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An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00359021
First received: July 28, 2006
Last updated: May 6, 2014
Last verified: May 2014
Results First Received: January 29, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1
Intervention: Drug: TMC125

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with human immunodeficiency virus – type 1 (HIV-1) infection were enrolled in this study from DUET Study TMC125-C206 or TMC125-C216 and met the definition of virologic failure at Week 24 or later in these studies, or who completed one of the DUET studies after 96 weeks of treatment.

Reporting Groups
  Description
DUET PLACEBO Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
DUET TMC125 Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.

Participant Flow:   Overall Study
    DUET PLACEBO   DUET TMC125
STARTED   256   247 
COMPLETED   175   195 
NOT COMPLETED   81   52 
Adverse Event                26                8 
Subject Non-Compliant                1                2 
Subject Ineligible To Continue The Trial                1                0 
Subject Reached A Virologic Endpoint                45                32 
Withdrawal by Subject                2                9 
Lost to Follow-up                1                0 
Not specified                4                1 
Pregnancy                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
DUET PLACEBO Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
DUET TMC125 Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
Total Total of all reporting groups

Baseline Measures
   DUET PLACEBO   DUET TMC125   Total 
Overall Participants Analyzed 
[Units: Participants]
 256   247   503 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   252   245   497 
>=65 years   4   2   6 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.9  (8.28)   46.6  (7.01)   46.7  (7.68) 
Gender 
[Units: Participants]
     
Female   27   37   64 
Male   229   210   439 


  Outcome Measures
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1.  Primary:   The Number of Participants Experiencing Adverse Events   [ Time Frame: 1 week to 180 weeks, with a median of 62 weeks ]

2.  Secondary:   The Percentage of Participants With Virologic Outcomes Over Time   [ Time Frame: Weeks 24, 48, and 96 ]

3.  Secondary:   Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)   [ Time Frame: Baseline, Week 24, Week 48, and Week 96 ]


  Serious Adverse Events
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Time Frame 07-Jun-2006 to 24-Jan-2012.
Additional Description All "Serious Adverse Events (SAEs)" emerging during the TMC125-C217 treatment period are reported below; "Other Adverse Events (not including SAEs)" provided below occurred in at least 0.5% of participants. The duration of the TMC125 treatment period ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.

Reporting Groups
  Description
DUET PLACEBO Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
DUET TMC125 Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
All Participants Participants who received placebo or TMC125 in a previous DUET study (DUET Placebo + DUET TMC125).

Serious Adverse Events
    DUET PLACEBO   DUET TMC125   All Participants
Total, serious adverse events       
# participants affected / at risk   46/256 (17.97%)   42/247 (17.00%)   88/503 (17.50%) 
Blood and lymphatic system disorders       
Anaemia * 1       
# participants affected / at risk   2/256 (0.78%)   2/247 (0.81%)   4/503 (0.80%) 
Febrile bone marrow aplasia * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Febrile neutropenia * 1       
# participants affected / at risk   2/256 (0.78%)   0/247 (0.00%)   2/503 (0.40%) 
Haemorrhagic diathesis * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Pancytopenia * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Thrombocytopenia * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Thrombotic thrombocytopenic purpura * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Cardiac disorders       
Angina unstable * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Atrial fibrillation * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Atrial flutter * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Bradycardia * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Cardiac failure * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Cardio-respiratory arrest * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Cardiopulmonary failure * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Coronary artery disease * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Coronary artery occlusion * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Myocardial infarction * 1       
# participants affected / at risk   2/256 (0.78%)   2/247 (0.81%)   4/503 (0.80%) 
Pericarditis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Gastrointestinal disorders       
Abdominal pain * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Ascites * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Colitis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Diarrhoea * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Dysphagia * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Eructation * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Gastric ulcer * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Haematemesis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Haemorrhoids * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Hernial eventration * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Intestinal polyp * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Mesenteric vein thrombosis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Pancreatitis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Proctitis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Rectal ulcer * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Subileus * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
General disorders       
Asthenia * 1       
# participants affected / at risk   2/256 (0.78%)   0/247 (0.00%)   2/503 (0.40%) 
Non-cardiac chest pain * 1       
# participants affected / at risk   1/256 (0.39%)   1/247 (0.40%)   2/503 (0.40%) 
Oedema peripheral * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Pyrexia * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Hepatobiliary disorders       
Chronic hepatic failure * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Immune system disorders       
Drug hypersensitivity * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Infections and infestations       
Anal abscess * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Appendicitis * 1       
# participants affected / at risk   1/256 (0.39%)   1/247 (0.40%)   2/503 (0.40%) 
Bronchopneumonia * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Cellulitis * 1       
# participants affected / at risk   3/256 (1.17%)   0/247 (0.00%)   3/503 (0.60%) 
Cerebral toxoplasmosis * 1       
# participants affected / at risk   1/256 (0.39%)   1/247 (0.40%)   2/503 (0.40%) 
Clostridium difficile colitis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Cryptococcosis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Cytomegalovirus chorioretinitis * 1       
# participants affected / at risk   1/256 (0.39%)   1/247 (0.40%)   2/503 (0.40%) 
Cytomegalovirus colitis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Cytomegalovirus infection * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Cytomegalovirus myelomeningoradiculitis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Gastroenteritis * 1       
# participants affected / at risk   2/256 (0.78%)   2/247 (0.81%)   4/503 (0.80%) 
HIV infection * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Hepatitis c * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Herpes simplex * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Herpes zoster * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Histoplasmosis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Histoplasmosis disseminated * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Keratitis fungal * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Localised infection * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Meningitis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Mycobacterium avium complex infection * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Oesophageal candidiasis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Oral candidiasis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Papilloma viral infection * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Pneumocystis jiroveci pneumonia * 1       
# participants affected / at risk   3/256 (1.17%)   0/247 (0.00%)   3/503 (0.60%) 
Pneumonia * 1       
# participants affected / at risk   5/256 (1.95%)   4/247 (1.62%)   9/503 (1.79%) 
Pneumonia influenzal * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Postoperative wound infection * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Pyomyositis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Pyothorax * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Scrotal abscess * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Sepsis * 1       
# participants affected / at risk   2/256 (0.78%)   2/247 (0.81%)   4/503 (0.80%) 
Staphylococcal bacteraemia * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Staphylococcal sepsis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Strongyloidiasis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Tuberculosis of central nervous system * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Urinary tract infection * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Urinary tract infection fungal * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Injury, poisoning and procedural complications       
Subdural haematoma * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Wrist fracture * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Investigations       
Arteriogram coronary * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Blood amylase increased * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Blood creatinine increased * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Haemoglobin decreased * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Lipase increased * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Weight decreased * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Metabolism and nutrition disorders       
Dehydration * 1       
# participants affected / at risk   2/256 (0.78%)   1/247 (0.40%)   3/503 (0.60%) 
Gout * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Hypertriglyceridaemia * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Hypokalaemia * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Hyponatraemia * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Back pain * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Muscular weakness * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Osteoarthritis * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Osteonecrosis * 1       
# participants affected / at risk   1/256 (0.39%)   2/247 (0.81%)   3/503 (0.60%) 
Osteoporosis * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Pain in extremity * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Pathological fracture * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anal cancer * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Female reproductive tract carcinoma in situ * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Haemangioma of liver * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Hodgkin's disease * 1       
# participants affected / at risk   0/256 (0.00%)   2/247 (0.81%)   2/503 (0.40%) 
Lymphoma * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Squamous cell carcinoma * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Uterine leiomyoma * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Nervous system disorders       
Cerebrovascular accident * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Coma * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Dementia * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Hypoaesthesia * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Lacunar infarction * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Post herpetic neuralgia * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Transient ischaemic attack * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Psychiatric disorders       
Confusional state * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Depression * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Generalised anxiety disorder * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Major depression * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Mood disorder due to a general medical condition * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Psychotic disorder * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Renal and urinary disorders       
Renal failure * 1       
# participants affected / at risk   2/256 (0.78%)   0/247 (0.00%)   2/503 (0.40%) 
Renal failure acute * 1       
# participants affected / at risk   1/256 (0.39%)   2/247 (0.81%)   3/503 (0.60%) 
Renal impairment * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Reproductive system and breast disorders       
Cervical dysplasia * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Skin and subcutaneous tissue disorders       
Night sweats * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Rash macular * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Surgical and medical procedures       
Abdominal hernia repair * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Abdominoplasty * 1       
# participants affected / at risk   0/256 (0.00%)   1/247 (0.40%)   1/503 (0.20%) 
Breast cosmetic surgery * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Liposuction * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Vascular disorders       
Hypertension * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
Phlebitis * 1       
# participants affected / at risk   1/256 (0.39%)   0/247 (0.00%)   1/503 (0.20%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 9.1




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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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