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Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general clinical practices.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician. | 16 weeks at maximum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions Not Expected From the LPD (Unknown Adverse Drug Reaction) | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to VFEND was assessed by the physician. | 16 weeks at maximum |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects who have been treated with voriconazole for severe mycosis
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XXXXXXX | Osaka | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | VFEND (Voriconazole) | Participants who received VFEND as indicated in the approved local product document were observed for a period of 16 weeks at maximum. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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A total of 89 participants were enrolled in this study. Of the 89 participants, 3 participants were excluded from the safety analysis set due to the following reason: Protocol violation (registration violation: 1, out of the study period: 2)
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| ID | Title | Description |
|---|---|---|
| BG000 | VFEND (Voriconazole) | Participants who received VFEND as indicated in the approved local product document were observed for a period of 16 weeks at maximum. The dosage can be adjusted as per physician's discretion. |
| 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 Adverse Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. | Posted | Number | Participants | 16 weeks at maximum |
|
16 weeks at maximum
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious 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 | VFEND (Voriconazole) | Participants who received VFEND as indicated in the approved local product document were observed for a period of 16 weeks at maximum. The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photophobia | Eye disorders | MedDRA 21.0 | Non-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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2018 | Sep 12, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 12, 2015 | Sep 13, 2019 | Prot_001.pdf |
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| Incidence of Aadverse Reactions by Diagnosis (Infection) | An ADR was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by diagnosis (infection) to assess whether it was a risk factor for the occurrence of ADRs. | 16 weeks at maximum |
| Overall Clinical Response | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as "effective", "not effective", or "indeterminate" by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. | 16 weeks at maximum |
| Clinical Response Rate by Diagnostic Name (Name of Infection) | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as "effective", "not effective", or "indeterminate" by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. Overall effectiveness of VFEND was determined by the physician based on the clinical course. Participants achieved clinical effectiveness by Diagnosis (Infection) were counted to assess whether it contributes to the clinical effectiveness. | 16 weeks at maximum |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Diagnostic Name (Name of Infection) | Diagnosis name (name of infection) include definitive diagnosis and suspected cases. | Number | Participants |
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| Secondary | Number of Participants With Adverse Drug Reactions Not Expected From the LPD (Unknown Adverse Drug Reaction) | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to VFEND was assessed by the physician. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. | Posted | Number | Participants | 16 weeks at maximum |
|
|
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| Secondary | Incidence of Aadverse Reactions by Diagnosis (Infection) | An ADR was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by diagnosis (infection) to assess whether it was a risk factor for the occurrence of ADRs. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 16 weeks at maximum |
|
|
|
| Secondary | Overall Clinical Response | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as "effective", "not effective", or "indeterminate" by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. | The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end of the observation period or at the time of treatment discontinuation. The efficacy analysis sets were 74 participants. Participants assessed as "indeterminate (n=7)" at the final observation were excluded from the calculation. | Posted | Number | 95% Confidence Interval | Parcentage of Participants | 16 weeks at maximum |
|
|
|
| Secondary | Clinical Response Rate by Diagnostic Name (Name of Infection) | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as "effective", "not effective", or "indeterminate" by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. Overall effectiveness of VFEND was determined by the physician based on the clinical course. Participants achieved clinical effectiveness by Diagnosis (Infection) were counted to assess whether it contributes to the clinical effectiveness. | The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end of the observation period or at the time of treatment discontinuation. The efficacy analysis sets were 74 participants. Participants assessed as "indeterminate (n=7)" at the final observation were excluded from the calculation. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 16 weeks at maximum |
|
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|
| 6 |
| 86 |
| 11 |
| 86 |
| 41 |
| 86 |
| Pneumonia bacterial | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Pulmonary mycosis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Cytokine storm | Immune system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Obliterative bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
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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.
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| Chronic necrotic pulmonary aspergillosis |
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| Candidemia |
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| Esophageal candidiasis |
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| Candida peritonitis |
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| Bronchopulmonary candidiasis |
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| Cryptococcal meningitis |
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| Pulmonary cryptococcosis |
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| Fusariosis |
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| Scedosporiosis |
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| Other invasive fungal infections |
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| Invasive fungal infections (multiple infections) |
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| Other than invasive fungal infections |
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| Chronic necrotic pulmonary aspergillosis |
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| Candidemia |
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| Esophageal candidiasis |
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| Candida peritonitis |
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| Bronchopulmonary candidiasis |
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| Cryptococcal meningitis |
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| Pulmonary cryptococcosis |
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| Fusariosis |
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| Scedosporiosis |
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| Other invasive fungal infections |
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| Invasive fungal infections (multiple infections) |
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