Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144170
First received: September 2, 2005
Last updated: May 18, 2012
Last verified: May 2012
Results First Received: September 11, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Tipranavir (with low dose ritonavir)
Drug: Comparitor protease inhibitor(CPI)/low dose ritonavir(r)

  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
The discrepancy with enrollment number in the protocol section is due to 16 patients not treated. (7 from TPV/r and 9 from CPI/r). These patients were not included in any analyses or results.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Participant Flow:   Overall Study
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
STARTED     438     428  
COMPLETED     86     32  
NOT COMPLETED     352     396  
Adverse Event                 84                 41  
Protocol Violation                 23                 16  
Lost to Follow-up                 5                 10  
Withdrawal by Subject                 29                 13  
Lack of Efficacy or Viral load failure                 174                 268  
Investigator decision                 2                 0  
Site closure                 5                 3  
Lost to follow-up or moved                 1                 0  
Patient decision                 1                 3  
Enrolled into other trial                 3                 24  
Half dose of Tipranavir taken                 1                 0  
Not allowed to take Fosamprenavir                 0                 2  
Switch to commercial product                 5                 2  
Viremia                 1                 0  
Started new HIV regimen                 4                 2  
Result of amendment 6                 0                 1  
Last visit not done                 1                 2  
incl./excl. criteria not met                 1                 2  
error of site                 0                 1  
Pregnancy                 4                 0  
missing                 7                 6  
Death                 1                 0  



  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
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.
Total Total of all reporting groups

Baseline Measures
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)     Total  
Number of Participants  
[units: participants]
  435     428     863  
Age [1]
[units: years]
Mean ± Standard Deviation
  42.5  ± 8.4     42.9  ± 8     42.7  ± 8.2  
Gender [1]
[units: participants]
     
Female     84     64     148  
Male     351     364     715  
[1] 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and AEs but not in the efficacy analysis.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Response at Week 48   [ Time Frame: after 48 weeks of treatment ]

2.  Primary:   Time to Treatment Failure Through 48 Weeks of Treatment   [ Time Frame: after 48 weeks of treatment ]

3.  Secondary:   Treatment Response at Week 2   [ Time Frame: week 2 ]

4.  Secondary:   Treatment Response at Week 4   [ Time Frame: week 4 ]

5.  Secondary:   Treatment Response at Week 8   [ Time Frame: week 8 ]

6.  Secondary:   Treatment Response at Week 16   [ Time Frame: week 16 ]

7.  Secondary:   Treatment Response at Week 24   [ Time Frame: Week 24 ]

8.  Secondary:   Treatment Response at Week 32   [ Time Frame: week 32 ]

9.  Secondary:   Treatment Response at Week 40   [ Time Frame: week 40 ]

10.  Secondary:   Treatment Response at Week 56   [ Time Frame: week 56 ]

11.  Secondary:   Treatment Response at Week 64   [ Time Frame: week 64 ]

12.  Secondary:   Treatment Response at Week 72   [ Time Frame: week 72 ]

13.  Secondary:   Treatment Response at Week 80   [ Time Frame: week 80 ]

14.  Secondary:   Treatment Response at Week 88   [ Time Frame: week 88 ]

15.  Secondary:   Treatment Response at Week 96   [ Time Frame: after 96 weeks of treatment ]

16.  Secondary:   Time to Treatment Failure Through 96 Weeks of Treatment   [ Time Frame: after 96 weeks of treatment ]

17.  Secondary:   Time to Confirmed Virologic Failure Through 48 Weeks of Treatment   [ Time Frame: after 48 weeks of treatment ]

18.  Secondary:   Time to Confirmed Virologic Failure Through 96 Weeks of Treatment   [ Time Frame: after 96 weeks of treatment ]

19.  Secondary:   Virologic Response   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

20.  Secondary:   Virologic Response at Week 2   [ Time Frame: Week 2 ]

21.  Secondary:   Virologic Response at Week 4   [ Time Frame: week 4 ]

22.  Secondary:   Virologic Response at Week 8   [ Time Frame: week 8 ]

23.  Secondary:   Virologic Response at Week 16   [ Time Frame: week 16 ]

24.  Secondary:   Virologic Response at Week 24   [ Time Frame: week 24 ]

25.  Secondary:   Virologic Response at Week 32   [ Time Frame: week 32 ]

26.  Secondary:   Virologic Response at Week 40   [ Time Frame: week 40 ]

27.  Secondary:   Virologic Response at Week 48   [ Time Frame: week 48 ]

28.  Secondary:   Virologic Response at Week 56   [ Time Frame: week 56 ]

29.  Secondary:   Virologic Response at Week 64   [ Time Frame: week 64 ]

30.  Secondary:   Virologic Response at Week 72   [ Time Frame: Week 72 ]

31.  Secondary:   Virologic Response at Week 80   [ Time Frame: Week 80 ]

32.  Secondary:   Virologic Response at Week 88   [ Time Frame: Week 88 ]

33.  Secondary:   Virologic Response at Week 96   [ Time Frame: Week 96 ]

34.  Secondary:   Median Change From Baseline in Viral Load (Week 2)   [ Time Frame: Baseline to Week 2 ]

35.  Secondary:   Median Change From Baseline in Viral Load (Week 4)   [ Time Frame: Baseline to Week 4 ]

36.  Secondary:   Median Change From Baseline in Viral Load (Week 8)   [ Time Frame: Baseline to Week 8 ]

37.  Secondary:   Median Change From Baseline in Viral Load (Week 16)   [ Time Frame: Baseline to Week 16 ]

38.  Secondary:   Median Change From Baseline in Viral Load (Week 24)   [ Time Frame: Baseline to Week 24 ]

39.  Secondary:   Median Change From Baseline in Viral Load (Week 32)   [ Time Frame: Baseline to Week 32 ]

40.  Secondary:   Median Change From Baseline in Viral Load (Week 40)   [ Time Frame: Baseline to Week 40 ]

41.  Secondary:   Median Change From Baseline in Viral Load (Week 48)   [ Time Frame: Baseline to Week 48 ]

42.  Secondary:   Median Change From Baseline in Viral Load (Week 56)   [ Time Frame: Baseline to Week 56 ]

43.  Secondary:   Median Change From Baseline in Viral Load (Week 64)   [ Time Frame: Baseline to Week 64 ]

44.  Secondary:   Median Change From Baseline in Viral Load (Week 72)   [ Time Frame: Baseline to Week 72 ]

45.  Secondary:   Median Change From Baseline in Viral Load (Week 80)   [ Time Frame: Baseline to Week 80 ]

46.  Secondary:   Median Change From Baseline in Viral Load (Week 88)   [ Time Frame: Baseline to Week 88 ]

47.  Secondary:   Median Change From Baseline in Viral Load (Week 96)   [ Time Frame: Baseline to Week 96 ]

48.  Secondary:   Virologic Response at Week 40   [ Time Frame: Week 40 ]

49.  Secondary:   Virologic Response   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

50.  Secondary:   Virologic Response at Week 2   [ Time Frame: Week 2 ]

51.  Secondary:   Virologic Response at Week 4   [ Time Frame: Week 4 ]

52.  Secondary:   Virologic Response at Week 8   [ Time Frame: Week 8 ]

53.  Secondary:   Virologic Response at Week 16   [ Time Frame: Week 16 ]

54.  Secondary:   Virologic Response at Week 24   [ Time Frame: Week 24 ]

55.  Secondary:   Virologic Response at Week 32   [ Time Frame: Week 32 ]

56.  Secondary:   Virologic Response at Week 48   [ Time Frame: Week 48 ]

57.  Secondary:   Virologic Response at Week 56   [ Time Frame: Week 56 ]

58.  Secondary:   Virologic Response at Week 64   [ Time Frame: Week 64 ]

59.  Secondary:   Virologic Response at Week 72   [ Time Frame: Week 72 ]

60.  Secondary:   Virologic Response at Week 80   [ Time Frame: Week 80 ]

61.  Secondary:   Virologic Response at Week 88   [ Time Frame: week 88 ]

62.  Secondary:   Virologic Response at Week 96   [ Time Frame: week 96 ]

63.  Secondary:   Virologic Response   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

64.  Secondary:   Virologic Response at Week 2   [ Time Frame: Week 2 ]

65.  Secondary:   Virologic Response at Week 4   [ Time Frame: Week 4 ]

66.  Secondary:   Virologic Response at Week 8   [ Time Frame: Week 8 ]

67.  Secondary:   Virologic Response at Week 16   [ Time Frame: Week 16 ]

68.  Secondary:   Virologic Response at Week 24   [ Time Frame: Week 24 ]

69.  Secondary:   Virologic Response at Week 32   [ Time Frame: Week 32 ]

70.  Secondary:   Virologic Response at Week 40   [ Time Frame: Week 40 ]

71.  Secondary:   Virologic Response at Week 48   [ Time Frame: Week 48 ]

72.  Secondary:   Virologic Response at Week 56   [ Time Frame: Week 56 ]

73.  Secondary:   Virologic Response at Week 64   [ Time Frame: Week 64 ]

74.  Secondary:   Virologic Response at Week 72   [ Time Frame: Week 72 ]

75.  Secondary:   Virologic Response at Week 80   [ Time Frame: Week 80 ]

76.  Secondary:   Virologic Response at Week 88   [ Time Frame: Week 88 ]

77.  Secondary:   Virologic Response at Week 96   [ Time Frame: Week 96 ]

78.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 2)   [ Time Frame: Baseline to Week 2 ]

79.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 4)   [ Time Frame: Baseline to Week 4 ]

80.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 16)   [ Time Frame: Baseline to Week 16 ]

81.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 24)   [ Time Frame: Baseline to Week 24 ]

82.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 32)   [ Time Frame: Baseline to Week 32 ]

83.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 40)   [ Time Frame: Baseline to Week 40 ]

84.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 48)   [ Time Frame: Baseline to Week 48 ]

85.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 56)   [ Time Frame: Baseline to Week 56 ]

86.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 64)   [ Time Frame: Baseline to Week 64 ]

87.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 72)   [ Time Frame: Baseline to Week 72 ]

88.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 80)   [ Time Frame: Baseline to Week 80 ]

89.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 88)   [ Time Frame: Baseline to Week 88 ]

90.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 96)   [ Time Frame: Baseline to Week 96 ]

91.  Secondary:   Time to New CDC Class C Progression Event or Death.   [ Time Frame: after 48 weeks of treatment ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and AEs but not in the efficacy analysis.

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Serious Adverse Events
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Total, serious adverse events      
# participants affected     113     61  
Blood and lymphatic system disorders      
Anemia † 1    
# participants affected / at risk     6/311 (1.93%)     4/309 (1.29%)  
Febrile neutropenia † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Leukopenia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Lymphadenopathy † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Lymphopenia † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Methaemoglobinaemia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Neutropenia † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Pancytopenia † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Thrombocytopenia † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Cardiac disorders      
Acute coronary syndrome † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Angina pectoris † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Aortic valve incompetence † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Atrial fibrillation † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cardiac disorder † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cardiac failure † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cardiac failure congestive † 1    
# participants affected / at risk     3/311 (0.96%)     1/309 (0.32%)  
Cardiac tamponade † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Cardio-respiratory arrest † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Coronary artery disease † 1    
# participants affected / at risk     2/311 (0.64%)     1/309 (0.32%)  
Hypertrophic cardiomyopathy † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Left ventricular dysfunction † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Myocardial infarction † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Myocardial ischaemia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Ventricle rupture † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Congenital, familial and genetic disorders      
Atrial septal defect † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Fanconi syndrome † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Endocrine disorders      
Hypothyroidism † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Eye disorders      
Mydriasis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Retinal detachment † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Sudden visual loss † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Visual impairment † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Gastrointestinal disorders      
Abdominal pain † 1    
# participants affected / at risk     3/311 (0.96%)     0/309 (0.00%)  
Abdominal pain upper † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Anorectal disorder † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Appendicitis perforated † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Ascites † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Colitis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Constipation † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Diarrhoea † 1    
# participants affected / at risk     9/311 (2.89%)     3/309 (0.97%)  
Duodenitis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Dysphagia † 1    
# participants affected / at risk     2/311 (0.64%)     1/309 (0.32%)  
Gastrointestinal haemorrhage † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Haematemesis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Haemorrhoidal haemorrhage † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Impaired gastric emptying † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Intestinal obstruction † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Large intestinal ulcer † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Nausea † 1    
# participants affected / at risk     3/311 (0.96%)     0/309 (0.00%)  
Odynophagia † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Oesophagitis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pancreatitis † 1    
# participants affected / at risk     4/311 (1.29%)     1/309 (0.32%)  
Periproctitis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Peritoneal adhesions † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Proctalgia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Proctitis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Rectal haemorrhage † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Stomatitis necrotising † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Upper gastrointestinal haemorrhage † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Varices oesophageal † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Vomiting † 1    
# participants affected / at risk     5/311 (1.61%)     0/309 (0.00%)  
General disorders      
Asthenia † 1    
# participants affected / at risk     2/311 (0.64%)     1/309 (0.32%)  
Chest pain † 1    
# participants affected / at risk     4/311 (1.29%)     3/309 (0.97%)  
Chills † 1    
# participants affected / at risk     3/311 (0.96%)     0/309 (0.00%)  
Cyst † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Death † 1    
# participants affected / at risk     3/311 (0.96%)     1/309 (0.32%)  
Drug withdrawal syndrome † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Fatigue † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Granuloma † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Hypothermia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Malaise † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Necrosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Oedema peripheral † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pain † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pyrexia † 1    
# participants affected / at risk     11/311 (3.54%)     3/309 (0.97%)  
Hepatobiliary disorders      
Cholecystitis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Cholelithiasis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Hepatic failure † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Hepatosplenomegaly † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Portal vein thrombosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Immune system disorders      
Drug hypersensitivity † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Immune reconstitution syndrome † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Infections and infestations      
Abdominal abscess † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Abscess jaw † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Abscess neck † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Acquired immunodeficiency syndrome † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Acute sinusitis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Anal abscess † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Anogenital warts † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Appendicitis † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Arthritis bacterial † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Bacteraemia † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Bronchitis † 1    
# participants affected / at risk     2/311 (0.64%)     1/309 (0.32%)  
Campylobacter infection † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Candidiasis † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Catheter related infection † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cavernous sinus thrombosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cellulitis † 1    
# participants affected / at risk     3/311 (0.96%)     1/309 (0.32%)  
Cerebral toxoplasmosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Clostridial infection † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Clostridium difficile colitis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cytomegalovirus chorioretinitis † 1    
# participants affected / at risk     2/311 (0.64%)     1/309 (0.32%)  
Cytomegalovirus colitis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cytomegalovirus gastritis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Cytomegalovirus infection † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cytomegalovirus oesophagitis † 1    
# participants affected / at risk     0/311 (0.00%)     2/309 (0.65%)  
Disseminated cryptococcosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Diverticulitis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
End stage AIDS † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Enteritis infectious † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Gangrene † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Gastroenteritis † 1    
# participants affected / at risk     4/311 (1.29%)     0/309 (0.00%)  
Groin abscess † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
HIV infection † 1    
# participants affected / at risk     3/311 (0.96%)     0/309 (0.00%)  
Herpes oesophagitis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Herpes virus infection † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Influenza † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Injection site cellulitis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Keratitis bacterial † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Lobar pneumonia † 1    
# participants affected / at risk     3/311 (0.96%)     0/309 (0.00%)  
Lung infection pseudomonal † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Meningitis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Meningitis aseptic † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Meningitis cryptococcal † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Molluscum contagiosum † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Mycobacterium avium complex infection † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Nosocomial infection † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Oesophageal candidiasis † 1    
# participants affected / at risk     5/311 (1.61%)     3/309 (0.97%)  
Oral infection † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Osteomyelitis † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Perineal abscess † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Periorbital cellulitis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pneumocystis jiroveci pneumonia † 1    
# participants affected / at risk     7/311 (2.25%)     2/309 (0.65%)  
Pneumonia † 1    
# participants affected / at risk     13/311 (4.18%)     2/309 (0.65%)  
Pneumonia bacterial † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pneumonia cytomegaloviral † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Pneumonia streptococcal † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Progressive multifocal leukoencephalopathy † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pseudomonal bacteraemia † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Pseudomonas infection † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pyelonephritis † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Scrotal abscess † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Sepsis † 1    
# participants affected / at risk     4/311 (1.29%)     0/309 (0.00%)  
Shigella infection † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Sinusitis † 1    
# participants affected / at risk     3/311 (0.96%)     0/309 (0.00%)  
Staphylococcal bacteraemia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Staphylococcal infection † 1    
# participants affected / at risk     3/311 (0.96%)     1/309 (0.32%)  
Staphylococcal sepsis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Subcutaneous abscess † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Thrombophlebitis septic † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Toxoplasmosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Urinary tract infection † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Urosepsis † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Viral infection † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Viral pericarditis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Viral pharyngitis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Injury, poisoning and procedural complications      
Arterial injury † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Back injury † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Brain herniation † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Fall † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Foreign body trauma † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Hip fracture † 1    
# participants affected / at risk     4/311 (1.29%)     0/309 (0.00%)  
Ligament injury † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Muscle rupture † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Muscle strain † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Patella fracture † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Post lumbar puncture syndrome † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Radius fracture † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Road traffic accident † 1    
# participants affected / at risk     2/311 (0.64%)     1/309 (0.32%)  
Stress fracture † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Vascular pseudoaneurysm ruptured † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Wrist fracture † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Investigations      
Alanine aminotransferase increased † 1    
# participants affected / at risk     3/311 (0.96%)     0/309 (0.00%)  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     3/311 (0.96%)     0/309 (0.00%)  
Blood creatine increased † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Blood creatinine increased † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Blood triglycerides increased † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Drug level increased † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Gamma-glutamyltransferase increased † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Haemoglobin decreased † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
International normalised ratio increased † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Prothrombin time prolonged † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Volume blood decreased † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Weight decreased † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Metabolism and nutrition disorders      
Acidosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Anorexia † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Cachexia † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Dehydration † 1    
# participants affected / at risk     10/311 (3.22%)     2/309 (0.65%)  
Diabetes mellitus † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Electrolyte imbalance † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Hypocalcaemia † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Hypokalaemia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Hypovolaemia † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Lactic acidosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Malnutrition † 1    
# participants affected / at risk     3/311 (0.96%)     1/309 (0.32%)  
Metabolic acidosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Type 1 diabetes mellitus † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Back pain † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Flank pain † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Groin pain † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Intervertebral disc protrusion † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Muscle spasms † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Muscular weakness † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Musculoskeletal chest pain † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Neck mass † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Neck pain † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Osteoarthritis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Osteonecrosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pain in extremity † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Acute myeloid leukaemia † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Adenocarcinoma † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Anal cancer † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
B-cell lymphoma † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Basal cell carcinoma † 1    
# participants affected / at risk     3/311 (0.96%)     1/309 (0.32%)  
Bladder cancer † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Bowen's disease † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Central nervous system lymphoma † 1    
# participants affected / at risk     2/311 (0.64%)     2/309 (0.65%)  
Diffuse large B-cell lymphoma † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Hodgkin's disease † 1    
# participants affected / at risk     3/311 (0.96%)     0/309 (0.00%)  
Kaposi's sarcoma † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Lipoma † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Lymphoma † 1    
# participants affected / at risk     2/311 (0.64%)     3/309 (0.97%)  
Malignant melanoma † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Metastatic malignant melanoma † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Metastatic neoplasm † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Non-Hodgkin's lymphoma † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Prostate cancer † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Rectal cancer † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Rectal cancer metastatic † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Rectal cancer stage 0 † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Squamous cell carcinoma of skin † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Vulval cancer † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Nervous system disorders      
Ataxia † 1    
# participants affected / at risk     1/311 (0.32%)     1/309 (0.32%)  
Balance disorder † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Carotid artery stenosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Central nervous system lesion † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cerebral haemorrhage † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cerebrovascular accident † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Convulsion † 1    
# participants affected / at risk     3/311 (0.96%)     2/309 (0.65%)  
Demyelinating polyneuropathy † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Diabetic hyperglycaemic coma † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Embolic stroke † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Encephalopathy † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Haemorrhage intracranial † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Headache † 1    
# participants affected / at risk     3/311 (0.96%)     1/309 (0.32%)  
Hemicephalalgia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Hemiparesis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Lethargy † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Mental retardation † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Metabolic encephalopathy † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Migraine † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Muscle spasticity † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Nervous system disorder † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Neurological symptom † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Polyneuropathy † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Radiculopathy † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Syncope † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Thalamus haemorrhage † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Tremor † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Psychiatric disorders      
Completed suicide † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Confusional state † 1    
# participants affected / at risk     1/311 (0.32%)     2/309 (0.65%)  
Depression † 1    
# participants affected / at risk     0/311 (0.00%)     3/309 (0.97%)  
Drug abuse † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Major depression † 1    
# participants affected / at risk     0/311 (0.00%)     3/309 (0.97%)  
Mental status changes † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Renal and urinary disorders      
Fanconi syndrome acquired † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Focal segmental glomerulosclerosis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Incontinence † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Nephrolithiasis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Renal colic † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Renal failure † 1    
# participants affected / at risk     4/311 (1.29%)     1/309 (0.32%)  
Renal failure acute † 1    
# participants affected / at risk     9/311 (2.89%)     2/309 (0.65%)  
Renal failure chronic † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Renal tubular acidosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Reproductive system and breast disorders      
Testicular mass † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Vulvar dysplasia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Acute respiratory distress syndrome † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Cough † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Dyspnoea † 1    
# participants affected / at risk     5/311 (1.61%)     2/309 (0.65%)  
Hypoxia † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Interstitial lung disease † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Organising pneumonia † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pleuritic pain † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Pneumomediastinum † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pneumonia aspiration † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Pneumothorax † 1    
# participants affected / at risk     2/311 (0.64%)     1/309 (0.32%)  
Productive cough † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Pulmonary embolism † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Pulmonary oedema † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Respiratory alkalosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Respiratory distress † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Respiratory failure † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Skin and subcutaneous tissue disorders      
Angioedema † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Night sweats † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Rash † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Rash macular † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Surgical and medical procedures      
Abortion induced † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Coronary arterial stent insertion † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Drug detoxification † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Intestinal anastomosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Intestinal operation † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Umbilical hernia repair † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Vascular disorders      
Aortic aneurysm † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Aortic stenosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Arterial haemorrhage † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Arterial rupture † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Arteriosclerosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Deep vein thrombosis † 1    
# participants affected / at risk     2/311 (0.64%)     2/309 (0.65%)  
Exsanguination † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Hypertension † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Hypotension † 1    
# participants affected / at risk     2/311 (0.64%)     0/309 (0.00%)  
Pelvic venous thrombosis † 1    
# participants affected / at risk     1/311 (0.32%)     0/309 (0.00%)  
Thrombosis † 1    
# participants affected / at risk     0/311 (0.00%)     1/309 (0.32%)  
Events were collected by systematic assessment
1 Term from vocabulary, MEDRA 11.1




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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00144170     History of Changes
Other Study ID Numbers: 1182.48, RESIST 2
Study First Received: September 2, 2005
Results First Received: September 11, 2009
Last Updated: May 18, 2012
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Bundesministerium fuer soziale Sicherheit und Generationen
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Ministry of Health
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Italy: Comitato Etico della Fondazione Centro San Raffaele del Monte Tabor - Milano
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Central Committee Research Involving Human Subjects
Portugal: INFARMED I.P. Parque da Saúde de Lisboa Av. do Brasil, nº 53 1749-004 Lisboa
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration