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This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. | Patients who are indicated for VFEND according to drug package insert. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| voriconazole IV | Drug | 6 mg/kg iv q 12 hours (loading) then maintenance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | 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). | Baseline (Day 1) up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | 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 medication; Not evaluable=a follow-up mycological cultivation is not performed. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are indicated for VFEND according to drug package insert.
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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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There were 692 participants enrolled in this study. Of these, 379 participants were treated with the IV formulation of Vfend only, and 313 participants were treated with Vfend IV and Vfend tablets sequentially or vice versa. These 313 participants are also included in study A1501068 (NCT01073631).
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| ID | Title | Description |
|---|---|---|
| FG000 | Vfend | Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vfend | Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD. |
| 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 | Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable | 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). | Safety population: participants received at least 1 dose of study drug for the 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 parameters at least once. | Posted | Number | percentage of participants | Baseline (Day 1) up to 2 years |
|
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.
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.
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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 | Vfend | Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA13.1 | 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 |
|---|---|
| D000072742 | Invasive Fungal Infections |
| 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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| Baseline (Day 1) up to 2 years |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
|
|
|
| Secondary | Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable | 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 medication; Not evaluable=a follow-up mycological cultivation is not performed. | ITT; N=number of subjects evaluated for mycological response. | Posted | Number | percentage of participants | Baseline (Day 1) up to 2 years |
|
|
|
| 239 |
| 692 |
| 94 |
| 692 |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
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| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
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| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA13.1 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA13.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
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| Neutropenic colitis | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
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| Brain death | General disorders | MedDRA13.1 | Systematic Assessment |
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| Condition aggravated | General disorders | MedDRA13.1 | Systematic Assessment |
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| Disease progression | General disorders | MedDRA13.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA13.1 | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA13.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA13.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
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| Hepatorenal failure | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
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| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
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| Hepatotoxicity | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
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| Acute graft versus host disease in intestine | Immune system disorders | MedDRA13.1 | Systematic Assessment |
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| Acute graft versus host disease in skin | Immune system disorders | MedDRA13.1 | Systematic Assessment |
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| Graft versus host disease | Immune system disorders | MedDRA13.1 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Aspergillosis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Brain abscess | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Enterococcal sepsis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Liver abscess | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Pneumonia fungal | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Pneumonia primary atypical | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA13.1 | Systematic Assessment |
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| Collapse of lung | Injury, poisoning and procedural complications | MedDRA13.1 | Systematic Assessment |
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| Acoustic stimulation tests | Investigations | MedDRA13.1 | Systematic Assessment |
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| Blood creatinine | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Cytomegalovirus test positive | Investigations | MedDRA13.1 | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA13.1 | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA13.1 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA13.1 | Systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
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| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Leukaemic infiltration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Paraplegia | Nervous system disorders | MedDRA13.1 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA13.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA13.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA13.1 | Systematic Assessment |
|
| Euthyroid sick syndrome | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Chemical peritonitis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Left ventricular dysfunction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA13.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA13.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA13.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | 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.
| Title | Measurements |
|---|---|
|
| Not evaluable |
|