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Prospective Observational Epidemiologic Study of Maraviroc's Safety (POEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00665561
Recruitment Status : Completed
First Posted : April 24, 2008
Results First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Human Immunodeficiency Virus
Interventions Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Drug: Optimized background antiretroviral drug regimen without maraviroc
Enrollment 2455
Recruitment Details  
Pre-assignment Details Study was conducted at multiple sites between 31 March 2008 and 14 February 2019.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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
Reason Not Completed
Death recorded on subject summary pages             75             75
Does not meet entrance criteria             19             21
Lost to Follow-up             203             264
Withdrawal by Subject             74             65
Other             123             108
Site closed             8             0
Withdrawn due to pregnancy             0             1
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed Total
Hide 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 Number of Baseline Participants 1316 1130 2446
Hide Baseline Analysis Population Description
Safety analysis set: All participants who were enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1316 participants 1130 participants 2446 participants
46.8  (9.3) 44.3  (10.0) 45.6  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1316 participants 1130 participants 2446 participants
Female
275
  20.9%
265
  23.5%
540
  22.1%
Male
1041
  79.1%
865
  76.5%
1906
  77.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1316 participants 1130 participants 2446 participants
White
983
  74.7%
684
  60.5%
1667
  68.2%
Black
271
  20.6%
390
  34.5%
661
  27.0%
Asian
13
   1.0%
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%
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
22.28
(18.57 to 26.73)
41.77
(36.09 to 48.34)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.42 to 0.67
Estimation Comments [Not Specified]
2.Primary Outcome
Title Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
0.38
(0.10 to 1.54)
0.46
(0.12 to 1.86)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.12 to 5.88
Estimation Comments [Not Specified]
3.Primary Outcome
Title Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
All Malignancies
12.87
(10.13 to 16.35)
13.69
(10.61 to 17.67)
AIDS defining Malignancies
2.31
(1.31 to 4.06)
3.71
(2.27 to 6.06)
Non-AIDS defining Malignancies
10.56
(8.11 to 13.76)
9.98
(7.40 to 13.45)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.66 to 1.33
Estimation Comments [Not Specified]
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.29 to 1.31
Estimation Comments [Not Specified]
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.71 to 1.58
Estimation Comments [Not Specified]
4.Primary Outcome
Title Density Rate Per 1000 Participant-Years for Incidence of Liver Failure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
2.50
(1.45 to 4.30)
2.55
(1.41 to 4.61)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.44 to 2.18
Estimation Comments [Not Specified]
5.Primary Outcome
Title Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
4.80
(3.24 to 7.11)
5.34
(3.55 to 8.03)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.51 to 1.59
Estimation Comments [Not Specified]
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'
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
8.26
(6.13 to 11.14)
7.43
(5.25 to 10.50)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.70 to 1.76
Estimation Comments [Not Specified]
7.Primary Outcome
Title Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
0.77
(0.29 to 2.05)
0.70
(0.22 to 2.16)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.25 to 4.93
Estimation Comments [Not Specified]
8.Primary Outcome
Title Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
0.77
(0.29 to 2.05)
1.16
(0.48 to 2.79)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.18 to 2.47
Estimation Comments [Not Specified]
9.Primary Outcome
Title Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
14.41
(11.49 to 18.07)
18.33
(14.70 to 22.86)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.57 to 1.08
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
22.36
(18.56 to 26.94)
28.70
(23.98 to 34.34)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.61 to 0.99
Estimation Comments [Not Specified]
11.Primary Outcome
Title Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
All Malignancies
12.49
(9.72 to 16.05)
13.54
(10.44 to 17.56)
AIDS defining Malignancies
2.31
(1.29 to 4.13)
3.31
(1.95 to 5.62)
Non-AIDS defining Malignancies
9.87
(7.44 to 13.09)
9.86
(7.27 to 13.37)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.64 to 1.33
Estimation Comments [Not Specified]
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.32 to 1.52
Estimation Comments [Not Specified]
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.66 to 1.52
Estimation Comments [Not Specified]
12.Primary Outcome
Title Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
2.08
(1.21 to 3.56)
3.37
(2.06 to 5.52)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.35 to 1.10
Estimation Comments [Not Specified]
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'
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
5.65
(3.97 to 8.05)
5.99
(4.13 to 8.68)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.59 to 1.52
Estimation Comments [Not Specified]
14.Primary Outcome
Title Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: events per 1000 participant-years
14.39
(11.41 to 18.16)
15.64
(12.30 to 19.89)
Hide 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 [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.66 to 1.28
Estimation Comments [Not Specified]
15.Primary Outcome
Title Percentage of Participants With All-Cause Mortality
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in the study.
Arm/Group Title Maraviroc Exposed Maraviroc Unexposed
Hide 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.
Overall Number of Participants Analyzed 1316 1130
Measure Type: Number
Unit of Measure: Percentage of participants
5.7 7.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc Exposed, Maraviroc Unexposed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6225
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.66 to 1.28
Estimation Comments [Not Specified]
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
Hide 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 (%) Affected / at Risk (%)
Total   75/1316 (5.70%)   79/1130 (6.99%) 
Hide Serious Adverse Events
Maraviroc Exposed Maraviroc Unexposed
Affected / at Risk (%) Affected / at Risk (%)
Total   435/1316 (33.05%)   352/1130 (31.15%) 
Blood and lymphatic system disorders     
Anaemia * 1  11/1316 (0.84%)  14/1130 (1.24%) 
Anaemia macrocytic * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Anaemia of chronic disease * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Eosinophilia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Febrile neutropenia * 1  4/1316 (0.30%)  2/1130 (0.18%) 
Haemolysis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Haemolytic anaemia * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Haemorrhagic anaemia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Heparin-induced thrombocytopenia * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Iron deficiency anaemia * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Leukocytosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Leukopenia * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Lymphadenopathy * 1  3/1316 (0.23%)  2/1130 (0.18%) 
Lymphocytosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Methaemoglobinaemia * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Neutropenia * 1  3/1316 (0.23%)  2/1130 (0.18%) 
Pancytopenia * 1  3/1316 (0.23%)  5/1130 (0.44%) 
Sickle cell anaemia with crisis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Splenomegaly * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Thrombocytopenia * 1  3/1316 (0.23%)  2/1130 (0.18%) 
Thrombotic thrombocytopenic purpura * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Cardiac disorders     
Acute coronary syndrome * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Acute myocardial infarction * 1  7/1316 (0.53%)  6/1130 (0.53%) 
Angina pectoris * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Angina unstable * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Arrhythmia * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Arteriosclerosis coronary artery * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Atrial fibrillation * 1  4/1316 (0.30%)  6/1130 (0.53%) 
Bradycardia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cardiac arrest * 1  5/1316 (0.38%)  2/1130 (0.18%) 
Cardiac failure * 1  4/1316 (0.30%)  1/1130 (0.09%) 
Cardiac failure congestive * 1  5/1316 (0.38%)  11/1130 (0.97%) 
Cardiac valve disease * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cardiac ventricular thrombosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Cardio-respiratory arrest * 1  4/1316 (0.30%)  1/1130 (0.09%) 
Cardiogenic shock * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Cardiomyopathy * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Congestive cardiomyopathy * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Coronary artery disease * 1  6/1316 (0.46%)  4/1130 (0.35%) 
Coronary artery stenosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Left ventricular dysfunction * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Left ventricular failure * 1  2/1316 (0.15%)  3/1130 (0.27%) 
Myocardial infarction * 1  16/1316 (1.22%)  12/1130 (1.06%) 
Myocardial ischaemia * 1  3/1316 (0.23%)  1/1130 (0.09%) 
Myocarditis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Palpitations * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Pericarditis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Supraventricular tachycardia * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Tachycardia * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Torsade de pointes * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Congenital, familial and genetic disorders     
Fanconi syndrome * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Sickle cell disease * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Ear and labyrinth disorders     
Deafness bilateral * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Tympanic membrane perforation * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Vertigo * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Vertigo positional * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Endocrine disorders     
Adrenal insufficiency * 1  3/1316 (0.23%)  1/1130 (0.09%) 
Adrenal mass * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Autoimmune hypothyroidism * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hypothyroidism * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Eye disorders     
Cataract * 1  4/1316 (0.30%)  0/1130 (0.00%) 
Central vision loss * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Iridocyclitis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Orbital cyst * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Pupils unequal * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Uveitis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Vision blurred * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Abdominal hernia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Abdominal pain * 1  8/1316 (0.61%)  11/1130 (0.97%) 
Abdominal pain lower * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Abdominal pain upper * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Abdominal wall haematoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Anal fissure * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Anal fistula * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Anal skin tags * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Anogenital dysplasia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Anorectal disorder * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Aphthous ulcer * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Ascites * 1  4/1316 (0.30%)  3/1130 (0.27%) 
Barrett’s oesophagus * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Colitis * 1  2/1316 (0.15%)  2/1130 (0.18%) 
Constipation * 1  5/1316 (0.38%)  2/1130 (0.18%) 
Crohn’s disease * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Diarrhoea * 1  10/1316 (0.76%)  13/1130 (1.15%) 
Diverticulum * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Duodenal ulcer * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Duodenal ulcer haemorrhage * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Duodenitis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Dyspepsia * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Dysphagia * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Faeces discoloured * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Gastritis * 1  2/1316 (0.15%)  3/1130 (0.27%) 
Gastrointestinal disorder * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Gastrointestinal haemorrhage * 1  4/1316 (0.30%)  1/1130 (0.09%) 
Gastrointestinal inflammation * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Gastrooesophageal reflux disease * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Haematemesis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Haematochezia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Haemorrhoidal haemorrhage * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Haemorrhoids * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Haemorrhoids thrombosed * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Ileus * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Inguinal hernia * 1  4/1316 (0.30%)  2/1130 (0.18%) 
Intestinal ischaemia * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Intestinal mass * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Intestinal obstruction * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Intestinal perforation * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Intussusception * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Irritable bowel syndrome * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Large intestine perforation * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Melaena * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Nausea * 1  4/1316 (0.30%)  2/1130 (0.18%) 
Odynophagia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Oesophageal haemorrhage * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Oesophageal rupture * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Oesophageal stenosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Oesophageal ulcer * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Oesophagitis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Oral pain * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pancreatic pseudocyst * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pancreatitis * 1  6/1316 (0.46%)  2/1130 (0.18%) 
Pancreatitis acute * 1  1/1316 (0.08%)  6/1130 (0.53%) 
Pancreatitis chronic * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Proctalgia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Proctitis * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Proctitis ulcerative * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Rectal haemorrhage * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Rectal perforation * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Rectal prolapse * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Small intestinal obstruction * 1  4/1316 (0.30%)  3/1130 (0.27%) 
Umbilical hernia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Upper gastrointestinal haemorrhage * 1  2/1316 (0.15%)  2/1130 (0.18%) 
Varices oesophageal * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Vomiting * 1  4/1316 (0.30%)  4/1130 (0.35%) 
General disorders     
Asthenia * 1  1/1316 (0.08%)  5/1130 (0.44%) 
Chest pain * 1  16/1316 (1.22%)  15/1130 (1.33%) 
Chills * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Death * 1  10/1316 (0.76%)  6/1130 (0.53%) 
Dysplasia * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Fatigue * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Gait disturbance * 1  2/1316 (0.15%)  0/1130 (0.00%) 
General physical health deterioration * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Generalised oedema * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hypothermia * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Malaise * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Mucosal inflammation * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Multi-organ disorder * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Multiple organ dysfunction syndrome * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Oedema peripheral * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pain * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Physical deconditioning * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pyrexia * 1  8/1316 (0.61%)  11/1130 (0.97%) 
Sudden cardiac death * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Sudden death * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Systemic inflammatory response syndrome * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Treatment noncompliance * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Ulcer * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hepatobiliary disorders     
Acute hepatic failure * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Bile duct stone * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Biliary dilatation * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cholecystitis * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Cholecystitis acute * 1  0/1316 (0.00%)  3/1130 (0.27%) 
Cholelithiasis * 1  4/1316 (0.30%)  1/1130 (0.09%) 
Hepatic cirrhosis * 1  4/1316 (0.30%)  2/1130 (0.18%) 
Hepatic failure * 1  3/1316 (0.23%)  4/1130 (0.35%) 
Hepatitis alcoholic * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Hepatitis toxic * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hepatorenal syndrome * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Jaundice * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Immune system disorders     
Drug hypersensitivity * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Hypersensitivity * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Jarisch-Herxheimer reaction * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Infections and infestations     
AIDS related complication * 1  1/1316 (0.08%)  0/1130 (0.00%) 
AIDS retinopathy * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Abdominal abscess * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Abdominal sepsis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Abscess * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Abscess limb * 1  0/1316 (0.00%)  4/1130 (0.35%) 
Acquired immunodeficiency syndrome * 1  2/1316 (0.15%)  6/1130 (0.53%) 
Acute hepatitis C * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Acute sinusitis * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Amoebiasis * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Amoebic dysentery * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Anal abscess * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Anorectal cellulitis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Appendicitis * 1  7/1316 (0.53%)  4/1130 (0.35%) 
Arthritis bacterial * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Aspergillus infection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Atypical mycobacterial infection * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Bacteraemia * 1  2/1316 (0.15%)  5/1130 (0.44%) 
Bacterial diarrhoea * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Bacterial infection * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Brain abscess * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Breast abscess * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Bronchiolitis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Bronchitis * 1  10/1316 (0.76%)  6/1130 (0.53%) 
Bronchitis viral * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Burkholderia cepacia complex sepsis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
CNS ventriculitis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Campylobacter gastroenteritis * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Campylobacter infection * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Candida infection * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Cellulitis * 1  12/1316 (0.91%)  18/1130 (1.59%) 
Cellulitis staphylococcal * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Cerebral toxoplasmosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Clostridium difficile colitis * 1  1/1316 (0.08%)  3/1130 (0.27%) 
Clostridium difficile infection * 1  0/1316 (0.00%)  4/1130 (0.35%) 
Corneal abscess * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cryptococcal fungaemia * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Cryptococcosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Cryptosporidiosis infection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Cytomegalovirus chorioretinitis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Cytomegalovirus colitis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cytomegalovirus infection * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Cytomegalovirus viraemia * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Device related infection * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Device related sepsis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Diabetic foot infection * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Diverticulitis * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Empyema * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Encephalitis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
End stage AIDS * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Endocarditis * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Enterococcal sepsis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Epididymitis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Erysipelas * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Escherichia bacteraemia * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Escherichia urinary tract infection * 1  0/1316 (0.00%)  3/1130 (0.27%) 
External ear cellulitis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Eye infection syphilitic * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Folliculitis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Fungal infection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Fungal oesophagitis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Furuncle * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Gangrene * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Gastroenteritis * 1  7/1316 (0.53%)  11/1130 (0.97%) 
Gastroenteritis bacterial * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Gastroenteritis clostridial * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Gastroenteritis cryptosporidial * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Gastroenteritis salmonella * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Gastroenteritis viral * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Genital herpes * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Genital herpes simplex * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Giardiasis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Gonorrhoea * 1  1/1316 (0.08%)  0/1130 (0.00%) 
HIV enteropathy * 1  1/1316 (0.08%)  0/1130 (0.00%) 
HIV infection * 1  0/1316 (0.00%)  2/1130 (0.18%) 
HIV wasting syndrome * 1  1/1316 (0.08%)  2/1130 (0.18%) 
HIV-associated neurocognitive disorder * 1  3/1316 (0.23%)  2/1130 (0.18%) 
Helicobacter gastritis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Helicobacter infection * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Hepatitis B reactivation * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hepatitis C * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Herpes pharyngitis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Herpes simplex * 1  1/1316 (0.08%)  4/1130 (0.35%) 
Herpes virus infection * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Herpes zoster * 1  5/1316 (0.38%)  4/1130 (0.35%) 
Herpes zoster disseminated * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Histoplasmosis * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Infectious colitis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Infective exacerbation of bronchiectasis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Influenza * 1  4/1316 (0.30%)  3/1130 (0.27%) 
Intervertebral discitis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Joint abscess * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Klebsiella sepsis * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Latent syphilis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Lower respiratory tract infection * 1  3/1316 (0.23%)  3/1130 (0.27%) 
Lung infection * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Meningitis * 1  3/1316 (0.23%)  1/1130 (0.09%) 
Meningitis aseptic * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Meningitis cryptococcal * 1  0/1316 (0.00%)  4/1130 (0.35%) 
Meningitis streptococcal * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Meningitis tuberculous * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Microsporidia infection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Mycobacterial infection * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Mycobacterium abscessus infection * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Mycobacterium avium complex infection * 1  0/1316 (0.00%)  4/1130 (0.35%) 
Mycobacterium fortuitum infection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Neurosyphilis * 1  2/1316 (0.15%)  2/1130 (0.18%) 
Neutropenic sepsis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Oesophageal candidiasis * 1  2/1316 (0.15%)  8/1130 (0.71%) 
Oral candidiasis * 1  3/1316 (0.23%)  3/1130 (0.27%) 
Oral hairy leukoplakia * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Oral herpes * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Orchitis * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Osteomyelitis * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Osteomyelitis chronic * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Otitis externa * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Otitis media * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Parvovirus infection * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Perirectal abscess * 1  0/1316 (0.00%)  3/1130 (0.27%) 
Peritonitis * 1  3/1316 (0.23%)  0/1130 (0.00%) 
Peritonitis bacterial * 1  2/1316 (0.15%)  2/1130 (0.18%) 
Pharyngitis * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Pilonidal cyst * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pneumococcal sepsis * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Pneumocystis jirovecii pneumonia * 1  9/1316 (0.68%)  13/1130 (1.15%) 
Pneumonia * 1  51/1316 (3.88%)  54/1130 (4.78%) 
Pneumonia bacterial * 1  1/1316 (0.08%)  4/1130 (0.35%) 
Pneumonia influenzal * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Pneumonia legionella * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pneumonia necrotising * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pneumonia pneumococcal * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Pneumonia pseudomonal * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Pneumonia staphylococcal * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Pneumonia streptococcal * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Post procedural infection * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Postoperative wound infection * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Progressive multifocal leukoencephalopathy * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Pyelonephritis * 1  2/1316 (0.15%)  5/1130 (0.44%) 
Pyelonephritis acute * 1  0/1316 (0.00%)  3/1130 (0.27%) 
Rectal abscess * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Respiratory tract infection * 1  2/1316 (0.15%)  2/1130 (0.18%) 
Salmonella sepsis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Secondary syphilis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Sepsis * 1  11/1316 (0.84%)  11/1130 (0.97%) 
Sepsis syndrome * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Septic embolus * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Septic shock * 1  5/1316 (0.38%)  3/1130 (0.27%) 
Shigella infection * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Sinusitis * 1  3/1316 (0.23%)  3/1130 (0.27%) 
Sinusitis bacterial * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Sinusitis fungal * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Staphylococcal abscess * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Staphylococcal bacteraemia * 1  1/1316 (0.08%)  3/1130 (0.27%) 
Staphylococcal infection * 1  3/1316 (0.23%)  4/1130 (0.35%) 
Staphylococcal skin infection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Streptococcal bacteraemia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Subcutaneous abscess * 1  1/1316 (0.08%)  4/1130 (0.35%) 
Superinfection bacterial * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Syphilis * 1  3/1316 (0.23%)  1/1130 (0.09%) 
Syphilis anal * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Tonsillitis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Tooth abscess * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Toxoplasmosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Trichomoniasis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Tuberculosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Upper respiratory tract infection * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Urinary tract infection * 1  10/1316 (0.76%)  8/1130 (0.71%) 
Urinary tract infection pseudomonal * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Urosepsis * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Vaginal infection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Vascular device infection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Viral infection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Vulval abscess * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Vulvovaginal mycotic infection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Injury, poisoning and procedural complications     
Accident * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Alcohol poisoning * 1  3/1316 (0.23%)  1/1130 (0.09%) 
Breast injury * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Chest injury * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Clavicle fracture * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Compression fracture * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Concussion * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Craniocerebral injury * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Facial bones fracture * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Fall * 1  6/1316 (0.46%)  1/1130 (0.09%) 
Femoral neck fracture * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Femur fracture * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Fibula fracture * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Foot fracture * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Foreign body in gastrointestinal tract * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Foreign body in respiratory tract * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Fractured sacrum * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Gastrointestinal stoma necrosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hand fracture * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Head injury * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Hip fracture * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Humerus fracture * 1  3/1316 (0.23%)  2/1130 (0.18%) 
Intentional overdose * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Jaw fracture * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Limb injury * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Lower limb fracture * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Lumbar vertebral fracture * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Meniscus injury * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Multiple injuries * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Overdose * 1  7/1316 (0.53%)  3/1130 (0.27%) 
Patella fracture * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Periorbital haematoma * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Post procedural haematoma * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Post procedural haemorrhage * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pubis fracture * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Radial nerve injury * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Rib fracture * 1  3/1316 (0.23%)  0/1130 (0.00%) 
Road traffic accident * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Spinal fracture * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Splenic injury * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Subdural haematoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Tibia fracture * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Toxicity to various agents * 1  3/1316 (0.23%)  1/1130 (0.09%) 
Traumatic liver injury * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Upper limb fracture * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Vascular graft thrombosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Wound * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Wound dehiscence * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Wrist fracture * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Investigations     
Atypical mycobacterium test positive * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Biopsy lymph gland * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Blood creatine phosphokinase increased * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Blood potassium decreased * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Body temperature increased * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Culture stool positive * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Drug clearance increased * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Electrocardiogram repolarisation abnormality * 1  1/1316 (0.08%)  0/1130 (0.00%) 
HIV test positive * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Haemophilus test positive * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Hepatic enzyme increased * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Liver function test abnormal * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Liver function test increased * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Staphylococcus test * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Staphylococcus test positive * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Transaminases increased * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Weight decreased * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Metabolism and nutrition disorders     
Alcoholic ketoacidosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cachexia * 1  2/1316 (0.15%)  2/1130 (0.18%) 
Decreased appetite * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Dehydration * 1  5/1316 (0.38%)  7/1130 (0.62%) 
Diabetes mellitus * 1  3/1316 (0.23%)  2/1130 (0.18%) 
Diabetic ketoacidosis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Electrolyte depletion * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Electrolyte imbalance * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Failure to thrive * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Fluid overload * 1  0/1316 (0.00%)  4/1130 (0.35%) 
Folate deficiency * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Gout * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Haemochromatosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hypercalcaemia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hyperglycaemia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hyperkalaemia * 1  1/1316 (0.08%)  6/1130 (0.53%) 
Hyperlipidaemia * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Hypernatraemia * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Hypocalcaemia * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Hypoglycaemia * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Hypokalaemia * 1  0/1316 (0.00%)  3/1130 (0.27%) 
Hypomagnesaemia * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Hyponatraemia * 1  4/1316 (0.30%)  4/1130 (0.35%) 
Hypovolaemia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Lactic acidosis * 1  5/1316 (0.38%)  2/1130 (0.18%) 
Malnutrition * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Metabolic acidosis * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Type 2 diabetes mellitus * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Vitamin D deficiency * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Arthritis reactive * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Arthropathy * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Back pain * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Bursitis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Costochondritis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Diastasis recti abdominis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Fistula * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Flank pain * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Intervertebral disc protrusion * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Lumbar spinal stenosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Musculoskeletal chest pain * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Musculoskeletal pain * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Myalgia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Myositis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Neck pain * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Osteoarthritis * 1  4/1316 (0.30%)  1/1130 (0.09%) 
Osteonecrosis * 1  2/1316 (0.15%)  2/1130 (0.18%) 
Pain in extremity * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Pseudarthrosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Rhabdomyolysis * 1  3/1316 (0.23%)  1/1130 (0.09%) 
Spinal column stenosis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Adenocarcinoma gastric * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Adenocarcinoma of colon * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Anal cancer * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Anal cancer stage 0 * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Anal squamous cell carcinoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Anaplastic large cell lymphoma T- and null-cell types * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Anogenital warts * 1  2/1316 (0.15%)  4/1130 (0.35%) 
B-cell lymphoma * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Basal cell carcinoma * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Bladder neoplasm * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Brain neoplasm malignant * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Breast cancer * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Burkitt’s lymphoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cancer pain * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cervix carcinoma * 1  3/1316 (0.23%)  2/1130 (0.18%) 
Cervix carcinoma stage 0 * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Colon cancer * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Diffuse large B-cell lymphoma * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Diffuse large B-cell lymphoma recurrent * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Endometrial cancer * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Fibrous histiocytoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Gastric cancer * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Gastrointestinal lymphoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Haemangioma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hepatic cancer * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Hepatocellular carcinoma * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Hodgkin’s disease * 1  6/1316 (0.46%)  1/1130 (0.09%) 
Kaposi’s sarcoma * 1  1/1316 (0.08%)  3/1130 (0.27%) 
Leiomyoma * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Lipoma * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Lung adenocarcinoma * 1  0/1316 (0.00%)  3/1130 (0.27%) 
Lung neoplasm malignant * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Lymphoma * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Lymphoproliferative disorder * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Malignant melanoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Malignant melanoma in situ * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Malignant melanoma stage II * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Malignant neoplasm of unknown primary site * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Metastases to liver * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Metastases to pleura * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Neoplasm prostate * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Non-Hodgkin’s lymphoma * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Ocular neoplasm * 1  1/1 (100.00%)  0/1130 (0.00%) 
Oesophageal adenocarcinoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Ovarian adenoma * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Ovarian germ cell teratoma benign * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Pancreatic carcinoma * 1  2/1316 (0.15%)  2/1130 (0.18%) 
Pancreatic carcinoma recurrent * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Papillary cystadenoma lymphomatosum * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Papillary thyroid cancer * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Plasmablastic lymphoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Prostate cancer * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Prostatic adenoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Rectal adenocarcinoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Rectal cancer * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Rectal neoplasm * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Renal cancer * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Skin cancer * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Small cell carcinoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Small cell lung cancer * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Small cell lung cancer metastatic * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Squamous cell carcinoma * 1  2/1316 (0.15%)  3/1130 (0.27%) 
Squamous cell carcinoma of the oral cavity * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Squamous cell carcinoma of the tongue * 1  0/1316 (0.00%)  1/1130 (0.09%) 
T-cell lymphoma * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Thyroid cancer * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Tongue neoplasm malignant stage unspecified * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Uterine leiomyoma * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Vaginal cancer * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Vulval cancer * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Infected neoplasm * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Nervous system disorders     
Alcoholic seizure * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Amputation stump pain * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Balance disorder * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Carpal tunnel syndrome * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Cerebellar infarction * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cerebral haemorrhage * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Cerebral infarction * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cerebral ischaemia * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Cerebrovascular accident * 1  7/1316 (0.53%)  4/1130 (0.35%) 
Clonic convulsion * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cranial nerve palsies multiple * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Dementia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Depressed level of consciousness * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Diabetic hyperglycaemic coma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Diabetic neuropathy * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Dizziness * 1  1/1316 (0.08%)  5/1130 (0.44%) 
Dysarthria * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Embolic stroke * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Encephalitis post varicella * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Encephalopathy * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Epilepsy * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Facial paralysis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Generalised tonic-clonic seizure * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Haemorrhage intracranial * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Haemorrhagic stroke * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Headache * 1  2/1316 (0.15%)  5/1130 (0.44%) 
Hemiparesis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hepatic encephalopathy * 1  3/1316 (0.23%)  5/1130 (0.44%) 
Hypoaesthesia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Intracranial aneurysm * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Intracranial pressure increased * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Intraventricular haemorrhage * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Ischaemic cerebral infarction * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Ischaemic stroke * 1  3/1316 (0.23%)  0/1130 (0.00%) 
Lacunar stroke * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Lethargy * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Lumbar radiculopathy * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Mental impairment * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Metabolic encephalopathy * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Migraine * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Motor dysfunction * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Myoclonus * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Nervous system disorder * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Neuropathy peripheral * 1  2/1316 (0.15%)  2/1130 (0.18%) 
Parkinson’s disease * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Polyneuropathy * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Posterior reversible encephalopathy syndrome * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Radiculopathy * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Seizure * 1  8/1316 (0.61%)  5/1130 (0.44%) 
Somnolence * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Subarachnoid haemorrhage * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Syncope * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Transient ischaemic attack * 1  3/1316 (0.23%)  0/1130 (0.00%) 
Unresponsive to stimuli * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion missed * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Abortion spontaneous * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Abortion spontaneous complete * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Ectopic pregnancy * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Product Issues     
Device dislocation * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Psychiatric disorders     
Adjustment disorder * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Affective disorder * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Aggression * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Alcohol withdrawal syndrome * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Alcoholism * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Bipolar I disorder * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Bipolar disorder * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Borderline personality disorder * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Completed suicide * 1  0/1316 (0.00%)  3/1130 (0.27%) 
Confusional state * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Delirium * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Depression * 1  3/1316 (0.23%)  6/1130 (0.53%) 
Depression suicidal * 1  0/1316 (0.00%)  3/1130 (0.27%) 
Drug abuse * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Homicidal ideation * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Major depression * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Mania * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Mental status changes * 1  3/1316 (0.23%)  8/1130 (0.71%) 
Organic brain syndrome * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Psychotic disorder * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Schizoaffective disorder * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Schizophrenia * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Substance abuse * 1  2/1316 (0.15%)  2/1130 (0.18%) 
Substance-induced psychotic disorder * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Suicidal ideation * 1  4/1316 (0.30%)  3/1130 (0.27%) 
Suicide attempt * 1  4/1316 (0.30%)  3/1130 (0.27%) 
Renal and urinary disorders     
Acute kidney injury * 1  8/1316 (0.61%)  18/1130 (1.59%) 
Calculus urinary * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Chronic kidney disease * 1  1/1316 (0.08%)  3/1130 (0.27%) 
End stage renal disease * 1  0/1316 (0.00%)  3/1130 (0.27%) 
Glomerulonephritis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Hydronephrosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Nephrolithiasis * 1  2/1316 (0.15%)  3/1130 (0.27%) 
Nephropathy * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Proteinuria * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Renal colic * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Renal failure * 1  10/1316 (0.76%)  4/1130 (0.35%) 
Renal haematoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Renal injury * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Renal tubular necrosis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Renal vein thrombosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Ureteric stenosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Urinary incontinence * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Reproductive system and breast disorders     
Breast enlargement * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Cervical dysplasia * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Fallopian tube obstruction * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Menorrhagia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Ovarian vein thrombosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Painful erection * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Pelvic adhesions * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Perineal rash * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Prostatomegaly * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Testicular swelling * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Uterine polyp * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Vaginal prolapse * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  0/1316 (0.00%)  3/1130 (0.27%) 
Acute respiratory failure * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Asthma * 1  5/1316 (0.38%)  4/1130 (0.35%) 
Bronchial hyperreactivity * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Bronchiectasis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Bronchitis chronic * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Bronchospasm * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Chronic obstructive pulmonary disease * 1  4/1316 (0.30%)  7/1130 (0.62%) 
Cough * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Dyspnoea * 1  6/1316 (0.46%)  2/1130 (0.18%) 
Emphysema * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Epistaxis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Haemoptysis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Hypoxia * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Interstitial lung disease * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Lung disorder * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Obstructive airways disorder * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Pleural effusion * 1  1/1316 (0.08%)  3/1130 (0.27%) 
Pleurisy * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Pneumonia aspiration * 1  2/1316 (0.15%)  4/1130 (0.35%) 
Pneumonitis * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Pneumothorax * 1  2/1316 (0.15%)  4/1130 (0.35%) 
Pulmonary embolism * 1  7/1316 (0.53%)  6/1130 (0.53%) 
Pulmonary eosinophilia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pulmonary fibrosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Pulmonary haemorrhage * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pulmonary hypertension * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pulmonary infarction * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Pulmonary mass * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Pulmonary oedema * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Respiratory arrest * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Respiratory disorder * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Respiratory failure * 1  3/1316 (0.23%)  8/1130 (0.71%) 
Stridor * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Dermal cyst * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hidradenitis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Lipodystrophy acquired * 1  3/1316 (0.23%)  0/1130 (0.00%) 
Neurodermatitis * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Night sweats * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Psoriasis * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Rash * 1  1/1316 (0.08%)  2/1130 (0.18%) 
Skin lesion * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Skin ulcer * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Stevens-Johnson syndrome * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Urticaria * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Surgical and medical procedures     
Abdominal hernia repair * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Abscess drainage * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Arterial stent insertion * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Arteriovenous fistula operation * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Cardiac resynchronisation therapy * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Cataract operation * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Colostomy * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Gastric banding reversal * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hip surgery * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hysterectomy * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Immune tolerance induction * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Inguinal hernia repair * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Knee arthroplasty * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Leg amputation * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Medical device removal * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Renal transplant * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Valvuloplasty cardiac * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Vascular disorders     
Aortic aneurysm * 1  2/1316 (0.15%)  1/1130 (0.09%) 
Aortic aneurysm rupture * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Aortic arteriosclerosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Bleeding varicose vein * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Circulatory collapse * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Deep vein thrombosis * 1  4/1316 (0.30%)  3/1130 (0.27%) 
Haematoma * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Hypertension * 1  4/1316 (0.30%)  6/1130 (0.53%) 
Hypertensive crisis * 1  0/1316 (0.00%)  2/1130 (0.18%) 
Hypotension * 1  1/1316 (0.08%)  7/1130 (0.62%) 
Hypovolaemic shock * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Iliac artery occlusion * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Jugular vein thrombosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Lymphoedema * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Orthostatic hypotension * 1  2/1316 (0.15%)  3/1130 (0.27%) 
Peripheral arterial occlusive disease * 1  3/1316 (0.23%)  2/1130 (0.18%) 
Peripheral artery occlusion * 1  1/1316 (0.08%)  1/1130 (0.09%) 
Peripheral artery stenosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Peripheral ischaemia * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Peripheral vascular disorder * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Subclavian artery thrombosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Subclavian vein thrombosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Thrombophlebitis * 1  2/1316 (0.15%)  0/1130 (0.00%) 
Thrombosis * 1  1/1316 (0.08%)  0/1130 (0.00%) 
Vascular stenosis * 1  0/1316 (0.00%)  1/1130 (0.09%) 
Vasospasm * 1  1/1316 (0.08%)  0/1130 (0.00%) 
1
Term from vocabulary, MedDRA v21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Maraviroc Exposed Maraviroc Unexposed
Affected / at Risk (%) Affected / at Risk (%)
Total   111/1316 (8.43%)   34/1130 (3.01%) 
Gastrointestinal disorders     
Diarrhoea * 1  32/1316 (2.43%)  14/1130 (1.24%) 
Nausea * 1  18/1316 (1.37%)  5/1130 (0.44%) 
General disorders     
Fatigue * 1  15/1316 (1.14%)  6/1130 (0.53%) 
Infections and infestations     
Bronchitis * 1  18/1316 (1.37%)  5/1130 (0.44%) 
Nasopharyngitis * 1  16/1316 (1.22%)  0/1130 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  18/1316 (1.37%)  3/1130 (0.27%) 
Nervous system disorders     
Headache * 1  16/1316 (1.22%)  6/1130 (0.53%) 
Skin and subcutaneous tissue disorders     
Rash * 1  17/1316 (1.29%)  5/1130 (0.44%) 
1
Term from vocabulary, MedDRA v21.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00665561    
Other Study ID Numbers: A4001067
2007-006148-24 ( EudraCT Number )
POEM ( Other Identifier: Alias Study Number )
First Submitted: April 23, 2008
First Posted: April 24, 2008
Results First Submitted: February 12, 2020
Results First Posted: April 7, 2020
Last Update Posted: April 7, 2020