A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00296504
First received: February 24, 2006
Last updated: April 11, 2013
Last verified: June 2012
Results First Received: September 30, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: fosamprenavir (GW433908)
Drug: ritonavir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
APV30005 enabled Human Immunodeficiency Virus (HIV)‐infected participants who had received a Fosamprenavir (FPV)‐containing or other regimen in a number of studies, including APV30001, APV30002, and APV30003, to receive FPV until 31 January 2006 (Interim Analysis) or until commercial supplies of FPV were available locally, whichever was later.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants are divided into arms depending on the regimen they received in Studies APV30001, APV30002, and APV30003 or whether they were PI-naïve or PI‐experienced at the time they enrolled into other studies. For the final analysis, 111 participants are included who continued in APV30005 after 31 January 2006 until study completion.

Reporting Groups
  Description
FPV Population (APV30001) Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)
NFV Population (APV30001) FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001
FPV Population (APV30002) FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
NFV Population (APV30002) FPV +/- RTV + background regimen in participants who had received NFV in APV30002
FPV/RTV Once Daily (QD) Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
FPV/RTV Twice Daily (BID) Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
Protease Inhibitor (PI)-Naïve Population (Other Studies) FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
PI-Experienced Population (Other Studies) FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Final Analysis Population (APV30005) FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006

Participant Flow for 2 periods

Period 1:   Interim Analysis
    FPV Population (APV30001)     NFV Population (APV30001)     FPV Population (APV30002)     NFV Population (APV30002)     FPV/RTV Once Daily (QD) Population (APV30003)     FPV/RTV Twice Daily (BID) Population (APV30003)     Protease Inhibitor (PI)-Naïve Population (Other Studies)     PI-Experienced Population (Other Studies)     Final Analysis Population (APV30005)  
STARTED     119     18     221     54     73     78     104     86     0  
Ongoing     32     12     16     22     0     0     30     1     0  
COMPLETED     43     0     116     11     36     41     30     37     0  
NOT COMPLETED     76     18     105     43     37     37     74     49     0  
Withdrawal by Subject                 8                 0                 12                 0                 5                 5                 9                 3                 0  
Lost to Follow-up                 13                 3                 26                 8                 14                 4                 11                 4                 0  
Clinical Progression                 1                 0                 1                 1                 0                 2                 1                 2                 0  
Insufficient Viral Load Response                 5                 1                 12                 2                 7                 9                 2                 24                 0  
Adverse Event                 0                 0                 13                 4                 6                 3                 4                 5                 0  
Protocol Violation                 0                 0                 2                 0                 1                 0                 0                 1                 0  
Insufficient CD4 Response                 0                 0                 0                 0                 1                 1                 0                 0                 0  
Switched to Commercially Available Drug                 2                 0                 4                 1                 0                 5                 3                 4                 0  
Pregnancy                 4                 1                 4                 2                 0                 1                 1                 1                 0  
Death                 1                 0                 3                 0                 0                 0                 0                 0                 0  
Participant Non-compliant                 0                 1                 2                 1                 1                 3                 6                 2                 0  
Participant Wanted to Become Pregnant                 0                 0                 2                 0                 0                 1                 0                 0                 0  
To Simplify Treatment                 0                 0                 1                 0                 0                 0                 2                 0                 0  
Participant Had Problems with Alcohol                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Participant Moved                 1                 0                 1                 0                 0                 1                 1                 0                 0  
Participant Was Incarcerated                 2                 0                 1                 0                 0                 0                 0                 0                 0  
Resistance to FPV                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Physician Decision                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Principle Investigator Discretion                 2                 0                 1                 1                 0                 0                 0                 0                 0  
Principle Investigator Terminated Study                 0                 0                 1                 0                 0                 0                 0                 0                 0  
Non-adherence                 2                 0                 0                 0                 1                 0                 0                 1                 0  
Site Closing                 1                 0                 0                 0                 0                 1                 2                 0                 0  
Lack of Personnel at Site                 1                 0                 0                 0                 0                 0                 0                 0                 0  
Missed Schedule Date                 1                 0                 0                 0                 0                 0                 0                 0                 0  
Inclusion in Other Protocol                 0                 0                 0                 1                 0                 0                 0                 0                 0  
Participant Stopped                 0                 0                 0                 0                 1                 0                 0                 0                 0  
Physician and Participant Decision                 0                 0                 0                 0                 0                 1                 0                 0                 0  
Participant Stopped HIV Medications                 0                 0                 0                 0                 0                 0                 1                 0                 0  
Study Ended                 0                 0                 0                 0                 0                 0                 1                 0                 0  
Participant Needed Interferon                 0                 0                 0                 0                 0                 0                 0                 1                 0  
Ongoing                 32                 12                 16                 22                 0                 0                 30                 1                 0  

Period 2:   Final Analysis
    FPV Population (APV30001)     NFV Population (APV30001)     FPV Population (APV30002)     NFV Population (APV30002)     FPV/RTV Once Daily (QD) Population (APV30003)     FPV/RTV Twice Daily (BID) Population (APV30003)     Protease Inhibitor (PI)-Naïve Population (Other Studies)     PI-Experienced Population (Other Studies)     Final Analysis Population (APV30005)  
STARTED     0     0     0     0     0     0     0     0     111 [1]
COMPLETED     0     0     0     0     0     0     0     0     90  
NOT COMPLETED     0     0     0     0     0     0     0     0     21  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 0                 0                 5  
Insufficient Viral Load Response                 0                 0                 0                 0                 0                 0                 0                 0                 6  
Adverse Event                 0                 0                 0                 0                 0                 0                 0                 0                 2  
Pregnancy                 0                 0                 0                 0                 0                 0                 0                 0                 4  
Tuberculosis                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Participant Moved to Another Country                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Poor Adherence                 0                 0                 0                 0                 0                 0                 0                 0                 1  
[1] Continued in study; commercial supplies of FPV were unavailable locally at end of Interim Analysis.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FPV Population (APV30001) FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
NFV Population (APV30001) FPV +/- RTV + background regimen in participants who had received NFV in APV30001
FPV Population (APV30002) FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
NFV Population (APV30002) FPV +/- RTV + background regimen in participants who had received NFV in APV30002
FPV/RTV QD Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
FPV/RTV BID Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
PI-Naïve Population (Other Studies) FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
PI-Experienced Population (Other Studies) FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Total Total of all reporting groups

Baseline Measures
    FPV Population (APV30001)     NFV Population (APV30001)     FPV Population (APV30002)     NFV Population (APV30002)     FPV/RTV QD Population (APV30003)     FPV/RTV BID Population (APV30003)     PI-Naïve Population (Other Studies)     PI-Experienced Population (Other Studies)     Total  
Number of Participants  
[units: participants]
  119     18     221     54     73     78     104     86     753  
Age, Customized  
[units: years]
Mean ( Full Range )
  36.3  
  ( 17 to 70 )  
  35.8  
  ( 22 to 54 )  
  37.7  
  ( 19 to 69 )  
  36.2  
  ( 26 to 63 )  
  41.9  
  ( 27 to 58 )  
  42.3  
  ( 24 to 71 )  
  39.3  
  ( 21 to 75 )  
  40.2  
  ( 19 to 60 )  
  38.7  
  ( 17 to 75 )  
Gender  
[units: Participants]
                 
Female     36     9     63     23     9     12     24     22     198  
Male     83     9     158     31     64     66     80     64     555  
Race/Ethnicity, Customized  
[units: participants]
                 
White     34     1     109     14     59     56     44     77     394  
Black     35     6     86     34     10     14     34     7     226  
Asian     1     0     4     0     1     1     1     0     8  
American Hispanic     49     11     16     2     3     7     23     2     113  
Other: Race Not Specified     0     0     6     4     0     0     2     0     12  
Number of Participants with the Indicated CDC Classification of HIV Infection [1]
[units: participants]
                 
Asymptomatic or lymphadenopathy     81     16     124     13     26     30     76     29     395  
Symptomatic, not AIDS     17     1     48     23     21     24     23     18     175  
Acquired Immune Deficiency Syndrome (AIDS)     21     1     49     18     26     24     5     39     183  
[1] The Centers for Disease Control and Prevention (CDC) 1993 classification system for HIV infection was based on three clinical categories (A, B, and C). Category A comprised asymptomatic acute or primary HIV infection or persistent generalized lymphadenopathy (lymphnode disease). Category B comprised symptomatic conditions not included in clinical categories A or C but attributed to a cell-mediated immunity defect or for which the clinical course or management was complicated by HIV infection. Category C comprised AIDS-defining conditions.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Event (AE): Interim Analysis   [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ]

2.  Primary:   Number of Participants With Any Adverse Event (AE): Final Analysis   [ Time Frame: Post January 2006; for up to 241 weeks ]

3.  Primary:   Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216   [ Time Frame: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216 ]

4.  Primary:   Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432   [ Time Frame: Weeks 120, 180, 204, 216, and 432 ]

5.  Primary:   Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216   [ Time Frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216 ]

6.  Primary:   Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168   [ Time Frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168 ]

7.  Primary:   Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432   [ Time Frame: Weeks 120, 180, 204, 216, and 432 ]

8.  Primary:   Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216   [ Time Frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216 ]

9.  Primary:   Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168   [ Time Frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168 ]

10.  Primary:   Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432   [ Time Frame: Weeks 120, 180, 204, 216, and 432 ]

11.  Secondary:   Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)   [ Time Frame: Baseline and Weeks 48, 120, 180, and 216 ]

12.  Secondary:   Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)   [ Time Frame: Baseline and Weeks 12, 24, 48, 60, 96, and 132 ]

13.  Secondary:   Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)   [ Time Frame: Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 ]

14.  Secondary:   Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis   [ Time Frame: Baseline and Weeks 48, 120, 168, 180, 204, and 216 ]

15.  Secondary:   Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis   [ Time Frame: Baseline and Weeks 24, 48, 96, 132, and 168 ]

16.  Secondary:   Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216   [ Time Frame: Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 ]

17.  Secondary:   Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168   [ Time Frame: Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 ]

18.  Secondary:   Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432   [ Time Frame: Weeks 180, 240, 300, 360, 420, and 432 ]

19.  Secondary:   Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline   [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ]

20.  Secondary:   Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions   [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ]

21.  Secondary:   Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions   [ Time Frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264) ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
FPV Population (APV30001) FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
NFV Population (APV30001) FPV +/- RTV + background regimen in participants who had received NFV in APV30001
FPV Population (APV30002) FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
NFV Population (APV30002) FPV +/- RTV + background regimen in participants who had received NFV in APV30002
FPV/RTV QD Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
FPV/RTV BID Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
PI-Naïve Population (Other Studies) FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
PI-Experienced Population (Other Studies) FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Final Analysis Population (APV30005) FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006

Serious Adverse Events
    FPV Population (APV30001)     NFV Population (APV30001)     FPV Population (APV30002)     NFV Population (APV30002)     FPV/RTV QD Population (APV30003)     FPV/RTV BID Population (APV30003)     PI-Naïve Population (Other Studies)     PI-Experienced Population (Other Studies)     Final Analysis Population (APV30005)  
Total, serious adverse events                    
# participants affected / at risk     33/119 (27.73%)     1/18 (5.56%)     62/221 (28.05%)     7/54 (12.96%)     20/73 (27.40%)     14/78 (17.95%)     7/104 (6.73%)     13/86 (15.12%)     15/111 (13.51%)  
Blood and lymphatic system disorders                    
Anaemia † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     2/86 (2.33%)     1/111 (0.90%)  
Cardiac disorders                    
Cardiomegaly † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Coronary artery disease † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Angina unstable † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Myocardial infarction † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Tachycardia † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Cardiac failure congestive † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Eye disorders                    
Pterygium † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Gastrointestinal disorders                    
Abdominal pain † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     1/104 (0.96%)     0/86 (0.00%)     0/111 (0.00%)  
Vomiting † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Diarrhoea † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Nausea † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pancreatitis acute † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Anal stenosis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Colitis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Inguinal hernia † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pancreatitis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
General disorders                    
Chest pain † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     5/221 (2.26%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Chest discomfort † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Feeling hot † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pyrexia † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Malaise † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Hepatobiliary disorders                    
Cholelithiasis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Immune system disorders                    
Drug hypersensitivity † 1                  
# participants affected / at risk     11/119 (9.24%)     0/18 (0.00%)     16/221 (7.24%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Infections and infestations                    
Anogenital warts † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Cellulitis of male external genital organ † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Enterocolitis infectious † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Gastroenteritis † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Gastroenteritis salmonella † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Herpes simplex † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Orchitis † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Peritonsillar abscess † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pneumocystis jiroveci pneumonia † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pneumonia † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     3/221 (1.36%)     0/54 (0.00%)     2/73 (2.74%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Scrotal abscess † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Sepsis † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Syphilis † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     1/104 (0.96%)     0/86 (0.00%)     0/111 (0.00%)  
Viral infection † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Lobar pneumonia † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Osteomyelitis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pyelonephritis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Appendicitis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Arthritis bacterial † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Bronchitis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     1/104 (0.96%)     0/86 (0.00%)     0/111 (0.00%)  
Bronchopneumonia † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Cellulitis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Erysipelas † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Influenza † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Localised infection † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Meningitis viral † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pneumonia primary atypical † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Respiratory tract infection † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Superinfection lung † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Tuberculosis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Urinary tract infection † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Abscess limb † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Meningitis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Hepatitis C † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Herpes zoster † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Leishmaniasis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Perianal abscess † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Upper respiratory tract infection † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Visceral leishmaniasis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Perirectal abscess † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     1/104 (0.96%)     0/86 (0.00%)     0/111 (0.00%)  
Urinary tract infection pseudomonal † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     1/104 (0.96%)     0/86 (0.00%)     0/111 (0.00%)  
Pneumonia bacterial † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Subcutaneous abscess † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Malaria † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Injury, poisoning and procedural complications                    
Joint dislocation † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Contusion † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Facial bones fracture † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Fall † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Forearm fracture † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Gastrointestinal injury † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Hand fracture † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Head injury † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Jaw fracture † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Overdose † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Patella fracture † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Road traffic accident † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Wrist fracture † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Alcohol poisoning † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Thermal burn † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Anastomotic leak † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Collapse of lung † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/0 (0.00%)     0/111 (0.00%)  
Injury † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Fibula fracture † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Tendon rupture † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Tibia fracture † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Ankle fracture † 1                  
# participants affected / at risk     0/119 (0.00%)     1/18 (5.56%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Arthropod bite † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Lower limb fracture † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Soft tissue injury † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Investigations                    
Alanine aminotransferase increased † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Aspartate aminotransferase increased † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Electrocardiogram abnormal † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Lipase increased † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Haemoglobin decreased † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Liver function test abnormal † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Metabolism and nutrition disorders                    
Diabetes mellitus † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Dehydration † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Hyperthyroidism † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Thyroiditis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Musculoskeletal and connective tissue disorders                    
Joint effusion † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Musculoskeletal pain † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pain in extremity † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Bursitis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Intervertebral disc protrusion † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Lumbar spinal stenosis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Rhabdomyolysis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Arthritis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Periarthritis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Rotator cuff syndrome † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                    
Breast cancer † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Squamous cell carcinoma † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Bladder transitional cell carcinoma † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Bowen's disease † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Lymphoma † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Laryngeal neoplasm † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Penis carcinoma † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Nervous system disorders                    
Paralysis † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Headache † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Convulsion † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Transient ischaemic attack † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Dizziness † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Myoclonus † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Post herpetic neuralgia † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Syncope † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Cerebrovascular accident † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Pregnancy, puerperium and perinatal conditions                    
Abortion spontaneous † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Ectopic pregnancy † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Psychiatric disorders                    
Bipolar disorder † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Depression † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     1/54 (1.85%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Schizoaffective disorder † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Suicide attempt † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     1/221 (0.45%)     1/54 (1.85%)     2/73 (2.74%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Mental status changes † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Alcoholism † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     1/54 (1.85%)     0/73 (0.00%)     0/78 (0.00%)     1/104 (0.96%)     0/86 (0.00%)     0/111 (0.00%)  
Conversion disorder † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Depression suicidal † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Suicidal ideation † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Mood altered † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Renal and urinary disorders                    
Nephrolithiasis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Urethral disorder † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Urethral stenosis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Renal colic † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Renal failure acute † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Reproductive system and breast disorders                    
Breast mass † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Fibrocystic breast disease † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Prostatitis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     1/104 (0.96%)     0/86 (0.00%)     0/111 (0.00%)  
Breast enlargement † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Respiratory, thoracic and mediastinal disorders                    
Dyspnoea † 1                  
# participants affected / at risk     2/119 (1.68%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Asthma † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     4/221 (1.81%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     1/104 (0.96%)     0/86 (0.00%)     0/111 (0.00%)  
Pleural effusion † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     1/104 (0.96%)     0/86 (0.00%)     0/111 (0.00%)  
Pneumonitis † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Respiratory failure † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Cough † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Epistaxis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     1/86 (1.16%)     0/111 (0.00%)  
Hypoxia † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pharyngolaryngeal pain † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pneumonia aspiration † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Emphysema † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Lung disorder † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pneumothorax † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Pulmonary embolism † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Chronic obstructive pulmonary disease † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     1/104 (0.96%)     0/86 (0.00%)     1/111 (0.90%)  
Skin and subcutaneous tissue disorders                    
Hyperhidrosis † 1                  
# participants affected / at risk     1/119 (0.84%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Skin ulcer † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Rash generalised † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     1/73 (1.37%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Erythema † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Vascular disorders                    
Hypertension † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     2/221 (0.90%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Arteriosclerosis † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     1/221 (0.45%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Peripheral arterial occlusive disease † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     1/78 (1.28%)     0/104 (0.00%)     0/86 (0.00%)     0/111 (0.00%)  
Peripheral ischaemia † 1                  
# participants affected / at risk     0/119 (0.00%)     0/18 (0.00%)     0/221 (0.00%)     0/54 (0.00%)     0/73 (0.00%)     0/78 (0.00%)     0/104 (0.00%)     0/86 (0.00%)     1/111 (0.90%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: ViiV Healthcare
phone: 866-435-7343


No publications provided


Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00296504     History of Changes
Other Study ID Numbers: APV30005
Study First Received: February 24, 2006
Results First Received: September 30, 2011
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration