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Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea

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ClinicalTrials.gov Identifier: NCT01073631
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : September 13, 2010
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Serious Fungal Infections
Intervention Drug: voriconazole tablet
Enrollment 543
Recruitment Details  
Pre-assignment Details There were 543 participants enrolled in this study. Of these, 230 participants were treated with the Vfend tablet formulation only, and 313 participants were treated with Vfend tablet and Vfend intravenous (IV) formulations sequentially or vice versa. These 313 participants are also included in Study A1501067 (NCT01073618).
Arm/Group Title Vfend
Hide Arm/Group Description Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Period Title: Overall Study
Started 543
Completed 374
Not Completed 169
Reason Not Completed
Death             82
Adverse Event             24
Other             63
Arm/Group Title Vfend
Hide Arm/Group Description Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Overall Number of Baseline Participants 543
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 543 participants
<18 years 74
Between 18 and 44 years 157
Between 45 and 64 years 207
>=65 years 105
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 543 participants
Female
211
  38.9%
Male
332
  61.1%
1.Primary Outcome
Title Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable
Hide Description Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).
Time Frame Baseline (Day 1) up to 2.1 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population: participants received at least 1 dose of study drug for approved indication (= Intent to treat [ITT] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related paramenters at least once.
Arm/Group Title Vfend
Hide Arm/Group Description:
Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 543
Measure Type: Number
Unit of Measure: Percentage of participants
Cure 36.83
Improvement 26.52
Failure 16.94
Unevaluable 19.71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vfend
Comments Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Normal approximation to binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Efficacy rate (percent)
Estimated Value 78.90
Confidence Interval (2-Sided) 95%
75.07 to 82.73
Estimation Comments Confidence Interval (CI) by normal approximation to binomial.
2.Secondary Outcome
Title Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable
Hide Description In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed.
Time Frame Baseline (Day 1) up to 2.1 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of participants evaluated for mycological response.
Arm/Group Title Vfend
Hide Arm/Group Description:
Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: Percentage of participants
Eradication 71.59
Persistence 23.86
Superinfection 2.27
Not evaluable 2.27
Time Frame Treatment emergent adverse events are reported from the time of the first dose of study treatment up to 28 days after last dose of study treatment.
Adverse Event Reporting 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.
 
Arm/Group Title Vfend
Hide Arm/Group Description Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
All-Cause Mortality
Vfend
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vfend
Affected / at Risk (%)
Total   119/543 (21.92%) 
Blood and lymphatic system disorders   
Disseminated intravascular coagulation  1  3/543 (0.55%) 
Febrile neutropenia  1  1/543 (0.18%) 
Thrombocytopenia  1  3/543 (0.55%) 
Thrombotic microangiopathy  1  1/543 (0.18%) 
Cardiac disorders   
Arrhythmia  1  1/543 (0.18%) 
Cardiac arrest  1  1/543 (0.18%) 
Cardiac failure  1  1/543 (0.18%) 
Cardiopulmonary failure  1  1/543 (0.18%) 
Left ventricular dysfunction  1  1/543 (0.18%) 
Supraventricular tachycardia  1  1/543 (0.18%) 
Congenital, familial and genetic disorders   
Tracheo-oesophageal fistula  1  1/543 (0.18%) 
Endocrine disorders   
Euthyroid sick syndrome  1  1/543 (0.18%) 
Gastrointestinal disorders   
Colitis  1  1/543 (0.18%) 
Gastric perforation  1  1/543 (0.18%) 
Gastric ulcer  1  1/543 (0.18%) 
Gastrointestinal haemorrhage  1  1/543 (0.18%) 
Neutropenic colitis  1  1/543 (0.18%) 
Abdominal pain upper  1  1/543 (0.18%) 
Erosive oesophagitis  1  1/543 (0.18%) 
General disorders   
Death  1  1/543 (0.18%) 
Disease progression  1  3/543 (0.55%) 
Multi-organ failure  1  6/543 (1.10%) 
Oedema peripheral  1  2/543 (0.37%) 
Pyrexia  1  5/543 (0.92%) 
Hepatobiliary disorders   
Cholecystitis  1  1/543 (0.18%) 
Cholecystitis acute  1  1/543 (0.18%) 
Hepatitis  1  1/543 (0.18%) 
Jaundice  1  1/543 (0.18%) 
Hepatic failure  1  1/543 (0.18%) 
Hepatic function abnormal  1  1/543 (0.18%) 
Hepatitis acute  1  1/543 (0.18%) 
Hepatotoxicity  1  1/543 (0.18%) 
Immune system disorders   
Acute graft versus host disease in intestine  1  2/543 (0.37%) 
Acute graft versus host disease in skin  1  2/543 (0.37%) 
Infections and infestations   
Anal abscess  1  1/543 (0.18%) 
Aspergillosis  1  4/543 (0.74%) 
Bronchitis  1  1/543 (0.18%) 
Cytomegalovirus infection  1  2/543 (0.37%) 
Enterococcal infection  1  1/543 (0.18%) 
Fungal infection  1  1/543 (0.18%) 
Infection  1  1/543 (0.18%) 
Liver abscess  1  1/543 (0.18%) 
Pneumonia  1  21/543 (3.87%) 
Pneumonia staphylococcal  1  1/543 (0.18%) 
Pseudomembranous colitis  1  1/543 (0.18%) 
Sepsis  1  15/543 (2.76%) 
Septic shock  1  18/543 (3.31%) 
Cellulitis  1  1/543 (0.18%) 
Central nervous system infection  1  1/543 (0.18%) 
Citrobacter sepsis  1  1/543 (0.18%) 
Cytomegalovirus chorioretinitis  1  1/543 (0.18%) 
Device related infection  1  1/543 (0.18%) 
Pneumonia fungal  1  1/543 (0.18%) 
Injury, poisoning and procedural complications   
Chemical peritonitis  1  1/543 (0.18%) 
Investigations   
Cytomegalovirus test positive  1  1/543 (0.18%) 
Oxygen saturation decreased  1  1/543 (0.18%) 
Acoustic stimulation tests  1  1/543 (0.18%) 
Metabolism and nutrition disorders   
Hyperkalaemia  1  1/543 (0.18%) 
Metabolic acidosis  1  1/543 (0.18%) 
Dehydration  1  1/543 (0.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute myeloid leukaemia  1  3/543 (0.55%) 
Diffuse large B-cell lymphoma  1  1/543 (0.18%) 
Leukaemia  1  12/543 (2.21%) 
Lymphoma  1  1/543 (0.18%) 
Nervous system disorders   
Cerebellar infarction  1  1/543 (0.18%) 
Cerebral haemorrhage  1  2/543 (0.37%) 
Convulsion  1  2/543 (0.37%) 
Grand mal convulsion  1  1/543 (0.18%) 
Intracranial pressure increased  1  1/543 (0.18%) 
Mental impairment  1  1/543 (0.18%) 
Psychiatric disorders   
Completed suicide  1  1/543 (0.18%) 
Renal and urinary disorders   
Azotaemia  1  1/543 (0.18%) 
Cystitis haemorrhagic  1  3/543 (0.55%) 
Renal failure acute  1  4/543 (0.74%) 
Renal impairment  1  1/543 (0.18%) 
Nephropathy toxic  1  1/543 (0.18%) 
Renal failure  1  1/543 (0.18%) 
Renal failure chronic  1  1/543 (0.18%) 
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema  1  1/543 (0.18%) 
Acute respiratory distress syndrome  1  2/543 (0.37%) 
Dyspnoea  1  6/543 (1.10%) 
Haemoptysis  1  2/543 (0.37%) 
Hypoxia  1  3/543 (0.55%) 
Pneumothorax  1  2/543 (0.37%) 
Pulmonary embolism  1  1/543 (0.18%) 
Pulmonary haemorrhage  1  3/543 (0.55%) 
Respiratory failure  1  3/543 (0.55%) 
Vascular disorders   
Haemorrhage  1  1/543 (0.18%) 
Shock  1  1/543 (0.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vfend
Affected / at Risk (%)
Total   154/543 (28.36%) 
Blood and lymphatic system disorders   
Anaemia  1  1/543 (0.18%) 
Eosinophilia  1  1/543 (0.18%) 
Febrile neutropenia  1  2/543 (0.37%) 
Neutropenia  1  7/543 (1.29%) 
Pancytopenia  1  1/543 (0.18%) 
Thrombocytopenia  1  5/543 (0.92%) 
Cardiac disorders   
Atrial fibrillation  1  1/543 (0.18%) 
Left ventricular dysfunction  1  1/543 (0.18%) 
Tachycardia  1  1/543 (0.18%) 
Angina pectoris  1  1/543 (0.18%) 
Ear and labyrinth disorders   
Otorrhoea  1  1/543 (0.18%) 
Endocrine disorders   
Adrenal insufficiency  1  1/543 (0.18%) 
Eye disorders   
Eye disorder  1  1/543 (0.18%) 
Eye pain  1  1/543 (0.18%) 
Keratoconjunctivitis sicca  1  1/543 (0.18%) 
Ocular hyperaemia  1  1/543 (0.18%) 
Vision blurred  1  2/543 (0.37%) 
Visual acuity reduced  1  3/543 (0.55%) 
Visual impairment  1  6/543 (1.10%) 
Gastrointestinal disorders   
Abdominal pain  1  2/543 (0.37%) 
Abdominal pain upper  1  1/543 (0.18%) 
Constipation  2  5/543 (0.92%) 
Diarrhoea  1  5/543 (0.92%) 
Dyspepsia  1  1/543 (0.18%) 
Gastric ulcer  1  1/543 (0.18%) 
Gastritis haemorrhagic  1  1/543 (0.18%) 
Haematochezia  1  1/543 (0.18%) 
Haemorrhoids  1  1/543 (0.18%) 
Mouth haemorrhage  1  1/543 (0.18%) 
Nausea  1  5/543 (0.92%) 
Oesophagitis  1  1/543 (0.18%) 
Perianal erythema  1  1/543 (0.18%) 
Reflux oesophagitis  1  1/543 (0.18%) 
Stomatitis  1  4/543 (0.74%) 
Vomiting  1  8/543 (1.47%) 
General disorders   
Chest discomfort  1  1/543 (0.18%) 
Feeling abnormal  1  1/543 (0.18%) 
Influenza like illness  1  1/543 (0.18%) 
Oedema  1  1/543 (0.18%) 
Oedema peripheral  1  1/543 (0.18%) 
Pain  1  2/543 (0.37%) 
Pyrexia  1  18/543 (3.31%) 
Hepatobiliary disorders   
Hepatic function abnormal  1  1/543 (0.18%) 
Hepatitis  1  1/543 (0.18%) 
Hepatitis toxic  1  1/543 (0.18%) 
Hepatotoxicity  1  1/543 (0.18%) 
Hyperbilirubinaemia  1  2/543 (0.37%) 
Immune system disorders   
Acute graft versus host disease in intestine  1  2/543 (0.37%) 
Graft versus host disease  1  2/543 (0.37%) 
Hypersensitivity  1  1/543 (0.18%) 
Infections and infestations   
Anal abscess  1  2/543 (0.37%) 
Appendicitis  1  1/543 (0.18%) 
Cytomegalovirus viraemia  1  5/543 (0.92%) 
Herpes virus infection  1  1/543 (0.18%) 
Herpes zoster  1  6/543 (1.10%) 
Infection  1  1/543 (0.18%) 
Molluscum contagiosum  1  1/543 (0.18%) 
Necrotising fasciitis  1  1/543 (0.18%) 
Onychomycosis  1  1/543 (0.18%) 
Oral herpes  1  1/543 (0.18%) 
Orchitis  1  1/543 (0.18%) 
Osteomyelitis  1  1/543 (0.18%) 
Pneumonia  1  3/543 (0.55%) 
Sinusitis  1  2/543 (0.37%) 
Staphylococcal bacteraemia  1  1/543 (0.18%) 
Tuberculosis  1  1/543 (0.18%) 
Urinary tract infection  1  1/543 (0.18%) 
Investigations   
Alanine aminotransferase increased  1  2/543 (0.37%) 
Aspartate aminotransferase increased  1  2/543 (0.37%) 
Blood alkaline phosphatase  1  1/543 (0.18%) 
Blood bilirubin increased  1  2/543 (0.37%) 
Blood creatine increased  1  2/543 (0.37%) 
Blood creatinine increased  1  4/543 (0.74%) 
Blood test  1  1/543 (0.18%) 
Blood urea increased  1  4/543 (0.74%) 
Haemoglobin decreased  1  2/543 (0.37%) 
Immunosuppressant drug level increased  1  1/543 (0.18%) 
Liver function test abnormal  1  9/543 (1.66%) 
Neutrophil count decreased  1  1/543 (0.18%) 
Platelet count decreased  1  2/543 (0.37%) 
Transaminases increased  1  5/543 (0.92%) 
White blood cell count decreased  1  3/543 (0.55%) 
White blood cell count increased  1  1/543 (0.18%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/543 (0.18%) 
Hyperglycaemia  1  2/543 (0.37%) 
Hyperkalaemia  1  2/543 (0.37%) 
Hypernatraemia  1  1/543 (0.18%) 
Hypomagnesaemia  1  1/543 (0.18%) 
Hyponatraemia  1  1/543 (0.18%) 
Hypophagia  1  1/543 (0.18%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/543 (0.18%) 
Muscular weakness  1  1/543 (0.18%) 
Musculoskeletal pain  1  1/543 (0.18%) 
Nervous system disorders   
Ataxia  1  1/543 (0.18%) 
Convulsion  1  2/543 (0.37%) 
Dizziness  1  1/543 (0.18%) 
Dysaesthesia  1  1/543 (0.18%) 
Dysarthria  1  1/543 (0.18%) 
Headache  1  2/543 (0.37%) 
Neuropathy peripheral  1  1/543 (0.18%) 
Peroneal nerve palsy  1  1/543 (0.18%) 
Somnolence  1  1/543 (0.18%) 
Tremor  1  1/543 (0.18%) 
VIIth nerve paralysis  1  1/543 (0.18%) 
Psychiatric disorders   
Delirium  1  2/543 (0.37%) 
Depression  1  1/543 (0.18%) 
Disorientation  1  1/543 (0.18%) 
Insomnia  1  6/543 (1.10%) 
Major depression  1  1/543 (0.18%) 
Renal and urinary disorders   
Cystitis haemorrhagic  1  1/543 (0.18%) 
Dysuria  1  1/543 (0.18%) 
Haematuria  1  1/543 (0.18%) 
Renal failure acute  1  2/543 (0.37%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/543 (0.18%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/543 (0.18%) 
Dyspnoea  1  7/543 (1.29%) 
Haemoptysis  1  4/543 (0.74%) 
Nasal congestion  1  1/543 (0.18%) 
Oropharyngeal pain  1  1/543 (0.18%) 
Pleural effusion  1  1/543 (0.18%) 
Pulmonary oedema  1  1/543 (0.18%) 
Skin and subcutaneous tissue disorders   
Dermatitis  1  1/543 (0.18%) 
Dermatitis contact  1  1/543 (0.18%) 
Drug eruption  1  2/543 (0.37%) 
Eczema asteatotic  1  1/543 (0.18%) 
Ingrowing nail  1  1/543 (0.18%) 
Palmar-plantar erythrodysaesthesia syndrome  1  1/543 (0.18%) 
Petechiae  1  1/543 (0.18%) 
Pruritus  1  5/543 (0.92%) 
Rash  1  4/543 (0.74%) 
Skin lesion  1  1/543 (0.18%) 
Urticaria  1  2/543 (0.37%) 
Vascular disorders   
Haemorrhage  3  1/543 (0.18%) 
Hypertension  1  2/543 (0.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
2
Term from vocabulary, MedDRA 15.1
3
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01073631     History of Changes
Other Study ID Numbers: A1501068
First Submitted: February 22, 2010
First Posted: February 23, 2010
Results First Submitted: August 16, 2010
Results First Posted: September 13, 2010
Last Update Posted: June 7, 2012