anticipated Posting Date Parameter Type Dispersion Type Unit of Measure Calculate Percentage Time Frame Units Analyzed Denominator Units Selected Arm/Group Information Denominators Classes Analyses Primary Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1 The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO 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. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NRI) analysis.
All randomized participants who received at least one dose of drug and who entered Study AMAH with sPGA (0,1).
Posted Number 95% Confidence Interval percentage of participants Week 104 ID Title Description OG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered SC Q8W.
OG001 250 mg Mirikizumab Q8W Excluding Secukinumab Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
OG002 Secukinumab/250 mg Mirikizumab Q8W Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Title Denominators Categories Title Measurements OG000 46.7 (42.2 to 51.2) OG001 55.7 (52.3 to 59.1) OG002 38.9 (33.3 to 44.4)
Primary Percentage of Participants Who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90 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. 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).
All randomized participants who received at least one dose of study drug and who entered AMAH with PASI 90 Response.
Posted Number 95% Confidence Interval percentage of participants Week 104 ID Title Description OG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered SC Q8W.
OG001 250 mg Mirikizumab Q8W Excluding Secukinumab Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
Secondary Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) 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. 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).
All randomized participants who received at least one dose of study drug.
Posted Number 95% Confidence Interval percentage of participants Week 104 ID Title Description OG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered SC Q8W.
OG001 250 mg Mirikizumab Q8W Excluding Secukinumab Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
OG002
Secondary Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (Free of Itch, Pain, Stinging, and Burning) in Those With a PSS Symptoms Score ≥1 at Baseline 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 sign score of 0 (no signs) to 30 (worst imaginable signs) will be reported.
All randomized participants with PSS symptom score of ≥1 at baseline.
Posted Number 95% Confidence Interval percentage of participants Week 104 ID Title Description OG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered SC Q8W.
OG001 250 mg Mirikizumab Q8W Excluding Secukinumab Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
OG002
Secondary 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 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". 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.
All randomized participants who had a baseline DLQI Total Score ≥5.
Posted Number 95% Confidence Interval percentage of participants Week 104 ID Title Description OG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered SC Q8W.
OG001 250 mg Mirikizumab Q8W Excluding Secukinumab Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
Secondary Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline The PPASI 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.
All randomized participants who had palmoplantar involvement at baseline.
Posted Mean Standard Deviation score on a scale Baseline, Week 104 ID Title Description OG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered SC Q8W.
OG001 250 mg Mirikizumab Q8W Excluding Secukinumab Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
OG002 Secukinumab/250 mg Mirikizumab Q8W Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Secondary Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline 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).
All randomized participants who had Scalp Involvement at baseline.
Posted Mean Standard Deviation score on a scale Baseline, Week 104 ID Title Description OG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered SC Q8W.
OG001 250 mg Mirikizumab Q8W Excluding Secukinumab Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
OG002 Secukinumab/250 mg Mirikizumab Q8W Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Secondary Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline 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).
All randomized participants who had Nail Psoriasis involvement at baseline.
Posted Mean Standard Deviation score on a scale Baseline, Week 104 ID Title Description OG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered SC Q8W.
OG001 250 mg Mirikizumab Q8W Excluding Secukinumab Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
OG002 Secukinumab/250 mg Mirikizumab Q8W
Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks
All participants who received at least one dose of drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 125 Milligram (mg) Mirikizumab Q8W Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
2 527 55 527 388 527 EG001 250 mg Mirikizumab Q8W Excluding Secukinumab Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ).
6 1,020 88 1,020 756 1,020 EG002 Secukinumab/250 mg Mirikizumab Q8W Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
0 389 35 389 288 389 EG003 125 Milligram (mg) Mirikizumab Q8W Follow-up Period Participants did not receive any intervention in post- treatment follow-up period.
1 453 7 453 70 453 EG004 250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period Participants did not receive any intervention in post- treatment follow-up period.
0 861 6 861 120 861 EG005 Secukinumab/250 mg Mirikizumab Q8W Follow-up Period Participants did not receive any intervention in post- treatment follow-up period.
0 333 0 333 47 333
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Acute coronary syndrome Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 0 events 0 affected 453 at risk EG004 0 events 0 affected 861 at risk EG005 0 events 0 affected 333 at risk Acute myocardial infarction Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Angina unstable Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Atrial fibrillation Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Cardiac failure Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cardiac failure congestive Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cardiogenic shock Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Coronary artery disease Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Coronary artery stenosis Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Myocardial infarction Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Myocardial ischaemia Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pericarditis Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ventricular tachycardia Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Odontogenic cyst Congenital, familial and genetic disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Sudden hearing loss Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vertigo Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Primary hyperaldosteronism Endocrine disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cataract Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Keratitis Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ocular hypertension Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Optic neuropathy Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Colitis ulcerative Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Diverticulum Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Gastric haemorrhage Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gastric ulcer Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gastritis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Large intestine polyp Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Pancreatitis acute Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Asthenia General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Death General disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gait disturbance General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Oedema peripheral General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cholecystitis Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cholecystitis acute Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Cholecystitis chronic Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cholelithiasis Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gallbladder fistula Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Corneal graft rejection Immune system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Abscess limb Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Acute sinusitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Appendicitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Appendicitis perforated Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Bacteraemia Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Bronchitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Campylobacter colitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Campylobacter gastroenteritis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cellulitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Chronic tonsillitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Covid-19 Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Covid-19 pneumonia Infections and infestations MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 8 events 8 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Diverticulitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Enterocolitis viral Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Erysipelas Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Escherichia pyelonephritis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Localised infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Neutropenic sepsis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Osteomyelitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pneumonia Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Pneumonia bacterial Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Post procedural infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Postoperative wound infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Scrotal abscess Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 1 events 1 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Sinusitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Soft tissue infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Animal bite Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ankle fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cervical vertebral fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Clavicle fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Closed globe injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Concussion Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Face injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Facial bones fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Femoral neck fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Foot fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Graft complication Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hand fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hip fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Joint dislocation Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Ligament sprain Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Limb injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Limb traumatic amputation Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lower limb fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lumbar vertebral fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Meniscus injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Muscle injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Neovaginal complication Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 1 events 1 affected 110 at risk EG003 Post procedural complication Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pulmonary contusion Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Radius fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Rib fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Road traffic accident Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Scapula fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Skull fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Spinal compression fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tendon injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tendon rupture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Aspartate aminotransferase increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Diabetes mellitus Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Shock hypoglycaemic Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Flank pain Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Intervertebral disc disorder Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Intervertebral disc protrusion Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Osteoarthritis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Rotator cuff syndrome Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Acute myeloid leukaemia Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Adenocarcinoma of colon Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 B-cell lymphoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Breast cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Colon cancer metastatic Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gastric cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Glioblastoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Growth hormone-producing pituitary tumour Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Haemangioma of bone Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Invasive lobular breast carcinoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lipoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lung adenocarcinoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Marginal zone lymphoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Myelodysplastic syndrome Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Non-small cell lung cancer stage iii Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Prostate cancer recurrent Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 0 events 0 affected 711 at risk EG002 1 events 1 affected 279 at risk EG003 Sinonasal papilloma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Squamous cell carcinoma of the oral cavity Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Superficial spreading melanoma stage unspecified Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Thyroid cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Carotid artery stenosis Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cerebral arteriosclerosis Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cerebral venous sinus thrombosis Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cerebrovascular accident Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Chronic inflammatory demyelinating polyradiculoneuropathy Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Essential tremor Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haemorrhage intracranial Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Headache Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ischaemic stroke Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Sedation Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Transient ischaemic attack Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Device dislocation Product Issues MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Alcohol withdrawal syndrome Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Depression Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Mental status changes Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nephrolithiasis Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ureterolithiasis Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Acquired phimosis Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 1 events 1 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Endometriosis Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 1 events 1 affected 110 at risk EG003 Genital haemorrhage Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haemorrhagic ovarian cyst Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 1 events 1 affected 110 at risk EG003 Uterine polyp Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 1 events 1 affected 110 at risk EG003 Asthma Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Asthmatic crisis Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Chronic obstructive pulmonary disease Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dyspnoea exertional Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypercapnia Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pulmonary embolism Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Respiratory failure Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Sleep apnoea syndrome Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dermatitis contact Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Drug eruption Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Urticaria Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Blepharoplasty Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cholecystectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Coronary revascularisation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Gastric polypectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hysterectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Percutaneous coronary intervention Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Peripheral revascularisation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Stent placement Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Stent removal Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Aortic aneurysm rupture Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Deep vein thrombosis Vascular disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Embolism Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haematoma Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypertension Vascular disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Peripheral arterial occlusive disease Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Varicose vein Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Vasculitis Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Anaemia Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 16 events 14 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 0 events 0 affected 453 at risk EG004 1 events 1 affected 861 at risk EG005 0 events 0 affected 333 at risk Anaemia macrocytic Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Anaemia of chronic disease Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Bone marrow oedema Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Eosinophilia Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Febrile neutropenia Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypercoagulation Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Iron deficiency anaemia Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Leukocytosis Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Leukopenia Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Lymphadenitis Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 3 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lymphadenopathy Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Lymphopenia Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Macrocytosis Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Neutropenia Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Neutrophilia Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Pancytopenia Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Splenomegaly Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Thrombocytopenia Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Thrombocytosis Blood and lymphatic system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Angina pectoris Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Angina unstable Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Aortic valve incompetence Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Aortic valve sclerosis Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Arrhythmia Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Atrial fibrillation Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Atrioventricular block first degree Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Bradycardia Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Bundle branch block left Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cardiac failure Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Cardiac failure congestive Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cardiomegaly Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cardiomyopathy Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cardiovascular disorder Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Coronary artery disease Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Coronary artery stenosis Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Coronary artery thrombosis Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Coronary ostial stenosis Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Extrasystoles Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Left atrial enlargement Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Left ventricular failure Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Left ventricular hypertrophy Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Mitral valve incompetence Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Myocardial ischaemia Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Palpitations Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pericarditis Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Right atrial enlargement Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Right ventricular hypertrophy Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Sinus bradycardia Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Sinus tachycardia Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tachycardia Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Tricuspid valve incompetence Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ventricular extrasystoles Cardiac disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Atrial septal defect Congenital, familial and genetic disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Block vertebra Congenital, familial and genetic disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dermoid cyst Congenital, familial and genetic disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Hydrocele Congenital, familial and genetic disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 1 events 1 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Cerumen impaction Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Deafness Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Deafness neurosensory Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Deafness unilateral Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Ear discomfort Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ear inflammation Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ear pain Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Eustachian tube dysfunction Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Eustachian tube obstruction Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 External ear inflammation Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypoacusis Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Inner ear inflammation Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Middle ear effusion Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tinnitus Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 3 events 2 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tympanic membrane perforation Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vertigo Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 7 events 6 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Vertigo positional Ear and labyrinth disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Acromegaly Endocrine disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Autoimmune thyroiditis Endocrine disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Goitre Endocrine disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hyperparathyroidism Endocrine disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hyperprolactinaemia Endocrine disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hyperthyroidism Endocrine disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Hypogonadism Endocrine disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Hypothyroidism Endocrine disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 6 events 6 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Thyroid mass Endocrine disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Arteriosclerotic retinopathy Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Blepharitis Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Blepharospasm Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cataract Eye disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 4 events 3 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Chalazion Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Chorioretinopathy Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Conjunctival haemorrhage Eye disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Conjunctival hyperaemia Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Conjunctivitis allergic Eye disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Diabetic retinopathy Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dry eye Eye disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Eye allergy Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Eye disorder Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Eye irritation Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Eye pain Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Eyelid thickening Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Glaucoma Eye disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Iridocyclitis Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lacrimation increased Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Macular degeneration Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ocular hyperaemia Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ocular surface disease Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Open angle glaucoma Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Optic disc drusen Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Optic neuropathy Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Trichiasis Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ulcerative keratitis Eye disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vision blurred Eye disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vitreous detachment Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Vitreous haemorrhage Eye disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vitreous prolapse Eye disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Abdominal discomfort Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Abdominal distension Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Abdominal hernia Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Abdominal pain Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 15 events 13 affected 1,020 at risk EG002 17 events 5 affected 389 at risk EG003 Abdominal pain lower Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Abdominal pain upper Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 4 events 3 affected 527 at risk EG001 10 events 9 affected 1,020 at risk EG002 6 events 6 affected 389 at risk EG003 Angular cheilitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Anorectal discomfort Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cheilitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Chronic gastritis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Colitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Constipation Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 9 events 9 affected 1,020 at risk EG002 5 events 4 affected 389 at risk EG003 Dental caries Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 13 events 12 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Diarrhoea Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 15 events 15 affected 527 at risk EG001 21 events 20 affected 1,020 at risk EG002 33 events 9 affected 389 at risk EG003 Dry mouth Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Duodenitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dyspepsia Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 9 events 6 affected 1,020 at risk EG002 16 events 5 affected 389 at risk EG003 Dysphagia Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Enteritis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Enterocolitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Epiploic appendagitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Flatulence Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Food poisoning Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Gastric polyps Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gastric ulcer Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gastritis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 10 events 8 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Gastritis erosive Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gastrointestinal disorder Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gastrointestinal pain Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gastrooesophageal reflux disease Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 9 events 8 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Gingival pain Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Glossitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haematochezia Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haemorrhagic erosive gastritis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haemorrhoids Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Hiatus hernia Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hyperaesthesia teeth Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ileus Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Inguinal hernia Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Intra-abdominal haematoma Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Irritable bowel syndrome Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Large intestine polyp Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lip erosion Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lip swelling Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lumbar hernia Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Melaena Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Mouth ulceration Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nausea Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 19 events 12 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Noninfective sialoadenitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Odynophagia Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Oesophageal obstruction Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Oesophagitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Oral hyperkeratosis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Oral lichen planus Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Oral papule Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pancreatic disorder Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Periodontal disease Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 6 events 6 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Proctitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Rectal polyp Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Stomatitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Terminal ileitis Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tooth disorder Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tooth impacted Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Toothache Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 19 events 16 affected 1,020 at risk EG002 9 events 9 affected 389 at risk EG003 Umbilical hernia Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vomiting Gastrointestinal disorders MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Adverse drug reaction General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 3 events 1 affected 389 at risk EG003 Asthenia General disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Chest discomfort General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Chest pain General disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Chills General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Cyst General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Effusion General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Fatigue General disorders MedDRA 24.1 Systematic Assessment EG000 6 events 5 affected 527 at risk EG001 10 events 10 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Granuloma General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Hyperthermia General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Implant site irritation General disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Influenza like illness General disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 5 events 4 affected 1,020 at risk EG002 6 events 4 affected 389 at risk EG003 Injection site bruising General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Injection site discolouration General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Injection site erythema General disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 26 events 8 affected 1,020 at risk EG002 6 events 3 affected 389 at risk EG003 Injection site haematoma General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 3 events 2 affected 389 at risk EG003 Injection site induration General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Injection site inflammation General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 3 events 2 affected 389 at risk EG003 Injection site oedema General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 5 events 3 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Injection site pain General disorders MedDRA 24.1 Systematic Assessment EG000 79 events 8 affected 527 at risk EG001 283 events 22 affected 1,020 at risk EG002 36 events 6 affected 389 at risk EG003 Injection site pruritus General disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 12 events 2 affected 1,020 at risk EG002 3 events 2 affected 389 at risk EG003 Injection site rash General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Injection site reaction General disorders MedDRA 24.1 Systematic Assessment EG000 15 events 6 affected 527 at risk EG001 108 events 19 affected 1,020 at risk EG002 44 events 19 affected 389 at risk EG003 Injection site swelling General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lithiasis General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Malaise General disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Mucosal inflammation General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nodule General disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Non-cardiac chest pain General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Oedema peripheral General disorders MedDRA 24.1 Systematic Assessment EG000 4 events 3 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Pain General disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Peripheral swelling General disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Puncture site pain General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pyrexia General disorders MedDRA 24.1 Systematic Assessment EG000 12 events 11 affected 527 at risk EG001 17 events 17 affected 1,020 at risk EG002 13 events 11 affected 389 at risk EG003 Swelling face General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Temperature regulation disorder General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tenderness General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ulcer General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vaccination site joint pain General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Vaccination site oedema General disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vaccination site pain General disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 16 events 12 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Vaccination site swelling General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Xerosis General disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Biliary colic Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cholangitis acute Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cholecystitis Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cholelithiasis Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 8 events 8 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Fatty liver alcoholic Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gallbladder polyp Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Hepatic cirrhosis Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hepatic cyst Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hepatic function abnormal Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hepatic steatosis Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 12 events 12 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Hepatitis alcoholic Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hepatomegaly Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Liver disorder Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Non-alcoholic steatohepatitis Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nonalcoholic fatty liver disease Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Primary biliary cholangitis Hepatobiliary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Allergy to animal Immune system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Allergy to arthropod bite Immune system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Allergy to arthropod sting Immune system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Anaphylactic reaction Immune system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Drug hypersensitivity Immune system disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Food allergy Immune system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypersensitivity Immune system disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Seasonal allergy Immune system disorders MedDRA 24.1 Systematic Assessment EG000 6 events 5 affected 527 at risk EG001 10 events 9 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Abdominal infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Abscess Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Abscess jaw Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Abscess limb Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Acarodermatitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 3 events 2 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Acute sinusitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 6 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Adenoviral conjunctivitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Appendicitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Appendicitis perforated Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Asymptomatic covid-19 Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Bacterial vaginosis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 1 events 1 affected 110 at risk EG003 Body tinea Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Bronchitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 11 events 10 affected 527 at risk EG001 25 events 24 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Bronchitis bacterial Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Candida infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cellulitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 6 events 6 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Chronic sinusitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Conjunctivitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 8 events 8 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Conjunctivitis bacterial Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Conjunctivitis viral Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Coronavirus infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Coronavirus pneumonia Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Covid-19 Infections and infestations MedDRA 24.1 Systematic Assessment EG000 33 events 33 affected 527 at risk EG001 67 events 66 affected 1,020 at risk EG002 28 events 26 affected 389 at risk EG003 Covid-19 pneumonia Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cystitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 4 events 3 affected 527 at risk EG001 8 events 7 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Cystitis bacterial Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Dermatophytosis of nail Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Diverticulitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 4 events 3 affected 389 at risk EG003 Ear infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Endocarditis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Enterococcal infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Epididymitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 3 events 3 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Erysipelas Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Erythema migrans Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Erythrasma Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Folliculitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 7 events 7 affected 527 at risk EG001 6 events 6 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Fungal infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Fungal skin infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Furuncle Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 8 events 6 affected 1,020 at risk EG002 6 events 4 affected 389 at risk EG003 Gastroenteritis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 6 events 6 affected 527 at risk EG001 17 events 15 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Gastroenteritis bacterial Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gastroenteritis norovirus Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Gastroenteritis viral Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 6 events 6 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Gastrointestinal infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gastrointestinal viral infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Genital candidiasis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Genital herpes Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 3 events 1 affected 389 at risk EG003 Genital herpes simplex Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Genital infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gingivitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Helicobacter infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hepatitis a Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Herpangina Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Herpes simplex Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 4 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Herpes zoster Infections and infestations MedDRA 24.1 Systematic Assessment EG000 6 events 6 affected 527 at risk EG001 8 events 7 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Herpes zoster infection neurological Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Histoplasmosis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Hordeolum Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Impetigo Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Infected cyst Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Influenza Infections and infestations MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 18 events 18 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Injection site infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Intervertebral discitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Laryngitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Latent tuberculosis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Localised infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lower respiratory tract infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Lyme disease Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lymphogranuloma venereum Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Molluscum contagiosum Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Mucocutaneous candidiasis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Mycobacterial infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Myringitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nasopharyngitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 69 events 55 affected 527 at risk EG001 226 events 157 affected 1,020 at risk EG002 57 events 43 affected 389 at risk EG003 Onychomycosis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Ophthalmic herpes simplex Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Oral candidiasis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Oral fungal infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Oral herpes Infections and infestations MedDRA 24.1 Systematic Assessment EG000 9 events 7 affected 527 at risk EG001 12 events 11 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Oral infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Oropharyngeal candidiasis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Otitis externa Infections and infestations MedDRA 24.1 Systematic Assessment EG000 3 events 2 affected 527 at risk EG001 4 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Otitis media Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Papilloma viral infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Paronychia Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Parotitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pericoronitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Perineal abscess Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Periodontitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Pharyngitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 11 events 9 affected 527 at risk EG001 19 events 17 affected 1,020 at risk EG002 10 events 10 affected 389 at risk EG003 Pharyngitis streptococcal Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Pharyngotonsillitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pilonidal cyst Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pneumonia Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Post procedural infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Postoperative wound infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Pulpitis dental Infections and infestations MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 5 events 3 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Rash pustular Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Respiratory tract infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 9 events 8 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Respiratory tract infection viral Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Rhinitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 12 events 11 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Rhinovirus infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Root canal infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Salmonellosis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Sinusitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 8 events 7 affected 527 at risk EG001 23 events 21 affected 1,020 at risk EG002 8 events 7 affected 389 at risk EG003 Skin candida Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Skin infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Soft tissue infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Subcutaneous abscess Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Superinfection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Superinfection mycobacterial Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Suspected covid-19 Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Testicular abscess Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 368 at risk EG001 0 events 0 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Tinea cruris Infections and infestations MedDRA 24.1 Systematic Assessment EG000 3 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tinea infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tinea pedis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 8 events 5 affected 527 at risk EG001 13 events 12 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Tinea versicolour Infections and infestations MedDRA 24.1 Systematic Assessment EG000 6 events 4 affected 527 at risk EG001 9 events 7 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Tonsillitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 5 events 4 affected 527 at risk EG001 10 events 10 affected 1,020 at risk EG002 5 events 5 affected 389 at risk EG003 Tooth abscess Infections and infestations MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Tooth infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 5 events 4 affected 527 at risk EG001 11 events 10 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Trichophytosis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tuberculosis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Upper respiratory tract infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 29 events 22 affected 527 at risk EG001 64 events 54 affected 1,020 at risk EG002 42 events 29 affected 389 at risk EG003 Urethritis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Urinary tract infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 14 events 11 affected 527 at risk EG001 38 events 30 affected 1,020 at risk EG002 9 events 9 affected 389 at risk EG003 Urinary tract infection enterococcal Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vaginal infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 159 at risk EG001 8 events 3 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Viral infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Viral sinusitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Viral upper respiratory tract infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Vulvovaginal candidiasis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 159 at risk EG001 4 events 2 affected 309 at risk EG002 1 events 1 affected 110 at risk EG003 Vulvovaginal mycotic infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 2 events 2 affected 110 at risk EG003 Vulvovaginitis Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 1 events 1 affected 110 at risk EG003 Wound infection Infections and infestations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Abdominal injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Accidental overdose Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Animal bite Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Animal scratch Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ankle fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Arthropod bite Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 8 events 6 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Arthropod sting Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Avulsion fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Back injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Bite Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Bone contusion Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Burns second degree Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Cartilage injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Chest injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Chillblains Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Clavicle fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Concussion Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Contusion Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 7 events 7 affected 1,020 at risk EG002 6 events 5 affected 389 at risk EG003 Corneal abrasion Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Epicondylitis Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Eye injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Fall Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 11 events 10 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Fibula fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Foot fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 3 events 2 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Forearm fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Foreign body in eye Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Foreign body in throat Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hand fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Heat stroke Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Humerus fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Joint dislocation Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Joint injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Ligament rupture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Ligament sprain Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 6 events 6 affected 527 at risk EG001 15 events 15 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Limb injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 8 events 8 affected 1,020 at risk EG002 5 events 5 affected 389 at risk EG003 Lower limb fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lumbar vertebral fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Meniscus injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Muscle injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Muscle rupture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Muscle strain Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Post procedural haematoma Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Post vaccination syndrome Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Post-traumatic neck syndrome Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Procedural nausea Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Procedural pain Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 7 events 6 affected 527 at risk EG001 9 events 9 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Radius fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Retinal injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Rib fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Road traffic accident Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Scar Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Skin abrasion Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Skin laceration Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 8 events 8 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 5 events 4 affected 389 at risk EG003 Soft tissue injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Spinal column injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Synovial rupture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tendon injury Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Tendon rupture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Thermal burn Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tooth fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Upper limb fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vaccination complication Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 3 events 2 affected 527 at risk EG001 13 events 13 affected 1,020 at risk EG002 5 events 4 affected 389 at risk EG003 Vascular pseudoaneurysm Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Wound Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Wound complication Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Wrist fracture Injury, poisoning and procedural complications MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Alanine aminotransferase increased Investigations MedDRA 24.1 Systematic Assessment EG000 10 events 9 affected 527 at risk EG001 28 events 23 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Arthroscopy Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Aspartate aminotransferase increased Investigations MedDRA 24.1 Systematic Assessment EG000 11 events 9 affected 527 at risk EG001 22 events 15 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Aspiration joint Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Basophil count increased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Bilirubin conjugated increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Biopsy lymph gland Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Biopsy skin Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Blood alkaline phosphatase increased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 5 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Blood bilirubin increased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Blood cholesterol increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Blood creatine phosphokinase increased Investigations MedDRA 24.1 Systematic Assessment EG000 11 events 10 affected 527 at risk EG001 25 events 20 affected 1,020 at risk EG002 8 events 7 affected 389 at risk EG003 Blood creatinine increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Blood gastrin increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Blood glucose increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Blood iron decreased Investigations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Blood parathyroid hormone increased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Blood potassium increased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Blood pressure abnormal Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Blood pressure increased Investigations MedDRA 24.1 Systematic Assessment EG000 4 events 3 affected 527 at risk EG001 6 events 4 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Blood testosterone decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Blood thyroid stimulating hormone increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Blood triglycerides increased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 11 events 9 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Blood urea increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Blood uric acid increased Investigations MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 5 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Body height decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Body temperature increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Bone scan Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cardiac murmur Investigations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Cardiac stress test Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Catheterisation cardiac Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Chest x-ray Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Colonoscopy Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Colonoscopy normal Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Computerised tomogram coronary artery Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Coronavirus test positive Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Culture urine positive Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Echocardiogram Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ejection fraction decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Electrocardiogram qt prolonged Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Endoscopy upper gastrointestinal tract Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gamma-glutamyltransferase increased Investigations MedDRA 24.1 Systematic Assessment EG000 11 events 9 affected 527 at risk EG001 28 events 21 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Glomerular filtration rate decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haematocrit increased Investigations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haemoglobin decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haemoglobin increased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Heart rate decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Heart rate increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Heart rate irregular Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hepatic enzyme increased Investigations MedDRA 24.1 Systematic Assessment EG000 6 events 5 affected 527 at risk EG001 11 events 10 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 High density lipoprotein increased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hormone level abnormal Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Influenza a virus test positive Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Intraocular pressure increased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Kl-6 increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Liver function test abnormal Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Liver function test increased Investigations MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lymphocyte count decreased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lymphocyte count increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lymphocyte morphology abnormal Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Mammogram Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Neutrophil count decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Neutrophil count increased Investigations MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Platelet count decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Platelet count increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Podiatric examination normal Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Prostatic specific antigen increased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 1 events 1 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Protein urine Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Red blood cell count decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Renal function test abnormal Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Sars-cov-2 test positive Investigations MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 5 events 5 affected 389 at risk EG003 Serum ferritin decreased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Smear cervix Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Spermatozoa progressive motility abnormal Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 0 events 0 affected 711 at risk EG002 1 events 1 affected 279 at risk EG003 Transaminases increased Investigations MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ultrasound kidney Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ultrasound scan Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Urine leukocyte esterase Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Urine output decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vitamin d decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Weight decreased Investigations MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Weight increased Investigations MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 11 events 11 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 White blood cell count decreased Investigations MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 White blood cell count increased Investigations MedDRA 24.1 Systematic Assessment EG000 3 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Abnormal weight gain Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Decreased appetite Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Diabetes mellitus Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 13 events 12 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Dyslipidaemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Glucose tolerance impaired Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Gout Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 13 events 9 affected 1,020 at risk EG002 4 events 3 affected 389 at risk EG003 Hypercalcaemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypercholesterolaemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 14 events 12 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Hyperglycaemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 10 events 10 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Hyperkalaemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Hyperlipidaemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 11 events 11 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypernatraemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypertriglyceridaemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 28 events 17 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hyperuricaemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 6 events 5 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Hypokalaemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypomagnesaemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hyponatraemia Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypovitaminosis Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Impaired fasting glucose Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Insulin resistance Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Iron deficiency Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Overweight Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Type 2 diabetes mellitus Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 8 events 8 affected 1,020 at risk EG002 5 events 5 affected 389 at risk EG003 Underweight Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vitamin b12 deficiency Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vitamin d deficiency Metabolism and nutrition disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Arthralgia Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 36 events 30 affected 527 at risk EG001 95 events 87 affected 1,020 at risk EG002 23 events 19 affected 389 at risk EG003 Arthritis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 10 events 10 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Arthropathy Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Axillary mass Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Back pain Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 27 events 25 affected 527 at risk EG001 61 events 48 affected 1,020 at risk EG002 22 events 20 affected 389 at risk EG003 Bursitis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 6 events 6 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cervical spinal stenosis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Chondrocalcinosis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Chondropathy Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Costochondritis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dactylitis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 5 events 3 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Enthesopathy Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Exostosis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Fibromyalgia Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Flank pain Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Groin pain Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haemarthrosis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Intervertebral disc degeneration Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Intervertebral disc disorder Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Intervertebral disc protrusion Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 7 events 7 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Intervertebral disc space narrowing Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Joint effusion Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Joint stiffness Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Joint swelling Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ligament disorder Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ligament pain Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lumbar spinal stenosis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Muscle contracture Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Muscle spasms Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 10 events 9 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Muscle tightness Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Musculoskeletal chest pain Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Musculoskeletal pain Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 4 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Musculoskeletal stiffness Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Myalgia Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 7 events 5 affected 527 at risk EG001 16 events 12 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Myositis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Neck pain Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 9 events 9 affected 1,020 at risk EG002 3 events 2 affected 389 at risk EG003 Osteoarthritis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 7 events 6 affected 527 at risk EG001 8 events 8 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Osteopenia Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Osteoporosis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pain in extremity Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 7 events 6 affected 527 at risk EG001 28 events 22 affected 1,020 at risk EG002 8 events 7 affected 389 at risk EG003 Pain in jaw Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Patellofemoral pain syndrome Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Periarthritis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Plantar fasciitis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Psoriatic arthropathy Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 9 events 9 affected 527 at risk EG001 12 events 12 affected 1,020 at risk EG002 12 events 10 affected 389 at risk EG003 Rheumatic disorder Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Rotator cuff syndrome Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Sacroiliitis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Scoliosis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Spinal osteoarthritis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 7 events 7 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Spinal pain Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 6 events 6 affected 527 at risk EG001 11 events 7 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Spinal retrolisthesis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Spondylolisthesis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Synovial cyst Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Synovitis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 5 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Tendon disorder Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Tendonitis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 10 events 10 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Tenosynovitis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tenosynovitis stenosans Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Trigger finger Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vertebral foraminal stenosis Musculoskeletal and connective tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Acrochordon Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Adenoma benign Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Anogenital warts Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Basal cell carcinoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Benign breast neoplasm Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Benign hepatobiliary neoplasm Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Benign neoplasm of thyroid gland Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Benign vascular neoplasm Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Bowen's disease Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Colon adenoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Dysplastic naevus Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 3 events 2 affected 389 at risk EG003 Fibroma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Fibrous histiocytoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Focal nodular hyperplasia Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haemangioma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lentigo maligna Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lipoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Malignant ascites Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Melanocytic naevus Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Meningioma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Neoplasm malignant Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pituitary tumour benign Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Prostate cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 1 events 1 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Pyogenic granuloma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Seborrhoeic keratosis Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Skin papilloma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 7 events 6 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Squamous cell carcinoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Uterine leiomyoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 159 at risk EG001 4 events 4 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Amnesia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Anosmia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Aphasia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Arachnoid cyst Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ataxia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Bell's palsy Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Burning sensation Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Carotid arteriosclerosis Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Carpal tunnel syndrome Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 6 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cerebrovascular accident Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cervical radiculopathy Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cervicobrachial syndrome Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Cognitive disorder Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Complex regional pain syndrome Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cubital tunnel syndrome Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Diabetic neuropathy Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dizziness Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 9 events 9 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Facial paralysis Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Generalised tonic-clonic seizure Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Headache Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 21 events 18 affected 527 at risk EG001 93 events 55 affected 1,020 at risk EG002 32 events 21 affected 389 at risk EG003 Hemianopia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Hemiparesis Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hyperaesthesia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypoaesthesia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lethargy Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Loss of consciousness Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lumbar radiculopathy Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Memory impairment Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Migraine Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 6 events 6 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Myelopathy Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nerve compression Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Neuralgia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Neuropathy peripheral Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Paraesthesia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 5 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Peripheral nerve lesion Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Peroneal nerve palsy Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pineal gland cyst Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Post herpetic neuralgia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Psychomotor hyperactivity Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Sciatica Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 11 events 9 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Seizure Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Somnolence Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Syncope Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Transient aphasia Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tremor Nervous system disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Adjustment disorder with depressed mood Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Affective disorder Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Alcohol abuse Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Anxiety Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 7 events 6 affected 527 at risk EG001 12 events 11 affected 1,020 at risk EG002 7 events 7 affected 389 at risk EG003 Attention deficit hyperactivity disorder Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Confusional state Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Depressed mood Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Depression Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 7 events 7 affected 527 at risk EG001 6 events 6 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Distractibility Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dysphoria Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Initial insomnia Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 3 events 2 affected 389 at risk EG003 Insomnia Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 11 events 11 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Major depression Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Mental fatigue Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Mental status changes Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Mood swings Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Panic attack Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Sleep disorder Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 7 events 6 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Stress Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Suicidal behaviour Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Suicidal ideation Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Suicide attempt Psychiatric disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Acute kidney injury Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Chronic kidney disease Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Cystitis noninfective Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dysuria Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Glycosuria Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haematuria Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Haemorrhage urinary tract Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hydronephrosis Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ketonuria Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Kidney congestion Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Leukocyturia Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nephritis Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nephrolithiasis Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 8 events 5 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nocturia Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Pollakiuria Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Proteinuria Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Renal colic Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 4 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Renal cyst Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Renal failure Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Renal impairment Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ureterolithiasis Renal and urinary disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Adenomyosis Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Balanoposthitis Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 368 at risk EG001 1 events 1 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Benign prostatic hyperplasia Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 368 at risk EG001 6 events 6 affected 711 at risk EG002 2 events 2 affected 279 at risk EG003 Breast calcifications Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Breast cyst Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Breast disorder Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Breast mass Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Breast pain Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cervical cyst Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Dysmenorrhoea Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 12 events 3 affected 309 at risk EG002 1 events 1 affected 110 at risk EG003 Endometrial thickening Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Endometriosis Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 1 events 1 affected 110 at risk EG003 Erectile dysfunction Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 1 events 1 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Genital erythema Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Genital lesion Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Heavy menstrual bleeding Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 1 events 1 affected 110 at risk EG003 Intermenstrual bleeding Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Menopausal symptoms Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Menstruation irregular Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Ovarian cyst Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 159 at risk EG001 2 events 2 affected 309 at risk EG002 2 events 2 affected 110 at risk EG003 Perineal cyst Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Perineal pain Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Polycystic ovaries Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Premenstrual pain Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Prostatitis Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 368 at risk EG001 0 events 0 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Pruritus genital Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Uterine cervical metaplasia Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Vulval eczema Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Vulvovaginal inflammation Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Vulvovaginal pruritus Reproductive system and breast disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Allergic cough Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Allergic pharyngitis Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Asthma Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 6 events 5 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Atelectasis Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Bronchitis chronic Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Catarrh Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Chronic obstructive pulmonary disease Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cough Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 16 events 16 affected 527 at risk EG001 30 events 28 affected 1,020 at risk EG002 8 events 8 affected 389 at risk EG003 Cough variant asthma Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Dysphonia Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dyspnoea Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 8 events 7 affected 1,020 at risk EG002 3 events 2 affected 389 at risk EG003 Dyspnoea exertional Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Epistaxis Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Hiccups Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hyperventilation Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Laryngeal disorder Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lower respiratory tract congestion Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nasal congestion Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 5 events 4 affected 527 at risk EG001 4 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nasal oedema Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nasal polyps Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nasal septum deviation Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Nasal turbinate abnormality Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nasal turbinate hypertrophy Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Nasal ulcer Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Oropharyngeal pain Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 5 events 3 affected 527 at risk EG001 12 events 11 affected 1,020 at risk EG002 6 events 6 affected 389 at risk EG003 Paranasal cyst Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Paranasal sinus discomfort Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pleural effusion Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Productive cough Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pulmonary hypertension Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pulmonary mass Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Pulmonary oedema Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Rhinitis allergic Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 17 events 15 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Rhinorrhoea Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 8 events 6 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Sinonasal obstruction Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Sinus congestion Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 6 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Sleep apnoea syndrome Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 6 events 6 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Sneezing Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Throat irritation Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Upper respiratory tract inflammation Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vocal cord leukoplakia Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vocal cord polyp Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Wheezing Respiratory, thoracic and mediastinal disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Acanthosis nigricans Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Acne Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 6 events 6 affected 1,020 at risk EG002 4 events 4 affected 389 at risk EG003 Acne varioliformis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Actinic keratosis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Alopecia Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Alopecia areata Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Angioedema Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Asteatosis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dermal cyst Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 1 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dermatitis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Dermatitis contact Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 4 events 4 affected 527 at risk EG001 12 events 10 affected 1,020 at risk EG002 8 events 5 affected 389 at risk EG003 Dermatitis papillaris capillitii Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Diabetic foot Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Drug eruption Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Dry skin Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 3 events 2 affected 389 at risk EG003 Dyshidrotic eczema Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 3 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Eczema Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 4 events 3 affected 527 at risk EG001 10 events 10 affected 1,020 at risk EG002 3 events 3 affected 389 at risk EG003 Eczema asteatotic Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Eczema nummular Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Erythema Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hand dermatitis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hyperhidrosis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hyperkeratosis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Ingrowing nail Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Intertrigo Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 5 events 4 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Itching scar Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lichen planus Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lichen sclerosus Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lichenification Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lichenoid keratosis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Mechanical urticaria Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Milia Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Miliaria Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 3 events 2 affected 389 at risk EG003 Nail discolouration Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nail dystrophy Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Neurodermatitis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Night sweats Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Onycholysis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Palmar erythema Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Papule Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Photosensitivity reaction Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Post inflammatory pigmentation change Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Prurigo Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Pruritus Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 12 events 12 affected 527 at risk EG001 20 events 17 affected 1,020 at risk EG002 7 events 6 affected 389 at risk EG003 Psoriasis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Rash Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 3 events 2 affected 527 at risk EG001 5 events 5 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Rosacea Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Seborrhoeic dermatitis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 4 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Skin burning sensation Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Skin erosion Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Skin exfoliation Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Skin fissures Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Skin lesion Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Skin plaque Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Skin tightness Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Skin ulcer Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Stasis dermatitis Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Urticaria Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 5 events 5 affected 527 at risk EG001 12 events 12 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Urticaria physical Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Vitiligo Skin and subcutaneous tissue disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Abscess drainage Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Acrochordon excision Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Ankle operation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Appendicectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cardiac ablation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Cardioversion Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Carpal tunnel decompression Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 4 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Cataract operation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 2 events 1 affected 389 at risk EG003 Cholecystectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Circumcision Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 1 events 1 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Corneal transplant Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Coronary revascularisation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dental care Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Dental implantation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 2 events 2 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Endodontic procedure Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Endoscopic sleeve gastroplasty Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Eyelid cyst removal Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Finger amputation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Gastric bypass Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Hernia hiatus repair Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hernia repair Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hysterectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 0 events 0 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Internal fixation of fracture Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Intra-uterine contraceptive device insertion Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Intraocular lens implant Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Knee arthroplasty Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 3 events 2 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Knee operation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Laparoscopic surgery Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Large intestinal polypectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lens extraction Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lipolysis procedure Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lipoma excision Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lithotripsy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 3 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Nasal operation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Open reduction of fracture Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Papilloma excision Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Percutaneous coronary intervention Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 6 events 5 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Peripheral nerve neurostimulation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Phlebectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Polypectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Pterygium operation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Rhinoplasty Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Sinus operation Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Skin neoplasm excision Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Splint application Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Suture insertion Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tenoplasty Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tonsillectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tooth extraction Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 9 events 7 affected 527 at risk EG001 23 events 22 affected 1,020 at risk EG002 2 events 2 affected 389 at risk EG003 Tooth restoration Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Tumour excision Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Uterine dilation and curettage Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 159 at risk EG001 1 events 1 affected 309 at risk EG002 0 events 0 affected 110 at risk EG003 Vasectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 368 at risk EG001 1 events 1 affected 711 at risk EG002 0 events 0 affected 279 at risk EG003 Vitrectomy Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Wisdom teeth removal Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Wound drainage Surgical and medical procedures MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Aortic thrombosis Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Arteriosclerosis Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Deep vein thrombosis Vascular disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Essential hypertension Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Flushing Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Haematoma Vascular disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hot flush Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Hypertension Vascular disorders MedDRA 24.1 Systematic Assessment EG000 22 events 22 affected 527 at risk EG001 54 events 52 affected 1,020 at risk EG002 15 events 14 affected 389 at risk EG003 Hypertensive crisis Vascular disorders MedDRA 24.1 Systematic Assessment EG000 3 events 3 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Hypotension Vascular disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Jugular vein thrombosis Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Lymphoedema Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Lymphorrhoea Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Orthostatic hypotension Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 1 events 1 affected 389 at risk EG003 Peripheral artery occlusion Vascular disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Peripheral venous disease Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 3 events 3 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Phlebitis superficial Vascular disorders MedDRA 24.1 Systematic Assessment EG000 1 events 1 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Post thrombotic syndrome Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Thrombosis Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 1 events 1 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 Varicose vein Vascular disorders MedDRA 24.1 Systematic Assessment EG000 5 events 2 affected 527 at risk EG001 0 events 0 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003 White coat hypertension Vascular disorders MedDRA 24.1 Systematic Assessment EG000 0 events 0 affected 527 at risk EG001 2 events 2 affected 1,020 at risk EG002 0 events 0 affected 389 at risk EG003
This study was terminated before completion of the long-term extension trial, due to strategic business decision made by the company.
Are all PI(s) employees of the sponsor? No
Results Disclosure Restriction on PI(s)? Yes
Title Organization Phone Extension Email Chief Medical Officer Eli Lilly and Company 800-545-5979 ClinicalTrials.gov@lilly.com
SAP No Yes No Statistical Analysis Plan Feb 13, 2020 Jan 31, 2023
First MCP Posted Date
ID Term D017444 Skin Diseases, Papulosquamous D012871 Skin Diseases D017437 Skin and Connective Tissue Diseases
ID Term C000708407 mirikizumab
1 subjects
FG001 0 subjects
FG002 0 subjects Lack of Efficacy FG000 4 subjects FG001 9 subjects FG002 13 subjects
Lost to Follow-up FG000 4 subjects FG001 14 subjects FG002 3 subjects
Pregnancy FG000 1 subjects FG001 4 subjects FG002 1 subjects
Study Terminated by Sponsor FG000 396 subjects FG001 750 subjects FG002 273 subjects
Withdrawal by Subject FG000 36 subjects FG001 65 subjects FG002 31 subjects
Physician Decision FG000 0 subjects FG001 3 subjects FG002 1 subjects
Site Terminated by Sponsor FG000 0 subjects FG001 1 subjects FG002 0 subjects
Study Discontinued by Sponsor FG000 0 subjects FG001 2 subjects FG002 1 subjects
Second Follow-up Visit: Patient Refused FG000 0 subjects FG001 1 subjects FG002 0 subjects
Study terminated & Subject Missed Follow-up Visit FG000 0 subjects FG001 1 subjects FG002 0 subjects
To Meet Exclusion Criteria of the AMAJ Study FG000 0 subjects FG001 0 subjects FG002 1 subjects
Second Follow-up Not Done, unable to reach Patient FG000 0 subjects FG001 0 subjects FG002 1 subjects
47.10
± 13.45
110
BG003 578 Male BG000 368 BG001 711 BG002 279 BG003 1358
20
BG003 112 Not Hispanic or Latino BG000 79 BG001 150 BG002 53 BG003 282
Unknown or Not Reported BG000 419 BG001 807 BG002 316 BG003 1542
2
BG003 65 Asian BG000 89 BG001 217 BG002 63 BG003 369
Native Hawaiian or Other Pacific Islander
Black or African American BG000 5 BG001 18 BG002 6 BG003 29
White BG000 415 BG001 734 BG002 315 BG003 1464
23
BG003 85 Australia Title Measurements BG000 16 BG001 21 BG002 19 BG003 56
Canada Title Measurements BG000 26 BG001 44 BG002 24 BG003 94
Czechia Title Measurements BG000 25 BG001 35 BG002 28 BG003 88
France Title Measurements BG000 20 BG001 15 BG002 18 BG003 53
Germany Title Measurements BG000 65 BG001 136 BG002 42 BG003 243
Hungary Title Measurements BG000 23 BG001 27 BG002 20 BG003 70
Israel Title Measurements BG000 12 BG001 15 BG002 15 BG003 42
Italy Title Measurements BG000 7 BG001 5 BG002 5 BG003 17
Japan Title Measurements BG000 39 BG001 86 BG002 37 BG003 162
Mexico Title Measurements BG000 15 BG001 56 BG002 0 BG003 71
Poland Title Measurements BG000 75 BG001 157 BG002 47 BG003 279
Russia Title Measurements BG000 3 BG001 43 BG002 0 BG003 46
South Korea Title Measurements BG000 24 BG001 68 BG002 13 BG003 105
Spain Title Measurements BG000 24 BG001 22 BG002 24 BG003 70
Taiwan Title Measurements BG000 9 BG001 44 BG002 0 BG003 53
United States Title Measurements BG000 110 BG001 214 BG002 73 BG003 397
OG002 Secukinumab/250 mg Mirikizumab Q8W Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Title Denominators Categories Title Measurements OG000 49.3 (44.8 to 53.9) OG001 56.8 (53.4 to 60.2) OG002 39.4 (33.9 to 44.9)
Secukinumab/250 mg Mirikizumab Q8W
Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Units Counts Participants OG000 527 OG001 1020 OG002 389
Title Denominators Categories Title Measurements OG000 30.4 (26.4 to 34.3) OG001 36.4 (33.4 to 39.3) OG002 22.6 (18.5 to 26.8)
Secukinumab/250 mg Mirikizumab Q8W
Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Units Counts Participants OG000 518 OG001 1008 OG002 376
Title Denominators Categories Title Measurements OG000 31.1 (27.1 to 35.1) OG001 33.6 (30.7 to 36.5) OG002 23.4 (19.1 to 27.7)
OG002 Secukinumab/250 mg Mirikizumab Q8W Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Title Denominators Categories Title Measurements OG000 41.5 (37.1 to 45.9) OG001 47.3 (44.1 to 50.5) OG002 34.5 (29.5 to 39.5)
Title Denominators Categories Title Measurements OG000 -6.55 ± 7.058 OG001 -6.80 ± 8.391 OG002 -7.38 ± 6.632
Title Denominators Categories Title Measurements OG000 -20.9 ± 15.79 OG001 -19.5 ± 13.48 OG002 -19.6 ± 13.44
Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
Title Denominators Categories Title Measurements OG000 -19.4 ± 17.75 OG001 -21.0 ± 17.69 OG002 -22.2 ± 18.75
0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 1 events 1 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 1 events 1 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 1 events 1 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 1 events 1 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 1 events
1 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 0 events
0 affected
453 at risk
EG004 0 events 0 affected 861 at risk
EG005 0 events 0 affected 333 at risk 1 events
1 affected
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