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Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT01151085
Recruitment Status : Completed
First Posted : June 25, 2010
Results First Posted : August 8, 2013
Last Update Posted : August 8, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Systemic Mycosis
Intervention Drug: Voriconazole
Enrollment 1002
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Voriconazole
Hide Arm/Group Description Participants taking Voriconazole according to Japanese Package Insert.
Period Title: Overall Study
Started 1002
Completed 946
Not Completed 56
Reason Not Completed
Lost to Follow-up             31
Protocol Violation             25
Arm/Group Title Voriconazole
Hide Arm/Group Description Participants taking Voriconazole according to Japanese Package Insert.
Overall Number of Baseline Participants 946
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 946 participants
<65 years 500
>=65 years 446
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 946 participants
Female
335
  35.4%
Male
611
  64.6%
1.Primary Outcome
Title Number of Participants With the Frequency of Treatment Related Adverse Events.
Hide Description Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis provided for the frequency of treatment related adverse events.
Arm/Group Title Voriconazole
Hide Arm/Group Description:
Participants taking Voriconazole according to Japanese Package Insert.
Overall Number of Participants Analyzed 946
Measure Type: Number
Unit of Measure: participants
220
2.Primary Outcome
Title Number of Participants That Responded to Voriconazole Treatment.
Hide Description The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Arm/Group Title Voriconazole
Hide Arm/Group Description:
Participants taking Voriconazole according to Japanese Package Insert.
Overall Number of Participants Analyzed 558
Measure Type: Number
Unit of Measure: participants
405
3.Secondary Outcome
Title Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.
Hide Description Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Voriconazole. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.
Arm/Group Title Voriconazole
Hide Arm/Group Description:
Participants taking Voriconazole according to Japanese Package Insert.
Overall Number of Participants Analyzed 946
Measure Type: Number
Unit of Measure: events
19
4.Secondary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.
Hide Description Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Arm/Group Title Male Female
Hide Arm/Group Description:
Male Participants taking Voriconazole according to Japanese Package Insert.
Female Participants taking Voriconazole according to Japanese Package Insert.
Overall Number of Participants Analyzed 611 335
Measure Type: Number
Unit of Measure: participants
156 64
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Male, Female
Comments The risk factor tested was "Gender". The null hypothesis is there is no difference between "Male and Female " in the Frequency of Treatment Related Adverse Events.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.030
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.
Hide Description Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild Infection Moderate Infection Severe Infection
Hide Arm/Group Description:
Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
Overall Number of Participants Analyzed 229 412 305
Measure Type: Number
Unit of Measure: participants
60 115 45
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild Infection, Moderate Infection, Severe Infection
Comments The risk factor tested was "Severity of infections". The null hypothesis is there is no difference among "mild, moderate and severe" in the Frequency of Treatment Related Adverse Events.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.
Hide Description Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Arm/Group Title With Past History Without Past History
Hide Arm/Group Description:
Participants with Past History who taking Voriconazole according to Japanese Package Insert.
Participants without Past History who taking Voriconazole according to Japanese Package Insert.
Overall Number of Participants Analyzed 271 673
Measure Type: Number
Unit of Measure: participants
77 142
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection With Past History, Without Past History
Comments The risk factor tested was "Past History". The null hypothesis is there is no difference between "with and without Past History" in the Frequency of Treatment Related Adverse Events.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.017
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.
Hide Description Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Arm/Group Title Mild Infection Moderate Infection Severe Infection
Hide Arm/Group Description:
Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
Overall Number of Participants Analyzed 129 269 160
Measure Type: Number
Unit of Measure: participants
106 202 97
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild Infection, Moderate Infection, Severe Infection
Comments Statistical Analysis for Risk Factors for the Proportion of Responders to Voriconazole treatment -Severity of infections.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The frequency of treatment related adverse events during the study.
 
Arm/Group Title Voriconazole
Hide Arm/Group Description Participants taking Voriconazole according to Japanese Package Insert.
All-Cause Mortality
Voriconazole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Voriconazole
Affected / at Risk (%) # Events
Total   24/946 (2.54%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1  2/946 (0.21%)  2
Endocrine disorders   
Inappropriate antidiuretic hormone secretion  1  1/946 (0.11%)  1
Eye disorders   
Photophobia  1  1/946 (0.11%)  1
General disorders   
Drug interaction  1  1/946 (0.11%)  1
Hepatobiliary disorders   
Jaundice  1  1/946 (0.11%)  1
Hepatic function abnormal  1  4/946 (0.42%)  4
Liver disorder  1  3/946 (0.32%)  3
Investigations   
Hepatic enzyme increased  1  1/946 (0.11%)  1
Blood alkaline phosphatase increased  1  1/946 (0.11%)  1
Metabolism and nutrition disorders   
Hyperammonaemia  1  1/946 (0.11%)  1
Hyponatraemia  1  1/946 (0.11%)  1
Nervous system disorders   
Hepatic encephalopathy  1  1/946 (0.11%)  1
Dizziness  1  1/946 (0.11%)  1
Renal and urinary disorders   
Renal failure acute  1  1/946 (0.11%)  1
Renal impairment  1  1/946 (0.11%)  1
Renal disorder  1  1/946 (0.11%)  1
Renal failure  1  2/946 (0.21%)  2
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease  1  1/946 (0.11%)  1
Pulmonary embolism  1  1/946 (0.11%)  1
Lung disorder  1  1/946 (0.11%)  1
Pulmonary alveolar haemorrhage  1  1/946 (0.11%)  1
Haemoptysis  1  1/946 (0.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Voriconazole
Affected / at Risk (%) # Events
Total   201/946 (21.25%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/946 (0.11%)  1
Neutropenia  1  1/946 (0.11%)  1
Leukopenia  1  1/946 (0.11%)  1
Congenital, familial and genetic disorders   
Colour blindness  1  2/946 (0.21%)  2
Eye disorders   
Eyelid disorder  1  1/946 (0.11%)  1
Colour blindness acquired  1  1/946 (0.11%)  1
Visual impairment  1  9/946 (0.95%)  9
Chromatopsia  1  3/946 (0.32%)  3
Vision blurred  1  6/946 (0.63%)  6
Photophobia  1  14/946 (1.48%)  14
Gastrointestinal disorders   
Nausea  1  3/946 (0.32%)  3
Gastric ulcer  1  1/946 (0.11%)  1
Lip dry  1  1/946 (0.11%)  1
Abdominal discomfort  1  2/946 (0.21%)  2
Vomiting  1  2/946 (0.21%)  2
General disorders   
Feeling abnormal  1  1/946 (0.11%)  1
Malaise  1  1/946 (0.11%)  1
Pyrexia  1  1/946 (0.11%)  1
Oedema  1  1/946 (0.11%)  1
Oedema peripheral  1  2/946 (0.21%)  2
Hepatobiliary disorders   
Hepatic function abnormal  1  57/946 (6.03%)  57
Liver disorder  1  26/946 (2.75%)  26
Hepatobiliary disease  1  1/946 (0.11%)  1
Hyperbilirubinaemia  1  1/946 (0.11%)  1
Investigations   
Aspartate aminotransferase increased  1  8/946 (0.85%)  8
Alanine aminotransferase increased  1  6/946 (0.63%)  6
Gamma-glutamyltransferase increased  1  16/946 (1.69%)  16
Liver function test abnormal  1  5/946 (0.53%)  5
Hepatic enzyme increased  1  3/946 (0.32%)  3
Blood alkaline phosphatase increased  1  11/946 (1.16%)  11
Blood creatinine increased  1  3/946 (0.32%)  3
Blood creatine increased  1  1/946 (0.11%)  1
Blood bilirubin increased  1  2/946 (0.21%)  2
Blood lactate dehydrogenase increased  1  3/946 (0.32%)  3
Blood urea increased  1  2/946 (0.21%)  2
Neutrophil count decreased  1  2/946 (0.21%)  2
White blood cell count decreased  1  2/946 (0.21%)  2
Metabolism and nutrition disorders   
Hyperphosphatasaemia  1  1/946 (0.11%)  1
Hyperkalaemia  1  3/946 (0.32%)  3
Decreased appetite  1  3/946 (0.32%)  3
Hypoalbuminaemia  1  1/946 (0.11%)  1
Hypokalaemia  1  1/946 (0.11%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/946 (0.21%)  2
Myalgia  1  1/946 (0.11%)  1
Back pain  1  1/946 (0.11%)  1
Nervous system disorders   
Altered state of consciousness  1  1/946 (0.11%)  1
Hypoaesthesia  1  1/946 (0.11%)  1
Memory impairment  1  1/946 (0.11%)  1
Tremor  1  3/946 (0.32%)  3
Headache  1  4/946 (0.42%)  4
Dizziness  1  3/946 (0.32%)  3
Neuropathy peripheral  1  1/946 (0.11%)  1
Psychiatric disorders   
Hallucination  1  11/946 (1.16%)  11
Hallucination, visual  1  3/946 (0.32%)  3
Hallucination, auditory  1  1/946 (0.11%)  1
Confusional state  1  1/946 (0.11%)  1
Disorientation  1  1/946 (0.11%)  1
Anxiety  1  1/946 (0.11%)  1
Insomnia  1  1/946 (0.11%)  1
Delirium  1  2/946 (0.21%)  2
Renal and urinary disorders   
Renal impairment  1  3/946 (0.32%)  3
Renal disorder  1  2/946 (0.21%)  2
Skin and subcutaneous tissue disorders   
Pruritus  1  1/946 (0.11%)  1
Photosensitivity reaction  1  2/946 (0.21%)  2
Blister  1  1/946 (0.11%)  1
Hyperhidrosis  1  1/946 (0.11%)  1
Rash  1  7/946 (0.74%)  7
Drug eruption  1  2/946 (0.21%)  2
Urticaria  1  1/946 (0.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01151085     History of Changes
Other Study ID Numbers: A1501076
First Submitted: June 24, 2010
First Posted: June 25, 2010
Results First Submitted: May 14, 2013
Results First Posted: August 8, 2013
Last Update Posted: August 8, 2013