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A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00369941
First received: August 29, 2006
Last updated: September 1, 2015
Last verified: September 2015
Results First Received: September 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: MK-0518
Drug: Comparator: efavirenz
Drug: Comparator: Truvada
Drug: Comparator: Placebo to MK-0518
Drug: Comparator: Placebo to efavirenz

  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

Primary therapy period: 14-Sep-2006 to 06-May-2009

Multicenter (67) in the United States (18) and Ex-US (49)


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
MK-0518 400 mg b.i.d. MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
Efavirenz 600 mg q.h.s. Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.

Participant Flow:   Overall Study
    MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s.
STARTED   282   284 
Treated   281   282 
COMPLETED   210   184 
NOT COMPLETED   72   100 
Never Treated                1                2 
Adverse Event                14                28 
Lack of Efficacy                6                10 
Lost to Follow-up                12                22 
Protocol Violation                5                3 
Withdrawal by Subject                5                18 
Pregnancy                4                2 
Completed, Did Not Enter Extension                5                6 
Moved                11                5 
Treatment with Prohibited Medication                3                1 
Employment Interfered with Study Visits                1                0 
Study Site Terminated                2                0 
Miscellaneous                3                3 



  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
MK-0518 400 mg b.i.d. MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
Efavirenz 600 mg q.h.s. Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
Total Total of all reporting groups

Baseline Measures
   MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s.   Total 
Overall Participants Analyzed 
[Units: Participants]
 281   282   563 
Age 
[Units: Years]
Mean (Full Range)
 38 
 (19 to 67) 
 37 
 (19 to 71) 
 37 
 (19 to 71) 
Gender 
[Units: Participants]
     
Female   54   51   105 
Male   227   231   458 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   116   123   239 
Black   33   23   56 
Asian   36   32   68 
Hispanic   60   67   127 
Others   36   37   73 
Cluster of Differentiation 4 (CD4) Cell Count 
[Units: Cells/mm^3]
Mean (Full Range)
 219 
 (1 to 620) 
 217 
 (4 to 807) 
 218 
 (1 to 807) 
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) 
[Units: Copies/mL]
Geometric Mean (Full Range)
 103205 
 (400 to 750000) 
 106215 
 (4410 to 750000) 
 104702 
 (400 to 750000) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48   [ Time Frame: 48 Weeks ]

2.  Primary:   Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48   [ Time Frame: 48 Weeks ]

3.  Primary:   Number of Participants With Serious CAEs at Week 48   [ Time Frame: 48 Weeks ]

4.  Primary:   Number of Participants With Drug-related CAEs at Week 48   [ Time Frame: 48 Weeks ]

5.  Primary:   Number of Participants With Serious Drug-related CAEs at Week 48   [ Time Frame: 48 Weeks ]

6.  Primary:   Number of Participants That Died by Week 48   [ Time Frame: 48 Weeks ]

7.  Primary:   Number of Participants That Discontinued With CAEs at Week 48   [ Time Frame: 48 Weeks ]

8.  Primary:   Number of Participants That Discontinued With Serious CAEs at Week 48   [ Time Frame: 48 Weeks ]

9.  Primary:   Number of Participants That Discontinued With Drug-related CAEs at Week 48   [ Time Frame: 48 Weeks ]

10.  Primary:   Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48   [ Time Frame: 48 Weeks ]

11.  Primary:   Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48   [ Time Frame: 48 Weeks ]

12.  Primary:   Number of Participants With Serious LAEs at Week 48   [ Time Frame: 48 Weeks ]

13.  Primary:   Number of Participants With Drug-related LAEs at Week 48   [ Time Frame: 48 Weeks ]

14.  Primary:   Number of Participants With Serious Drug-related LAEs at Week 48   [ Time Frame: 48 Weeks ]

15.  Primary:   Number of Participants Discontinued With LAEs at Week 48   [ Time Frame: 48 Weeks ]

16.  Primary:   Number of Participants Discontinued With Drug-related LAEs at Week 48   [ Time Frame: 48 Weeks ]

17.  Secondary:   Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48   [ Time Frame: 48 Weeks ]

18.  Secondary:   Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48   [ Time Frame: Baseline and Week 48 ]

19.  Secondary:   Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96   [ Time Frame: 96 Weeks ]

20.  Secondary:   Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96   [ Time Frame: 96 Weeks ]

21.  Secondary:   Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline and Week 96 ]

22.  Secondary:   Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156   [ Time Frame: 156 Weeks ]

23.  Secondary:   Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156   [ Time Frame: 156 Weeks ]

24.  Secondary:   Change From Baseline in CD4 Cell Count at Week 156   [ Time Frame: Baseline and Week 156 ]

25.  Secondary:   Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240   [ Time Frame: 240 Weeks ]

26.  Secondary:   Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240   [ Time Frame: 240 Weeks ]

27.  Secondary:   Change From Baseline in CD4 Cell Count at Week 240   [ Time Frame: Baseline and Week 240 ]

28.  Secondary:   Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8   [ Time Frame: 8 Weeks ]

29.  Secondary:   Number of Participants With CAEs at Week 96   [ Time Frame: 96 Weeks ]

30.  Secondary:   Number of Participants With CAEs at Week 156   [ Time Frame: 156 Weeks ]

31.  Secondary:   Number of Participants With CAEs at Week 240   [ Time Frame: 240 Weeks ]

32.  Secondary:   Number of Participants With Serious CAEs at Week 96   [ Time Frame: 96 Weeks ]

33.  Secondary:   Number of Participants With Serious CAEs at Week 156   [ Time Frame: 156 Weeks ]

34.  Secondary:   Number of Participants With Serious CAEs at Week 240   [ Time Frame: 240 Weeks ]

35.  Secondary:   Number of Participants With Drug-related CAEs at Week 96   [ Time Frame: 96 Weeks ]

36.  Secondary:   Number of Participants With Drug-related CAEs at Week 156   [ Time Frame: 156 Weeks ]

37.  Secondary:   Number of Participants With Drug-related CAEs at Week 240   [ Time Frame: 240 Weeks ]

38.  Secondary:   Number of Participants With Serious Drug-related CAEs at Week 96   [ Time Frame: 96 Weeks ]

39.  Secondary:   Number of Participants With Serious Drug-related CAEs at Week 156   [ Time Frame: 156 Weeks ]

40.  Secondary:   Number of Participants With Serious Drug-related CAEs at Week 240   [ Time Frame: 240 Weeks ]

41.  Secondary:   Number of Participants That Died by Week 96   [ Time Frame: 96 Weeks ]

42.  Secondary:   Number of Participants That Died by Week 156   [ Time Frame: 156 Weeks ]

43.  Secondary:   Number of Participants That Died by Week 240   [ Time Frame: 240 Weeks ]

44.  Secondary:   Number of Participants That Discontinued With CAEs at Week 96   [ Time Frame: 96 Weeks ]

45.  Secondary:   Number of Participants That Discontinued With CAEs at Week 156   [ Time Frame: 156 Weeks ]

46.  Secondary:   Number of Participants That Discontinued With CAEs at Week 240   [ Time Frame: 240 Weeks ]

47.  Secondary:   Number of Participants That Discontinued With Drug-related CAEs at Week 96   [ Time Frame: 96 Weeks ]

48.  Secondary:   Number of Participants That Discontinued With Drug-related CAEs at Week 156   [ Time Frame: 156 Weeks ]

49.  Secondary:   Number of Participants That Discontinued With Drug-related CAEs at Week 240   [ Time Frame: 240 Weeks ]

50.  Secondary:   Number of Participants That Discontinued With Serious CAEs at Week 96   [ Time Frame: 96 Weeks ]

51.  Secondary:   Number of Participants That Discontinued With Serious CAEs at Week 156   [ Time Frame: 156 Weeks ]

52.  Secondary:   Number of Participants That Discontinued With Serious CAEs at Week 240   [ Time Frame: 240 Weeks ]

53.  Secondary:   Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96   [ Time Frame: 96 Weeks ]

54.  Secondary:   Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156   [ Time Frame: 156 Weeks ]

55.  Secondary:   Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240   [ Time Frame: 240 Weeks ]

56.  Secondary:   Number of Participants With LAEs at Week 96   [ Time Frame: 96 Weeks ]

57.  Secondary:   Number of Participants With LAEs at Week 156   [ Time Frame: 156 Weeks ]

58.  Secondary:   Number of Participants With LAEs at Week 240   [ Time Frame: 240 Weeks ]

59.  Secondary:   Number of Participants With Drug-related LAEs at Week 96   [ Time Frame: 96 Weeks ]

60.  Secondary:   Number of Participants With Drug-related LAEs at Week 156   [ Time Frame: 156 Weeks ]

61.  Secondary:   Number of Participants With Drug-related LAEs at Week 240   [ Time Frame: 240 Weeks ]

62.  Secondary:   Number of Participants With Serious LAEs at Week 96   [ Time Frame: 96 Weeks ]

63.  Secondary:   Number of Participants With Serious LAEs at Week 156   [ Time Frame: 156 Weeks ]

64.  Secondary:   Number of Participants With Serious LAEs at Week 240   [ Time Frame: 240 Weeks ]

65.  Secondary:   Number of Participants With Serious Drug-related LAEs at Week 96   [ Time Frame: 96 Weeks ]

66.  Secondary:   Number of Participants With Serious Drug-related LAEs at Week 156   [ Time Frame: 156 Weeks ]

67.  Secondary:   Number of Participants With Serious Drug-related LAEs at Week 240   [ Time Frame: 240 Weeks ]

68.  Secondary:   Number of Participants Discontinued With LAEs at Week 96   [ Time Frame: 96 Weeks ]

69.  Secondary:   Number of Participants Discontinued With LAEs at Week 156   [ Time Frame: 156 Weeks ]

70.  Secondary:   Number of Participants Discontinued With LAEs at Week 240   [ Time Frame: 240 Weeks ]

71.  Secondary:   Number of Participants Discontinued With Drug-related LAEs at Week 96   [ Time Frame: 96 Weeks ]

72.  Secondary:   Number of Participants Discontinued With Drug-related LAEs at Week 156   [ Time Frame: 156 Weeks ]

73.  Secondary:   Number of Participants Discontinued With Drug-related LAEs at Week 240   [ Time Frame: 240 Weeks ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame 240 weeks
Additional Description Adverse events are reported for the entire 240-week study.

Reporting Groups
  Description
MK-0518 400 mg b.i.d. MK-0518 400 mg taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, taken PO (q.h.s.) on an empty stomach preferably at bedtime (q.h.s.). All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily with food with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
Efavirenz 600 mg q.h.s. Efavirenz 600 mg taken by mouth on an empty stomach preferably at bedtime (q.h.s.), and placebo to MK-0518 taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.

Serious Adverse Events
    MK-0518 400 mg b.i.d.   Efavirenz 600 mg q.h.s.
Total, serious adverse events     
# participants affected / at risk   57/281 (20.28%)   59/282 (20.92%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   3/281 (1.07%)   1/282 (0.35%) 
# events   3   1 
Eosinophilia † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Iron deficiency anaemia † 1     
# participants affected / at risk   1/281 (0.36%)   1/282 (0.35%) 
# events   1   1 
Lymphadenitis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Pancytopenia † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Cardiac disorders     
Acute myocardial infarction † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Cardiac failure † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Coronary artery disease † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Congenital, familial and genetic disorders     
Branchial cleft cyst † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Heart disease congenital † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Eye disorders     
Conjunctivitis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Uveitis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   1/281 (0.36%)   1/282 (0.35%) 
# events   1   1 
Anal fistula † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Colitis † 1     
# participants affected / at risk   1/281 (0.36%)   1/282 (0.35%) 
# events   1   1 
Duodenal ulcer † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Gastrointestinal disorder † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Nausea † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Oesophagitis † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Pancreatitis † 1     
# participants affected / at risk   2/281 (0.71%)   1/282 (0.35%) 
# events   2   1 
Pancreatitis acute † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Peptic ulcer † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Proctalgia † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Rectal haemorrhage † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Vomiting † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
General disorders     
Chest pain † 1     
# participants affected / at risk   1/281 (0.36%)   2/282 (0.71%) 
# events   1   2 
Death † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Hepatobiliary disorders     
Cholangitis † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Cholecystitis chronic † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Immune system disorders     
Immune reconstitution syndrome † 1     
# participants affected / at risk   5/281 (1.78%)   2/282 (0.71%) 
# events   5   2 
Infections and infestations     
Abscess limb † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Appendicitis † 1     
# participants affected / at risk   0/281 (0.00%)   3/282 (1.06%) 
# events   0   3 
Bacteraemia † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Bone tuberculosis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Cellulitis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Cytomegalovirus colitis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Dengue fever † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Diarrhoea infectious † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Endometritis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Enterocolitis infectious † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Extrapulmonary tuberculosis † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Gastroenteritis † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Hepatitis B † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Hepatitis C † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Herpes zoster † 1     
# participants affected / at risk   1/281 (0.36%)   1/282 (0.35%) 
# events   1   1 
Infectious mononucleosis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Influenza † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   2 
Lung infection † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Lymphangitis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Meningitis † 1     
# participants affected / at risk   2/281 (0.71%)   0/282 (0.00%) 
# events   2   0 
Mycobacterium avium complex infection † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Neurosyphilis † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Oesophageal candidiasis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Orchitis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Pneumocystis jiroveci pneumonia † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Pneumonia † 1     
# participants affected / at risk   2/281 (0.71%)   5/282 (1.77%) 
# events   2   5 
Pulmonary tuberculosis † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Pyelonephritis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Pyelonephritis acute † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Secondary syphilis † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Sepsis † 1     
# participants affected / at risk   1/281 (0.36%)   1/282 (0.35%) 
# events   1   1 
Septic shock † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   2 
Subcutaneous abscess † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Syphilis † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Urinary tract infection † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Vestibular neuronitis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Viral upper respiratory tract infection † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Injury, poisoning and procedural complications     
Accidental exposure † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Accidental overdose † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Alcohol poisoning † 1     
# participants affected / at risk   1/281 (0.36%)   1/282 (0.35%) 
# events   1   1 
Cervical vertebral fracture † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Chemical poisoning † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Femoral neck fracture † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Intentional overdose † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Joint dislocation † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Laceration † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Limb injury † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Maternal exposure during pregnancy † 1     
# participants affected / at risk   1/281 (0.36%)   1/282 (0.35%) 
# events   1   1 
Multiple injuries † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Rib fracture † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Subdural haematoma † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Toxicity to various agents † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Traumatic lung injury † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Investigations     
Alanine aminotransferase increased † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Aspartate aminotransferase increased † 1     
# participants affected / at risk   0/281 (0.00%)   2/282 (0.71%) 
# events   0   2 
Blood alkaline phosphatase increased † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Musculoskeletal and connective tissue disorders     
Back pain † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   2   0 
Intervertebral disc protrusion † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Musculoskeletal pain † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Myopathy † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal cancer † 1     
# participants affected / at risk   0/281 (0.00%)   2/282 (0.71%) 
# events   0   2 
Anogenital warts † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Basal cell carcinoma † 1     
# participants affected / at risk   2/281 (0.71%)   3/282 (1.06%) 
# events   3   3 
Bone neoplasm malignant † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Breast cancer † 1     
# participants affected / at risk   2/281 (0.71%)   0/282 (0.00%) 
# events   2   0 
Kaposi's sarcoma AIDS related † 1     
# participants affected / at risk   2/281 (0.71%)   6/282 (2.13%) 
# events   2   7 
Leukaemia † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Lung cancer metastatic † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Lung neoplasm malignant † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Plasmablastic lymphoma † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Uterine leiomyoma † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Nervous system disorders     
Cerebral haemorrhage † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Convulsion † 1     
# participants affected / at risk   1/281 (0.36%)   1/282 (0.35%) 
# events   1   1 
Dizziness † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Hypoaesthesia † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Migraine † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   6   0 
Nervous system disorder † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Syncope † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Psychiatric disorders     
Anxiety † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Conversion disorder † 1     
# participants affected / at risk   0/281 (0.00%)   2/282 (0.71%) 
# events   0   2 
Depression † 1     
# participants affected / at risk   3/281 (1.07%)   3/282 (1.06%) 
# events   6   3 
Drug abuse † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Mental disorder † 1     
# participants affected / at risk   1/281 (0.36%)   1/282 (0.35%) 
# events   1   1 
Psychosomatic disease † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Psychotic disorder † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Schizoaffective disorder † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Suicidal ideation † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Suicide attempt † 1     
# participants affected / at risk   4/281 (1.42%)   0/282 (0.00%) 
# events   4   0 
Renal and urinary disorders     
Urinary bladder haemorrhage † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Reproductive system and breast disorders     
Menorrhagia † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Respiratory, thoracic and mediastinal disorders     
Bronchial hyperreactivity † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Haemoptysis † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Hypoxia † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Pleural effusion † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Respiratory failure † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Sleep apnoea syndrome † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Vascular disorders     
Arteriosclerosis obliterans † 1     
# participants affected / at risk   0/281 (0.00%)   1/282 (0.35%) 
# events   0   1 
Deep vein thrombosis † 1     
# participants affected / at risk   1/281 (0.36%)   0/282 (0.00%) 
# events   1   0 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 14.1




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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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