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To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.
All the subjects whom an investigator prescribes the first voriconazole (VFEND) should be registered consecutively until the number of subjects reaches target number in order to extract subjects enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voriconazole | Subjects who are treated with voriconazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voriconazole | Drug | Voriconazole Intravenous Solution 200 mg: Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults. Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg: administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward. Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased. However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily. In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward. Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Frequency of Treatment Related Adverse Events. | 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. | 16 weeks |
| Number of Participants That Responded to Voriconazole Treatment. | 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. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A1501076 prescribes the voriconazole (VFEND).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Voriconazole | Participants taking Voriconazole according to Japanese Package Insert. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Voriconazole | Participants taking Voriconazole according to Japanese Package Insert. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With the Frequency of Treatment Related Adverse Events. | 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. | No statistical analysis provided for the frequency of treatment related adverse events. | Posted | Number | participants | 16 weeks |
|
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The frequency of treatment related adverse events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Voriconazole | Participants taking Voriconazole according to Japanese Package Insert. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA-J 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA-J 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| 16 weeks |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Gender. | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor. | 16 weeks |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections. | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor. | 16 weeks |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Past History. | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor. | 16 weeks |
| Number of Participants That Responded to Voriconazole Treatment -Severity of Infections. | Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor. | 16 weeks |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants That Responded to Voriconazole Treatment. | 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. | 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). | Posted | Number | participants | 16 weeks |
|
|
|
| Secondary | Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. | 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. | No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert. | Posted | Number | events | 16 weeks |
|
|
|
| Secondary | Risk Factors for the Frequency of Treatment Related Adverse Events -Gender. | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 16 weeks |
|
|
|
|
| Secondary | Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections. | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor. | Posted | Number | participants | 16 weeks |
|
|
|
|
| Secondary | Risk Factors for the Frequency of Treatment Related Adverse Events -Past History. | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 16 weeks |
|
|
|
|
| Secondary | Number of Participants That Responded to Voriconazole Treatment -Severity of Infections. | Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor. | 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). | Posted | Number | participants | 16 weeks |
|
|
|
|
| 24 |
| 946 |
| 201 |
| 946 |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Drug interaction | General disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyperphosphatasaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Eyelid disorder | Eye disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Colour blindness acquired | Eye disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Chromatopsia | Eye disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Colour blindness | Congenital, familial and genetic disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
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.