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The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159861
First received: September 8, 2005
Last updated: December 20, 2013
Last verified: December 2013
Results First Received: April 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Pulmonary Hypertension
Intervention: Drug: Sildenafil citrate

  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
Subjects were entered into the open-label extension study portion upon completion of the preceding 16-week, placebo controlled core study portion or, for subjects who required a change in epoprostenol dose due to clinical deterioration, after at least 4 weeks in the core study portion.

Reporting Groups
  Description
Placebo: Core Study / Sildenafil: Extension Study Core Study: Placebo (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration); Extension Study: Sildenafil (until last enrolled subject completed 3 years of treatment) - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
Sildenafil: Core Study / Sildenafil: Extension Study Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator

Participant Flow for 2 periods

Period 1:   Core Study - 16 Weeks
    Placebo: Core Study / Sildenafil: Extension Study   Sildenafil: Core Study / Sildenafil: Extension Study
STARTED   133   134 
Treated   131   134 
COMPLETED   108 [1]   122 [2] 
NOT COMPLETED   25   12 
Death                3                0 
Adverse Event                12                6 
Lack of Efficacy                2                3 
Reason Unspecified                5                3 
Subject Defaulted                1                0 
Randomized but not Treated                2                0 
[1] Entered A1481153: 115; Did not enter A1481153: 16
[2] Entered A1481153: 127; Did not enter A1481153: 7

Period 2:   Extension Study - up to 3 Years
    Placebo: Core Study / Sildenafil: Extension Study   Sildenafil: Core Study / Sildenafil: Extension Study
STARTED   115 [1]   127 [1] 
Treated   115   127 
COMPLETED   53   56 
NOT COMPLETED   62   71 
Death                24                28 
Adverse Event                14                14 
Lack of Efficacy                5                1 
Reason Unspecified                12                19 
Withdrawal by Subject                7                9 
[1] Subjects may have entered extension study after 4 weeks in core study (prior to completion).



  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
Placebo/Sildenafil Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
Sildenafil/Sildenafil Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
Total Total of all reporting groups

Baseline Measures
   Placebo/Sildenafil   Sildenafil/Sildenafil   Total 
Overall Participants Analyzed 
[Units: Participants]
 131   134   265 
Age, Customized 
[Units: Participants]
     
18 to 44 years   47   54   101 
45 to 64 years   73   64   137 
>= 65 years   11   16   27 
Gender 
[Units: Participants]
     
Female   102   110   212 
Male   29   24   53 


  Outcome Measures
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1.  Primary:   Categorized Change From Baseline in 6-Minute Walking Distance   [ Time Frame: 1 Year, 2 Year, 3 Year ]

2.  Secondary:   Survival Status   [ Time Frame: 1, 2, 3, 4, and 5 years ]

3.  Secondary:   Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class   [ Time Frame: 1 Year, 2 Year, 3 Year ]

4.  Secondary:   Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)   [ Time Frame: Baseline, Month 15, Month 27, Month 39 ]

5.  Secondary:   Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score   [ Time Frame: Baseline, Month 15, Month 27, Month 39 ]

6.  Secondary:   Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score   [ Time Frame: Baseline, Month 15, Month 27, Month 39 ]

7.  Secondary:   Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score   [ Time Frame: Baseline, Month 15, Month 27, Month 39 ]

8.  Secondary:   Change From Baseline in BORG Dyspnea Score   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]

9.  Other Pre-specified:   Change in Epoprostenol Dose From Baseline Maintained for 6 Months   [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, and at 3-month intervals through Month 69 ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Reporting Groups
  Description
Placebo/Sildenafil Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
Sildenafil/Sildenafil Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
Placebo/Discontinued Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Discontinued

Serious Adverse Events
    Placebo/Sildenafil   Sildenafil/Sildenafil   Placebo/Discontinued
Total, serious adverse events       
# participants affected / at risk   93/115 (80.87%)   104/134 (77.61%)   7/16 (43.75%) 
Blood and lymphatic system disorders       
Anaemia † 1       
# participants affected / at risk   9/115 (7.83%)   2/134 (1.49%)   0/16 (0.00%) 
Febrile neutropenia † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Neutropenia † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Pancytopenia † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Splenomegaly † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Thrombocytopenia † 1       
# participants affected / at risk   4/115 (3.48%)   3/134 (2.24%)   0/16 (0.00%) 
Thrombotic thrombocytopenic purpura † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Cardiac disorders       
Aortic valve incompetence † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Arrhythmia † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Atrial fibrillation † 1       
# participants affected / at risk   3/115 (2.61%)   5/134 (3.73%)   0/16 (0.00%) 
Atrial flutter † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Atrial tachycardia † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Cardiac arrest † 1       
# participants affected / at risk   3/115 (2.61%)   8/134 (5.97%)   0/16 (0.00%) 
Cardiac failure † 1       
# participants affected / at risk   6/115 (5.22%)   5/134 (3.73%)   0/16 (0.00%) 
Cardiac failure chronic † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Cardiac valve vegetation † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Cardio-respiratory arrest † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Cardiogenic shock † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Coronary artery disease † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Coronary artery stenosis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Electromechanical dissociation † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Myocardial infarction † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Palpitations † 1       
# participants affected / at risk   2/115 (1.74%)   2/134 (1.49%)   0/16 (0.00%) 
Pericardial effusion † 1       
# participants affected / at risk   2/115 (1.74%)   0/134 (0.00%)   0/16 (0.00%) 
Pericarditis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Right ventricular failure † 1       
# participants affected / at risk   16/115 (13.91%)   13/134 (9.70%)   2/16 (12.50%) 
Sinus arrest † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Supraventricular tachycardia † 1       
# participants affected / at risk   5/115 (4.35%)   2/134 (1.49%)   0/16 (0.00%) 
Tachycardia † 1       
# participants affected / at risk   0/115 (0.00%)   2/134 (1.49%)   1/16 (6.25%) 
Endocrine disorders       
Adrenal insufficiency † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Goitre † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Hyperthyroidism † 1       
# participants affected / at risk   3/115 (2.61%)   0/134 (0.00%)   0/16 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Abdominal distension † 1       
# participants affected / at risk   0/115 (0.00%)   4/134 (2.99%)   0/16 (0.00%) 
Abdominal hernia † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Abdominal pain † 1       
# participants affected / at risk   4/115 (3.48%)   7/134 (5.22%)   0/16 (0.00%) 
Abdominal pain upper † 1       
# participants affected / at risk   3/115 (2.61%)   2/134 (1.49%)   0/16 (0.00%) 
Ascites † 1       
# participants affected / at risk   5/115 (4.35%)   4/134 (2.99%)   0/16 (0.00%) 
Colitis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Colonic obstruction † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Colonic polyp † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Constipation † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Diarrhoea † 1       
# participants affected / at risk   1/115 (0.87%)   3/134 (2.24%)   0/16 (0.00%) 
Diarrhoea haemorrhagic † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Femoral hernia, obstructive † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Gastric polyps † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Gastric ulcer † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Gastritis † 1       
# participants affected / at risk   2/115 (1.74%)   1/134 (0.75%)   0/16 (0.00%) 
Gastritis erosive † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Gastrointestinal haemorrhage † 1       
# participants affected / at risk   5/115 (4.35%)   3/134 (2.24%)   0/16 (0.00%) 
Haemorrhagic ascites † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Hiatus hernia † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Ileus † 1       
# participants affected / at risk   0/115 (0.00%)   2/134 (1.49%)   0/16 (0.00%) 
Impaired gastric emptying † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Inflammatory bowel disease † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Inguinal hernia † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Intestinal perforation † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Intestinal polyp † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Intra-abdominal haemorrhage † 1       
# participants affected / at risk   0/115 (0.00%)   0/134 (0.00%)   1/16 (6.25%) 
Lower gastrointestinal haemorrhage † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Nausea † 1       
# participants affected / at risk   2/115 (1.74%)   6/134 (4.48%)   0/16 (0.00%) 
Pancreatitis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Pancreatitis acute † 1       
# participants affected / at risk   1/115 (0.87%)   3/134 (2.24%)   0/16 (0.00%) 
Peritoneal haemorrhage † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Proctocolitis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Rectal haemorrhage † 1       
# participants affected / at risk   3/115 (2.61%)   2/134 (1.49%)   0/16 (0.00%) 
Retroperitoneal haemorrhage † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Small intestinal obstruction † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Umbilical hernia † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Upper gastrointestinal haemorrhage † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Vomiting † 1       
# participants affected / at risk   2/115 (1.74%)   6/134 (4.48%)   0/16 (0.00%) 
General disorders       
Asthenia † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Catheter related complication † 1       
# participants affected / at risk   14/115 (12.17%)   3/134 (2.24%)   0/16 (0.00%) 
Catheter site erythema † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Catheter site haemorrhage † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Catheter site inflammation † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Catheter site pain † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Chest pain † 1       
# participants affected / at risk   9/115 (7.83%)   3/134 (2.24%)   0/16 (0.00%) 
Drug interaction † 1       
# participants affected / at risk   1/115 (0.87%)   2/134 (1.49%)   0/16 (0.00%) 
Drug withdrawal syndrome † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Fatigue † 1       
# participants affected / at risk   2/115 (1.74%)   0/134 (0.00%)   0/16 (0.00%) 
General physical health deterioration † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Influenza like illness † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   1/16 (6.25%) 
Malaise † 1       
# participants affected / at risk   2/115 (1.74%)   0/134 (0.00%)   0/16 (0.00%) 
Oedema † 1       
# participants affected / at risk   2/115 (1.74%)   0/134 (0.00%)   0/16 (0.00%) 
Oedema peripheral † 1       
# participants affected / at risk   2/115 (1.74%)   3/134 (2.24%)   0/16 (0.00%) 
Pyrexia † 1       
# participants affected / at risk   2/115 (1.74%)   4/134 (2.99%)   0/16 (0.00%) 
Hepatobiliary disorders       
Biliary colic † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Cholecystitis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Cholecystitis acute † 1       
# participants affected / at risk   2/115 (1.74%)   1/134 (0.75%)   0/16 (0.00%) 
Cholelithiasis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Cytolytic hepatitis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Hepatitis acute † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Hepatomegaly † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Immune system disorders       
Anaphylactic shock † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Drug hypersensitivity † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Infections and infestations       
Abscess † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Arthritis bacterial † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Bacteraemia † 1       
# participants affected / at risk   4/115 (3.48%)   5/134 (3.73%)   0/16 (0.00%) 
Bacterial infection † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Bacterial sepsis † 1       
# participants affected / at risk   0/115 (0.00%)   0/134 (0.00%)   1/16 (6.25%) 
Breast cellulitis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Bronchitis † 1       
# participants affected / at risk   5/115 (4.35%)   2/134 (1.49%)   0/16 (0.00%) 
Catheter bacteraemia † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Catheter related infection † 1       
# participants affected / at risk   15/115 (13.04%)   17/134 (12.69%)   0/16 (0.00%) 
Catheter sepsis † 1       
# participants affected / at risk   4/115 (3.48%)   5/134 (3.73%)   0/16 (0.00%) 
Catheter site cellulitis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Catheter site infection † 1       
# participants affected / at risk   6/115 (5.22%)   6/134 (4.48%)   0/16 (0.00%) 
Cellulitis † 1       
# participants affected / at risk   1/115 (0.87%)   4/134 (2.99%)   0/16 (0.00%) 
Cellulitis staphylococcal † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Central line infection † 1       
# participants affected / at risk   8/115 (6.96%)   13/134 (9.70%)   0/16 (0.00%) 
Clostridial infection † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Device related infection † 1       
# participants affected / at risk   4/115 (3.48%)   1/134 (0.75%)   0/16 (0.00%) 
Endocarditis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Endocarditis bacterial † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Endocarditis staphylococcal † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Gastroenteritis † 1       
# participants affected / at risk   1/115 (0.87%)   2/134 (1.49%)   0/16 (0.00%) 
Gastroenteritis viral † 1       
# participants affected / at risk   0/115 (0.00%)   2/134 (1.49%)   0/16 (0.00%) 
Implant site infection † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Infusion site infection † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Listeriosis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Lobar pneumonia † 1       
# participants affected / at risk   1/115 (0.87%)   2/134 (1.49%)   0/16 (0.00%) 
Lower respiratory tract infection † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Lung infection † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Oropharyngeal candidiasis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Pneumonia † 1       
# participants affected / at risk   11/115 (9.57%)   12/134 (8.96%)   0/16 (0.00%) 
Sepsis † 1       
# participants affected / at risk   9/115 (7.83%)   6/134 (4.48%)   0/16 (0.00%) 
Septic shock † 1       
# participants affected / at risk   0/115 (0.00%)   2/134 (1.49%)   0/16 (0.00%) 
Serratia infection † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Skin infection † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Staphylococcal bacteraemia † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Staphylococcal infection † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Staphylococcal sepsis † 1       
# participants affected / at risk   1/115 (0.87%)   2/134 (1.49%)   1/16 (6.25%) 
Upper respiratory tract infection † 1       
# participants affected / at risk   0/115 (0.00%)   2/134 (1.49%)   0/16 (0.00%) 
Urinary tract infection † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Viral infection † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Injury, poisoning and procedural complications       
Accidental overdose † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Arthropod sting † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Complications of transplant surgery † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Contusion † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Device breakage † 1       
# participants affected / at risk   3/115 (2.61%)   0/134 (0.00%)   0/16 (0.00%) 
Device failure † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Device malfunction † 1       
# participants affected / at risk   0/115 (0.00%)   3/134 (2.24%)   0/16 (0.00%) 
Device migration † 1       
# participants affected / at risk   5/115 (4.35%)   0/134 (0.00%)   0/16 (0.00%) 
Drug toxicity † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Fall † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Head injury † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Hip fracture † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Humerus fracture † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Iatrogenic injury † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Lumbar vertebral fracture † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Overdose † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Post procedural complication † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Post procedural haemorrhage † 1       
# participants affected / at risk   0/115 (0.00%)   2/134 (1.49%)   0/16 (0.00%) 
Road traffic accident † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Seroma † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Subdural haematoma † 1       
# participants affected / at risk   2/115 (1.74%)   0/134 (0.00%)   0/16 (0.00%) 
Therapeutic agent toxicity † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Vascular pseudoaneurysm † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Investigations       
Bleeding time prolonged † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Blood creatinine increased † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Blood uric acid increased † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Body temperature increased † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Electrocardiogram change † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Haemoglobin decreased † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
International normalised ratio increased † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Pulmonary arterial pressure increased † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Weight decreased † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Metabolism and nutrition disorders       
Dehydration † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Diabetes mellitus † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Diabetic ketoacidosis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Electrolyte imbalance † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Fluid overload † 1       
# participants affected / at risk   2/115 (1.74%)   1/134 (0.75%)   0/16 (0.00%) 
Fluid retention † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Hypervolaemia † 1       
# participants affected / at risk   0/115 (0.00%)   2/134 (1.49%)   0/16 (0.00%) 
Hypoglycaemia † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Hypokalaemia † 1       
# participants affected / at risk   2/115 (1.74%)   0/134 (0.00%)   0/16 (0.00%) 
Hyponatraemia † 1       
# participants affected / at risk   2/115 (1.74%)   0/134 (0.00%)   0/16 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Arthritis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Back pain † 1       
# participants affected / at risk   2/115 (1.74%)   1/134 (0.75%)   0/16 (0.00%) 
Costochondritis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Musculoskeletal chest pain † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Neck pain † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Pain in extremity † 1       
# participants affected / at risk   1/115 (0.87%)   2/134 (1.49%)   0/16 (0.00%) 
Systemic lupus erythematosus † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder neoplasm † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Breast cancer † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Gastrointestinal tract adenoma † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Lung adenocarcinoma † 1       
# participants affected / at risk   0/115 (0.00%)   0/134 (0.00%)   1/16 (6.25%) 
Nervous system disorders       
Aphasia † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Brain stem infarction † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Cerebral haemorrhage † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Cerebrovascular accident † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Convulsion † 1       
# participants affected / at risk   0/115 (0.00%)   2/134 (1.49%)   0/16 (0.00%) 
Diplegia † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Dizziness † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Embolic stroke † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Encephalopathy † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Facial palsy † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Hemiplegia † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Ischaemic stroke † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Lethargy † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Loss of consciousness † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Paraesthesia † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Presyncope † 1       
# participants affected / at risk   3/115 (2.61%)   0/134 (0.00%)   0/16 (0.00%) 
Sciatica † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Syncope † 1       
# participants affected / at risk   8/115 (6.96%)   4/134 (2.99%)   0/16 (0.00%) 
Transient ischaemic attack † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Transverse sinus thrombosis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Oligohydramnios † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Pregnancy † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Premature baby † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Psychiatric disorders       
Anxiety † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Confusional state † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Psychotic disorder † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Suicide attempt † 1       
# participants affected / at risk   0/115 (0.00%)   2/134 (1.49%)   0/16 (0.00%) 
Renal and urinary disorders       
Hypertonic bladder † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Renal failure † 1       
# participants affected / at risk   2/115 (1.74%)   2/134 (1.49%)   0/16 (0.00%) 
Renal failure acute † 1       
# participants affected / at risk   3/115 (2.61%)   0/134 (0.00%)   0/16 (0.00%) 
Reproductive system and breast disorders       
Endometriosis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Uterine enlargement † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Alveolitis allergic † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Chronic obstructive pulmonary disease † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Cough † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Dyspnoea † 1       
# participants affected / at risk   11/115 (9.57%)   14/134 (10.45%)   1/16 (6.25%) 
Dyspnoea exertional † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Epistaxis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Haemoptysis † 1       
# participants affected / at risk   3/115 (2.61%)   7/134 (5.22%)   1/16 (6.25%) 
Hypoventilation † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Hypoxia † 1       
# participants affected / at risk   0/115 (0.00%)   4/134 (2.99%)   1/16 (6.25%) 
Interstitial lung disease † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Lung disorder † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Pulmonary alveolar haemorrhage † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Pulmonary arterial hypertension † 1       
# participants affected / at risk   1/115 (0.87%)   3/134 (2.24%)   0/16 (0.00%) 
Pulmonary hypertension † 1       
# participants affected / at risk   15/115 (13.04%)   22/134 (16.42%)   2/16 (12.50%) 
Pulmonary oedema † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Respiratory arrest † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Respiratory distress † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Respiratory failure † 1       
# participants affected / at risk   0/115 (0.00%)   4/134 (2.99%)   0/16 (0.00%) 
Throat tightness † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Skin and subcutaneous tissue disorders       
Hyperhidrosis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Rash erythematous † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Rash maculo-papular † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Skin reaction † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Surgical and medical procedures       
Cardiac ablation † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Catheter placement † 1       
# participants affected / at risk   1/115 (0.87%)   1/134 (0.75%)   0/16 (0.00%) 
Drug therapy changed † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Haematoma evacuation † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Indwelling catheter management † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Vascular disorders       
Deep vein thrombosis † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Flushing † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Haemorrhage † 1       
# participants affected / at risk   1/115 (0.87%)   2/134 (1.49%)   0/16 (0.00%) 
Hypotension † 1       
# participants affected / at risk   5/115 (4.35%)   4/134 (2.99%)   0/16 (0.00%) 
Orthostatic hypotension † 1       
# participants affected / at risk   0/115 (0.00%)   1/134 (0.75%)   0/16 (0.00%) 
Shock † 1       
# participants affected / at risk   3/115 (2.61%)   0/134 (0.00%)   0/16 (0.00%) 
Thrombosis † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Vasodilatation † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Venous thrombosis limb † 1       
# participants affected / at risk   1/115 (0.87%)   0/134 (0.00%)   0/16 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.0




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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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