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POEM: Prospective Observational Epidemiologic Study of Maraviroc's Safety

Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT00665561
Collaborator
Pfizer (Industry)
2,455
Enrollment
267
Locations
130.5
Actual Duration (Months)
9.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

Condition or Disease Intervention/Treatment Phase
  • Drug: Maraviroc along with an optimized background antiretroviral drug regimen
  • Drug: Optimized background antiretroviral drug regimen without maraviroc

Detailed Description

All patients meeting the study eligibility criteria at participating sites will be invited to participate.

Study Design

Study Type:
Observational
Actual Enrollment :
2455 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS
Actual Study Start Date :
Mar 31, 2008
Actual Primary Completion Date :
Feb 14, 2019
Actual Study Completion Date :
Feb 14, 2019

Arms and Interventions

Arm Intervention/Treatment
Maraviroc exposed

Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Maraviroc prescribed per approved local label.
Other Names:
  • Selzentry, Celsentri

    		•
    Maraviroc unexposed

    Drug: Optimized background antiretroviral drug regimen without maraviroc
    Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.

    Outcome Measures

    Primary Outcome Measures

    1. Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections [Up to 5 years following enrollment]

      Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).

    2. Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis [Up to 5 years following enrollment]

      Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    3. Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) [Up to 5 years following enrollment]

      Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    4. Density Rate Per 1000 Participant-Years for Incidence of Liver Failure [Up to 5 years following enrollment]

      Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    5. Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' [Up to 5 years following enrollment]

      Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.

    6. Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' [Up to 5 years following enrollment]

      Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.

    7. Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis [Up to 5 years following enrollment]

      Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    8. Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause [Up to 5 years following enrollment]

      Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    9. Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause [Up to 5 years following enrollment]

      Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

    10. Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections [Up to 5 years following enrollment]

      Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI.

    11. Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) [Up to 5 years following enrollment]

      Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.

    12. Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' [Up to 5 years following enrollment]

      Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.

    13. Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data' [Up to 5 years following enrollment]

      Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.

    14. Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause [Up to 5 years following enrollment]

      Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.

    15. Percentage of Participants With All-Cause Mortality [Up to 5 years following enrollment]

      All-cause death was defined as the death due to any cause during the course of study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Treatment experienced, HIV-1 infected patients

    • 18 years or older

    • Receive an approved assay for determination of HIV-1 tropism

    Exclusion Criteria:

    • Pregnant or lactating

    • Using CCR5 inhibitor other than maraviroc

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Health Services Center Hobson City Alabama United States 36201
    2 AAC/Davis Clinic Huntsville Alabama United States 35801
    3 Alabama Infectious Diseases Center Huntsville Alabama United States 35801
    4 Office of Franco Antonio Felizarta MD Bakersfield California United States 93301
    5 Providence Clinical Research Burbank California United States 91505
    6 Lalla-Reddy Medical Corporation Fountain Valley California United States 92708
    7 Bickerstaff Pediatric Family HIV Center Long Beach California United States 90806
    8 LA Gay and Lesbian Center Los Angeles California United States 90028
    9 Office of Peter J. Ruane, MD Los Angeles California United States 90036
    10 Cedars Sinai Medical Group Los Angeles California United States 90048
    11 Alta Bates Summit Medical Center East Bay AIDS Center Oakland California United States 95035
    12 University of California Irvine Medical Center Orange California United States 92868
    13 A Professional Corporation, Research Department Palm Desert California United States 92211
    14 Stanford ACTG Palo Alto California United States 94304-5350
    15 University of California Sacramento California United States 95817
    16 Kaiser Permanente Medical Center San Francisco California United States 94118
    17 San Francisco Veterans Affairs Medical Center San Francisco California United States 94121
    18 Statnford University Medical Center Stanford California United States 94305
    19 Bipin Bhagat MD Inc. Victorville California United States 92395
    20 Kaiser Permanente Denver Colorado United States 80205
    21 National Jewish Health Denver Colorado United States 80206
    22 Kaiser Permanete of Colorado Rock Creek Medical Offices Lafayette Colorado United States 80026
    23 Yale University School of Medicine Aids Program New Haven Connecticut United States 06510
    24 Clinical AIDS & HIV New Haven Connecticut United States 06511
    25 Hospital of Saint Raphael New Haven Connecticut United States 06511
    26 Circle Medical, LLC Norwalk Connecticut United States 06851
    27 Dupont Circle Physician's Group Washington District of Columbia United States 20009
    28 Family Medical Counseling Service Washington District of Columbia United States 20020
    29 Division of Infectious Diseases, George Washington University Medical Center Washington District of Columbia United States 20037
    30 George Washington University Medical Faculty Assoc Washington District of Columbia United States 20037
    31 Office of Mahmoud H. Mustafa, MD, FACP Washington District of Columbia United States 20037
    32 ID Consultants Inc & Infectious Disease Research Corp. Boynton Beach Florida United States 33426
    33 Daniel A. Warner/Consultive Medicine Daytona Beach Florida United States 32114
    34 The McGregor Clinic Fort Myers Florida United States 33901
    35 Associates in Infectious Disease Fort Pierce Florida United States 34982
    36 Duval County Health Department Jacksonville Florida United States 32206
    37 Office of Albert Canas, MD Miami Beach Florida United States 33139
    38 University of Miami Miami Florida United States 33136
    39 Care Resource Miami Florida United States 33137
    40 South Florida Infectious Deisease and Tropical Medicine Center Miami Florida United States 33176
    41 Health Positive Safety Harbor Florida United States 34695
    42 Pinellas Care Clinic Saint Petersburg Florida United States 33713
    43 Infectious Disease Research Institute, Inc Tampa Florida United States 33614
    44 Midtown Medical Center Tampa Florida United States 33614
    45 St. Joseph's Hospital Comprehensive Research Institute Tampa Florida United States 33614
    46 Tampa Care Clinic Tampa Florida United States 33614
    47 Rowan Tree Medical, PA Wilton Manors Florida United States 33305
    48 Atlanta Infectious Disease Group Atlanta Georgia United States 30309
    49 Family Health Care of Atlanta, PC Atlanta Georgia United States 30318
    50 Absolute Care Medical Center Atlanta Georgia United States 30329
    51 Kaiser Permanente Atlanta Georgia United States 30339-3915
    52 Atlanta Specialty Research Atlanta Georgia United States 30342
    53 Georgia Health Sciences University Augusta Georgia United States 30912
    54 Atlanta VA Medical Center Decatur Georgia United States 30033
    55 WellStar Clinical Trials Office Marietta Georgia United States 30060
    56 WellStar Infectious Disease Marietta Georgia United States 30060
    57 WellStar Kennestone Hospital Marietta Georgia United States 30060
    58 Infectious Diseases Associates Riverdale Georgia United States 30274
    59 Chatham County Health Department Savannah Georgia United States 31401
    60 Ruth M. Rothstein CORE Center Chicago Illinois United States 60612
    61 Howard Brown Health Center Chicago Illinois United States 60613
    62 University of Chicago Chicago Illinois United States 60637
    63 Office of William Johnson, M.D. Olympia Fields Illinois United States 60461
    64 Southside Health Association Olympia Fields Illinois United States 60461
    65 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    66 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    67 Blue Grass Care Clinic Lexington Kentucky United States 40536
    68 University of Kentucky Medical Center Lexington Kentucky United States 40536
    69 University of Kentucky Lexington Kentucky United States 40536
    70 Louisiana State University Health Sciences Center New Orleans Louisiana United States 70112
    71 Louisiana State University Health Sciences Center New Orleans Louisiana United States 70119
    72 Montgomery Infectious Disease Associates, P.A. (Private Practice) Silver Spring Maryland United States 20910
    73 St. Elizabeth's Medical Center Brighton Massachusetts United States 02135
    74 The Research Institute Springfield Massachusetts United States 01107
    75 Baystate Infectious Diseases Clinical Research Springfield Massachusetts United States 01199
    76 University Of Michigan Health Systems Ann Arbor Michigan United States 48109
    77 Henry Ford Hospital Detroit Michigan United States 48202
    78 St. John hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
    79 Ingham County Health Department Lansing Michigan United States 48910
    80 Michigan State University College of Osteopathic Medicine Lansing Michigan United States 48910
    81 Newland Medical Associates Southfield Michigan United States 48075
    82 Federal Medical Center Rochester Rochester Minnesota United States 55904
    83 Mayo Medical Clinic Rochester Minnesota United States 55905
    84 Nemechek Health Renewal Kansas City Missouri United States 64111-2610
    85 Central West Clinical Research Saint Louis Missouri United States 63108
    86 Monmouth Medical Center Long Branch New Jersey United States 07740
    87 Jersey Shore Medical Center Neptune New Jersey United States 07754
    88 Meridian Medical Associates Neptune New Jersey United States 07754
    89 Saint Michael's Medical Center Newark New Jersey United States 07102
    90 Erie County Medical Center, HIV Services Buffalo New York United States 14215
    91 Guthrie Medical Group Ithaca New York United States 14850
    92 North Shore University Hospital Manhasset New York United States 11030
    93 Beth Israel Medical Center New York New York United States 10003
    94 Beth Israel Medical Clinic New York New York United States 10003
    95 Mount Sinai Beth Israel Medical Center New York New York United States 10003
    96 HIV & Internal Medicine New York New York United States 10011
    97 Mount Sinai Downtown Comprehensive Health Program New York New York United States 10011
    98 Columbia University Medical Center New York New York United States 10032
    99 CUMC Research Pharmacy New York New York United States 10032
    100 AIDS Care Rochester New York United States 14607
    101 New York Medical College Valhalla New York United States 10595
    102 Westchester Medical Center Valhalla New York United States 10595
    103 ID Associates Gastonia North Carolina United States 28054
    104 East Carolina University Greenville North Carolina United States 27834
    105 Rosedale Infectious Diseases Huntersville North Carolina United States 28078
    106 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    107 University of Cincinnati Medical Center Cincinnati Ohio United States 45267
    108 The Ohio State University Medical Center Columbus Ohio United States 43210
    109 University of Toledo: Health Sciences Campus Toledo Ohio United States 43614
    110 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    111 The Research and Education Group Portland Oregon United States 97210
    112 Kaiser Permanente Northwest Region, Immune Deficiency Clinic Portland Oregon United States 97227
    113 Lehigh Valley Hospital Allentown Pennsylvania United States 18102
    114 Pinnacle Health Medical Services Harrisburg Pennsylvania United States 17110
    115 University of Pennsylvania Philadelphia Pennsylvania United States 19104-6073
    116 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    117 Philadelphia Fight Philadelphia Pennsylvania United States 19107
    118 Guthrie Clinic, Ltd. Sayre Pennsylvania United States 18840
    119 Low Country Infectious Diseases, P.A. Charleston South Carolina United States 29414
    120 Medical University of South Carolina Charleston South Carolina United States 29425
    121 MCC Clinic Columbia South Carolina United States 29203
    122 University of South Carolina School of Medicine Columbia South Carolina United States 29203
    123 University Speciality Clinics Columbia South Carolina United States 29203
    124 Central Texas Clinical Research Austin Texas United States 78705
    125 Saint Hope Foundation Bellaire Texas United States 77401
    126 Dallas VA Medical Center Dallas Texas United States 75216
    127 Southwest Infectious Disease Clinical Research, Inc. Dallas Texas United States 75219
    128 UT Southwestern Medical Center HIV/AIDS Research Unit Dallas Texas United States 75235
    129 Pillar Clinical Research LLC Dallas Texas United States 75243
    130 Office of Allan Rowan Kelly MD Fort Worth Texas United States 76104
    131 Tarrant County Infectious Disease Assocciates Fort Worth Texas United States 76104
    132 Tarrant County Infectious Disease Associates Fort Worth Texas United States 76104
    133 Garcias' Family Health Group Harlingen Texas United States 78550
    134 Valley Aids Council Harlingen Texas United States 78550
    135 Michael E. DeBakey Veterans Affairs Medical Center Houston Texas United States 77030
    136 Diversified Medical Practices, PA Houston Texas United States 77057
    137 Dr. Howard Kussman, MD Plano Texas United States 75075
    138 University Health Care System San Antonio Texas United States 78207
    139 South Texas Veterans Health Care System San Antonio Texas United States 78229
    140 Infectious Diseases Associates of Central Virginia Danville Virginia United States 24541
    141 Infectious Diseases Associates of Central Virginia Lynchburg Virginia United States 24501
    142 Group Health Cooperative Seattle Washington United States 98112
    143 Marshall University Joan C. Edwards School of Medicine Huntington West Virginia United States 25701
    144 Institute of Tropical Medicine Antwerpen Belgium B-2000
    145 CHU Saint Pierre Brussels Belgium 1000
    146 Cliniques Universitaires Saint-Luc Brussels Belgium 1200
    147 Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde Leuven Belgium B-3000
    148 C.H.U. Sart-Tilman Liege Belgium 4000
    149 Hospital Dia Brasilia DF Brazil 70351-580
    150 Instituto A.Z. de Pesquisa e Ensino Curitiba Parana Brazil 80240-280
    151 Hospital Geral de Nova Iguacu Nova Iguacu RJ Brazil 26030-380
    152 Faculdade de Medicina do ABC Santo André SP Brazil 09060-650
    153 Centro de Referencia e Treinamento DST/AIDS Sao Paulo SP Brazil 04121-000
    154 Hospital Heliopolis São Paulo SP Brazil 04231-030
    155 University of British Columbia/ Downtown Infectious Diseases Clinic Vancouver British Columbia Canada V6Z 2C7
    156 Queen Elizabeth II Health Sciences Center Halifax Nova Scotia Canada B3H 1V7
    157 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    158 University Health Network Toronto Ontario Canada M5G 2N2
    159 Clinique Medicale du Quartier Latin Montreal Quebec Canada H2L 5B1
    160 CHUM, Hotel-Dieu Hospital Montreal Quebec Canada H2W 1T8
    161 Recherche Clinique Médicale des Campus Quebec Canada G1V 4X7
    162 Hopital Jean Verdier, Unite de maladies infectieuses Bondy France 93140
    163 Hopital Saint-andre CHU de Bordeaux Bordeaux France 33075
    164 Hopital Pellegrin Bordeaux France 33076
    165 Raymond Poincare Hospital Garches France 92380
    166 Hopital de L'Hotel Dieu Lyon France 69288
    167 Hopital Sainte Marguerite Marseille Cedex 09 France 13274
    168 Cochin Hospital Saint Vincent de Paul Paris Cedex 14 France 75014
    169 Saint-Louis Hospital Paris France 75010
    170 Hopital Tenon Paris France 75020
    171 Hopital Pitie Salpetriere Paris France 75651
    172 Hopital Europeen Georges Pompidou Paris France 75908
    173 CH Perpignan Perpignan France 66000
    174 Hôpital Haut - Leveque - Centre Francois Magendie PESSAC Cedex France 33604
    175 Centre Hospitalier Universitaire de Rennes Rennes France 35033 Cedex 09
    176 Centre Hospitalier de Tourcoing Tourcoing France 59208
    177 Arztpraxis fuer Innere Medizin Dr. Knechten Aachen Germany 52062
    178 Praxis City Ost Medizinisches Zentrum Berlin Germany 10243
    179 Praxis Dr. Christiane Cordes Berlin Germany D-10243
    180 Klinikum Dortmund Dortmund Germany 44137
    181 Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie Dresden Germany D-01307
    182 Hospital of the J.W. Goethe University, Medical Clinic II Frankfurt am Main Germany D-60590
    183 Praxis Dr. Lothar Schneider Interne Medizin, HIV Schwerpunkt Fuerth Germany 90762
    184 IPM - Study - Center Hamburg Germany 20146
    185 ifi-Institut am Allgemeines Krankenhaus St.Georg Hamburg Germany D-20099
    186 Universitaetsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie Hamburg Germany D-20246
    187 Klinik I fuer Innere Medizin der Uni-Klinik Koeln Koeln Germany D-50937
    188 Universitaetsklinikum Mainz, I. Medizinische Klinik und Poliklinik, Mainz Germany D-55131
    189 Mannheimer Onkologie Praxis Mannheim Germany D-68161
    190 Gemeinschaftspraxis Untersendling Muenchen Germany 81371
    191 Medizinisches Versorgungszentrum Muenchen Germany D 80335
    192 Ludwig-Maximilians-Universitaet, Klinikum Innenstadt, Medizinische Poliklinik Muenchen Germany D-80336
    193 Centrum fuer interdisziplinaere Medizin Muenster GmbH Muenster Germany 48143
    194 Klinikum Osnabruck Osnabruck Germany D-49090
    195 Infectomed GbR Zentrum für medizinische Studien Stuttgart Germany D-70197
    196 Privatpraxis Ulmer, Frietsch, Müller Stuttgart Germany D-70197
    197 University Hospital of Patras Patras Achaia Greece 26 500
    198 Andreas Syngros Hospital Athens Greece 161 21
    199 Tzaneion General Hospital of Piraeus Piraues Greece 185 36
    200 Clinica Malattie Infettive Bari Italy 70124
    201 Ambulatorio Day Hospital Malattie Infettive Bologna Italy 40133
    202 Dipartimento di Medicina Clinica Specialistica e Sperimentale Bologna Italy 40138
    203 Busto Arsizio Hospital Busto Arsizio-Varese Italy 21052
    204 SOD Malattie Infettive, La Piastra dei Servizi Firenze Italy 50139
    205 Ente Ospedaliero Ospedali Galliera Genova Italy 16128
    206 1 Divisione di Malattive Infettive e Servizio di Allergologia, Ospedale L. Sacco Milano Italy 20157
    207 Universita' degli Studi di Milano, Dipartimento di scienza clinica Luigi Sacco Milano Italy 20157
    208 San Raffaele Hospital Milan Italy 20127
    209 Clinic of Infectious and Tropical Diseases-University of Milan-San Paolo Hospital Milan Italy 20142
    210 Azienda Ospedaliero Universitaria Policlinico di Modena Modena Italy 41100
    211 Azienda Ospedal Universitaria II Univ degli Studi di Napoli Servizio di Diagnosi e Terapia Naples Italy 80135
    212 Azienda Ospedaliera "Domenico Cotugno" Napoli Italy 80137
    213 AOUP Paolo Giaccone, UOC Malattie Infettive Palermo Italy 90127
    214 Fondazione IRCCS Policlinico San Matteo Pavia Italy 27100
    215 Azienda Sanitaria Locale Ospedale Civile dello Spirito Santo Presidio Ospedaliero Pescara Italy 65100
    216 Istituto Nazionale Malattie Infettive "L.Spallanzani"-IRCCS Roma Italy 00149
    217 Istituto Nazionale Malattie Infettive INMI- "L. Spallanzani"- I.R.C.C.S. Roma Italy 00149
    218 Universita' di Roma La Sapienza, Dipartimento di Malattie Infettive e Tropicali Roma Italy 00161
    219 Universita'Cattolica del Sacro Cuore Policlinico Gemelli Roma Italy 00168
    220 Azienda Ospedaliera San Giovanni Addolorata Presidia Santa Maria Rome Italy 00184
    221 Ospedale Amedeo di Savoia Torino Italy 10100
    222 Ospedale Amedeo di Savoia, Clinica Universitaria di Malattie Infettive Torino Italy 10149
    223 Ararat Research Center Ponce Puerto Rico 00717-1567
    224 HOPE Clinical Research San Juan Puerto Rico 00909
    225 Clinica Mutua de Terrassa Terrassa Barcelona Spain 08221
    226 Hospital San Pedro Logroño LA Rioja Spain 26006
    227 Hospital de Tortosa Verge de La Cinta Tortosa Tarragona Spain 43500
    228 Complejo Hospitalario Juan Canalejo A Coruña Spain 15006
    229 Hospital General Universitário de Alicante Alicante Spain 03010
    230 Hospital Del Mar Barcelona Spain 08003
    231 Hospital Clinic I Provincial de Barcelona Barcelona Spain 08036
    232 Hospital Universitario Germans Tias I Pujol Barcelona Spain 08916
    233 Unidad de Enfermedades Infecciosas Cadiz Spain 11009
    234 Hospital Universitario Reina Sofia Cordoba Spain 14004
    235 Hospital General Universitario de Elche Elche Spain 03203
    236 Hospital Clinico San Cecilio Granada Spain 18012
    237 Hospital Universitario de La Princesa Madrid Spain 28006
    238 Hospital Carlos Iii Madrid Spain 28029
    239 Hospital Ramon Y Cajal Madrid Spain 28034
    240 Hospital Clinico San Carlos Madrid Spain 28040
    241 Hospital Universitario 12 de Octubre Madrid Spain 28041
    242 Hospital Univ. La Paz Madrid Spain 28046
    243 Complejo Hospitalario Carlos Haya Malaga Spain 29010
    244 Mataro Hospital Mataro Spain 08304
    245 Hospital de Mostoles Mostoles, Madrid Spain 28935
    246 Hospital Donostia San Sebastian Spain 20014
    247 Hospital Universitario Virgen de La Macarena Sevilla Spain 41009
    248 Hospital Universitario Virgen Del Rocio Sevilla Spain 41013
    249 Hospital Universitario de Canarias Tenerife Spain 38320
    250 Hospital Clinico Universitario Valencia Spain 46010
    251 Hull & East Yorkshire Hospitals NHS Trust Cottingham EAST Yorkshire United Kingdom HU16 5JQ
    252 Clinical Resource Building, Level 7 Newcastle upon Tyne Newcastle United Kingdom NE1 4LP
    253 Royal Victoria Hospital Belfast United Kingdom BT12 6BA
    254 Selly Oak Hospital Birmingham United Kingdom B4 6DH
    255 Brighton and Sussex University Hospitals NHS Trust Brighton United Kingdom BN2 1ES
    256 North Manchester General Hospital Crumpsall, Manchester United Kingdom M8 5RB
    257 Darlington Memorial Hospital Darlington United Kingdom DL36HX
    258 Regional Infectious Diseases Unit Edinburgh United Kingdom EH4 2XU
    259 Grahame Hayton Unit London United Kingdom E1 1BB
    260 North Middlesex Hospital London United Kingdom N18 1QX
    261 Royal Free Hospital, Ian Charleson Day Centre London United Kingdom NW3 2QG
    262 1st Floor St Stephens Centre London United Kingdom SW10 9NH
    263 Royal Victoria Infirmary Hospital Newcastle Upon Tyne United Kingdom NE1 4LP
    264 Royal Victoria Infirmary Newcastle upon Tyne United Kingdom NE1 4LP
    265 Warren browne Unit, Southlands Hospital Shoreham-by-sea, West Sussex United Kingdom BN43 6TQ
    266 Cobridge Community Health Centre Stoke On Trent, Staffordshire United Kingdom ST6 2JW
    267 St. George's Hospital Tooting United Kingdom SW17 0QT

    Sponsors and Collaborators

    • ViiV Healthcare
    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    ViiV Healthcare
    ClinicalTrials.gov Identifier:
    NCT00665561
    Other Study ID Numbers:
    • A4001067
    • 2007-006148-24
    • POEM
    First Posted:
    Apr 24, 2008
    Last Update Posted:
    Apr 7, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ViiV Healthcare
    Maraviroc
    HIV-1
    Safety
    Non-interventional
    Additional relevant MeSH terms:
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Maraviroc
    Anti-Retroviral Agents

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Study was conducted at multiple sites between 31 March 2008 and 14 February 2019.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Period Title: Overall Study
    STARTED 1316 1130
    COMPLETED 814 596
    NOT COMPLETED 502 534

    Baseline Characteristics

    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed Total
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. Total of all reporting groups
    Overall Participants 1316 1130 2446
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.8
    (9.3)
    44.3
    (10.0)
    45.6
    (9.7)
    Sex: Female, Male (Count of Participants)
    Female
    275
    20.9%
    265
    23.5%
    540
    22.1%
    Male
    1041
    79.1%
    865
    76.5%
    1906
    77.9%
    Race/Ethnicity, Customized (Count of Participants)
    White
    983
    74.7%
    684
    60.5%
    1667
    68.2%
    Black
    271
    20.6%
    390
    34.5%
    661
    27%
    Asian
    13
    1%
    7
    0.6%
    20
    0.8%
    Other
    48
    3.6%
    48
    4.2%
    96
    3.9%
    Unspecified
    1
    0.1%
    1
    0.1%
    2
    0.1%

    Outcome Measures

    1. Primary Outcome
    Title Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections
    Description Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    22.28
    41.77
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude risk ratio (RR) and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.53
    Confidence Interval (2-Sided) 95%
    0.42 to 0.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis
    Description Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    0.38
    0.46
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.83
    Confidence Interval (2-Sided) 95%
    0.12 to 5.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Primary Outcome
    Title Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)
    Description Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    All Malignancies
    12.87
    13.69
    AIDS defining Malignancies
    2.31
    3.71
    Non-AIDS defining Malignancies
    10.56
    9.98
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments All Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.94
    Confidence Interval (2-Sided) 95%
    0.66 to 1.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.62
    Confidence Interval (2-Sided) 95%
    0.29 to 1.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Non-AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 1.06
    Confidence Interval (2-Sided) 95%
    0.71 to 1.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Primary Outcome
    Title Density Rate Per 1000 Participant-Years for Incidence of Liver Failure
    Description Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    2.50
    2.55
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.98
    Confidence Interval (2-Sided) 95%
    0.44 to 2.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Primary Outcome
    Title Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'
    Description Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    4.80
    5.34
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.90
    Confidence Interval (2-Sided) 95%
    0.51 to 1.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Primary Outcome
    Title Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'
    Description Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    8.26
    7.43
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 1.11
    Confidence Interval (2-Sided) 95%
    0.70 to 1.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Primary Outcome
    Title Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis
    Description Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    0.77
    0.70
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 1.10
    Confidence Interval (2-Sided) 95%
    0.25 to 4.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Primary Outcome
    Title Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause
    Description Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    0.77
    1.16
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.66
    Confidence Interval (2-Sided) 95%
    0.18 to 2.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Primary Outcome
    Title Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause
    Description Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    14.41
    18.33
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.79
    Confidence Interval (2-Sided) 95%
    0.57 to 1.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Primary Outcome
    Title Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections
    Description Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    22.36
    28.70
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.78
    Confidence Interval (2-Sided) 95%
    0.61 to 0.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Primary Outcome
    Title Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)
    Description Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    All Malignancies
    12.49
    13.54
    AIDS defining Malignancies
    2.31
    3.31
    Non-AIDS defining Malignancies
    9.87
    9.86
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments All malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.92
    Confidence Interval (2-Sided) 95%
    0.64 to 1.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.70
    Confidence Interval (2-Sided) 95%
    0.32 to 1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Non-AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 1.00
    Confidence Interval (2-Sided) 95%
    0.66 to 1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Primary Outcome
    Title Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'
    Description Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    2.08
    3.37
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.62
    Confidence Interval (2-Sided) 95%
    0.35 to 1.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Primary Outcome
    Title Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'
    Description Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    5.65
    5.99
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.94
    Confidence Interval (2-Sided) 95%
    0.59 to 1.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Primary Outcome
    Title Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause
    Description Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number (95% Confidence Interval) [events per 1000 participant-years]
    14.39
    15.64
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.92
    Confidence Interval (2-Sided) 95%
    0.66 to 1.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Primary Outcome
    Title Percentage of Participants With All-Cause Mortality
    Description All-cause death was defined as the death due to any cause during the course of study.
    Time Frame Up to 5 years following enrollment

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set included all participants who were enrolled in the study.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    Measure Participants 1316 1130
    Number [Percentage of participants]
    5.7
    0.4%
    7.0
    0.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6225
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.92
    Confidence Interval (2-Sided) 95%
    0.66 to 1.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Up to 5 years following enrollment
    Adverse Event Reporting Description Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
    Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
    Arm/Group Description Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment. HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
    All Cause Mortality
    Maraviroc Exposed Maraviroc Unexposed
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 75/1316 (5.7%) 79/1130 (7%)
    Serious Adverse Events
    Maraviroc Exposed Maraviroc Unexposed
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 435/1316 (33.1%) 352/1130 (31.2%)
    Blood and lymphatic system disorders
    Anaemia 11/1316 (0.8%) 14/1130 (1.2%)
    Anaemia macrocytic 0/1316 (0%) 1/1130 (0.1%)
    Anaemia of chronic disease 0/1316 (0%) 1/1130 (0.1%)
    Eosinophilia 1/1316 (0.1%) 0/1130 (0%)
    Febrile neutropenia 4/1316 (0.3%) 2/1130 (0.2%)
    Haemolysis 1/1316 (0.1%) 0/1130 (0%)
    Haemolytic anaemia 2/1316 (0.2%) 0/1130 (0%)
    Haemorrhagic anaemia 1/1316 (0.1%) 0/1130 (0%)
    Heparin-induced thrombocytopenia 0/1316 (0%) 1/1130 (0.1%)
    Iron deficiency anaemia 2/1316 (0.2%) 1/1130 (0.1%)
    Leukocytosis 0/1316 (0%) 1/1130 (0.1%)
    Leukopenia 2/1316 (0.2%) 0/1130 (0%)
    Lymphadenopathy 3/1316 (0.2%) 2/1130 (0.2%)
    Lymphocytosis 0/1316 (0%) 1/1130 (0.1%)
    Methaemoglobinaemia 0/1316 (0%) 1/1130 (0.1%)
    Neutropenia 3/1316 (0.2%) 2/1130 (0.2%)
    Pancytopenia 3/1316 (0.2%) 5/1130 (0.4%)
    Sickle cell anaemia with crisis 0/1316 (0%) 1/1130 (0.1%)
    Splenomegaly 1/1316 (0.1%) 0/1130 (0%)
    Thrombocytopenia 3/1316 (0.2%) 2/1130 (0.2%)
    Thrombotic thrombocytopenic purpura 0/1316 (0%) 1/1130 (0.1%)
    Cardiac disorders
    Acute coronary syndrome 2/1316 (0.2%) 1/1130 (0.1%)
    Acute myocardial infarction 7/1316 (0.5%) 6/1130 (0.5%)
    Angina pectoris 2/1316 (0.2%) 1/1130 (0.1%)
    Angina unstable 1/1316 (0.1%) 1/1130 (0.1%)
    Arrhythmia 0/1316 (0%) 1/1130 (0.1%)
    Arteriosclerosis coronary artery 1/1316 (0.1%) 0/1130 (0%)
    Atrial fibrillation 4/1316 (0.3%) 6/1130 (0.5%)
    Bradycardia 1/1316 (0.1%) 0/1130 (0%)
    Cardiac arrest 5/1316 (0.4%) 2/1130 (0.2%)
    Cardiac failure 4/1316 (0.3%) 1/1130 (0.1%)
    Cardiac failure congestive 5/1316 (0.4%) 11/1130 (1%)
    Cardiac valve disease 1/1316 (0.1%) 0/1130 (0%)
    Cardiac ventricular thrombosis 0/1316 (0%) 1/1130 (0.1%)
    Cardio-respiratory arrest 4/1316 (0.3%) 1/1130 (0.1%)
    Cardiogenic shock 2/1316 (0.2%) 0/1130 (0%)
    Cardiomyopathy 0/1316 (0%) 2/1130 (0.2%)
    Congestive cardiomyopathy 0/1316 (0%) 2/1130 (0.2%)
    Coronary artery disease 6/1316 (0.5%) 4/1130 (0.4%)
    Coronary artery stenosis 0/1316 (0%) 1/1130 (0.1%)
    Left ventricular dysfunction 0/1316 (0%) 1/1130 (0.1%)
    Left ventricular failure 2/1316 (0.2%) 3/1130 (0.3%)
    Myocardial infarction 16/1316 (1.2%) 12/1130 (1.1%)
    Myocardial ischaemia 3/1316 (0.2%) 1/1130 (0.1%)
    Myocarditis 0/1316 (0%) 1/1130 (0.1%)
    Palpitations 0/1316 (0%) 1/1130 (0.1%)
    Pericarditis 1/1316 (0.1%) 1/1130 (0.1%)
    Supraventricular tachycardia 0/1316 (0%) 2/1130 (0.2%)
    Tachycardia 0/1316 (0%) 1/1130 (0.1%)
    Torsade de pointes 1/1316 (0.1%) 0/1130 (0%)
    Congenital, familial and genetic disorders
    Fanconi syndrome 1/1316 (0.1%) 1/1130 (0.1%)
    Sickle cell disease 0/1316 (0%) 1/1130 (0.1%)
    Ear and labyrinth disorders
    Deafness bilateral 0/1316 (0%) 1/1130 (0.1%)
    Tympanic membrane perforation 0/1316 (0%) 1/1130 (0.1%)
    Vertigo 1/1316 (0.1%) 2/1130 (0.2%)
    Vertigo positional 1/1316 (0.1%) 0/1130 (0%)
    Endocrine disorders
    Adrenal insufficiency 3/1316 (0.2%) 1/1130 (0.1%)
    Adrenal mass 1/1316 (0.1%) 0/1130 (0%)
    Autoimmune hypothyroidism 1/1316 (0.1%) 0/1130 (0%)
    Hypothyroidism 1/1316 (0.1%) 1/1130 (0.1%)
    Eye disorders
    Cataract 4/1316 (0.3%) 0/1130 (0%)
    Central vision loss 1/1316 (0.1%) 0/1130 (0%)
    Iridocyclitis 1/1316 (0.1%) 0/1130 (0%)
    Orbital cyst 0/1316 (0%) 1/1130 (0.1%)
    Pupils unequal 1/1316 (0.1%) 0/1130 (0%)
    Uveitis 1/1316 (0.1%) 1/1130 (0.1%)
    Vision blurred 0/1316 (0%) 1/1130 (0.1%)
    Gastrointestinal disorders
    Abdominal distension 1/1316 (0.1%) 1/1130 (0.1%)
    Abdominal hernia 1/1316 (0.1%) 0/1130 (0%)
    Abdominal pain 8/1316 (0.6%) 11/1130 (1%)
    Abdominal pain lower 1/1316 (0.1%) 0/1130 (0%)
    Abdominal pain upper 0/1316 (0%) 1/1130 (0.1%)
    Abdominal wall haematoma 1/1316 (0.1%) 0/1130 (0%)
    Anal fissure 1/1316 (0.1%) 0/1130 (0%)
    Anal fistula 1/1316 (0.1%) 1/1130 (0.1%)
    Anal skin tags 1/1316 (0.1%) 0/1130 (0%)
    Anogenital dysplasia 1/1316 (0.1%) 0/1130 (0%)
    Anorectal disorder 1/1316 (0.1%) 0/1130 (0%)
    Aphthous ulcer 0/1316 (0%) 1/1130 (0.1%)
    Ascites 4/1316 (0.3%) 3/1130 (0.3%)
    Barrett's oesophagus 1/1316 (0.1%) 0/1130 (0%)
    Colitis 2/1316 (0.2%) 2/1130 (0.2%)
    Constipation 5/1316 (0.4%) 2/1130 (0.2%)
    Crohn's disease 1/1316 (0.1%) 0/1130 (0%)
    Diarrhoea 10/1316 (0.8%) 13/1130 (1.2%)
    Diverticulum 1/1316 (0.1%) 0/1130 (0%)
    Duodenal ulcer 0/1316 (0%) 1/1130 (0.1%)
    Duodenal ulcer haemorrhage 1/1316 (0.1%) 0/1130 (0%)
    Duodenitis 0/1316 (0%) 1/1130 (0.1%)
    Dyspepsia 0/1316 (0%) 2/1130 (0.2%)
    Dysphagia 2/1316 (0.2%) 1/1130 (0.1%)
    Faeces discoloured 0/1316 (0%) 1/1130 (0.1%)
    Gastritis 2/1316 (0.2%) 3/1130 (0.3%)
    Gastrointestinal disorder 1/1316 (0.1%) 0/1130 (0%)
    Gastrointestinal haemorrhage 4/1316 (0.3%) 1/1130 (0.1%)
    Gastrointestinal inflammation 0/1316 (0%) 1/1130 (0.1%)
    Gastrooesophageal reflux disease 1/1316 (0.1%) 2/1130 (0.2%)
    Haematemesis 1/1316 (0.1%) 1/1130 (0.1%)
    Haematochezia 1/1316 (0.1%) 0/1130 (0%)
    Haemorrhoidal haemorrhage 1/1316 (0.1%) 0/1130 (0%)
    Haemorrhoids 1/1316 (0.1%) 0/1130 (0%)
    Haemorrhoids thrombosed 1/1316 (0.1%) 0/1130 (0%)
    Ileus 1/1316 (0.1%) 1/1130 (0.1%)
    Inguinal hernia 4/1316 (0.3%) 2/1130 (0.2%)
    Intestinal ischaemia 2/1316 (0.2%) 0/1130 (0%)
    Intestinal mass 0/1316 (0%) 1/1130 (0.1%)
    Intestinal obstruction 1/1316 (0.1%) 0/1130 (0%)
    Intestinal perforation 0/1316 (0%) 1/1130 (0.1%)
    Intussusception 0/1316 (0%) 1/1130 (0.1%)
    Irritable bowel syndrome 0/1316 (0%) 1/1130 (0.1%)
    Large intestine perforation 2/1316 (0.2%) 0/1130 (0%)
    Melaena 1/1316 (0.1%) 0/1130 (0%)
    Nausea 4/1316 (0.3%) 2/1130 (0.2%)
    Odynophagia 1/1316 (0.1%) 0/1130 (0%)
    Oesophageal haemorrhage 1/1316 (0.1%) 0/1130 (0%)
    Oesophageal rupture 1/1316 (0.1%) 0/1130 (0%)
    Oesophageal stenosis 1/1316 (0.1%) 0/1130 (0%)
    Oesophageal ulcer 1/1316 (0.1%) 1/1130 (0.1%)
    Oesophagitis 1/1316 (0.1%) 0/1130 (0%)
    Oral pain 1/1316 (0.1%) 0/1130 (0%)
    Pancreatic pseudocyst 1/1316 (0.1%) 0/1130 (0%)
    Pancreatitis 6/1316 (0.5%) 2/1130 (0.2%)
    Pancreatitis acute 1/1316 (0.1%) 6/1130 (0.5%)
    Pancreatitis chronic 1/1316 (0.1%) 0/1130 (0%)
    Proctalgia 1/1316 (0.1%) 0/1130 (0%)
    Proctitis 0/1316 (0%) 2/1130 (0.2%)
    Proctitis ulcerative 0/1316 (0%) 1/1130 (0.1%)
    Rectal haemorrhage 0/1316 (0%) 2/1130 (0.2%)
    Rectal perforation 1/1316 (0.1%) 0/1130 (0%)
    Rectal prolapse 0/1316 (0%) 1/1130 (0.1%)
    Small intestinal obstruction 4/1316 (0.3%) 3/1130 (0.3%)
    Umbilical hernia 1/1316 (0.1%) 0/1130 (0%)
    Upper gastrointestinal haemorrhage 2/1316 (0.2%) 2/1130 (0.2%)
    Varices oesophageal 0/1316 (0%) 1/1130 (0.1%)
    Vomiting 4/1316 (0.3%) 4/1130 (0.4%)
    General disorders
    Asthenia 1/1316 (0.1%) 5/1130 (0.4%)
    Chest pain 16/1316 (1.2%) 15/1130 (1.3%)
    Chills 0/1316 (0%) 1/1130 (0.1%)
    Death 10/1316 (0.8%) 6/1130 (0.5%)
    Dysplasia 1/1316 (0.1%) 1/1130 (0.1%)
    Fatigue 0/1316 (0%) 1/1130 (0.1%)
    Gait disturbance 2/1316 (0.2%) 0/1130 (0%)
    General physical health deterioration 2/1316 (0.2%) 1/1130 (0.1%)
    Generalised oedema 1/1316 (0.1%) 0/1130 (0%)
    Hypothermia 0/1316 (0%) 1/1130 (0.1%)
    Malaise 1/1316 (0.1%) 0/1130 (0%)
    Mucosal inflammation 1/1316 (0.1%) 0/1130 (0%)
    Multi-organ disorder 0/1316 (0%) 1/1130 (0.1%)
    Multiple organ dysfunction syndrome 2/1316 (0.2%) 1/1130 (0.1%)
    Oedema peripheral 1/1316 (0.1%) 0/1130 (0%)
    Pain 1/1316 (0.1%) 0/1130 (0%)
    Physical deconditioning 1/1316 (0.1%) 0/1130 (0%)
    Pyrexia 8/1316 (0.6%) 11/1130 (1%)
    Sudden cardiac death 1/1316 (0.1%) 1/1130 (0.1%)
    Sudden death 1/1316 (0.1%) 0/1130 (0%)
    Systemic inflammatory response syndrome 0/1316 (0%) 1/1130 (0.1%)
    Treatment noncompliance 2/1316 (0.2%) 1/1130 (0.1%)
    Ulcer 1/1316 (0.1%) 0/1130 (0%)
    Hepatobiliary disorders
    Acute hepatic failure 1/1316 (0.1%) 0/1130 (0%)
    Bile duct stone 1/1316 (0.1%) 1/1130 (0.1%)
    Biliary dilatation 1/1316 (0.1%) 0/1130 (0%)
    Cholecystitis 2/1316 (0.2%) 1/1130 (0.1%)
    Cholecystitis acute 0/1316 (0%) 3/1130 (0.3%)
    Cholelithiasis 4/1316 (0.3%) 1/1130 (0.1%)
    Hepatic cirrhosis 4/1316 (0.3%) 2/1130 (0.2%)
    Hepatic failure 3/1316 (0.2%) 4/1130 (0.4%)
    Hepatitis alcoholic 0/1316 (0%) 2/1130 (0.2%)
    Hepatitis toxic 1/1316 (0.1%) 0/1130 (0%)
    Hepatorenal syndrome 1/1316 (0.1%) 1/1130 (0.1%)
    Jaundice 1/1316 (0.1%) 0/1130 (0%)
    Immune system disorders
    Drug hypersensitivity 1/1316 (0.1%) 1/1130 (0.1%)
    Hypersensitivity 0/1316 (0%) 1/1130 (0.1%)
    Jarisch-Herxheimer reaction 0/1316 (0%) 1/1130 (0.1%)
    Infections and infestations
    AIDS related complication 1/1316 (0.1%) 0/1130 (0%)
    AIDS retinopathy 1/1316 (0.1%) 0/1130 (0%)
    Abdominal abscess 1/1316 (0.1%) 0/1130 (0%)
    Abdominal sepsis 1/1316 (0.1%) 0/1130 (0%)
    Abscess 2/1316 (0.2%) 1/1130 (0.1%)
    Abscess limb 0/1316 (0%) 4/1130 (0.4%)
    Acquired immunodeficiency syndrome 2/1316 (0.2%) 6/1130 (0.5%)
    Acute hepatitis C 1/1316 (0.1%) 0/1130 (0%)
    Acute sinusitis 1/1316 (0.1%) 2/1130 (0.2%)
    Amoebiasis 1/1316 (0.1%) 2/1130 (0.2%)
    Amoebic dysentery 0/1316 (0%) 2/1130 (0.2%)
    Anal abscess 0/1316 (0%) 2/1130 (0.2%)
    Anorectal cellulitis 1/1316 (0.1%) 0/1130 (0%)
    Appendicitis 7/1316 (0.5%) 4/1130 (0.4%)
    Arthritis bacterial 1/1316 (0.1%) 2/1130 (0.2%)
    Aspergillus infection 0/1316 (0%) 1/1130 (0.1%)
    Atypical mycobacterial infection 1/1316 (0.1%) 0/1130 (0%)
    Bacteraemia 2/1316 (0.2%) 5/1130 (0.4%)
    Bacterial diarrhoea 1/1316 (0.1%) 1/1130 (0.1%)
    Bacterial infection 1/1316 (0.1%) 0/1130 (0%)
    Brain abscess 1/1316 (0.1%) 0/1130 (0%)
    Breast abscess 0/1316 (0%) 2/1130 (0.2%)
    Bronchiolitis 1/1316 (0.1%) 1/1130 (0.1%)
    Bronchitis 10/1316 (0.8%) 6/1130 (0.5%)
    Bronchitis viral 1/1316 (0.1%) 0/1130 (0%)
    Burkholderia cepacia complex sepsis 0/1316 (0%) 1/1130 (0.1%)
    CNS ventriculitis 1/1316 (0.1%) 0/1130 (0%)
    Campylobacter gastroenteritis 2/1316 (0.2%) 0/1130 (0%)
    Campylobacter infection 1/1316 (0.1%) 0/1130 (0%)
    Candida infection 0/1316 (0%) 2/1130 (0.2%)
    Cellulitis 12/1316 (0.9%) 18/1130 (1.6%)
    Cellulitis staphylococcal 0/1316 (0%) 1/1130 (0.1%)
    Cerebral toxoplasmosis 0/1316 (0%) 1/1130 (0.1%)
    Clostridium difficile colitis 1/1316 (0.1%) 3/1130 (0.3%)
    Clostridium difficile infection 0/1316 (0%) 4/1130 (0.4%)
    Corneal abscess 1/1316 (0.1%) 0/1130 (0%)
    Cryptococcal fungaemia 0/1316 (0%) 1/1130 (0.1%)
    Cryptococcosis 0/1316 (0%) 1/1130 (0.1%)
    Cryptosporidiosis infection 0/1316 (0%) 1/1130 (0.1%)
    Cytomegalovirus chorioretinitis 1/1316 (0.1%) 1/1130 (0.1%)
    Cytomegalovirus colitis 1/1316 (0.1%) 0/1130 (0%)
    Cytomegalovirus infection 0/1316 (0%) 2/1130 (0.2%)
    Cytomegalovirus viraemia 1/1316 (0.1%) 1/1130 (0.1%)
    Device related infection 1/1316 (0.1%) 1/1130 (0.1%)
    Device related sepsis 0/1316 (0%) 1/1130 (0.1%)
    Diabetic foot infection 1/1316 (0.1%) 0/1130 (0%)
    Diverticulitis 2/1316 (0.2%) 0/1130 (0%)
    Empyema 1/1316 (0.1%) 1/1130 (0.1%)
    Encephalitis 1/1316 (0.1%) 0/1130 (0%)
    End stage AIDS 1/1316 (0.1%) 1/1130 (0.1%)
    Endocarditis 1/1316 (0.1%) 2/1130 (0.2%)
    Enterococcal sepsis 0/1316 (0%) 1/1130 (0.1%)
    Epididymitis 0/1316 (0%) 1/1130 (0.1%)
    Erysipelas 2/1316 (0.2%) 1/1130 (0.1%)
    Escherichia bacteraemia 1/1316 (0.1%) 2/1130 (0.2%)
    Escherichia urinary tract infection 0/1316 (0%) 3/1130 (0.3%)
    External ear cellulitis 1/1316 (0.1%) 1/1130 (0.1%)
    Eye infection syphilitic 1/1316 (0.1%) 1/1130 (0.1%)
    Folliculitis 0/1316 (0%) 1/1130 (0.1%)
    Fungal infection 0/1316 (0%) 1/1130 (0.1%)
    Fungal oesophagitis 1/1316 (0.1%) 1/1130 (0.1%)
    Furuncle 0/1316 (0%) 1/1130 (0.1%)
    Gangrene 0/1316 (0%) 2/1130 (0.2%)
    Gastroenteritis 7/1316 (0.5%) 11/1130 (1%)
    Gastroenteritis bacterial 0/1316 (0%) 1/1130 (0.1%)
    Gastroenteritis clostridial 1/1316 (0.1%) 0/1130 (0%)
    Gastroenteritis cryptosporidial 0/1316 (0%) 1/1130 (0.1%)
    Gastroenteritis salmonella 0/1316 (0%) 2/1130 (0.2%)
    Gastroenteritis viral 0/1316 (0%) 2/1130 (0.2%)
    Genital herpes 2/1316 (0.2%) 1/1130 (0.1%)
    Genital herpes simplex 1/1316 (0.1%) 2/1130 (0.2%)
    Giardiasis 1/1316 (0.1%) 0/1130 (0%)
    Gonorrhoea 1/1316 (0.1%) 0/1130 (0%)
    HIV enteropathy 1/1316 (0.1%) 0/1130 (0%)
    HIV infection 0/1316 (0%) 2/1130 (0.2%)
    HIV wasting syndrome 1/1316 (0.1%) 2/1130 (0.2%)
    HIV-associated neurocognitive disorder 3/1316 (0.2%) 2/1130 (0.2%)
    Helicobacter gastritis 1/1316 (0.1%) 0/1130 (0%)
    Helicobacter infection 1/1316 (0.1%) 2/1130 (0.2%)
    Hepatitis B reactivation 1/1316 (0.1%) 0/1130 (0%)
    Hepatitis C 0/1316 (0%) 2/1130 (0.2%)
    Herpes pharyngitis 1/1316 (0.1%) 0/1130 (0%)
    Herpes simplex 1/1316 (0.1%) 4/1130 (0.4%)
    Herpes virus infection 1/1316 (0.1%) 0/1130 (0%)
    Herpes zoster 5/1316 (0.4%) 4/1130 (0.4%)
    Herpes zoster disseminated 0/1316 (0%) 1/1130 (0.1%)
    Histoplasmosis 1/1316 (0.1%) 2/1130 (0.2%)
    Infectious colitis 0/1316 (0%) 1/1130 (0.1%)
    Infective exacerbation of bronchiectasis 0/1316 (0%) 1/1130 (0.1%)
    Influenza 4/1316 (0.3%) 3/1130 (0.3%)
    Intervertebral discitis 1/1316 (0.1%) 0/1130 (0%)
    Joint abscess 0/1316 (0%) 1/1130 (0.1%)
    Klebsiella sepsis 0/1316 (0%) 2/1130 (0.2%)
    Latent syphilis 1/1316 (0.1%) 0/1130 (0%)
    Lower respiratory tract infection 3/1316 (0.2%) 3/1130 (0.3%)
    Lung infection 1/1316 (0.1%) 0/1130 (0%)
    Meningitis 3/1316 (0.2%) 1/1130 (0.1%)
    Meningitis aseptic 1/1316 (0.1%) 2/1130 (0.2%)
    Meningitis cryptococcal 0/1316 (0%) 4/1130 (0.4%)
    Meningitis streptococcal 0/1316 (0%) 1/1130 (0.1%)
    Meningitis tuberculous 0/1316 (0%) 1/1130 (0.1%)
    Microsporidia infection 0/1316 (0%) 1/1130 (0.1%)
    Mycobacterial infection 2/1316 (0.2%) 0/1130 (0%)
    Mycobacterium abscessus infection 1/1316 (0.1%) 0/1130 (0%)
    Mycobacterium avium complex infection 0/1316 (0%) 4/1130 (0.4%)
    Mycobacterium fortuitum infection 0/1316 (0%) 1/1130 (0.1%)
    Neurosyphilis 2/1316 (0.2%) 2/1130 (0.2%)
    Neutropenic sepsis 1/1316 (0.1%) 0/1130 (0%)
    Oesophageal candidiasis 2/1316 (0.2%) 8/1130 (0.7%)
    Oral candidiasis 3/1316 (0.2%) 3/1130 (0.3%)
    Oral hairy leukoplakia 0/1316 (0%) 1/1130 (0.1%)
    Oral herpes 0/1316 (0%) 1/1130 (0.1%)
    Orchitis 0/1316 (0%) 2/1130 (0.2%)
    Osteomyelitis 1/1316 (0.1%) 2/1130 (0.2%)
    Osteomyelitis chronic 0/1316 (0%) 1/1130 (0.1%)
    Otitis externa 0/1316 (0%) 1/1130 (0.1%)
    Otitis media 1/1316 (0.1%) 2/1130 (0.2%)
    Parvovirus infection 1/1316 (0.1%) 0/1130 (0%)
    Perirectal abscess 0/1316 (0%) 3/1130 (0.3%)
    Peritonitis 3/1316 (0.2%) 0/1130 (0%)
    Peritonitis bacterial 2/1316 (0.2%) 2/1130 (0.2%)
    Pharyngitis 0/1316 (0%) 2/1130 (0.2%)
    Pilonidal cyst 1/1316 (0.1%) 0/1130 (0%)
    Pneumococcal sepsis 2/1316 (0.2%) 0/1130 (0%)
    Pneumocystis jirovecii pneumonia 9/1316 (0.7%) 13/1130 (1.2%)
    Pneumonia 51/1316 (3.9%) 54/1130 (4.8%)
    Pneumonia bacterial 1/1316 (0.1%) 4/1130 (0.4%)
    Pneumonia influenzal 0/1316 (0%) 1/1130 (0.1%)
    Pneumonia legionella 1/1316 (0.1%) 0/1130 (0%)
    Pneumonia necrotising 1/1316 (0.1%) 0/1130 (0%)
    Pneumonia pneumococcal 1/1316 (0.1%) 2/1130 (0.2%)
    Pneumonia pseudomonal 0/1316 (0%) 1/1130 (0.1%)
    Pneumonia staphylococcal 2/1316 (0.2%) 1/1130 (0.1%)
    Pneumonia streptococcal 1/1316 (0.1%) 2/1130 (0.2%)
    Post procedural infection 1/1316 (0.1%) 0/1130 (0%)
    Postoperative wound infection 1/1316 (0.1%) 1/1130 (0.1%)
    Progressive multifocal leukoencephalopathy 1/1316 (0.1%) 2/1130 (0.2%)
    Pyelonephritis 2/1316 (0.2%) 5/1130 (0.4%)
    Pyelonephritis acute 0/1316 (0%) 3/1130 (0.3%)
    Rectal abscess 1/1316 (0.1%) 0/1130 (0%)
    Respiratory tract infection 2/1316 (0.2%) 2/1130 (0.2%)
    Salmonella sepsis 0/1316 (0%) 1/1130 (0.1%)
    Secondary syphilis 1/1316 (0.1%) 1/1130 (0.1%)
    Sepsis 11/1316 (0.8%) 11/1130 (1%)
    Sepsis syndrome 0/1316 (0%) 1/1130 (0.1%)
    Septic embolus 1/1316 (0.1%) 0/1130 (0%)
    Septic shock 5/1316 (0.4%) 3/1130 (0.3%)
    Shigella infection 1/1316 (0.1%) 1/1130 (0.1%)
    Sinusitis 3/1316 (0.2%) 3/1130 (0.3%)
    Sinusitis bacterial 0/1316 (0%) 1/1130 (0.1%)
    Sinusitis fungal 1/1316 (0.1%) 0/1130 (0%)
    Staphylococcal abscess 0/1316 (0%) 1/1130 (0.1%)
    Staphylococcal bacteraemia 1/1316 (0.1%) 3/1130 (0.3%)
    Staphylococcal infection 3/1316 (0.2%) 4/1130 (0.4%)
    Staphylococcal skin infection 0/1316 (0%) 1/1130 (0.1%)
    Streptococcal bacteraemia 1/1316 (0.1%) 0/1130 (0%)
    Subcutaneous abscess 1/1316 (0.1%) 4/1130 (0.4%)
    Superinfection bacterial 0/1316 (0%) 1/1130 (0.1%)
    Syphilis 3/1316 (0.2%) 1/1130 (0.1%)
    Syphilis anal 1/1316 (0.1%) 0/1130 (0%)
    Tonsillitis 0/1316 (0%) 1/1130 (0.1%)
    Tooth abscess 0/1316 (0%) 1/1130 (0.1%)
    Toxoplasmosis 0/1316 (0%) 1/1130 (0.1%)
    Trichomoniasis 1/1316 (0.1%) 1/1130 (0.1%)
    Tuberculosis 1/1316 (0.1%) 0/1130 (0%)
    Upper respiratory tract infection 2/1316 (0.2%) 1/1130 (0.1%)
    Urinary tract infection 10/1316 (0.8%) 8/1130 (0.7%)
    Urinary tract infection pseudomonal 1/1316 (0.1%) 0/1130 (0%)
    Urosepsis 2/1316 (0.2%) 1/1130 (0.1%)
    Vaginal infection 0/1316 (0%) 1/1130 (0.1%)
    Vascular device infection 0/1316 (0%) 1/1130 (0.1%)
    Viral infection 0/1316 (0%) 1/1130 (0.1%)
    Vulval abscess 1/1316 (0.1%) 0/1130 (0%)
    Vulvovaginal mycotic infection 0/1316 (0%) 1/1130 (0.1%)
    Injury, poisoning and procedural complications
    Accident 1/1316 (0.1%) 0/1130 (0%)
    Alcohol poisoning 3/1316 (0.2%) 1/1130 (0.1%)
    Breast injury 0/1316 (0%) 1/1130 (0.1%)
    Chest injury 1/1316 (0.1%) 0/1130 (0%)
    Clavicle fracture 1/1316 (0.1%) 1/1130 (0.1%)
    Compression fracture 0/1316 (0%) 1/1130 (0.1%)
    Concussion 0/1316 (0%) 1/1130 (0.1%)
    Craniocerebral injury 1/1316 (0.1%) 2/1130 (0.2%)
    Facial bones fracture 1/1316 (0.1%) 0/1130 (0%)
    Fall 6/1316 (0.5%) 1/1130 (0.1%)
    Femoral neck fracture 1/1316 (0.1%) 0/1130 (0%)
    Femur fracture 2/1316 (0.2%) 0/1130 (0%)
    Fibula fracture 0/1316 (0%) 1/1130 (0.1%)
    Foot fracture 0/1316 (0%) 1/1130 (0.1%)
    Foreign body in gastrointestinal tract 0/1316 (0%) 1/1130 (0.1%)
    Foreign body in respiratory tract 1/1316 (0.1%) 0/1130 (0%)
    Fractured sacrum 1/1316 (0.1%) 0/1130 (0%)
    Gastrointestinal stoma necrosis 1/1316 (0.1%) 0/1130 (0%)
    Hand fracture 1/1316 (0.1%) 0/1130 (0%)
    Head injury 2/1316 (0.2%) 0/1130 (0%)
    Hip fracture 1/1316 (0.1%) 1/1130 (0.1%)
    Humerus fracture 3/1316 (0.2%) 2/1130 (0.2%)
    Intentional overdose 1/1316 (0.1%) 0/1130 (0%)
    Jaw fracture 1/1316 (0.1%) 0/1130 (0%)
    Limb injury 0/1316 (0%) 1/1130 (0.1%)
    Lower limb fracture 1/1316 (0.1%) 2/1130 (0.2%)
    Lumbar vertebral fracture 1/1316 (0.1%) 0/1130 (0%)
    Meniscus injury 0/1316 (0%) 1/1130 (0.1%)
    Multiple injuries 2/1316 (0.2%) 0/1130 (0%)
    Overdose 7/1316 (0.5%) 3/1130 (0.3%)
    Patella fracture 0/1316 (0%) 1/1130 (0.1%)
    Periorbital haematoma 0/1316 (0%) 1/1130 (0.1%)
    Post procedural haematoma 0/1316 (0%) 2/1130 (0.2%)
    Post procedural haemorrhage 1/1316 (0.1%) 0/1130 (0%)
    Pubis fracture 1/1316 (0.1%) 0/1130 (0%)
    Radial nerve injury 0/1316 (0%) 1/1130 (0.1%)
    Rib fracture 3/1316 (0.2%) 0/1130 (0%)
    Road traffic accident 1/1316 (0.1%) 0/1130 (0%)
    Spinal fracture 1/1316 (0.1%) 0/1130 (0%)
    Splenic injury 1/1316 (0.1%) 0/1130 (0%)
    Subdural haematoma 1/1316 (0.1%) 0/1130 (0%)
    Tibia fracture 1/1316 (0.1%) 2/1130 (0.2%)
    Toxicity to various agents 3/1316 (0.2%) 1/1130 (0.1%)
    Traumatic liver injury 0/1316 (0%) 1/1130 (0.1%)
    Upper limb fracture 0/1316 (0%) 1/1130 (0.1%)
    Vascular graft thrombosis 1/1316 (0.1%) 0/1130 (0%)
    Wound 1/1316 (0.1%) 0/1130 (0%)
    Wound dehiscence 0/1316 (0%) 1/1130 (0.1%)
    Wrist fracture 1/1316 (0.1%) 0/1130 (0%)
    Investigations
    Atypical mycobacterium test positive 1/1316 (0.1%) 0/1130 (0%)
    Biopsy lymph gland 1/1316 (0.1%) 0/1130 (0%)
    Blood creatine phosphokinase increased 1/1316 (0.1%) 0/1130 (0%)
    Blood potassium decreased 1/1316 (0.1%) 0/1130 (0%)
    Body temperature increased 1/1316 (0.1%) 0/1130 (0%)
    Culture stool positive 0/1316 (0%) 1/1130 (0.1%)
    Drug clearance increased 1/1316 (0.1%) 0/1130 (0%)
    Electrocardiogram repolarisation abnormality 1/1316 (0.1%) 0/1130 (0%)
    HIV test positive 0/1316 (0%) 1/1130 (0.1%)
    Haemophilus test positive 0/1316 (0%) 1/1130 (0.1%)
    Hepatic enzyme increased 1/1316 (0.1%) 0/1130 (0%)
    Liver function test abnormal 1/1316 (0.1%) 0/1130 (0%)
    Liver function test increased 0/1316 (0%) 1/1130 (0.1%)
    Staphylococcus test 1/1316 (0.1%) 0/1130 (0%)
    Staphylococcus test positive 0/1316 (0%) 1/1130 (0.1%)
    Transaminases increased 1/1316 (0.1%) 1/1130 (0.1%)
    Weight decreased 2/1316 (0.2%) 1/1130 (0.1%)
    Metabolism and nutrition disorders
    Alcoholic ketoacidosis 1/1316 (0.1%) 0/1130 (0%)
    Cachexia 2/1316 (0.2%) 2/1130 (0.2%)
    Decreased appetite 0/1316 (0%) 1/1130 (0.1%)
    Dehydration 5/1316 (0.4%) 7/1130 (0.6%)
    Diabetes mellitus 3/1316 (0.2%) 2/1130 (0.2%)
    Diabetic ketoacidosis 1/1316 (0.1%) 1/1130 (0.1%)
    Electrolyte depletion 0/1316 (0%) 1/1130 (0.1%)
    Electrolyte imbalance 0/1316 (0%) 2/1130 (0.2%)
    Failure to thrive 1/1316 (0.1%) 1/1130 (0.1%)
    Fluid overload 0/1316 (0%) 4/1130 (0.4%)
    Folate deficiency 1/1316 (0.1%) 0/1130 (0%)
    Gout 0/1316 (0%) 1/1130 (0.1%)
    Haemochromatosis 1/1316 (0.1%) 0/1130 (0%)
    Hypercalcaemia 1/1316 (0.1%) 0/1130 (0%)
    Hyperglycaemia 1/1316 (0.1%) 0/1130 (0%)
    Hyperkalaemia 1/1316 (0.1%) 6/1130 (0.5%)
    Hyperlipidaemia 0/1316 (0%) 1/1130 (0.1%)
    Hypernatraemia 0/1316 (0%) 1/1130 (0.1%)
    Hypocalcaemia 1/1316 (0.1%) 1/1130 (0.1%)
    Hypoglycaemia 0/1316 (0%) 2/1130 (0.2%)
    Hypokalaemia 0/1316 (0%) 3/1130 (0.3%)
    Hypomagnesaemia 0/1316 (0%) 1/1130 (0.1%)
    Hyponatraemia 4/1316 (0.3%) 4/1130 (0.4%)
    Hypovolaemia 1/1316 (0.1%) 0/1130 (0%)
    Lactic acidosis 5/1316 (0.4%) 2/1130 (0.2%)
    Malnutrition 1/1316 (0.1%) 0/1130 (0%)
    Metabolic acidosis 0/1316 (0%) 2/1130 (0.2%)
    Type 2 diabetes mellitus 1/1316 (0.1%) 0/1130 (0%)
    Vitamin D deficiency 1/1316 (0.1%) 0/1130 (0%)
    Musculoskeletal and connective tissue disorders
    Arthritis 0/1316 (0%) 2/1130 (0.2%)
    Arthritis reactive 1/1316 (0.1%) 0/1130 (0%)
    Arthropathy 1/1316 (0.1%) 0/1130 (0%)
    Back pain 2/1316 (0.2%) 1/1130 (0.1%)
    Bursitis 0/1316 (0%) 1/1130 (0.1%)
    Costochondritis 1/1316 (0.1%) 0/1130 (0%)
    Diastasis recti abdominis 1/1316 (0.1%) 0/1130 (0%)
    Fistula 1/1316 (0.1%) 0/1130 (0%)
    Flank pain 0/1316 (0%) 1/1130 (0.1%)
    Intervertebral disc protrusion 2/1316 (0.2%) 1/1130 (0.1%)
    Lumbar spinal stenosis 1/1316 (0.1%) 0/1130 (0%)
    Musculoskeletal chest pain 2/1316 (0.2%) 1/1130 (0.1%)
    Musculoskeletal pain 0/1316 (0%) 1/1130 (0.1%)
    Myalgia 1/1316 (0.1%) 0/1130 (0%)
    Myositis 1/1316 (0.1%) 0/1130 (0%)
    Neck pain 1/1316 (0.1%) 1/1130 (0.1%)
    Osteoarthritis 4/1316 (0.3%) 1/1130 (0.1%)
    Osteonecrosis 2/1316 (0.2%) 2/1130 (0.2%)
    Pain in extremity 2/1316 (0.2%) 1/1130 (0.1%)
    Pseudarthrosis 0/1316 (0%) 1/1130 (0.1%)
    Rhabdomyolysis 3/1316 (0.2%) 1/1130 (0.1%)
    Spinal column stenosis 1/1316 (0.1%) 1/1130 (0.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma 1/1316 (0.1%) 2/1130 (0.2%)
    Adenocarcinoma gastric 0/1316 (0%) 1/1130 (0.1%)
    Adenocarcinoma of colon 2/1316 (0.2%) 0/1130 (0%)
    Anal cancer 2/1316 (0.2%) 0/1130 (0%)
    Anal cancer stage 0 1/1316 (0.1%) 0/1130 (0%)
    Anal squamous cell carcinoma 1/1316 (0.1%) 0/1130 (0%)
    Anaplastic large cell lymphoma T- and null-cell types 1/1316 (0.1%) 0/1130 (0%)
    Anogenital warts 2/1316 (0.2%) 4/1130 (0.4%)
    B-cell lymphoma 0/1316 (0%) 1/1130 (0.1%)
    Basal cell carcinoma 2/1316 (0.2%) 0/1130 (0%)
    Bladder neoplasm 1/1316 (0.1%) 0/1130 (0%)
    Brain neoplasm malignant 0/1316 (0%) 1/1130 (0.1%)
    Breast cancer 1/1316 (0.1%) 2/1130 (0.2%)
    Burkitt's lymphoma 1/1316 (0.1%) 0/1130 (0%)
    Cancer pain 1/1316 (0.1%) 0/1130 (0%)
    Cervix carcinoma 3/1316 (0.2%) 2/1130 (0.2%)
    Cervix carcinoma stage 0 1/1316 (0.1%) 0/1130 (0%)
    Colon cancer 1/1316 (0.1%) 1/1130 (0.1%)
    Diffuse large B-cell lymphoma 1/1316 (0.1%) 1/1130 (0.1%)
    Diffuse large B-cell lymphoma recurrent 0/1316 (0%) 1/1130 (0.1%)
    Endometrial cancer 0/1316 (0%) 1/1130 (0.1%)
    Fibrous histiocytoma 1/1316 (0.1%) 0/1130 (0%)
    Gastric cancer 1/1316 (0.1%) 0/1130 (0%)
    Gastrointestinal lymphoma 1/1316 (0.1%) 0/1130 (0%)
    Haemangioma 1/1316 (0.1%) 0/1130 (0%)
    Hepatic cancer 1/1316 (0.1%) 2/1130 (0.2%)
    Hepatocellular carcinoma 1/1316 (0.1%) 1/1130 (0.1%)
    Hodgkin's disease 6/1316 (0.5%) 1/1130 (0.1%)
    Kaposi's sarcoma 1/1316 (0.1%) 3/1130 (0.3%)
    Leiomyoma 0/1316 (0%) 1/1130 (0.1%)
    Lipoma 0/1316 (0%) 1/1130 (0.1%)
    Lung adenocarcinoma 0/1316 (0%) 3/1130 (0.3%)
    Lung neoplasm malignant 1/1316 (0.1%) 2/1130 (0.2%)
    Lymphoma 1/1316 (0.1%) 1/1130 (0.1%)
    Lymphoproliferative disorder 0/1316 (0%) 1/1130 (0.1%)
    Malignant melanoma 1/1316 (0.1%) 0/1130 (0%)
    Malignant melanoma in situ 0/1316 (0%) 1/1130 (0.1%)
    Malignant melanoma stage II 0/1316 (0%) 1/1130 (0.1%)
    Malignant neoplasm of unknown primary site 1/1316 (0.1%) 0/1130 (0%)
    Metastases to liver 2/1316 (0.2%) 0/1130 (0%)
    Metastases to pleura 0/1316 (0%) 1/1130 (0.1%)
    Neoplasm prostate 1/1316 (0.1%) 0/1130 (0%)
    Non-Hodgkin's lymphoma 2/1316 (0.2%) 0/1130 (0%)
    Ocular neoplasm 1/1 (100%) 0/1130 (0%)
    Oesophageal adenocarcinoma 1/1316 (0.1%) 0/1130 (0%)
    Ovarian adenoma 0/1316 (0%) 1/1130 (0.1%)
    Ovarian germ cell teratoma benign 0/1316 (0%) 1/1130 (0.1%)
    Pancreatic carcinoma 2/1316 (0.2%) 2/1130 (0.2%)
    Pancreatic carcinoma recurrent 1/1316 (0.1%) 0/1130 (0%)
    Papillary cystadenoma lymphomatosum 1/1316 (0.1%) 0/1130 (0%)
    Papillary thyroid cancer 1/1316 (0.1%) 1/1130 (0.1%)
    Plasmablastic lymphoma 1/1316 (0.1%) 0/1130 (0%)
    Prostate cancer 1/1316 (0.1%) 2/1130 (0.2%)
    Prostatic adenoma 1/1316 (0.1%) 0/1130 (0%)
    Rectal adenocarcinoma 1/1316 (0.1%) 0/1130 (0%)
    Rectal cancer 2/1316 (0.2%) 0/1130 (0%)
    Rectal neoplasm 1/1316 (0.1%) 0/1130 (0%)
    Renal cancer 1/1316 (0.1%) 0/1130 (0%)
    Skin cancer 1/1316 (0.1%) 1/1130 (0.1%)
    Small cell carcinoma 1/1316 (0.1%) 0/1130 (0%)
    Small cell lung cancer 1/1316 (0.1%) 0/1130 (0%)
    Small cell lung cancer metastatic 0/1316 (0%) 1/1130 (0.1%)
    Squamous cell carcinoma 2/1316 (0.2%) 3/1130 (0.3%)
    Squamous cell carcinoma of the oral cavity 1/1316 (0.1%) 1/1130 (0.1%)
    Squamous cell carcinoma of the tongue 0/1316 (0%) 1/1130 (0.1%)
    T-cell lymphoma 0/1316 (0%) 1/1130 (0.1%)
    Thyroid cancer 1/1316 (0.1%) 0/1130 (0%)
    Tongue neoplasm malignant stage unspecified 1/1316 (0.1%) 0/1130 (0%)
    Uterine leiomyoma 1/1316 (0.1%) 2/1130 (0.2%)
    Vaginal cancer 2/1316 (0.2%) 0/1130 (0%)
    Vulval cancer 2/1316 (0.2%) 0/1130 (0%)
    Infected neoplasm 1/1316 (0.1%) 0/1130 (0%)
    Nervous system disorders
    Alcoholic seizure 1/1316 (0.1%) 0/1130 (0%)
    Amputation stump pain 1/1316 (0.1%) 0/1130 (0%)
    Balance disorder 1/1316 (0.1%) 1/1130 (0.1%)
    Carpal tunnel syndrome 0/1316 (0%) 1/1130 (0.1%)
    Cerebellar infarction 1/1316 (0.1%) 0/1130 (0%)
    Cerebral haemorrhage 1/1316 (0.1%) 1/1130 (0.1%)
    Cerebral infarction 1/1316 (0.1%) 0/1130 (0%)
    Cerebral ischaemia 2/1316 (0.2%) 0/1130 (0%)
    Cerebrovascular accident 7/1316 (0.5%) 4/1130 (0.4%)
    Clonic convulsion 1/1316 (0.1%) 0/1130 (0%)
    Cranial nerve palsies multiple 1/1316 (0.1%) 0/1130 (0%)
    Dementia 1/1316 (0.1%) 0/1130 (0%)
    Depressed level of consciousness 0/1316 (0%) 1/1130 (0.1%)
    Diabetic hyperglycaemic coma 1/1316 (0.1%) 0/1130 (0%)
    Diabetic neuropathy 0/1316 (0%) 1/1130 (0.1%)
    Dizziness 1/1316 (0.1%) 5/1130 (0.4%)
    Dysarthria 1/1316 (0.1%) 0/1130 (0%)
    Embolic stroke 0/1316 (0%) 1/1130 (0.1%)
    Encephalitis post varicella 0/1316 (0%) 1/1130 (0.1%)
    Encephalopathy 1/1316 (0.1%) 2/1130 (0.2%)
    Epilepsy 1/1316 (0.1%) 2/1130 (0.2%)
    Facial paralysis 1/1316 (0.1%) 1/1130 (0.1%)
    Generalised tonic-clonic seizure 1/1316 (0.1%) 1/1130 (0.1%)
    Haemorrhage intracranial 0/1316 (0%) 1/1130 (0.1%)
    Haemorrhagic stroke 0/1316 (0%) 1/1130 (0.1%)
    Headache 2/1316 (0.2%) 5/1130 (0.4%)
    Hemiparesis 1/1316 (0.1%) 0/1130 (0%)
    Hepatic encephalopathy 3/1316 (0.2%) 5/1130 (0.4%)
    Hypoaesthesia 1/1316 (0.1%) 0/1130 (0%)
    Intracranial aneurysm 0/1316 (0%) 1/1130 (0.1%)
    Intracranial pressure increased 0/1316 (0%) 1/1130 (0.1%)
    Intraventricular haemorrhage 0/1316 (0%) 1/1130 (0.1%)
    Ischaemic cerebral infarction 0/1316 (0%) 1/1130 (0.1%)
    Ischaemic stroke 3/1316 (0.2%) 0/1130 (0%)
    Lacunar stroke 0/1316 (0%) 1/1130 (0.1%)
    Lethargy 1/1316 (0.1%) 0/1130 (0%)
    Lumbar radiculopathy 1/1316 (0.1%) 0/1130 (0%)
    Mental impairment 0/1316 (0%) 2/1130 (0.2%)
    Metabolic encephalopathy 1/1316 (0.1%) 0/1130 (0%)
    Migraine 1/1316 (0.1%) 0/1130 (0%)
    Motor dysfunction 1/1316 (0.1%) 0/1130 (0%)
    Myoclonus 1/1316 (0.1%) 0/1130 (0%)
    Nervous system disorder 0/1316 (0%) 2/1130 (0.2%)
    Neuropathy peripheral 2/1316 (0.2%) 2/1130 (0.2%)
    Parkinson's disease 1/1316 (0.1%) 0/1130 (0%)
    Polyneuropathy 1/1316 (0.1%) 1/1130 (0.1%)
    Posterior reversible encephalopathy syndrome 0/1316 (0%) 1/1130 (0.1%)
    Radiculopathy 1/1316 (0.1%) 0/1130 (0%)
    Seizure 8/1316 (0.6%) 5/1130 (0.4%)
    Somnolence 1/1316 (0.1%) 0/1130 (0%)
    Subarachnoid haemorrhage 1/1316 (0.1%) 1/1130 (0.1%)
    Syncope 2/1316 (0.2%) 1/1130 (0.1%)
    Transient ischaemic attack 3/1316 (0.2%) 0/1130 (0%)
    Unresponsive to stimuli 1/1316 (0.1%) 0/1130 (0%)
    Pregnancy, puerperium and perinatal conditions
    Abortion missed 1/1316 (0.1%) 0/1130 (0%)
    Abortion spontaneous 1/1316 (0.1%) 1/1130 (0.1%)
    Abortion spontaneous complete 0/1316 (0%) 1/1130 (0.1%)
    Ectopic pregnancy 1/1316 (0.1%) 0/1130 (0%)
    Product Issues
    Device dislocation 1/1316 (0.1%) 1/1130 (0.1%)
    Psychiatric disorders
    Adjustment disorder 0/1316 (0%) 1/1130 (0.1%)
    Affective disorder 1/1316 (0.1%) 0/1130 (0%)
    Aggression 0/1316 (0%) 1/1130 (0.1%)
    Alcohol withdrawal syndrome 1/1316 (0.1%) 1/1130 (0.1%)
    Alcoholism 0/1316 (0%) 2/1130 (0.2%)
    Bipolar I disorder 0/1316 (0%) 1/1130 (0.1%)
    Bipolar disorder 1/1316 (0.1%) 0/1130 (0%)
    Borderline personality disorder 1/1316 (0.1%) 0/1130 (0%)
    Completed suicide 0/1316 (0%) 3/1130 (0.3%)
    Confusional state 2/1316 (0.2%) 0/1130 (0%)
    Delirium 1/1316 (0.1%) 1/1130 (0.1%)
    Depression 3/1316 (0.2%) 6/1130 (0.5%)
    Depression suicidal 0/1316 (0%) 3/1130 (0.3%)
    Drug abuse 1/1316 (0.1%) 2/1130 (0.2%)
    Homicidal ideation 0/1316 (0%) 1/1130 (0.1%)
    Major depression 1/1316 (0.1%) 1/1130 (0.1%)
    Mania 1/1316 (0.1%) 1/1130 (0.1%)
    Mental status changes 3/1316 (0.2%) 8/1130 (0.7%)
    Organic brain syndrome 1/1316 (0.1%) 0/1130 (0%)
    Psychotic disorder 1/1316 (0.1%) 1/1130 (0.1%)
    Schizoaffective disorder 0/1316 (0%) 1/1130 (0.1%)
    Schizophrenia 1/1316 (0.1%) 2/1130 (0.2%)
    Substance abuse 2/1316 (0.2%) 2/1130 (0.2%)
    Substance-induced psychotic disorder 2/1316 (0.2%) 0/1130 (0%)
    Suicidal ideation 4/1316 (0.3%) 3/1130 (0.3%)
    Suicide attempt 4/1316 (0.3%) 3/1130 (0.3%)
    Renal and urinary disorders
    Acute kidney injury 8/1316 (0.6%) 18/1130 (1.6%)
    Calculus urinary 0/1316 (0%) 1/1130 (0.1%)
    Chronic kidney disease 1/1316 (0.1%) 3/1130 (0.3%)
    End stage renal disease 0/1316 (0%) 3/1130 (0.3%)
    Glomerulonephritis 0/1316 (0%) 1/1130 (0.1%)
    Hydronephrosis 0/1316 (0%) 1/1130 (0.1%)
    Nephrolithiasis 2/1316 (0.2%) 3/1130 (0.3%)
    Nephropathy 0/1316 (0%) 2/1130 (0.2%)
    Proteinuria 1/1316 (0.1%) 0/1130 (0%)
    Renal colic 1/1316 (0.1%) 2/1130 (0.2%)
    Renal failure 10/1316 (0.8%) 4/1130 (0.4%)
    Renal haematoma 1/1316 (0.1%) 0/1130 (0%)
    Renal injury 0/1316 (0%) 1/1130 (0.1%)
    Renal tubular necrosis 1/1316 (0.1%) 1/1130 (0.1%)
    Renal vein thrombosis 0/1316 (0%) 1/1130 (0.1%)
    Ureteric stenosis 1/1316 (0.1%) 0/1130 (0%)
    Urinary incontinence 1/1316 (0.1%) 0/1130 (0%)
    Reproductive system and breast disorders
    Breast enlargement 0/1316 (0%) 1/1130 (0.1%)
    Cervical dysplasia 1/1316 (0.1%) 2/1130 (0.2%)
    Fallopian tube obstruction 0/1316 (0%) 1/1130 (0.1%)
    Menorrhagia 1/1316 (0.1%) 0/1130 (0%)
    Ovarian vein thrombosis 1/1316 (0.1%) 0/1130 (0%)
    Painful erection 0/1316 (0%) 1/1130 (0.1%)
    Pelvic adhesions 1/1316 (0.1%) 0/1130 (0%)
    Perineal rash 0/1316 (0%) 1/1130 (0.1%)
    Prostatomegaly 1/1316 (0.1%) 0/1130 (0%)
    Testicular swelling 0/1316 (0%) 1/1130 (0.1%)
    Uterine polyp 1/1316 (0.1%) 0/1130 (0%)
    Vaginal prolapse 1/1316 (0.1%) 0/1130 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome 0/1316 (0%) 3/1130 (0.3%)
    Acute respiratory failure 0/1316 (0%) 1/1130 (0.1%)
    Asthma 5/1316 (0.4%) 4/1130 (0.4%)
    Bronchial hyperreactivity 0/1316 (0%) 1/1130 (0.1%)
    Bronchiectasis 1/1316 (0.1%) 0/1130 (0%)
    Bronchitis chronic 0/1316 (0%) 1/1130 (0.1%)
    Bronchospasm 1/1316 (0.1%) 1/1130 (0.1%)
    Chronic obstructive pulmonary disease 4/1316 (0.3%) 7/1130 (0.6%)
    Cough 1/1316 (0.1%) 2/1130 (0.2%)
    Dyspnoea 6/1316 (0.5%) 2/1130 (0.2%)
    Emphysema 1/1316 (0.1%) 0/1130 (0%)
    Epistaxis 0/1316 (0%) 1/1130 (0.1%)
    Haemoptysis 1/1316 (0.1%) 1/1130 (0.1%)
    Hypoxia 2/1316 (0.2%) 1/1130 (0.1%)
    Interstitial lung disease 2/1316 (0.2%) 1/1130 (0.1%)
    Lung disorder 2/1316 (0.2%) 0/1130 (0%)
    Obstructive airways disorder 0/1316 (0%) 1/1130 (0.1%)
    Pleural effusion 1/1316 (0.1%) 3/1130 (0.3%)
    Pleurisy 0/1316 (0%) 1/1130 (0.1%)
    Pneumonia aspiration 2/1316 (0.2%) 4/1130 (0.4%)
    Pneumonitis 1/1316 (0.1%) 1/1130 (0.1%)
    Pneumothorax 2/1316 (0.2%) 4/1130 (0.4%)
    Pulmonary embolism 7/1316 (0.5%) 6/1130 (0.5%)
    Pulmonary eosinophilia 1/1316 (0.1%) 0/1130 (0%)
    Pulmonary fibrosis 0/1316 (0%) 1/1130 (0.1%)
    Pulmonary haemorrhage 1/1316 (0.1%) 0/1130 (0%)
    Pulmonary hypertension 1/1316 (0.1%) 0/1130 (0%)
    Pulmonary infarction 1/1316 (0.1%) 0/1130 (0%)
    Pulmonary mass 1/1316 (0.1%) 1/1130 (0.1%)
    Pulmonary oedema 1/1316 (0.1%) 0/1130 (0%)
    Respiratory arrest 0/1316 (0%) 1/1130 (0.1%)
    Respiratory disorder 1/1316 (0.1%) 1/1130 (0.1%)
    Respiratory failure 3/1316 (0.2%) 8/1130 (0.7%)
    Stridor 0/1316 (0%) 1/1130 (0.1%)
    Skin and subcutaneous tissue disorders
    Decubitus ulcer 0/1316 (0%) 1/1130 (0.1%)
    Dermal cyst 1/1316 (0.1%) 0/1130 (0%)
    Hidradenitis 0/1316 (0%) 1/1130 (0.1%)
    Lipodystrophy acquired 3/1316 (0.2%) 0/1130 (0%)
    Neurodermatitis 1/1316 (0.1%) 2/1130 (0.2%)
    Night sweats 0/1316 (0%) 1/1130 (0.1%)
    Psoriasis 2/1316 (0.2%) 0/1130 (0%)
    Rash 1/1316 (0.1%) 2/1130 (0.2%)
    Skin lesion 0/1316 (0%) 1/1130 (0.1%)
    Skin ulcer 1/1316 (0.1%) 0/1130 (0%)
    Stevens-Johnson syndrome 1/1316 (0.1%) 0/1130 (0%)
    Urticaria 0/1316 (0%) 1/1130 (0.1%)
    Surgical and medical procedures
    Abdominal hernia repair 0/1316 (0%) 1/1130 (0.1%)
    Abscess drainage 2/1316 (0.2%) 0/1130 (0%)
    Arterial stent insertion 1/1316 (0.1%) 0/1130 (0%)
    Arteriovenous fistula operation 0/1316 (0%) 1/1130 (0.1%)
    Cardiac resynchronisation therapy 1/1316 (0.1%) 0/1130 (0%)
    Cataract operation 0/1316 (0%) 1/1130 (0.1%)
    Colostomy 1/1316 (0.1%) 0/1130 (0%)
    Gastric banding reversal 1/1316 (0.1%) 0/1130 (0%)
    Hip surgery 1/1316 (0.1%) 0/1130 (0%)
    Hysterectomy 0/1316 (0%) 1/1130 (0.1%)
    Immune tolerance induction 0/1316 (0%) 1/1130 (0.1%)
    Inguinal hernia repair 1/1316 (0.1%) 0/1130 (0%)
    Knee arthroplasty 1/1316 (0.1%) 0/1130 (0%)
    Leg amputation 1/1316 (0.1%) 0/1130 (0%)
    Medical device removal 0/1316 (0%) 1/1130 (0.1%)
    Renal transplant 1/1316 (0.1%) 0/1130 (0%)
    Valvuloplasty cardiac 1/1316 (0.1%) 0/1130 (0%)
    Vascular disorders
    Aortic aneurysm 2/1316 (0.2%) 1/1130 (0.1%)
    Aortic aneurysm rupture 1/1316 (0.1%) 0/1130 (0%)
    Aortic arteriosclerosis 1/1316 (0.1%) 0/1130 (0%)
    Bleeding varicose vein 1/1316 (0.1%) 0/1130 (0%)
    Circulatory collapse 1/1316 (0.1%) 0/1130 (0%)
    Deep vein thrombosis 4/1316 (0.3%) 3/1130 (0.3%)
    Haematoma 1/1316 (0.1%) 0/1130 (0%)
    Hypertension 4/1316 (0.3%) 6/1130 (0.5%)
    Hypertensive crisis 0/1316 (0%) 2/1130 (0.2%)
    Hypotension 1/1316 (0.1%) 7/1130 (0.6%)
    Hypovolaemic shock 0/1316 (0%) 1/1130 (0.1%)
    Iliac artery occlusion 1/1316 (0.1%) 0/1130 (0%)
    Jugular vein thrombosis 1/1316 (0.1%) 0/1130 (0%)
    Lymphoedema 1/1316 (0.1%) 0/1130 (0%)
    Orthostatic hypotension 2/1316 (0.2%) 3/1130 (0.3%)
    Peripheral arterial occlusive disease 3/1316 (0.2%) 2/1130 (0.2%)
    Peripheral artery occlusion 1/1316 (0.1%) 1/1130 (0.1%)
    Peripheral artery stenosis 1/1316 (0.1%) 0/1130 (0%)
    Peripheral ischaemia 1/1316 (0.1%) 0/1130 (0%)
    Peripheral vascular disorder 0/1316 (0%) 1/1130 (0.1%)
    Subclavian artery thrombosis 1/1316 (0.1%) 0/1130 (0%)
    Subclavian vein thrombosis 0/1316 (0%) 1/1130 (0.1%)
    Thrombophlebitis 2/1316 (0.2%) 0/1130 (0%)
    Thrombosis 1/1316 (0.1%) 0/1130 (0%)
    Vascular stenosis 0/1316 (0%) 1/1130 (0.1%)
    Vasospasm 1/1316 (0.1%) 0/1130 (0%)
    Other (Not Including Serious) Adverse Events
    Maraviroc Exposed Maraviroc Unexposed
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 111/1316 (8.4%) 34/1130 (3%)
    Gastrointestinal disorders
    Diarrhoea 32/1316 (2.4%) 14/1130 (1.2%)
    Nausea 18/1316 (1.4%) 5/1130 (0.4%)
    General disorders
    Fatigue 15/1316 (1.1%) 6/1130 (0.5%)
    Infections and infestations
    Bronchitis 18/1316 (1.4%) 5/1130 (0.4%)
    Nasopharyngitis 16/1316 (1.2%) 0/1130 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 18/1316 (1.4%) 3/1130 (0.3%)
    Nervous system disorders
    Headache 16/1316 (1.2%) 6/1130 (0.5%)
    Skin and subcutaneous tissue disorders
    Rash 17/1316 (1.3%) 5/1130 (0.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    ViiV Healthcare
    ClinicalTrials.gov Identifier:
    NCT00665561
    Other Study ID Numbers:
    • A4001067
    • 2007-006148-24
    • POEM
    First Posted:
    Apr 24, 2008
    Last Update Posted:
    Apr 7, 2020
    Last Verified:
    Mar 1, 2020