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Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine (MERIT)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00098293
First received: December 6, 2004
Last updated: August 7, 2013
Last verified: August 2013
Results First Received: July 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: HIV-1
Interventions: Drug: Maraviroc + Zidovudine/Lamivudine
Drug: Efavirenz + Zidovudine/Lamivudine
Drug: Maraviroc (UK-427,857) + Zidovudine/Lamivudine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Data Safety Monitoring Board (DSMB) recommended termination of maraviroc once daily treatment after interim analysis at nominal week 16, 130 participants of 177 randomized were switched to open-label (OL) maraviroc twice daily.

Reporting Groups
  Description
Maraviroc Once Daily + CBV (DB) Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
Maraviroc Twice Daily + CBV (DB and OL) Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
Efavirenz Once Daily + CBV (DB and OL) Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
Maraviroc Twice Daily + CBV (OL) Participants who received maraviroc 300 mg tablet orally once daily treatment during the DB phase and who were eligible based on safety criteria and virologic response, switched to OL maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, following the DSMB recommendation to terminate the maraviroc once daily treatment arm after planned interim analysis. OL phase continued for at least 3 years after DB phase.
Maraviroc Twice Daily + CBV (SP) Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.

Participant Flow for 4 periods

Period 1:   Double-blind (DB) Phase
    Maraviroc Once Daily + CBV (DB)     Maraviroc Twice Daily + CBV (DB and OL)     Efavirenz Once Daily + CBV (DB and OL)     Maraviroc Twice Daily + CBV (OL)     Maraviroc Twice Daily + CBV (SP)  
STARTED     177     368     372     0     0  
Treated     174     360     361     0     0  
COMPLETED     0     202     202     0     0  
NOT COMPLETED     177     166     170     0     0  
Adverse Event                 14                 27                 60                 0                 0  
Pregnancy                 0                 7                 9                 0                 0  
Participant Defaulted                 11                 40                 36                 0                 0  
Lack of Efficacy                 11                 64                 30                 0                 0  
Death                 1                 2                 2                 0                 0  
Randomized, Not Treated                 3                 8                 11                 0                 0  
Protocol Violation                 2                 18                 22                 0                 0  
Terminated by sponsor                 135                 0                 0                 0                 0  

Period 2:   Between DB and OL Phase
    Maraviroc Once Daily + CBV (DB)     Maraviroc Twice Daily + CBV (DB and OL)     Efavirenz Once Daily + CBV (DB and OL)     Maraviroc Twice Daily + CBV (OL)     Maraviroc Twice Daily + CBV (SP)  
STARTED     0     202     202     0     0  
COMPLETED     0     202     199     0     0  
NOT COMPLETED     0     0     3     0     0  
Did Not Enter Open-label Phase                 0                 0                 3                 0                 0  

Period 3:   Open-label (OL) Phase
    Maraviroc Once Daily + CBV (DB)     Maraviroc Twice Daily + CBV (DB and OL)     Efavirenz Once Daily + CBV (DB and OL)     Maraviroc Twice Daily + CBV (OL)     Maraviroc Twice Daily + CBV (SP)  
STARTED     0     202     199     130     0  
COMPLETED     0     177     158     65     0  
NOT COMPLETED     0     25     41     65     0  
Adverse Event                 0                 3                 7                 6                 0  
Lack of Efficacy                 0                 7                 2                 20                 0  
Pregnancy                 0                 1                 0                 3                 0  
Protocol Violation                 0                 6                 13                 16                 0  
Participant Defaulted                 0                 6                 16                 20                 0  
Death                 0                 2                 3                 0                 0  

Period 4:   Supplemental Phase (SP)
    Maraviroc Once Daily + CBV (DB)     Maraviroc Twice Daily + CBV (DB and OL)     Efavirenz Once Daily + CBV (DB and OL)     Maraviroc Twice Daily + CBV (OL)     Maraviroc Twice Daily + CBV (SP)  
STARTED     0     0     0     0     127  
COMPLETED     0     0     0     0     94  
NOT COMPLETED     0     0     0     0     33  
Death                 0                 0                 0                 0                 1  
Lost to Follow-up                 0                 0                 0                 0                 2  
Withdrawal by Subject                 0                 0                 0                 0                 8  
Unspecified                 0                 0                 0                 0                 22  



  Baseline Characteristics
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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
Maraviroc Once Daily + CBV (DB) Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
Maraviroc Twice Daily + CBV (DB and OL) Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
Efavirenz Once Daily + CBV (DB and OL) Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, up to week 96 in DB phase. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily from Week 97 up to Week 240 in open-label (OL) phase.
Total Total of all reporting groups

Baseline Measures
    Maraviroc Once Daily + CBV (DB)     Maraviroc Twice Daily + CBV (DB and OL)     Efavirenz Once Daily + CBV (DB and OL)     Total  
Number of Participants  
[units: participants]
  174     360     361     895  
Age, Customized  
[units: participants]
       
Less than 18 years     0     0     0     0  
18 to 24 years     17     24     25     66  
25 to 34 years     47     147     120     314  
35 to 44 years     73     117     141     331  
45 to 54 years     29     56     55     140  
55 to 64 years     7     14     15     36  
Greater than or equal to 65 years     1     2     5     8  
Gender  
[units: participants]
       
Female     44     104     102     250  
Male     130     256     259     645  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population   [ Time Frame: Week 48 ]

2.  Primary:   Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population   [ Time Frame: Week 48 ]

3.  Secondary:   Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression   [ Time Frame: Week 48 ]

4.  Secondary:   Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression   [ Time Frame: Week 96 ]

5.  Secondary:   Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96   [ Time Frame: Baseline, Week 48, Week 96 ]

6.  Secondary:   Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels   [ Time Frame: Baseline up to Week 48 and Week 96 ]

7.  Secondary:   Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96   [ Time Frame: Baseline, Week 48, Week 96 ]

8.  Secondary:   Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96   [ Time Frame: Baseline, Week 48, Week 96 ]

9.  Secondary:   Time to Virologic Failure   [ Time Frame: Week 48, Week 96 ]

10.  Secondary:   Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48   [ Time Frame: Baseline, time of failure through Week 48 ]

11.  Secondary:   Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96   [ Time Frame: Baseline, time of failure through Week 96 ]

12.  Secondary:   Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96   [ Time Frame: Screening, time of failure through Week 48, Week 96 ]

13.  Secondary:   Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96   [ Time Frame: Screening, time of failure through Week 48, Week 96 ]

14.  Secondary:   Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96   [ Time Frame: Screening, time of failure through Week 48, Week 96 ]

15.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening   [ Time Frame: Baseline, Week 48, Week 96 ]

16.  Other Pre-specified:   Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96   [ Time Frame: Week 96 ]

17.  Post-Hoc:   Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants   [ Time Frame: Week 48 ]

18.  Post-Hoc:   Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants   [ Time Frame: Week 96 ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Reporting Groups
  Description
Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL) Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
Maraviroc Twice Daily + CBV (DB and OL) Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
Efavirenz Once Daily + CBV (DB and OL) Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
Maraviroc Twice Daily + CBV (SP) Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.

Serious Adverse Events
    Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)     Maraviroc Twice Daily + CBV (DB and OL)     Efavirenz Once Daily + CBV (DB and OL)     Maraviroc Twice Daily + CBV (SP)  
Total, serious adverse events          
# participants affected / at risk     47/174 (27.01%)     77/360 (21.39%)     82/361 (22.71%)     4/127 (3.15%)  
Blood and lymphatic system disorders          
Anaemia * 1        
# participants affected / at risk     6/174 (3.45%)     7/360 (1.94%)     6/361 (1.66%)     0/127 (0.00%)  
Leukocytosis * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Neutropenia * 1        
# participants affected / at risk     3/174 (1.72%)     2/360 (0.56%)     2/361 (0.55%)     0/127 (0.00%)  
Pancytopenia * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     2/361 (0.55%)     0/127 (0.00%)  
Cardiac disorders          
Acute myocardial infarction * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     2/361 (0.55%)     0/127 (0.00%)  
Angina unstable * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Cardiopulmonary failure * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Myocardial infarciton * 1        
# participants affected / at risk     0/174 (0.00%)     2/360 (0.56%)     1/361 (0.28%)     0/127 (0.00%)  
Pericardial effusion * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Pulseless electrical activity * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Congenital, familial and genetic disorders          
Bicuspid aortic valve * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Tinnitus * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Vertigo * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Ear and labyrinth disorders          
Haematotympanum * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Eye disorders          
Diabetic eye disease * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Uveitis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Gastrointestinal disorders          
Abdominal pain * 1        
# participants affected / at risk     1/174 (0.57%)     4/360 (1.11%)     1/361 (0.28%)     0/127 (0.00%)  
Abdominal pain lower * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Anal fistula * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     2/361 (0.55%)     0/127 (0.00%)  
Ascites * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Colitis * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Diarrhoea * 1        
# participants affected / at risk     2/174 (1.15%)     2/360 (0.56%)     0/361 (0.00%)     0/127 (0.00%)  
Duodenal ulcer * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Gastric ulcer * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Gastritis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Gastrointestinal haemorrhage * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Haemorrhoids * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Ileus * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Inguinal hernia * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Mesenteric vein thrombosis * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Nausea * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Pancreatitis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Rectal haemorrhage * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Rectal polyp * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Small intestinal obstruction * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Vomiting * 1        
# participants affected / at risk     0/174 (0.00%)     2/360 (0.56%)     0/361 (0.00%)     0/127 (0.00%)  
Umbilical hernia * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     0/361 (0.00%)     1/127 (0.79%)  
General disorders          
Asthenia * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Chest pain * 1        
# participants affected / at risk     2/174 (1.15%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Influenza like illness * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     2/361 (0.55%)     0/127 (0.00%)  
Pyrexia * 1        
# participants affected / at risk     4/174 (2.30%)     4/360 (1.11%)     5/361 (1.39%)     0/127 (0.00%)  
Sudden cardiac death * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Hepatobiliary disorders          
Biliary colic * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Cholelithiasis * 1        
# participants affected / at risk     0/174 (0.00%)     2/360 (0.56%)     2/361 (0.55%)     0/127 (0.00%)  
Hepatitis * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Hepatitis toxic * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Hypertransaminasaemia * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Immune system disorders          
Anaphylactic shock * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Drug hypersensitivity * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Hypersensitivity * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Infections and infestations          
Anal abscess * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Anal fistula infection * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Anogenital warts * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Appendicitis * 1        
# participants affected / at risk     0/174 (0.00%)     3/360 (0.83%)     3/361 (0.83%)     0/127 (0.00%)  
Appendicitis perforated * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Bronchitis * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     2/361 (0.55%)     1/127 (0.79%)  
Bronchopneumonia * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Cellulitis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Cryptosporidiosis infection * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Disseminated tuberculosis * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Diverticulitis * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Hepatitis A * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Hepatitis C * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Herpes zoster * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Intervertebral discitis * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Lobar pneumonia * 1        
# participants affected / at risk     0/174 (0.00%)     2/360 (0.56%)     2/361 (0.55%)     0/127 (0.00%)  
Localised infection * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Lower respiratory tract infection * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Meningitis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Meningitis bacterial * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Neurosyphilis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Orchitis * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Osteomyelitis * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Parasitic gastroenteritis * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Pelvic inflamatory disease * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Penile infection * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Peritoneal abscess * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Pneumocystis jiroveci infection * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Pneumocystis jiroveci pneumonia * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Pneumonia * 1        
# participants affected / at risk     1/174 (0.57%)     3/360 (0.83%)     5/361 (1.39%)     0/127 (0.00%)  
Pneumonia staphylococcal * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Pulmonary tuberculosis * 1        
# participants affected / at risk     0/174 (0.00%)     2/360 (0.56%)     3/361 (0.83%)     0/127 (0.00%)  
Sepsis * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Sinobronchitis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Sinusitis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Staphylococcal bacteraemia * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Staphylococcal infection * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Subcutaneous abscess * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     2/361 (0.55%)     0/127 (0.00%)  
Syphilis * 1        
# participants affected / at risk     0/174 (0.00%)     2/360 (0.56%)     0/361 (0.00%)     0/127 (0.00%)  
Upper respiratory tract infection * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Urinary tract infection * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Injury, poisoning and procedural complications          
Ankle fracture * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Chest injury * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Concussion * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Femoral neck fracture * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Head injury * 1        
# participants affected / at risk     0/174 (0.00%)     2/360 (0.56%)     0/361 (0.00%)     0/127 (0.00%)  
Heart injury * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Hip fracture * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Human bite * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Injury * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Jaw fracture * 1        
# participants affected / at risk     2/174 (1.15%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Laceration * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     2/361 (0.55%)     0/127 (0.00%)  
Limb injury * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Multiple fracture * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Overdose * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     2/361 (0.55%)     1/127 (0.79%)  
Pubis fracture * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Rib fracture * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Skull fracture * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Soft tissue injury * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Spinal compression fracture * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Tendon rupture * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Whiplash injury * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Injury * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     0/361 (0.00%)     1/127 (0.79%)  
Back injury * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     0/361 (0.00%)     1/127 (0.79%)  
Investigations          
Alanine aminotransferase increased * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Aspartate aminotransferase increased * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     2/361 (0.55%)     0/127 (0.00%)  
Blood creatine phosphokinase increased * 1        
# participants affected / at risk     1/174 (0.57%)     2/360 (0.56%)     3/361 (0.83%)     0/127 (0.00%)  
Blood lactate dehydrogenase increased * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Blood sodium decreased * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Gama-glutamytransferase increased * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     2/361 (0.55%)     0/127 (0.00%)  
Haemoglobin decreased * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Hepatic enzyme increased * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Transaminases increased * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Metabolism and nutrition disorders          
Decreased appetite * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Dehydration * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Hyperkalaemia * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Musculoskeletal and connective tissue disorders          
Arthralgia * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Back pain * 1        
# participants affected / at risk     0/174 (0.00%)     2/360 (0.56%)     0/361 (0.00%)     0/127 (0.00%)  
Flank pain * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Myalgia * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Osteoarthritis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Pain in extremity * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Rhabdomyolysis * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)          
Basal cell carcinoma * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Breast cancer in situ * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Castleman's disease * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Diffuse large B-cell lymphoma * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Fibroma * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Hoadgkin's disease * 1        
# participants affected / at risk     0/174 (0.00%)     2/360 (0.56%)     3/361 (0.83%)     0/127 (0.00%)  
Kaposi's sarcoma * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Metastases to bone * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Metastatic neoplasm * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Multiple myeloma * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Nasopharyngeal cancer * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Neoplasm * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Non-Hodgkin's lymphoma * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Non-small cell lung cancer * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Rectal cancer * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Squamous cell carcinoma * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Thyroid cancer * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Thyroid neoplasm * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Vulval neoplasm * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Nervous system disorders          
Ataxia * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     2/361 (0.55%)     0/127 (0.00%)  
Balance disorder * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Cerebrovascular accident * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Convulsion * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     2/361 (0.55%)     0/127 (0.00%)  
Cranial nerve paralysis * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Dysarthria * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Dyspraxia * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Encephalitis * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Grand mal convulsion * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Headache * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Ischaemic stroke * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Loss of consciousness * 1        
# participants affected / at risk     0/174 (0.00%)     2/360 (0.56%)     0/361 (0.00%)     0/127 (0.00%)  
Monoparesis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Syncope * 1        
# participants affected / at risk     1/174 (0.57%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Thoracic outlet syndrome * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Transient ischaemic attack * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Vascular demetia * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Pregnancy, puerperium and perinatal conditions          
Abortion * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Abortion spontaneous * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Pregnancy * 1        
# participants affected / at risk     3/174 (1.72%)     5/360 (1.39%)     8/361 (2.22%)     0/127 (0.00%)  
Psychiatric disorders          
Completed suicide * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Depression * 1        
# participants affected / at risk     1/174 (0.57%)     2/360 (0.56%)     0/361 (0.00%)     0/127 (0.00%)  
Depression suicidal * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Drug abuse * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Drug dependence * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Intentional self-injury * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Major depression * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Mental status changes * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Post-traumatic stress disorder * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Suicidal ideation * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Suicide attempt * 1        
# participants affected / at risk     2/174 (1.15%)     0/360 (0.00%)     2/361 (0.55%)     0/127 (0.00%)  
Renal and urinary disorders          
Calculus bladder * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Haematuria * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Nephrolithiasis * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Renal failure * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Renal failure acute * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Reproductive system and breast disorders          
Cervix haemorrhage uterine * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Epididymitis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Ovarian cyst * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Testicular pain * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Uterine cervical laceration * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Respiratory, thoracic and mediastinal disorders          
Atelectasis * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Haemoptysis * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Pleural effusion * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Pneumothorax * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Pulmonary embolism * 1        
# participants affected / at risk     1/174 (0.57%)     3/360 (0.83%)     0/361 (0.00%)     0/127 (0.00%)  
Skin and subcutaneous tissue disorders          
Dermal cyst * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Drug eruption * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Penile ulceration * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Rash * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Rash erythematous * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Rash pruritic * 1        
# participants affected / at risk     0/174 (0.00%)     0/360 (0.00%)     1/361 (0.28%)     0/127 (0.00%)  
Stevens-Johnson syndrome * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Social circumstances          
Drug abuser * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
Pregnancy of partner * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Surgical and medical procedures          
Cholecystectomy * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Finger amputation * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     0/361 (0.00%)     0/127 (0.00%)  
Vascular disorders          
Deep vein thrombosis * 1        
# participants affected / at risk     0/174 (0.00%)     1/360 (0.28%)     1/361 (0.28%)     0/127 (0.00%)  
Hypertension * 1        
# participants affected / at risk     1/174 (0.57%)     0/360 (0.00%)     0/361 (0.00%)     0/127 (0.00%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 14.0




  Other Adverse Events


  Limitations and Caveats
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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
Following DSMB decision to discontinue maraviroc 300 mg once daily, inferential statistical analyses was performed between maraviroc 300 mg twice daily and efavirenz 600 mg once daily only. Data at Week 24 was not analyzed as planned in protocol.


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