CSP #512 - Options in Management With Anti-Retrovirals (OPTIMA)

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00050089
First received: November 20, 2002
Last updated: January 17, 2014
Last verified: January 2014
Results First Received: September 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: AIDS
HIV Infections
Interventions: Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
Drug: Standard ART vs Mega ART

  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
A total of 368 participants were enrolled in the trial: 41 in Canada, 39 in the UK and 288 in the US-VA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
339 participants were randomized to factorial design(Canada=41;UK=10;US-VA=288). 29 participants in the UK were enrolled in a protocol-approved option, where they were allowed to select one of the factors and be randomized to the other. All 29 selected the ARDFP vs No ARDFP factor and were randomized to the Standard-ART vs Mega-ART factor.

Reporting Groups
  Description
No ARDFP+Standard-ART

No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART

Standard-ART: up to 4 anti-HIV drugs

No ARDFP+Mega-ART

No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART

Mega-ART: 5 or more anti-HIV drugs

ARDFP+Standard-ART

Antiretroviral Drug-Free Period (ARDFP) and Standard-ART

Intended duration of ARDFP: 12 week2 Standard-ART: up to 4 anti-HIV drugs

ARDFP+Mega-ART

Antiretroviral Drug-Free Period (ARDFP) and Mega-ART

Intended duration of ARDFP: 12 weeks Mega-ART: 5 or more anti-HIV drugs


Participant Flow:   Overall Study
    No ARDFP+Standard-ART     No ARDFP+Mega-ART     ARDFP+Standard-ART     ARDFP+Mega-ART  
STARTED     106     98     86     78  
Baseline     91 [1]   84 [2]   86     78  
COMPLETED     106 [3]   98 [3]   86 [3]   78 [3]
NOT COMPLETED     0     0     0     0  
[1] 15 participants randomized in the UK Option scheme (not displayed in the 2X2 baseline data)
[2] 14 participants randomized in the UK Option scheme (not shown in 2X2 baseline data)
[3] For primary outcome assessment



  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.
HIV-positive patients with a CD4 count <=300 cells/ul who had prior anti-retroviral treatment failure requiring retreatment

Reporting Groups
  Description
No ARDFP + Standard ART Standard Antiretroviral Treatment regimen
No ARDFP + Mega ART Intensive Antiretroviral Treatment regimen
ARDFP + Standard ART Antiretroviral Treatment Interruption and Standard ART
ARDFP + Mega ART Antiretroviral Treatment Interruption and Intensive ART
Total Total of all reporting groups

Baseline Measures
    No ARDFP + Standard ART     No ARDFP + Mega ART     ARDFP + Standard ART     ARDFP + Mega ART     Total  
Number of Participants  
[units: participants]
  91     84     86     78     339  
Age  
[units: years]
Mean ± Standard Deviation
  48.7  ± 8.99     48.3  ± 7.92     49.2  ± 8.1     48.2  ± 8.58     48.6  ± 8.39  
Age, Customized  
[units: participants]
         
31-40 years     16     11     12     15     54  
41-50 years     35     41     36     30     142  
51-60 years     33     28     31     28     120  
>60 years     7     4     7     5     23  
Gender  
[units: participants]
         
Female     1     2     2     2     7  
Male     90     82     84     76     332  
Race/Ethnicity, Customized  
[units: participants]
         
White     42     45     38     35     160  
Black     41     30     36     31     138  
Asian     1     0     0     0     1  
Hispanic     6     9     9     12     36  
Aboriginal     1     0     1     0     2  
Other     0     0     2     0     2  
Region of Enrollment  
[units: participants]
         
United States     77     71     73     67     288  
United Kingdom     2     2     3     3     10  
Canada     12     11     10     8     41  
log10 Viral Load  
[units: log10┬ácopies/mL]
Mean ± Standard Deviation
  4.76  ± 0.55     4.75  ± 0.76     4.64  ± 0.67     4.7  ± 0.75     4.71  ± 0.68  
CD4 cells/mm3  
[units: cells/mm^3]
Mean ± Standard Deviation
  136  ± 112     127  ± 107     130  ± 106     127  ± 106     130  ± 108  
CD4 level  
[units: participants]
         
CD4 <=100 cells/mm^3     38     38     36     33     145  
CD4 >100 cells/mm^3     53     46     50     45     194  
Mode of HIV Infection  
[units: participants]
         
Blood     12     7     8     7     34  
Heterosexual     20     19     22     19     80  
Intravenous Drug Use (IVDU)     11     16     15     9     51  
Men who have Sex with Men (MSM)     42     37     37     39     155  
Other     6     5     2     4     17  
Unknown     0     0     2     0     2  
AIDS at entry [1]
[units: participants]
         
Yes     59     46     44     51     200  
No     32     38     42     27     139  
Hepatitis B (HBsAg)  
[units: participants]
         
Yes     10     4     15     8     37  
No     81     80     71     70     302  
Hepatitis C (Hep C anti-HCV)  
[units: participants]
         
Yes     17     21     27     12     77  
No     74     63     59     66     262  
OI medications for prophylaxis [2]
[units: participants]
         
Anti-PCP     75     67     71     62     275  
Anti-CMV     2     0     2     0     4  
Antibacterial     43     39     33     37     152  
Antifungal     22     23     22     19     86  
Concomitant Medications [3]
[units: participants]
         
Lipid Lowering     24     20     33     21     98  
Other antiviral     43     30     30     33     136  
[1] History of AIDS event at study entry
[2] Opportunistic Infections medications for prophylaxis at study entry
[3] Not all study participants were on other Concomitant Medications. Numbers provided represent participants on those medications at baseline.



  Outcome Measures
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1.  Primary:   Participants Who Developed a New or Recurrent AIDS Event or Death   [ Time Frame: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years ]

2.  Primary:   Participants Who Developed a New or Recurrent AIDS Event or Death   [ Time Frame: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years ]

3.  Primary:   Participants Who Developed a New or Recurrent AIDS Event or Death   [ Time Frame: From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description MedDRA was used to code SAE of participants randomized to the 2x2 factorial design (n=339).Hence the number at risk for the four arms reflects only participants enrolled in the 2x2 factorial. Not Serious Adverse events were not coded using MedDRA.

Reporting Groups
  Description
No ARDFP + Standard ART Standard Antiretroviral Treatment regimen
No ARDFP + Mega ART Intensive Antiretroviral Treatment regimen
ARDFP + Standard ART Antiretroviral Treatment Interruption and Standard ART
ARDFP + Mega ART Antiretroviral Treatment Interruption and Intensive ART

Serious Adverse Events
    No ARDFP + Standard ART     No ARDFP + Mega ART     ARDFP + Standard ART     ARDFP + Mega ART  
Total, serious adverse events          
# participants affected / at risk     55/91 (60.44%)     56/84 (66.67%)     54/86 (62.79%)     49/78 (62.82%)  
Blood and lymphatic system disorders          
Acquired methaemoglobinaemia † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     2     0  
Anaemia NOS † 1        
# participants affected / at risk     5/91 (5.49%)     5/84 (5.95%)     6/86 (6.98%)     5/78 (6.41%)  
# events     7     6     10     6  
Anaemia of chronic disease † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     1     0     2  
Bone marrow depression NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     2     0     0  
Febrile neutropenia † 1        
# participants affected / at risk     2/91 (2.20%)     1/84 (1.19%)     1/86 (1.16%)     1/78 (1.28%)  
# events     2     1     2     1  
Leukocytosis † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Neutropenia † 1        
# participants affected / at risk     2/91 (2.20%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     2     1     0     0  
Pancytopenia † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     1     0     1     0  
Secondary anaemia † 1        
# participants affected / at risk     2/91 (2.20%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     2     0     0     0  
Thrombocytopenia † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     1/86 (1.16%)     1/78 (1.28%)  
# events     0     3     2     1  
Cardiac disorders          
Acute coronary syndrome † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Acute myocardial infarction † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Atrial tachycardia † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Bradycardia NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     2     0     0  
Cardiac aneurysm † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Cardiac arrest † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Cardiac disorder NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Cardiac failure NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     1     0     1  
Cardiac failure congestive † 1        
# participants affected / at risk     2/91 (2.20%)     3/84 (3.57%)     0/86 (0.00%)     1/78 (1.28%)  
# events     3     3     0     2  
Cardio-respiratory arrest † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     1     0     1  
Cardiomyopathy NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Cardiovascular disorder NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Coronary artery atherosclerosis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Coronary artery disease NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Diastolic dysfunction † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     2  
Endocarditis NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Myocardial infarction † 1        
# participants affected / at risk     2/91 (2.20%)     0/84 (0.00%)     1/86 (1.16%)     1/78 (1.28%)  
# events     2     0     1     1  
Myocardial ischaemia † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Tachycardia NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Ventricular hypokinesia † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Ear and labyrinth disorders          
Deafness neurosensory † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Ear pain † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Vertigo † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Endocrine disorders          
Adrenal insufficiency NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Diabetes insipidus † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     2     0     0  
Eye disorders          
Retinitis NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Uveitis NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     1     0     1     0  
Vision abnormal NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Gastrointestinal disorders          
Abdominal distension † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Abdominal pain NOS † 1        
# participants affected / at risk     4/91 (4.40%)     1/84 (1.19%)     1/86 (1.16%)     1/78 (1.28%)  
# events     4     1     1     1  
Abdominal pain lower † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Abdominal pain upper † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Alcoholic pancreatitis † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Anal fissure † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Ascites † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     2     0     2  
Caecitis † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Diarrhoea NOS † 1        
# participants affected / at risk     5/91 (5.49%)     4/84 (4.76%)     4/86 (4.65%)     1/78 (1.28%)  
# events     5     5     4     1  
Diverticulitis NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Dysphagia † 1        
# participants affected / at risk     2/91 (2.20%)     0/84 (0.00%)     1/86 (1.16%)     1/78 (1.28%)  
# events     2     0     1     1  
Gastrointestinal disorder NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Gastrointestinal haemorrhage NOS † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     1     1     0     1  
Haemorrhoidal haemorrhage † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Haemorrhoids † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Intestinal perforation NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Intestinal ulcer † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Lower gastrointestinal haemorrhage † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Melaena † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Nausea † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     1     1     0  
Oesophageal ulcer † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     2/86 (2.33%)     1/78 (1.28%)  
# events     0     0     2     2  
Oesophagitis NOS † 1        
# participants affected / at risk     2/91 (2.20%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     2     0     0     1  
Pancreatic pseudocyst † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Pancreatitis NOS † 1        
# participants affected / at risk     0/91 (0.00%)     2/84 (2.38%)     1/86 (1.16%)     1/78 (1.28%)  
# events     0     2     2     2  
Pancreatitis acute † 1        
# participants affected / at risk     1/91 (1.10%)     2/84 (2.38%)     0/86 (0.00%)     3/78 (3.85%)  
# events     1     2     0     3  
Pancreatitis relapsing † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     2/78 (2.56%)  
# events     0     0     0     5  
Perirectal abscess † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Vomiting NOS † 1        
# participants affected / at risk     4/91 (4.40%)     1/84 (1.19%)     0/86 (0.00%)     2/78 (2.56%)  
# events     6     1     0     3  
General disorders          
Adverse drug reaction NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     2/78 (2.56%)  
# events     0     0     1     2  
Chest pain † 1        
# participants affected / at risk     2/91 (2.20%)     1/84 (1.19%)     3/86 (3.49%)     0/78 (0.00%)  
# events     2     2     3     0  
Death NOS † 1        
# participants affected / at risk     5/91 (5.49%)     0/84 (0.00%)     7/86 (8.14%)     6/78 (7.69%)  
# events     5     0     7     6  
Drug interaction NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Fall † 1        
# participants affected / at risk     2/91 (2.20%)     2/84 (2.38%)     2/86 (2.33%)     0/78 (0.00%)  
# events     2     2     2     0  
Fatigue † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Influenza like illness † 1        
# participants affected / at risk     3/91 (3.30%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     3     1     0     0  
Mucosal inflammation NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     2     0     0  
Multi-organ failure † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Necrosis NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     2  
Pain NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Pyrexia † 1        
# participants affected / at risk     7/91 (7.69%)     1/84 (1.19%)     3/86 (3.49%)     3/78 (3.85%)  
# events     7     4     3     4  
Weakness † 1        
# participants affected / at risk     2/91 (2.20%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     2     1     0     1  
Hepatobiliary disorders          
Bile duct stenosis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Cholecystitis NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     2  
Hepatic disorder NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Hepatic failure † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Hepatitis NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Hepatitis acute † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     1     0     0     1  
Hepatorenal failure † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Jaundice NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Immune system disorders          
Anaphylactic reaction † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     1     0     0  
Drug hypersensitivity † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     1/78 (1.28%)  
# events     0     0     1     1  
Hypersensitivity NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     1     0     1     0  
Immune reconstitution syndrome † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Serum sickness † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Infections and infestations          
Abscess NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     1/86 (1.16%)     1/78 (1.28%)  
# events     0     1     1     2  
Abscess limb † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Acquired immunodeficiency syndrome NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     1     0     0     1  
Arterio-venous fistula infection † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     2  
Aspergillosis † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     2     0     0     0  
Bacteraemia † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     1     1     0  
Bacterial sepsis † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Bronchitis NOS † 1        
# participants affected / at risk     2/91 (2.20%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     2     0     0     0  
Bronchitis bacterial NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Bronchopulmonary aspergillosis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     3  
Campylobacter gastroenteritis † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Carbuncle † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     3     0     0     0  
Catheter related infection † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     2/86 (2.33%)     0/78 (0.00%)  
# events     1     1     2     0  
Cellulitis † 1        
# participants affected / at risk     3/91 (3.30%)     0/84 (0.00%)     4/86 (4.65%)     2/78 (2.56%)  
# events     3     0     4     2  
Cellulitis orbital † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Central nervous system infection NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Chronic HIV infection † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Clostridial infection NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     1/86 (1.16%)     1/78 (1.28%)  
# events     0     1     1     1  
Colitis pseudomembranous † 1        
# participants affected / at risk     4/91 (4.40%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     4     1     0     0  
Cryptococcosis † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Cytomegalovirus colitis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Cytomegalovirus gastroenteritis † 1        
# participants affected / at risk     0/91 (0.00%)     2/84 (2.38%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     2     0     0  
Cytomegalovirus infection † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Cytomegalovirus retinitis † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Diarrhoea infectious † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Epidural abscess † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Escherichia urinary tract infection † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
External ear infection NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Eye infection syphilitic † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Fungal infection NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Gastroenteritis NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Gastroenteritis cryptosporidial † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Gastroenteritis viral NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     1     1     0  
Giardiasis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Gram-positive bacterial infection † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
HIV wasting syndrome † 1        
# participants affected / at risk     0/91 (0.00%)     2/84 (2.38%)     1/86 (1.16%)     4/78 (5.13%)  
# events     0     3     1     4  
Herpes simplex † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     1/78 (1.28%)  
# events     0     0     1     1  
Herpes viral infection NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Herpes zoster † 1        
# participants affected / at risk     2/91 (2.20%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     2     0     0     0  
Herpetic stomatitis † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Histoplasmosis disseminated † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     2     0     0     0  
Infected insect bite † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Infected skin ulcer † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Infection NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Lobar pneumonia NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Lower respiratory tract infection NOS † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     1/86 (1.16%)     0/78 (0.00%)  
# events     1     1     1     0  
Lung infection pseudomonal † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     2     0     0     1  
Meningitis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Meningitis bacterial NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     2     0     0     0  
Meningitis cryptococcal † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     2     1     0     1  
Meningitis viral NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Methicillin-resistant staphylococcal aureus infection † 1        
# participants affected / at risk     0/91 (0.00%)     2/84 (2.38%)     2/86 (2.33%)     3/78 (3.85%)  
# events     0     2     2     4  
Mucormycosis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Mycobacterium avium complex † 1        
# participants affected / at risk     2/91 (2.20%)     1/84 (1.19%)     1/86 (1.16%)     2/78 (2.56%)  
# events     2     1     1     3  
Necrotising fasciitis NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Nosocomial infection † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Oesophageal candidiasis † 1        
# participants affected / at risk     2/91 (2.20%)     3/84 (3.57%)     1/86 (1.16%)     1/78 (1.28%)  
# events     3     7     1     1  
Oral candidiasis † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     1     2     0     1  
Oropharyngeal candidiasis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Osteomyelitis NOS † 1        
# participants affected / at risk     0/91 (0.00%)     2/84 (2.38%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     3     1     0  
Otitis media acute NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Parvovirus infection † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     1     0     0     1  
Penile abscess † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Perianal abscess † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     1     0     0     1  
Periorbital cellulitis † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Peritonsillar abscess † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Pneumocystis carinii pneumonia † 1        
# participants affected / at risk     6/91 (6.59%)     7/84 (8.33%)     6/86 (6.98%)     5/78 (6.41%)  
# events     8     8     7     8  
Pneumonia NOS † 1        
# participants affected / at risk     6/91 (6.59%)     9/84 (10.71%)     9/86 (10.47%)     4/78 (5.13%)  
# events     9     12     11     4  
Pneumonia bacterial NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     1/86 (1.16%)     2/78 (2.56%)  
# events     1     0     1     2  
Pneumonia staphylococcal † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     1/78 (1.28%)  
# events     0     0     1     1  
Pneumonia streptococcal † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     1/86 (1.16%)     1/78 (1.28%)  
# events     0     2     1     1  
Pseudomonas aeruginosa infection NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Pseudomonas infection NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Pyomyositis † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     1     0     1     0  
Respiratory tract infection NOS † 1        
# participants affected / at risk     2/91 (2.20%)     0/84 (0.00%)     2/86 (2.33%)     0/78 (0.00%)  
# events     2     0     2     0  
Scrotal abscess † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Sepsis MRSA † 1        
# participants affected / at risk     0/91 (0.00%)     2/84 (2.38%)     1/86 (1.16%)     1/78 (1.28%)  
# events     0     2     1     1  
Sepsis NOS † 1        
# participants affected / at risk     1/91 (1.10%)     2/84 (2.38%)     3/86 (3.49%)     1/78 (1.28%)  
# events     1     2     3     1  
Septic shock † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     2/86 (2.33%)     2/78 (2.56%)  
# events     0     0     2     2  
Septicaemia gram-positive † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     2/86 (2.33%)     0/78 (0.00%)  
# events     0     0     2     0  
Septicaemia pseudomonal † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Septicaemia salmonella † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Sinusitis NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Skin and subcutaneous tissue abscess NOS † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     1/86 (1.16%)     1/78 (1.28%)  
# events     2     1     1     1  
Skin fungal infection NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Skin infection NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Staphylococcal abscess † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Staphylococcal bacteraemia † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     1/86 (1.16%)     0/78 (0.00%)  
# events     2     1     1     0  
Stenotrophomonas infection † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Systemic candida † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Thrombophlebitis septic † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     1     0     1  
Toxoplasmosis NOS † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     1     0     0  
Upper respiratory tract infection NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Upper respiratory tract infection viral NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Urinary tract infection NOS † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     1/86 (1.16%)     1/78 (1.28%)  
# events     1     1     2     1  
Urinary tract infection bacterial † 1        
# participants affected / at risk     0/91 (0.00%)     2/84 (2.38%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     2     0     2  
Urinary tract infection enterococcal † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Urinary tract infection fungal † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Urosepsis † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     2     0     0     0  
Viral infection NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Viral rash NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Injury, poisoning and procedural complications          
Feeding tube complication † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Gun shot wound † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Head injury † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Limb injury NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Overdose NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Post procedural haemorrhage † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     2     0     2     0  
Shunt malfunction NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Shunt occlusion † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Tibia fracture † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Wound NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Investigations          
Acid fast stain positive † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Aspartate aminotransferase increased † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Biopsy NOS † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Blood creatine phosphokinase increased † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     2     1     0  
Blood creatinine increased † 1        
# participants affected / at risk     0/91 (0.00%)     2/84 (2.38%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     2     0     0  
Blood pressure increased † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Laboratory test abnormal NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Liver function tests NOS abnormal † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     2/86 (2.33%)     1/78 (1.28%)  
# events     0     0     2     1  
Weight decreased † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     1     0     0  
Metabolism and nutrition disorders          
Cachexia † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     2/86 (2.33%)     1/78 (1.28%)  
# events     0     0     2     2  
Dehydration † 1        
# participants affected / at risk     2/91 (2.20%)     3/84 (3.57%)     0/86 (0.00%)     1/78 (1.28%)  
# events     3     4     0     1  
Diabetes mellitus NOS † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     2/78 (2.56%)  
# events     1     1     0     2  
Failure to thrive † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     1/86 (1.16%)     1/78 (1.28%)  
# events     1     0     1     3  
Fluid overload † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     5  
Hypercalcaemia † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     2     0     1  
Hyperglycaemia NOS † 1        
# participants affected / at risk     0/91 (0.00%)     2/84 (2.38%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     2     0     1  
Hyperkalaemia † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Hypertriglyceridaemia † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Hypoglycaemia NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     1     0     0     1  
Hypokalaemia † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Hyponatraemia † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Lactic acidosis † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     1/78 (1.28%)  
# events     1     1     0     1  
Musculoskeletal and connective tissue disorders          
Arthralgia † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Back pain † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     1     0     0  
Costochondritis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Haemarthrosis † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Intervertebral disc herniation † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Muscle spasms † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Musculoskeletal chest pain † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     1     0     0     1  
Osteoarthritis NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Rhabdomyolysis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     2/86 (2.33%)     0/78 (0.00%)  
# events     0     0     2     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)          
Anal canal cancer NOS † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     1     0     0  
Anal cancer stage II † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
B-cell lymphoma NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     3     0     0     0  
Bile duct cancer NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Castleman's disease † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Central nervous system lymphoma † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Diffuse large B-cell lymphoma NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Hepatic neoplasm malignant NOS † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Hodgkin's disease NOS stage III † 1        
# participants affected / at risk     1/91 (1.10%)     0/84 (0.00%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     0     0     0  
Kaposi's sarcoma AIDS related † 1        
# participants affected / at risk     1/91 (1.10%)     2/84 (2.38%)     1/86 (1.16%)     1/78 (1.28%)  
# events     1     2     3     1  
Laryngeal cancer NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Lung nodule † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     1     1     0     0  
Lymphoma NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Papillary tumour of renal pelvis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Prostate cancer NOS † 1        
# participants affected / at risk     2/91 (2.20%)     1/84 (1.19%)     1/86 (1.16%)     2/78 (2.56%)  
# events     2     1     1     2  
Prostate cancer metastatic † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     2     0     0  
Rectal cancer NOS † 1        
# participants affected / at risk     1/91 (1.10%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     4     1     0     0  
Squamous cell carcinoma † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
T-cell lymphoma NOS † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     1/86 (1.16%)     0/78 (0.00%)  
# events     0     0     1     0  
Nervous system disorders          
Amyotrophic lateral sclerosis † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     4     0     0  
Aphasia † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Carotid artery stenosis † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0     0     1  
Cerebral disorder † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     0/86 (0.00%)     0/78 (0.00%)  
# events     0     1     0     0  
Cerebrovascular accident † 1        
# participants affected / at risk     0/91 (0.00%)     1/84 (1.19%)     1/86 (1.16%)     2/78 (2.56%)  
# events     0     1     1     2  
Cervical radiculopathy † 1        
# participants affected / at risk     0/91 (0.00%)     0/84 (0.00%)     0/86 (0.00%)     1/78 (1.28%)  
# events     0     0