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: June 23, 2014
Last verified: April 2014
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: Comparator 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.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Participant Flow:   Overall Study
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator 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  
Other reason not defined above                 211                 316  



  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 adverse events 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 at Viral Load Nadir During Study Treatment Through 96 Weeks   [ 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 8)   [ Time Frame: Baseline to Week 8 ]

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

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

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

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

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

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

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

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

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

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

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

92.  Secondary:   Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.   [ Time Frame: up to 75 weeks of treatment ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame 240 weeks
Additional Description 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events 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 / at risk     123/438 (28.08%)     89/428 (20.79%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     2/438 (0.46%)     3/428 (0.70%)  
Febrile neutropenia † 1    
# participants affected / at risk     1/438 (0.23%)     3/428 (0.70%)  
Haematotoxicity † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Lymphadenopathy † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Neutropenia † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Thrombocytopenia † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Cardiac disorders      
Acute coronary syndrome † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Acute myocardial infarction † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Angina pectoris † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Angina unstable † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Cardiac arrest † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Cardiac tamponade † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Cardio-respiratory arrest † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Myocardial infarction † 1    
# participants affected / at risk     2/438 (0.46%)     2/428 (0.47%)  
Pericardial effusion † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Ventricular fibrillation † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Ear and labyrinth disorders      
Ear pain † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Eye disorders      
Blindness † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Chorioretinitis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Retinal detachment † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Retinitis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Gastrointestinal disorders      
Abdominal pain † 1    
# participants affected / at risk     6/438 (1.37%)     2/428 (0.47%)  
Anal fistula † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Anal ulcer † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Ascites † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Colitis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Diarrhoea † 1    
# participants affected / at risk     3/438 (0.68%)     2/428 (0.47%)  
Dysphagia † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Enterocolitis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Gastrointestinal haemorrhage † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Haemorrhoids † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Ileus † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Inguinal hernia † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Intestinal haemorrhage † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Intestinal perforation † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Intra-abdominal haemorrhage † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Irritable bowel syndrome † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Megacolon † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Odynophagia † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Pancreatitis † 1    
# participants affected / at risk     5/438 (1.14%)     0/428 (0.00%)  
Pancreatitis acute † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Peptic ulcer † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Tooth disorder † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Vomiting † 1    
# participants affected / at risk     1/438 (0.23%)     4/428 (0.93%)  
General disorders      
Asthenia † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Chest pain † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Chills † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Death † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Gait disturbance † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
General physical health deterioration † 1    
# participants affected / at risk     2/438 (0.46%)     2/428 (0.47%)  
Local swelling † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Mucosal inflammation † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Multi-organ failure † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Oedema † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Oedema peripheral † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Pain † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Pyrexia † 1    
# participants affected / at risk     13/438 (2.97%)     9/428 (2.10%)  
Sudden death † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Hepatobiliary disorders      
Cholangitis chronic † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Cholecystitis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Cholecystitis acute † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Gallbladder disorder † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Gallbladder polyp † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Hepatic cirrhosis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Hepatic failure † 1    
# participants affected / at risk     3/438 (0.68%)     0/428 (0.00%)  
Hepatic steatosis † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Hepatitis toxic † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Hyperbilirubinaemia † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Portal hypertension † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Immune system disorders      
Drug hypersensitivity † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Infections and infestations      
AIDS encephalopathy † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Abdominal abscess † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Acarodermatitis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Actinomycotic pulmonary infection † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Acute sinusitis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Amoebic dysentery † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Anal abscess † 1    
# participants affected / at risk     1/438 (0.23%)     2/428 (0.47%)  
Anal infection † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Anogenital warts † 1    
# participants affected / at risk     4/438 (0.91%)     1/428 (0.23%)  
Appendiceal abscess † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Appendicitis † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Arthritis infective † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Atypical mycobacterial infection † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Bacteraemia † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Bronchitis † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Campylobacter intestinal infection † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Cerebral toxoplasmosis † 1    
# participants affected / at risk     3/438 (0.68%)     4/428 (0.93%)  
Cryptosporidiosis infection † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Cyclosporidium infection † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Cytomegalovirus chorioretinitis † 1    
# participants affected / at risk     2/438 (0.46%)     3/428 (0.70%)  
Cytomegalovirus colitis † 1    
# participants affected / at risk     2/438 (0.46%)     2/428 (0.47%)  
Cytomegalovirus infection † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Diarrhoea infectious † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Disseminated cryptococcosis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Endocarditis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Erysipelas † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Fungal oesophagitis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Gastroenteritis † 1    
# participants affected / at risk     2/438 (0.46%)     4/428 (0.93%)  
Gastroenteritis cryptosporidial † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
HIV infection † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Haemophilus sepsis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Helicobacter sepsis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Herpes oesophagitis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Herpes ophthalmic † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Herpes zoster † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Histoplasmosis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Isosporiasis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Malaria † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Meningoencephalitis herpetic † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Nocardiosis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Oesophageal candidiasis † 1    
# participants affected / at risk     3/438 (0.68%)     3/428 (0.70%)  
Orchitis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Osteomyelitis chronic † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Parotitis † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Pneumocystis jiroveci infection † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Pneumocystis jiroveci pneumonia † 1    
# participants affected / at risk     4/438 (0.91%)     3/428 (0.70%)  
Pneumonia † 1    
# participants affected / at risk     11/438 (2.51%)     3/428 (0.70%)  
Pneumonia bacterial † 1    
# participants affected / at risk     0/438 (0.00%)     2/428 (0.47%)  
Pneumonia pneumococcal † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Postoperative wound infection † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Progressive multifocal leukoencephalopathy † 1    
# participants affected / at risk     2/438 (0.46%)     3/428 (0.70%)  
Pulmonary tuberculosis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Pyelonephritis acute † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Respiratory tract infection † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Salmonella sepsis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Salmonellosis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Sepsis † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Septic shock † 1    
# participants affected / at risk     3/438 (0.68%)     1/428 (0.23%)  
Sinusitis † 1    
# participants affected / at risk     1/438 (0.23%)     2/428 (0.47%)  
Skin infection † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Staphylococcal sepsis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Subcutaneous abscess † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Syphilis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Tuberculosis † 1    
# participants affected / at risk     1/438 (0.23%)     2/428 (0.47%)  
Urinary tract infection † 1    
# participants affected / at risk     1/438 (0.23%)     2/428 (0.47%)  
Urosepsis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Visceral leishmaniasis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Wound infection † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Injury, poisoning and procedural complications      
Accident at home † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Coronary artery restenosis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Facial bones fracture † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Humerus fracture † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Injury † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Limb injury † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Lower limb fracture † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Overdose † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Post procedural haemorrhage † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Road traffic accident † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Skin laceration † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Tibia fracture † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Investigations      
Alanine aminotransferase increased † 1    
# participants affected / at risk     4/438 (0.91%)     0/428 (0.00%)  
Aspartate aminotransferase increased † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Blood creatinine increased † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Blood glucose increased † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Blood lactic acid increased † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Blood triglycerides increased † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Electrocardiogram change † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Gamma-glutamyltransferase increased † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Liver function test abnormal † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Transaminases increased † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Weight decreased † 1    
# participants affected / at risk     3/438 (0.68%)     1/428 (0.23%)  
Metabolism and nutrition disorders      
Acidosis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Cachexia † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Dehydration † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Hyperamylasaemia † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Hypertriglyceridaemia † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Hypokalaemia † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Lactic acidosis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Metabolic acidosis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Mitochondrial toxicity † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Obesity † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Polydipsia † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Musculoskeletal and connective tissue disorders      
Arthralgia † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Arthritis † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Back pain † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Flank pain † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Intervertebral disc protrusion † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Myalgia † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Neck pain † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Osteoarthritis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Osteonecrosis † 1    
# participants affected / at risk     0/438 (0.00%)     2/428 (0.47%)  
Rhabdomyolysis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Acute lymphocytic leukaemia † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Anal cancer † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Anal cancer recurrent † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Anal cancer stage 0 † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
B-cell lymphoma † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Basal cell carcinoma † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Breast cancer † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Burkitt's lymphoma † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Cervix carcinoma † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Cervix carcinoma stage 0 † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Colorectal cancer † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Hodgkin's disease † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Hodgkin's disease mixed cellularity stage unspecified † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Kaposi's sarcoma † 1    
# participants affected / at risk     3/438 (0.68%)     2/428 (0.47%)  
Lipoma † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Lung adenocarcinoma † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Lymphoma † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Non-Hodgkin's lymphoma † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Plasmacytoma † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Rectal cancer † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Recurrent cancer † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Skin papilloma † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Squamous cell carcinoma † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Uterine carcinoma in situ † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Nervous system disorders      
Balance disorder † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Central nervous system lesion † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Cerebral ataxia † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Cerebral haematoma † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Cerebral ischaemia † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Cerebrovascular accident † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Cervical root pain † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Coma † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Convulsion † 1    
# participants affected / at risk     1/438 (0.23%)     2/428 (0.47%)  
Dizziness † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Embolic cerebral infarction † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Encephalitis † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Headache † 1    
# participants affected / at risk     2/438 (0.46%)     3/428 (0.70%)  
Hemiparesis † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Intracranial pressure increased † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Intraventricular haemorrhage † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Ischaemic stroke † 1    
# participants affected / at risk     1/438 (0.23%)     2/428 (0.47%)  
Lacunar infarction † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Nervous system disorder † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Neuropathy peripheral † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Neurotoxicity † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Parkinsonism † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Polyneuropathy † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Syncope vasovagal † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Tremor † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Pregnancy, puerperium and perinatal conditions      
Abortion spontaneous † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Psychiatric disorders      
Anxiety † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Depression † 1    
# participants affected / at risk     1/438 (0.23%)     2/428 (0.47%)  
Depression suicidal † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Disorientation † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Hallucination † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Suicide attempt † 1    
# participants affected / at risk     1/438 (0.23%)     2/428 (0.47%)  
Renal and urinary disorders      
Calculus bladder † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Dysuria † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Glomerulonephritis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Hydronephrosis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Nephrogenic diabetes insipidus † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Nephrolithiasis † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Nephrotic syndrome † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Oliguria † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Polyuria † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Renal colic † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Renal failure † 1    
# participants affected / at risk     2/438 (0.46%)     1/428 (0.23%)  
Renal failure acute † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Reproductive system and breast disorders      
Cervical dysplasia † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Ovarian cyst † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Ovarian mass † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Respiratory, thoracic and mediastinal disorders      
Acute pulmonary oedema † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Acute respiratory failure † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Asthma † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Bronchospasm † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Cough † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Dyspnoea † 1    
# participants affected / at risk     2/438 (0.46%)     2/428 (0.47%)  
Hypoxia † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Interstitial lung disease † 1    
# participants affected / at risk     3/438 (0.68%)     0/428 (0.00%)  
Lung disorder † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Pleural effusion † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Pneumonitis † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Pulmonary cavitation † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Pulmonary hypertension † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Respiratory failure † 1    
# participants affected / at risk     4/438 (0.91%)     0/428 (0.00%)  
Vocal cord thickening † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Skin and subcutaneous tissue disorders      
Hyperhidrosis † 1    
# participants affected / at risk     2/438 (0.46%)     0/428 (0.00%)  
Lipodystrophy acquired † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Petechiae † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Pyoderma gangrenosum † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Rash † 1    
# participants affected / at risk     1/438 (0.23%)     1/428 (0.23%)  
Surgical and medical procedures      
Eventration procedure † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Hip arthroplasty † 1    
# participants affected / at risk     0/438 (0.00%)     1/428 (0.23%)  
Vascular disorders      
Hypertension † 1    
# participants affected / at risk     1/438 (0.23%)     0/428 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MEDDRA 11.1




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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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