The Effects Of Fx-1006A On Transthyretin Stabilization And Clinical Outcome Measures In Patients With V122I Or Wild-Type TTR Amyloid Cardiomyopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00694161
First received: June 6, 2008
Last updated: January 4, 2013
Last verified: January 2013
Results First Received: November 16, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cardiomyopathy
Intervention: Drug: Fx-1006A

  Participant Flow
  Hide Participant Flow

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
Tafamidis Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.

Participant Flow for 2 periods

Period 1:   Part 1 (up to Week 6)
    Tafamidis  
STARTED     35  
COMPLETED     35  
NOT COMPLETED     0  

Period 2:   Part 2 (After Week 6 up to Month 12)
    Tafamidis  
STARTED     35  
COMPLETED     32  
NOT COMPLETED     3  
Adverse Event                 1  
Physician Decision                 1  
Death                 1  



  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
Tafamidis Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.

Baseline Measures
    Tafamidis  
Number of Participants  
[units: participants]
  35  
Age  
[units: Years]
Mean ± Standard Deviation
  76.4  ± 4.7  
Gender  
[units: Participants]
 
Female     3  
Male     32  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Week 6   [ Time Frame: Week 6 ]

2.  Secondary:   Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Month 6 and 12   [ Time Frame: Month 6, Month 12 ]

3.  Other Pre-specified:   Number of Participants With Treatment-Emergent Adverse Events (AEs)   [ Time Frame: Baseline up to 30 days after the last dose ]

4.  Other Pre-specified:   Number of Participants With Greater Than or Equal to (>=) Grade 3 Treatment-Emergent AEs   [ Time Frame: Baseline up to 30 days after the last dose ]

5.  Other Pre-specified:   Number of Participants With Clinically Significant Treatment-Emergent Echocardiography (ECHO) Findings   [ Time Frame: Baseline up to Month 12 ]

6.  Other Pre-specified:   Number of Participants Discontinuing From The Study Due to Clinically Significant Clinical or Laboratory Adverse Events (AEs)   [ Time Frame: Baseline up to Month 12 ]

7.  Other Pre-specified:   Change From Baseline in Echocardiographic (ECHO) Parameters at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

8.  Other Pre-specified:   Change From Baseline in Left Ventricular Mass (LVM) at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

9.  Other Pre-specified:   Change From Baseline in Left Ventricular Ejection Fraction at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

10.  Other Pre-specified:   Change From Baseline in Doppler Data: E/A and E/e' Ratio at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

11.  Other Pre-specified:   Change From Baseline in Doppler Data: Mitral Deceleration Time at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

12.  Other Pre-specified:   Change From Baseline in Tissue Doppler- Septal and Lateral Velocity at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

13.  Other Pre-specified:   Change From Baseline in Pericardial Effusion at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

14.  Other Pre-specified:   Number of Participants With Change From Baseline in Valvular Abnormalities at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

15.  Other Pre-specified:   Change From Baseline in Left Ventricular Anteroseptal, Left Ventricular Inferolateral Wall Thickness and Right Ventricular End Diastolic Free Wall Thickness at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

16.  Other Pre-specified:   Change From Baseline in Left Ventricular Mass, Mass of Left Ventricular Myocardium With Amyloidosis, Mass of Left Ventricular Myocardium With Fibrosis/Scar and Right Ventricular End Diastolic Mass at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

17.  Other Pre-specified:   Change From Baseline in Left Ventricle End Diastolic Volume, Left Ventricle End Systolic Volume, Left Ventricle Stroke Volume, Right Ventricle End Diastolic Volume, Right Ventricle End Systolic Volume, Right Ventricle Stroke Volume at Month 6 and 12.   [ Time Frame: Baseline, Month 6, Month 12 ]

18.  Other Pre-specified:   Change From Baseline in Left Ventricular Ejection Fraction and Right Ventricular Ejection Fraction at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

19.  Other Pre-specified:   Change From Baseline in Left Ventricular Cardiac Output and Right Ventricular Cardiac Output at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

20.  Other Pre-specified:   Change From Baseline in Percentage of Left Ventricular Myocardial Mass With Amyloidosis and Left Ventricular Myocardial Mass With Fibrosis/Scar at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

21.  Other Pre-specified:   Change From Baseline in 4 Chamber Interatrial Septal Thickness at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

22.  Other Pre-specified:   Change From Baseline in 4 Chamber Left Atrial Dimension and 4 Chamber Right Atrial Dimension at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

23.  Other Pre-specified:   Number of Participants With Atrial Fibrillation/Flutter, Atrial Tachycardia, Non-Sustained Ventricular Tachycardia (NSVT) Beats), Sustained Ventricular Tachycardia (SVT), Sinus Pause at Month 6 and 12   [ Time Frame: Baseline, Month 6, Month 12 ]

24.  Other Pre-specified:   24-Hour Average Heart Rate and Maximium/Minimum Heart Rate   [ Time Frame: Baseline, Month 6, Month 12 ]

25.  Other Pre-specified:   Number of Participants With Complete Heart Block   [ Time Frame: Baseline, Month 6, Month 12 ]

26.  Other Pre-specified:   Heart Rate Variability (HRV)- Standard Deviation (SD) Parameters   [ Time Frame: Baseline, Month 6, Month 12 ]

27.  Other Pre-specified:   Heart Rate Variability- Percentage of Successive R-R Intervals With Greater Than 50 Msec Difference Between Normal Beats (pNN50)   [ Time Frame: Baseline, Month 6, Month 12 ]

28.  Other Pre-specified:   Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Week 6, Month 3, 6 and 12   [ Time Frame: Baseline, Week 6, Month 3, Month 6, Month 12 ]

29.  Other Pre-specified:   Cardiothoracic (CT) Ratio   [ Time Frame: Baseline, Month 6, Month 12 ]

30.  Other Pre-specified:   Number of Participants With Increased Interstitial Markings and Pleural Effusions   [ Time Frame: Baseline, Month 6, Month 12 ]

31.  Other Pre-specified:   Number of Participants With Change in Patient Global Assessment (PtGA) at Month 3, 6 and 12   [ Time Frame: Baseline, Month 3, Month 6, Month 12 ]

32.  Other Pre-specified:   Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at Month 3, 6 and 12   [ Time Frame: Baseline, Month 3, Month 6, Month 12 ]

33.  Other Pre-specified:   Change From Baseline in the Short Form 36 (SF-36) at Month 3, 6 and 12   [ Time Frame: Baseline, Month 3, Month 6, Month 12 ]

34.  Other Pre-specified:   Change From Baseline in Troponin I and Troponin T at Week 2, 6, Month 3, 6 and 12   [ Time Frame: Baseline, Week 2, Week 6, Month 3, Month 6, Month 12 ]

35.  Other Pre-specified:   Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide(NT-proBNP) Levels at Week 2, 6, Month 3, 6 and 12   [ Time Frame: Baseline, Week 2, Week 6, Month 3, Month 6, Month 12 ]

36.  Other Pre-specified:   Change From Baseline in 6-Minute Walk Test (6MWT) at Month 3, 6 and 12   [ Time Frame: Baseline, Month 3, Month 6, Month 12 ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description The same event may appear as both an AE and a SAE. 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.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Tafamidis Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.

Other Adverse Events
    Tafamidis  
Total, other (not including serious) adverse events    
# participants affected / at risk     34/35  
Blood and lymphatic system disorders    
Anaemia * 1  
# participants affected / at risk     1/35 (2.86%)  
Cardiac disorders    
Atrial fibrillation * 1  
# participants affected / at risk     4/35 (11.43%)  
Cardiac failure congestive * 1  
# participants affected / at risk     3/35 (8.57%)  
Cardiac failure * 1  
# participants affected / at risk     2/35 (5.71%)  
Atrial tachycardia * 1  
# participants affected / at risk     1/35 (2.86%)  
Bradycardia * 1  
# participants affected / at risk     1/35 (2.86%)  
Bundle branch block right * 1  
# participants affected / at risk     1/35 (2.86%)  
Palpitations * 1  
# participants affected / at risk     1/35 (2.86%)  
Sinus arrhythmia * 1  
# participants affected / at risk     1/35 (2.86%)  
Ventricular tachycardia * 1  
# participants affected / at risk     1/35 (2.86%)  
Bundle branch block * 1  
# participants affected / at risk     1/35 (2.86%)  
Congenital, familial and genetic disorders    
Colour blindness * 1  
# participants affected / at risk     1/35 (2.86%)  
Eye disorders    
Corneal disorder * 1  
# participants affected / at risk     1/35 (2.86%)  
Vitreous floaters * 1  
# participants affected / at risk     1/35 (2.86%)  
Gastrointestinal disorders    
Diarrhoea * 1  
# participants affected / at risk     7/35 (20.00%)  
Constipation * 1  
# participants affected / at risk     5/35 (14.29%)  
Nausea * 1  
# participants affected / at risk     5/35 (14.29%)  
Abdominal pain upper * 1  
# participants affected / at risk     3/35 (8.57%)  
Flatulence * 1  
# participants affected / at risk     3/35 (8.57%)  
Dry mouth * 1  
# participants affected / at risk     2/35 (5.71%)  
Vomiting * 1  
# participants affected / at risk     2/35 (5.71%)  
Abdominal pain * 1  
# participants affected / at risk     1/35 (2.86%)  
Cheilitis * 1  
# participants affected / at risk     1/35 (2.86%)  
Faecal incontinence * 1  
# participants affected / at risk     1/35 (2.86%)  
Inguinal hernia * 1  
# participants affected / at risk     1/35 (2.86%)  
General disorders    
Fatigue * 1  
# participants affected / at risk     8/35 (22.86%)  
Oedema peripheral * 1  
# participants affected / at risk     6/35 (17.14%)  
Asthenia * 1  
# participants affected / at risk     3/35 (8.57%)  
Oedema * 1  
# participants affected / at risk     3/35 (8.57%)  
Thirst * 1  
# participants affected / at risk     3/35 (8.57%)  
Catheter related complication * 1  
# participants affected / at risk     1/35 (2.86%)  
Chest discomfort * 1  
# participants affected / at risk     1/35 (2.86%)  
Chest pain * 1  
# participants affected / at risk     1/35 (2.86%)  
Hernia * 1  
# participants affected / at risk     1/35 (2.86%)  
Hot flush * 1  
# participants affected / at risk     1/35 (2.86%)  
Localised oedema * 1  
# participants affected / at risk     1/35 (2.86%)  
Pain * 1  
# participants affected / at risk     1/35 (2.86%)  
Pyrexia * 1  
# participants affected / at risk     1/35 (2.86%)  
Hepatobiliary disorders    
Hepatomegaly * 1  
# participants affected / at risk     4/35 (11.43%)  
Immune system disorders    
Seasonal allergy * 1  
# participants affected / at risk     3/35 (8.57%)  
Infections and infestations    
Upper respiratory tract infection * 1  
# participants affected / at risk     6/35 (17.14%)  
Urinary tract infection * 1  
# participants affected / at risk     3/35 (8.57%)  
Influenza * 1  
# participants affected / at risk     2/35 (5.71%)  
Nasopharyngitis * 1  
# participants affected / at risk     2/35 (5.71%)  
Bronchitis * 1  
# participants affected / at risk     1/35 (2.86%)  
Cellulitis * 1  
# participants affected / at risk     1/35 (2.86%)  
Furuncle * 1  
# participants affected / at risk     1/35 (2.86%)  
Infection * 1  
# participants affected / at risk     1/35 (2.86%)  
Lower respiratory tract infection * 1  
# participants affected / at risk     1/35 (2.86%)  
Nail infection * 1  
# participants affected / at risk     1/35 (2.86%)  
Injury, poisoning and procedural complications    
Contusion * 1  
# participants affected / at risk     2/35 (5.71%)  
Excoriation * 1  
# participants affected / at risk     2/35 (5.71%)  
Fall * 1  
# participants affected / at risk     2/35 (5.71%)  
Joint injury * 1  
# participants affected / at risk     2/35 (5.71%)  
Skin laceration * 1  
# participants affected / at risk     2/35 (5.71%)  
Joint sprain * 1  
# participants affected / at risk     1/35 (2.86%)  
Laceration * 1  
# participants affected / at risk     1/35 (2.86%)  
Post procedural haematuria * 1  
# participants affected / at risk     1/35 (2.86%)  
Tooth injury * 1  
# participants affected / at risk     1/35 (2.86%)  
Investigations    
Weight decreased * 1  
# participants affected / at risk     6/35 (17.14%)  
Work increased * 1  
# participants affected / at risk     5/35 (14.29%)  
Alanine aminotransferase increased * 1  
# participants affected / at risk     2/35 (5.71%)  
Aspartate aminotransferase increased * 1  
# participants affected / at risk     2/35 (5.71%)  
Blood cholesterol increased * 1  
# participants affected / at risk     2/35 (5.71%)  
Blood thyroid stimulating hormone increased * 1  
# participants affected / at risk     2/35 (5.71%)  
Aspiration pleural cavity * 1  
# participants affected / at risk     1/35 (2.86%)  
Blood creatinine increased * 1  
# participants affected / at risk     1/35 (2.86%)  
Blood pressure decreased * 1  
# participants affected / at risk     1/35 (2.86%)  
Blood thyroid stimulating hormone decreased * 1  
# participants affected / at risk     1/35 (2.86%)  
Blood urine present * 1  
# participants affected / at risk     1/35 (2.86%)  
Blood natriuretic peptide increased * 1  
# participants affected / at risk     1/35 (2.86%)  
Ejection fraction decreased * 1  
# participants affected / at risk     1/35 (2.86%)  
Gamma-glutamyltransferase increased * 1  
# participants affected / at risk     1/35 (2.86%)  
Heart rate increased * 1  
# participants affected / at risk     1/35 (2.86%)  
International normalised ratio increased * 1  
# participants affected / at risk     1/35 (2.86%)  
Urine output increased * 1  
# participants affected / at risk     1/35 (2.86%)  
Venous pressure jugular increased * 1  
# participants affected / at risk     1/35 (2.86%)  
Metabolism and nutrition disorders    
Anorexia * 1  
# participants affected / at risk     2/35 (5.71%)  
Decreased appetite * 1  
# participants affected / at risk     2/35 (5.71%)  
Fluid overload * 1  
# participants affected / at risk     2/35 (5.71%)  
Gout * 1  
# participants affected / at risk     2/35 (5.71%)  
Fluid retention * 1  
# participants affected / at risk     1/35 (2.86%)  
Hyperkalaemia * 1  
# participants affected / at risk     1/35 (2.86%)  
Hypochloraemia * 1  
# participants affected / at risk     1/35 (2.86%)  
Hyponatraemia * 1  
# participants affected / at risk     1/35 (2.86%)  
Musculoskeletal and connective tissue disorders    
Back pain * 1  
# participants affected / at risk     3/35 (8.57%)  
Pain in extremity * 1  
# participants affected / at risk     3/35 (8.57%)  
Muscle spasms * 1  
# participants affected / at risk     2/35 (5.71%)  
Arthralgia * 1  
# participants affected / at risk     1/35 (2.86%)  
Finger deformity * 1  
# participants affected / at risk     1/35 (2.86%)  
Joint swelling * 1  
# participants affected / at risk     1/35 (2.86%)  
Muscle twitching * 1  
# participants affected / at risk     1/35 (2.86%)  
Musculoskeletal discomfort * 1  
# participants affected / at risk     1/35 (2.86%)  
Musculoskeletal pain * 1  
# participants affected / at risk     1/35 (2.86%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Basal cell carcinoma * 1  
# participants affected / at risk     1/35 (2.86%)  
Benign neoplasm * 1  
# participants affected / at risk     1/35 (2.86%)  
Lentigo * 1  
# participants affected / at risk     1/35 (2.86%)  
Prostate cancer * 1  
# participants affected / at risk     1/35 (2.86%)  
Nervous system disorders    
Dizziness * 1  
# participants affected / at risk     7/35 (20.00%)  
Dizziness postural * 1  
# participants affected / at risk     6/35 (17.14%)  
Balance disorder * 1  
# participants affected / at risk     5/35 (14.29%)  
Aguesia * 1  
# participants affected / at risk     3/35 (8.57%)  
Tremor * 1  
# participants affected / at risk     2/35 (5.71%)  
Amnesia * 1  
# participants affected / at risk     1/35 (2.86%)  
Disturbance in attention * 1  
# participants affected / at risk     1/35 (2.86%)  
Headache * 1  
# participants affected / at risk     1/35 (2.86%)  
Loss of consciousness * 1  
# participants affected / at risk     1/35 (2.86%)  
Memory impairment * 1  
# participants affected / at risk     1/35 (2.86%)  
Migraine * 1  
# participants affected / at risk     1/35 (2.86%)  
Neuralgia * 1  
# participants affected / at risk     1/35 (2.86%)  
Neuropathy * 1  
# participants affected / at risk     1/35 (2.86%)  
Neuropathy peripheral * 1  
# participants affected / at risk     1/35 (2.86%)  
Restless legs syndrome * 1  
# participants affected / at risk     1/35 (2.86%)  
Somnolence * 1  
# participants affected / at risk     1/35 (2.86%)  
Syncope * 1  
# participants affected / at risk     1/35 (2.86%)  
Psychiatric disorders    
Insomnia * 1  
# participants affected / at risk     3/35 (8.57%)  
Confusional state * 1  
# participants affected / at risk     2/35 (5.71%)  
Depression * 1  
# participants affected / at risk     2/35 (5.71%)  
Anxiety * 1  
# participants affected / at risk     1/35 (2.86%)  
Nervousness * 1  
# participants affected / at risk     1/35 (2.86%)  
Panic attack * 1  
# participants affected / at risk     1/35 (2.86%)  
Renal and urinary disorders    
Haematuria * 1  
# participants affected / at risk     2/35 (5.71%)  
Dysuria * 1  
# participants affected / at risk     1/35 (2.86%)  
Pollakiuria * 1  
# participants affected / at risk     1/35 (2.86%)  
Urinary incontinence * 1  
# participants affected / at risk     1/35 (2.86%)  
Reproductive system and breast disorders    
Nipple pain * 1  
# participants affected / at risk     2/35 (5.71%)  
Gynaecomastia * 1  
# participants affected / at risk     1/35 (2.86%)  
Scrotal oedema * 1  
# participants affected / at risk     1/35 (2.86%)  
Respiratory, thoracic and mediastinal disorders    
Dyspnoea * 1  
# participants affected / at risk     11/35 (31.43%)  
Dyspnoea exertional * 1  
# participants affected / at risk     6/35 (17.14%)  
Epistaxis * 1  
# participants affected / at risk     3/35 (8.57%)  
Rhinorrhoea * 1  
# participants affected / at risk     3/35 (8.57%)  
Cough * 1  
# participants affected / at risk     2/35 (5.71%)  
Pleural effusion * 1  
# participants affected / at risk     2/35 (5.71%)  
Sinus congestion * 1  
# participants affected / at risk     2/35 (5.71%)  
Dysphonia * 1  
# participants affected / at risk     1/35 (2.86%)  
Postnasal drip * 1  
# participants affected / at risk     1/35 (2.86%)  
Productive cough * 1  
# participants affected / at risk     1/35 (2.86%)  
Pulmonary congestion * 1  
# participants affected / at risk     1/35 (2.86%)  
Rales * 1  
# participants affected / at risk     1/35 (2.86%)  
Skin and subcutaneous tissue disorders    
Pruritus * 1  
# participants affected / at risk     3/35 (8.57%)  
Rash * 1  
# participants affected / at risk     3/35 (8.57%)  
Skin ulcer * 1  
# participants affected / at risk     3/35 (8.57%)  
Blister * 1  
# participants affected / at risk     1/35 (2.86%)  
Ingrowing nail * 1  
# participants affected / at risk     1/35 (2.86%)  
Rash maculo-papular * 1  
# participants affected / at risk     1/35 (2.86%)  
Skin discolouration * 1  
# participants affected / at risk     1/35 (2.86%)  
Skin exfoliation * 1  
# participants affected / at risk     1/35 (2.86%)  
Skin lesion * 1  
# participants affected / at risk     1/35 (2.86%)  
Surgical and medical procedures    
Foot operation * 1  
# participants affected / at risk     1/35 (2.86%)  
Implantable defibrillator insertion * 1  
# participants affected / at risk     1/35 (2.86%)  
Mole excision * 1  
# participants affected / at risk     1/35 (2.86%)  
Tooth extraction * 1  
# participants affected / at risk     1/35 (2.86%)  
Vascular disorders    
Hypotension * 1  
# participants affected / at risk     1/35 (2.86%)  
Varicose vein * 1  
# participants affected / at risk     1/35 (2.86%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA v 10.0



  Limitations and Caveats
  Hide Limitations and Caveats

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
Results for Holter monitoring parameters, increased interstitial markings, pleural effusions, PtGA and cardiothoracic ratio are presented as absolute values at specified time points and not as change from baseline as planned.


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