An observational study in Fungal Infection, sponsored by Pfizer. Completed. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Pfizer · Observational
Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use under general clinical practices.
260 studies on the registry are indexed under Mycoses; 37 are open to participants now.
This study's enrollment of 241 is above the median of 153 across 85 observational studies indexed under Mycoses.
Browse Mycoses studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
The subjects who have been treated with voriconazole for prophylaxis of invasive fungal infections in patients undergoing HSCT (Hematopoietic Stem Cell Transplantation)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Number of Participants With Adverse Drug 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.
Time frame: Maximum 3 years
Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions)
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.
Time frame: Maximum 3 years
Proportion of Participants With Adverse Drug Reactions by Age
An adverse drug reaction (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 age (\<15 years, ≥15 years) to assess whether it was a risk factor for the occurrence of ADRs.
Time frame: Maximum 3 years
Proportion of Participants With Adverse Drug Reactions by Reason for Use
An adverse drug reaction (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 reason for use to assess whether it was a risk factor for the occurrence of ADRs.
Time frame: Maximum 3 years
Proportion of Participants With Adverse Drug Reactions by Long-term Use
An adverse drug reaction (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 long-term use to assess whether it was a risk factor for the occurrence of ADRs.
Time frame: Maximum 3 years
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate)
IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate.
Time frame: Maximum 3 years
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age
IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by age (\<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.
Time frame: Maximum 3 years
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use
IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.
Time frame: Maximum 3 years
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate)
Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate.
Time frame: Maximum 3 years
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age
Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by age (\<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.
Time frame: Maximum 3 years
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use
Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.
Time frame: Maximum 3 years
| Milestone | VFEND (Voriconazole) |
|---|---|
| Started | 241 |
| Completed | 237 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 4 |
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.
| Participants | VFEND (Voriconazole) |
|---|---|
| ADR | 62 |
| Serious ADR | 5 |
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.
| Participants | VFEND (Voriconazole) |
|---|---|
| Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions) | 6 |
An adverse drug reaction (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 age (\<15 years, ≥15 years) to assess whether it was a risk factor for the occurrence of ADRs.
| Percentage of Participants | VFEND (Voriconazole) |
|---|---|
| <15 years | 20.25 (12.043 to 30.796) |
| ≥15 years | 29.87 (22.770 to 37.763) |
An adverse drug reaction (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 reason for use to assess whether it was a risk factor for the occurrence of ADRs.
| Percentage of Participants | VFEND (Voriconazole) |
|---|---|
| Primary prophylaxis | 26.39 (20.641 to 32.797) |
| Secondary prophylaxis | 31.25 (11.017 to 58.662) |
| Others | 0.00 (0.000 to 97.500) |
An adverse drug reaction (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 long-term use to assess whether it was a risk factor for the occurrence of ADRs.
| Percentage of Participants | VFEND (Voriconazole) |
|---|---|
| <180 days | 24.56 (18.311 to 31.715) |
| ≥180 days | 32.26 (20.940 to 45.336) |
IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate.
| Percentage of Participants | VFEND (Voriconazole) |
|---|---|
| Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) | 1.5 (0.31 to 4.36) |
IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by age (\<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.
| Percentage of Participants | VFEND (Voriconazole) |
|---|---|
| <15 years | 1.5 (0.04 to 7.92) |
| ≥15 years | 1.5 (0.19 to 5.45) |
IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.
| Percentage of Participants | VFEND (Voriconazole) |
|---|---|
| Primary prophylaxis | 1.1 (0.13 to 3.87) |
| Secondary prophylaxis | 7.1 (0.18 to 33.87) |
Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate.
| Percentage of Participants | VFEND (Voriconazole) |
|---|---|
| Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) | 97.5 (94.21 to 99.18) |
Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by age (\<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.
| Percentage of Participants | VFEND (Voriconazole) |
|---|---|
| <15 years | 98.5 (92.08 to 99.96) |
| ≥15 years | 96.9 (92.31 to 99.16) |
Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.
| Percentage of Participants | VFEND (Voriconazole) |
|---|---|
| Primary prophylaxis | 97.8 (94.53 to 99.40) |
| Secondary prophylaxis | 92.9 (66.13 to 99.82) |
Collected over 3 years at Maximum. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VFEND (Voriconazole) | 19/233 (8.2%) | 60/233 (25.8%) | 153/233 (65.7%) |
| Event | VFEND (Voriconazole) |
|---|---|
| Graft versus host diseaseImmune system disorders | 12/233 |
| Febrile neutropeniaBlood and lymphatic system disorders | 5/233 |
| Renal impairmentRenal and urinary disorders | 4/233 |
| PneumoniaInfections and infestations | 3/233 |
| Acute graft versus host diseaseImmune system disorders | 3/233 |
| Blood bilirubin increasedInvestigations | 3/233 |
| Neutrophil count decreasedInvestigations | 3/233 |
| Myelodysplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/233 |
| Bone marrow failureBlood and lymphatic system disorders | 2/233 |
| Graft versus host disease in lungImmune system disorders | 2/233 |
| Event | VFEND (Voriconazole) |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 33/233 |
| Graft versus host diseaseImmune system disorders | 31/233 |
| Gamma-glutamyltransferase increasedInvestigations | 30/233 |
| Alanine aminotransferase increasedInvestigations | 24/233 |
| Aspartate aminotransferase increasedInvestigations | 23/233 |
| Blood alkaline phosphatase increasedInvestigations | 19/233 |
| Liver disorderHepatobiliary disorders | 14/233 |
| Platelet count decreasedInvestigations | 12/233 |
| White blood cell count decreasedInvestigations | 12/233 |
| ThrombocytopeniaBlood and lymphatic system disorders | 10/233 |
A total of 237 participants completed this study. Of the 237 participants, 4 participants were excluded from the safety analysis set due to the following reasons: Protocol violation (registration violation, 3; contract violation/deficiency, 1)
| Age, Customized(Participants) | VFEND (Voriconazole) |
|---|---|
| <15 years | 79 |
| ≥15 and <65 years | 128 |
| ≥65 years | 26 |
| Sex: Female, Male(Participants) | VFEND (Voriconazole) |
|---|---|
| Female | 96 |
| Male | 137 |
| Race and Ethnicity Not Collected(Participants) | VFEND (Voriconazole) |
|---|
| Reason for Use(Participants) | VFEND (Voriconazole) |
|---|---|
| Primary prophylaxis | 216 |
| Secondary prophylaxis | 16 |
| Others | 1 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
Ran from Mar 2016 to primary completion in Jul 2019, 39 months.
Results were first posted in Jul 2020, 1 year after primary completion.
Of 28 observational studies under Mycoses, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 17. This study's 39 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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