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Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects (MOTIVATE 2)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00098722
First received: December 7, 2004
Last updated: April 16, 2012
Last verified: April 2012
Results First Received: April 16, 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 Infections
Interventions: Drug: Maraviroc (UK-427,857)
Drug: optimized background therapy

  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
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Reporting Groups
  Description
Maraviroc QD, Double Blind Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc BID, Double Blind Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo, Double Blind Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Maraviroc BID, Open Label Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
In Study-off Drug (ISOD), Open Label Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
Maraviroc BID, Observation Phase Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
In Study-off Drug (ISOD), Observation Phase Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.

Participant Flow for 3 periods

Period 1:   Double Blind Phase
    Maraviroc QD, Double Blind     Maraviroc BID, Double Blind     Placebo, Double Blind     Maraviroc BID, Open Label     In Study-off Drug (ISOD), Open Label     Maraviroc BID, Observation Phase     In Study-off Drug (ISOD), Observation Phase  
STARTED     186     194     94     0     0     0     0  
Treated     182     191     91     0     0     0     0  
COMPLETED     0     0     0     0     0     0     0  
NOT COMPLETED     186     194     94     0     0     0     0  
Adverse Event                 7                 7                 3                 0                 0                 0                 0  
Death                 2                 5                 0                 0                 0                 0                 0  
Lack of Efficacy                 21                 23                 15                 0                 0                 0                 0  
Participant defaulted                 16                 11                 9                 0                 0                 0                 0  
Pregnancy                 1                 0                 0                 0                 0                 0                 0  
Randomized, not treated                 4                 3                 3                 0                 0                 0                 0  
Ongoing at cut-off date                 128                 137                 57                 0                 0                 0                 0  
Unspecified                 7                 8                 7                 0                 0                 0                 0  

Period 2:   Open Label Phase
    Maraviroc QD, Double Blind     Maraviroc BID, Double Blind     Placebo, Double Blind     Maraviroc BID, Open Label     In Study-off Drug (ISOD), Open Label     Maraviroc BID, Observation Phase     In Study-off Drug (ISOD), Observation Phase  
STARTED     0     0     0     272     50     0     0  
COMPLETED     0     0     0     0     0     0     0  
NOT COMPLETED     0     0     0     272     50     0     0  
Adverse Event                 0                 0                 0                 5                 0                 0                 0  
Death                 0                 0                 0                 2                 0                 0                 0  
Lack of Efficacy                 0                 0                 0                 8                 0                 0                 0  
Pregnancy                 0                 0                 0                 1                 0                 0                 0  
Participant defaulted                 0                 0                 0                 18                 0                 0                 0  
Ongoing at cut-off date                 0                 0                 0                 220                 50                 0                 0  
Unspecified                 0                 0                 0                 18                 0                 0                 0  

Period 3:   Observation Phase
    Maraviroc QD, Double Blind     Maraviroc BID, Double Blind     Placebo, Double Blind     Maraviroc BID, Open Label     In Study-off Drug (ISOD), Open Label     Maraviroc BID, Observation Phase     In Study-off Drug (ISOD), Observation Phase  
STARTED     0     0     0     0     0     205     65  
COMPLETED     0     0     0     0     0     160     48  
NOT COMPLETED     0     0     0     0     0     45     17  
Death                 0                 0                 0                 0                 0                 5                 3  
Lack of Efficacy                 0                 0                 0                 0                 0                 2                 0  
Participant defaulted                 0                 0                 0                 0                 0                 17                 4  
Unspecified                 0                 0                 0                 0                 0                 21                 10  



  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 QD Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc BID Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Total Total of all reporting groups

Baseline Measures
    Maraviroc QD     Maraviroc BID     Placebo     Total  
Number of Participants  
[units: participants]
  182     191     91     464  
Age, Customized [1]
[units: participants]
       
Less than 18 years     1     0     0     1  
18 to 24 years     1     1     0     2  
25 to 34 years     8     9     6     23  
35 to 44 years     85     71     40     196  
45 to 54 years     63     70     32     165  
55 to 64 years     19     37     11     67  
Greater than or equal to 65 years     5     3     2     10  
Gender [2]
[units: participants]
       
Female     29     21     12     62  
Male     153     170     79     402  
[1] Out of a total of 474 participants, data for baseline measure (age) was available for 464 participants who were treated.
[2] Out of a total of 474 participants, data for baseline measure (gender) was available for 464 participants who were treated.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline   [ Time Frame: Baseline ]

2.  Primary:   Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24   [ Time Frame: Baseline and Week 24 ]

3.  Primary:   Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48   [ Time Frame: Baseline and Week 48 ]

4.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL   [ Time Frame: Week 24 and 48 ]

5.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline   [ Time Frame: Week 24 and 48 ]

6.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline   [ Time Frame: Week 24 and 48 ]

7.  Secondary:   Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL   [ Time Frame: Week 24 and 48 ]

8.  Secondary:   Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline   [ Time Frame: Baseline ]

9.  Secondary:   Change From Baseline in CD4 Cell Count at Week 24 and 48   [ Time Frame: Week 24 and 48 ]

10.  Secondary:   Change From Baseline in CD8 Cell Count at Week 24 and 48   [ Time Frame: Week 24 and 48 ]

11.  Secondary:   Time to Virological Failure   [ Time Frame: Week 48 ]

12.  Secondary:   Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels   [ Time Frame: Baseline to Week 24 and Week 48 ]

13.  Secondary:   Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening   [ Time Frame: Screening ]

14.  Secondary:   Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24   [ Time Frame: Screening and time of failure through Week 24 ]

15.  Secondary:   Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48   [ Time Frame: Screening and time of failure through Week 48 ]

16.  Secondary:   Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24   [ Time Frame: Baseline and time of failure through Week 24 ]

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

18.  Secondary:   Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening   [ Time Frame: Baseline, Week 24 and Week 48 ]


  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 QD Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
Maraviroc BID Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Placebo Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
Maraviroc BID, Open Label Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
In Study-off Drug, Open Label Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
Maraviroc BID, Observation Phase Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
In Study-off Drug, Observation Phase Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.

Serious Adverse Events
    Maraviroc QD     Maraviroc BID     Placebo     Maraviroc BID, Open Label     In Study-off Drug, Open Label     Maraviroc BID, Observation Phase     In Study-off Drug, Observation Phase  
Total, serious adverse events                
# participants affected / at risk     40/182 (21.98%)     46/191 (24.08%)     16/91 (17.58%)     28/272 (10.29%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Blood and lymphatic system disorders                
Anaemia * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     2/272 (0.74%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Febrile neutropenia * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Haemolytic anaemia * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Lymphadenopathy * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Neutropenia * 1              
# participants affected / at risk     1/182 (0.55%)     2/191 (1.05%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pancytopenia * 1              
# participants affected / at risk     0/182 (0.00%)     2/191 (1.05%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Thrombocytopenia * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Cardiac disorders                
Aortic valve disease * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Arrhythmia * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Cardiac failure acute * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Cardio-respiratory arrest * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Coronary artery occlusion * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Myocardial infarction * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Supraventricular tachyarrhythmia * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Endocrine disorders                
Hypothyroidism * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Eye disorders                
Retinal detachment * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Gastrointestinal disorders                
Abdominal pain * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Diarrhoea * 1              
# participants affected / at risk     2/182 (1.10%)     2/191 (1.05%)     1/91 (1.10%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Dysphagia * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Inguinal hernia * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Nausea * 1              
# participants affected / at risk     3/182 (1.65%)     2/191 (1.05%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Proctitis * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Rectal ulcer * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Vomiting * 1              
# participants affected / at risk     3/182 (1.65%)     3/191 (1.57%)     2/91 (2.20%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Reflux oesophagitis * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
General disorders                
Chest pain * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Fatigue * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Hyperthermia * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Oedema peripheral * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pyrexia * 1              
# participants affected / at risk     1/182 (0.55%)     2/191 (1.05%)     3/91 (3.30%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Mucosal erosion * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Sudden death * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Hepatobiliary disorders                
Bile duct stone * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Cholecystitis * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Hepatic failure * 1              
# participants affected / at risk     0/182 (0.00%)     2/191 (1.05%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Jaundice cholestatic * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Immune system disorders                
Drug hypersensitivity * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Immune reconstitution syndrome * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Infections and infestations                
Anogenital warts * 1              
# participants affected / at risk     2/182 (1.10%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Appendicitis * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Aspergillosis * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Bronchitis * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Bronchopneumonia * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Cellulitis * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Cystitis * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Endocarditis * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Gastroenteritis * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Genital herpes * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Genitourinary tract infection * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Herpes simplex * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Herpes virus infection * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Herpes zoster * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Herpes zoster disseminated * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Klebsiella sepsis * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Laryngitis * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Liver abscess * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Lobar pneumonia * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Lung infection * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Malaria * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Mycobacterial infection * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Mycobacterium avium complex infection * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     1/91 (1.10%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Mycoplasma infection * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Neurosyphilis * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Oesophageal candidiasis * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Oral candidiasis * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pneumococcal sepsis * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pneumocystis jiroveci pneumonia * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pneumonia * 1              
# participants affected / at risk     2/182 (1.10%)     5/191 (2.62%)     1/91 (1.10%)     3/272 (1.10%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pneumonia bacterial * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pneumonia cytomegaloviral * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Progressive multifocal leukoencephalopathy * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pyothorax * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Respiratory tract infection * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Sepsis * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Septic shock * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Sinusitis * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Syphilis * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Tuberculosis * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Upper respiratory tract infection * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Urinary tract infection * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Injury, poisoning and procedural complications                
Post procedural discomfort * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Investigations                
Alanine aminotransferase increased * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Aspartate aminotransferase increased * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Blood bilirubin increased * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Blood creatine phosphokinase increased * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Hepatic enzyme increased * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Liver function test abnormal * 1              
# participants affected / at risk     2/182 (1.10%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Weight decreased * 1              
# participants affected / at risk     1/182 (0.55%)     2/191 (1.05%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Metabolism and nutrition disorders                
Decreased appetite * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Dehydration * 1              
# participants affected / at risk     0/182 (0.00%)     2/191 (1.05%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Diabetes mellitus * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Gout * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Musculoskeletal and connective tissue disorders                
Back pain * 1              
# participants affected / at risk     2/182 (1.10%)     1/191 (0.52%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Costochondritis * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Flank pain * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Intervertebral disc protrusion * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Myositis * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Osteoporotic fracture * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Osteonecrosis * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                
Anal cancer * 1              
# participants affected / at risk     2/182 (1.10%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Bile duct cancer * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Bronchial carcinoma * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Hodgkin’s disease * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     2/272 (0.74%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Kaposi’s sarcoma * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Lymphoma * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Metastases to bone * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Metastases to liver * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Metastases to peritoneum * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Metastatic salivary gland cancer * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Metastatic squamous cell carcinoma * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Paraganglion neoplasm * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Prostate cancer * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Squamous cell carcinoma * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Squamous cell carcinoma of skin * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Tongue neoplasm malignant stage unspecified * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Nervous system disorders                
Cerebral haemorrhage * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Convulsion * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Demyelination * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Encephalitis * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Epilepsy * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
IIIrd nerve disorder * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Lumbar radiculopathy * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Polyneuropathy * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Syncope * 1              
# participants affected / at risk     0/182 (0.00%)     2/191 (1.05%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Transient ischaemic attack * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pregnancy, puerperium and perinatal conditions                
Pregnancy * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Psychiatric disorders                
Abnormal behaviour * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Depression * 1              
# participants affected / at risk     2/182 (1.10%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Schizophrenia * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Suicidal ideation * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Renal and urinary disorders                
Proteinuria * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Renal colic * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Renal failure * 1              
# participants affected / at risk     0/182 (0.00%)     2/191 (1.05%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Renal failure acute * 1              
# participants affected / at risk     1/182 (0.55%)     1/191 (0.52%)     2/91 (2.20%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Respiratory, thoracic and mediastinal disorders                
Acute respiratory failure * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Asthma * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     2/272 (0.74%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Chronic obstructive pulmonary disease * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Dyspnoea * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Lung disorder * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pulmonary embolism * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Pulmonary hypertension * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Respiratory arrest * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Skin and subcutaneous tissue disorders                
Lipohypertrophy * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Purpura * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Urticaria * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Surgical and medical procedures                
Arterial bypass operation * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Osteotomy * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     0/91 (0.00%)     1/272 (0.37%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Vascular disorders                
Aortic arteriosclerosis * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Arterial occlusive disease * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Haematoma * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Hypertension * 1              
# participants affected / at risk     1/182 (0.55%)     0/191 (0.00%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Iliac artery stenosis * 1              
# participants affected / at risk     0/182 (0.00%)     0/191 (0.00%)     1/91 (1.10%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
Orthostatic hypotension * 1              
# participants affected / at risk     0/182 (0.00%)     1/191 (0.52%)     0/91 (0.00%)     0/272 (0.00%)     0/50 (0.00%)     0/205 (0.00%)     0/65 (0.00%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 13.0




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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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00098722     History of Changes
Other Study ID Numbers: A4001028
Study First Received: December 7, 2004
Results First Received: April 16, 2012
Last Updated: April 16, 2012
Health Authority: United States: Food and Drug Administration