Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00389207
First received: October 17, 2006
Last updated: December 9, 2013
Last verified: December 2013
Results First Received: January 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: nevirapine bid
Drug: nevirapine qd
Drug: atazanavir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

Reporting Groups
  Description
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®

Participant Flow:   Overall Study
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
STARTED     188 [1]   188 [2]   193  
COMPLETED     125     116     152  
NOT COMPLETED     63     72     41  
Adverse Event                 26                 32                 10  
Protocol Violation                 3                 1                 4  
Lost to Follow-up                 12                 9                 7  
Withdrawal by Subject                 5                 7                 11  
Not specified                 17                 23                 9  
[1] 3 patients were randomized to NVP QD but not treated and so not part of the Full Analysis Set (FAS)
[2] 4 patients were randomized to NVP BID but not treated and so are not part of the FAS



  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
Nevirapine QD Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®
Total Total of all reporting groups

Baseline Measures
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir     Total  
Number of Participants  
[units: participants]
  188     188     193     569  
Age  
[units: years]
Mean ± Standard Deviation
  38.4  ± 9.7     40.0  ± 10.5     37.6  ± 9.5     38.6  ± 9.9  
Gender  
[units: participants]
       
Female     36     25     31     92  
Male     152     163     162     477  
Baseline HIV viral load category  
[units: participants]
       
Baseline HIV viral load ≤ 100,000 copies/mL     71     71     65     207  
Baseline HIV viral load > 100,000 copies/mL     117     117     128     362  
Baseline log10 HIV viral load [1]
[units: log¬†10¬†Copies/mL]
Mean ± Standard Deviation
  5.1  ± 0.7     5.1  ± 0.6     5.1  ± 0.7     5.1  ± 0.7  
Baseline CD4+ cell count [1]
[units: Cells/mm^3]
Mean ± Standard Deviation
  183.3  ± 95.5     202.9  ± 93.6     193.2  ± 95.8     193.2  ± 95.1  
[1] 185 NVP QD patients, 188 NVP BID patients and 192 ATZ/R patients had data



  Outcome Measures
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1.  Primary:   Treatment Response at Week 48   [ Time Frame: From baseline to Week 48 ]

2.  Secondary:   Treatment Response at Week 48 (TLOVR Algorithm)   [ Time Frame: From baseline to Week 48 ]

3.  Secondary:   Proportion of Patients With VL < 50 Copies/ml   [ Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT ]

4.  Secondary:   Proportion of Patients With VL < 400 Copies/ml   [ Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT ]

5.  Secondary:   Change in CD4+ Count From Baseline   [ Time Frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT ]

6.  Secondary:   Change in Framingham Score From Baseline   [ Time Frame: From baseline to Weeks 48, 96 and 144/EOT ]

7.  Secondary:   Change in Mental Health Summary (MHS) Score From Baseline   [ Time Frame: From baseline to Weeks 48, 96 and 144/EOT ]

8.  Secondary:   Change in Physical Health Summary (PHS) Score From Baseline   [ Time Frame: From baseline to Weeks 48, 96 and 144/EOT ]

9.  Secondary:   Number of Patients Hospitalized   [ Time Frame: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT ]

10.  Secondary:   Non-scheduled Physician Visits   [ Time Frame: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT ]

11.  Secondary:   Genotypic Resistance Associated With Virologic Failure   [ Time Frame: From baseline to Week 48 ]

12.  Secondary:   Treatment-emergent AIDS-defining Illness   [ Time Frame: From baseline to Week 144 ]

13.  Secondary:   Treatment-emergent AIDS-defining Illness Leading to Death   [ Time Frame: From baseline to Week 144 ]

14.  Secondary:   Lipodystrophy   [ Time Frame: From baseline to Week 144 ]

15.  Secondary:   Serum Lipid Abnormalities   [ Time Frame: From baseline to Week 144 ]

16.  Secondary:   Glycaemic Abnormalities   [ Time Frame: From baseline to Week 144 ]

17.  Secondary:   Treatment Response at Week 96   [ Time Frame: From baseline to Week 96 ]

18.  Secondary:   Treatment Response at Week 144   [ Time Frame: From baseline to Week 144 ]

19.  Secondary:   Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144   [ Time Frame: at Week 24, 48, 96, 144 ]

20.  Secondary:   Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144   [ Time Frame: at Week 24, 48, 96, 144 ]

21.  Secondary:   Proportion of Patients With Virologic Failure at Week 48, 96, 144   [ Time Frame: at Week 48, 96, 144 ]

22.  Secondary:   Time to Treatment Response (First Confirmed VL<50 Copies/mL)   [ Time Frame: baseline to week 144 ]

23.  Secondary:   Time to Loss of Virologic Response (Rebound)   [ Time Frame: Baseline to week 144 ]

24.  Secondary:   Time to Treatment Failure   [ Time Frame: baseline to week 144 ]

25.  Secondary:   Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144   [ Time Frame: From baseline to Week 48, 96, 144 ]

26.  Secondary:   Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities   [ Time Frame: week 148 ]

27.  Secondary:   Proportion of Patients Reporting Rash of Any Severity   [ Time Frame: week 148 ]

28.  Secondary:   Proportion of Patients Reporting Hepatic Events of Any Severity   [ Time Frame: week 148 ]

29.  Secondary:   Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity   [ Time Frame: week 148 ]

30.  Secondary:   Change of Cholesterol Values From Baseline to Week 48, 96, 144   [ Time Frame: baseline to week 48, 96, 144 ]

31.  Secondary:   Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144   [ Time Frame: baseline to week 48, 96, 144 ]

32.  Secondary:   Change of hsCRP From Baseline to Week 48, 96, 144   [ Time Frame: baseline to week 48, 96, 144 ]

33.  Secondary:   Change of Total Triglycerides From Baseline to Week 48, 96, 144   [ Time Frame: baseline to week 48, 96, 144 ]

34.  Secondary:   Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144   [ Time Frame: baseline to week 48, 96, 144 ]


  Serious Adverse Events
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Time Frame 148 weeks
Additional Description No text entered.

Reporting Groups
  Description
Nevirapine QD NVP 400mg QD on a background of the fixed combination Truvada®
Nevirapine BID NVP 200mg BID on a background of the fixed combination Truvada®
Atazanvir/Ritonavir ATZ/r on a background of the fixed combination Truvada®

Serious Adverse Events
    Nevirapine QD     Nevirapine BID     Atazanvir/Ritonavir  
Total, serious adverse events        
# participants affected / at risk     25/188 (13.30%)     31/188 (16.49%)     27/193 (13.99%)  
Blood and lymphatic system disorders        
Anaemia † 1      
# participants affected / at risk     0/188 (0.00%)     2/188 (1.06%)     0/193 (0.00%)  
Neutropenia † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Cardiac disorders        
Acute myocardial infarction † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Angina pectoris † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Angina unstable † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Cardiac failure † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Myocardial infarction † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Myopericarditis † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Endocrine disorders        
Goitre † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Eye disorders        
Retinal detachment † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Gastrointestinal disorders        
Constipation † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Inguinal hernia † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Peritonitis † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
General disorders        
Asthenia † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Fatigue † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Multi-organ failure † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Pain † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Puncture site haemorrhage † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Pyrexia † 1      
# participants affected / at risk     1/188 (0.53%)     3/188 (1.60%)     0/193 (0.00%)  
Hepatobiliary disorders        
Cholecystitis † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Cholecystitis acute † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Cholelithiasis † 1      
# participants affected / at risk     0/188 (0.00%)     3/188 (1.60%)     0/193 (0.00%)  
Cholestasis † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Immune system disorders        
Drug hypersensitivity † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Infections and infestations        
Abscess jaw † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Anal abscess † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Anogenital warts † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     5/193 (2.59%)  
Appendicitis † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Candida pneumonia † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Cerebral toxoplasmosis † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Cryptococcosis † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Cytomegalovirus infection † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Gastroenteritis † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
H1N1 influenza † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
HIV infection † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Hepatitis A † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     2/193 (1.04%)  
Herpes zoster † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Meningitis viral † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Neurosyphilis † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Orchitis † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Papilloma viral infection † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Pneumocystis jiroveci pneumonia † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Pneumonia † 1      
# participants affected / at risk     2/188 (1.06%)     0/188 (0.00%)     3/193 (1.55%)  
Postoperative wound infection † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Pulmonary tuberculosis † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Salpingitis † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Sepsis † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Sinusitis † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Subcutaneous abscess † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Tuberculosis † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Urinary tract infection † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Injury, poisoning and procedural complications        
Drug exposure during pregnancy † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Fall † 1      
# participants affected / at risk     1/188 (0.53%)     1/188 (0.53%)     0/193 (0.00%)  
Fracture of penis † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Meniscus lesion † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Multiple injuries † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Rib fracture † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Subdural haematoma † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Upper limb fracture † 1      
# participants affected / at risk     1/188 (0.53%)     2/188 (1.06%)     0/193 (0.00%)  
Investigations        
Alanine aminotransferase increased † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     1/193 (0.52%)  
Aspartate aminotransferase increased † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Blood bilirubin increased † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     1/193 (0.52%)  
Blood creatine phosphokinase increased † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Gamma-glutamyltransferase increased † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Haemoglobin decreased † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Transaminases increased † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Musculoskeletal and connective tissue disorders        
Arthralgia † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Back pain † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Flank pain † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Musculoskeletal stiffness † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Myalgia † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Neck pain † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Basal cell carcinoma † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Bladder neoplasm † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Bone neoplasm † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Hodgkin's disease † 1      
# participants affected / at risk     2/188 (1.06%)     2/188 (1.06%)     0/193 (0.00%)  
Kaposi's sarcoma † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Lung carcinoma cell type unspecified recurrent † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Lung neoplasm malignant † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Lymphoma † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Myelodysplastic syndrome † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Non-Hodgkin's lymphoma † 1      
# participants affected / at risk     0/188 (0.00%)     2/188 (1.06%)     0/193 (0.00%)  
Pancreatic carcinoma † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Nervous system disorders        
Carpal tunnel syndrome † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Cerebellar syndrome † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Cerebrovascular accident † 1      
# participants affected / at risk     0/188 (0.00%)     2/188 (1.06%)     0/193 (0.00%)  
Convulsion † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Epilepsy † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Headache † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     1/193 (0.52%)  
Hypoaesthesia † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Neuralgia † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Neuropathy peripheral † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Psychiatric disorders        
Alcohol abuse † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Depression † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Schizophrenia † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Suicide attempt † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Renal and urinary disorders        
Renal failure † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Renal failure acute † 1      
# participants affected / at risk     1/188 (0.53%)     1/188 (0.53%)     0/193 (0.00%)  
Reproductive system and breast disorders        
Cervical dysplasia † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Ovarian cyst ruptured † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Asthma † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Chronic obstructive pulmonary disease † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Cough † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Dyspnoea † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Interstitial lung disease † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Pleural effusion † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Pleurisy † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Pulmonary oedema † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Skin and subcutaneous tissue disorders        
Rash † 1      
# participants affected / at risk     1/188 (0.53%)     0/188 (0.00%)     0/193 (0.00%)  
Surgical and medical procedures        
Breast prosthesis implantation † 1      
# participants affected / at risk     0/188 (0.00%)     1/188 (0.53%)     0/193 (0.00%)  
Mastoidectomy † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Tympanoplasty † 1      
# participants affected / at risk     0/188 (0.00%)     0/188 (0.00%)     1/193 (0.52%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 14.0




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