Vfend Special Investigation For Prophylaxis
Study Details
Study Description
Brief Summary
Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use under general clinical practices.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Drug Reactions [Maximum 3 years]
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.
Secondary Outcome Measures
- Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions) [Maximum 3 years]
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.
- Proportion of Participants With Adverse Drug Reactions by Age [Maximum 3 years]
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.
- Proportion of Participants With Adverse Drug Reactions by Reason for Use [Maximum 3 years]
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.
- Proportion of Participants With Adverse Drug Reactions by Long-term Use [Maximum 3 years]
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.
- Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) [Maximum 3 years]
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.
- Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age [Maximum 3 years]
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.
- Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use [Maximum 3 years]
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.
- Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) [Maximum 3 years]
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.
- Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age [Maximum 3 years]
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.
- Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use [Maximum 3 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).
Exclusion Criteria:
- Patients who have been previously enrolled in this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- A1501106
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Period Title: Overall Study | |
STARTED | 237 |
COMPLETED | 233 |
NOT COMPLETED | 4 |
Baseline Characteristics
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Overall Participants | 233 |
Age, Customized (Number) [Number] | |
<15 years |
79
33.9%
|
≥15 and <65 years |
128
54.9%
|
≥65 years |
26
11.2%
|
Sex: Female, Male (Count of Participants) | |
Female |
96
41.2%
|
Male |
137
58.8%
|
Race and Ethnicity Not Collected (Count of Participants) | |
Reason for Use (Number) [Number] | |
Primary prophylaxis |
216
92.7%
|
Secondary prophylaxis |
16
6.9%
|
Others |
1
0.4%
|
Outcome Measures
Title | Number of Participants With Adverse Drug Reactions |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 233 |
ADR |
62
26.6%
|
Serious ADR |
5
2.1%
|
Title | Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 233 |
Number [Participants] |
6
2.6%
|
Title | Proportion of Participants With Adverse Drug Reactions by Age |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 233 |
<15 years |
20.25
8.7%
|
≥15 years |
29.87
12.8%
|
Title | Proportion of Participants With Adverse Drug Reactions by Reason for Use |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 233 |
Primary prophylaxis |
26.39
11.3%
|
Secondary prophylaxis |
31.25
13.4%
|
Others |
0.00
0%
|
Title | Proportion of Participants With Adverse Drug Reactions by Long-term Use |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 233 |
<180 days |
24.56
10.5%
|
≥180 days |
32.26
13.8%
|
Title | Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 198 |
Number (95% Confidence Interval) [Percentage of Participants] |
1.5
0.6%
|
Title | Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 198 |
<15 years |
1.5
0.6%
|
≥15 years |
1.5
0.6%
|
Title | Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 198 |
Primary prophylaxis |
1.1
0.5%
|
Secondary prophylaxis |
7.1
3%
|
Title | Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 198 |
Number (95% Confidence Interval) [Percentage of Participants] |
97.5
41.8%
|
Title | Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 198 |
<15 years |
98.5
42.3%
|
≥15 years |
96.9
41.6%
|
Title | Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation. |
Arm/Group Title | VFEND (Voriconazole) |
---|---|
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. |
Measure Participants | 198 |
Primary prophylaxis |
97.8
42%
|
Secondary prophylaxis |
92.9
39.9%
|
Adverse Events
Time Frame | 3 years at Maximum | |
---|---|---|
Adverse Event Reporting Description | 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. | |
Arm/Group Title | VFEND (Voriconazole) | |
Arm/Group Description | Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion. | |
All Cause Mortality |
||
VFEND (Voriconazole) | ||
Affected / at Risk (%) | # Events | |
Total | 19/233 (8.2%) | |
Serious Adverse Events |
||
VFEND (Voriconazole) | ||
Affected / at Risk (%) | # Events | |
Total | 60/233 (25.8%) | |
Blood and lymphatic system disorders | ||
Anaemia | 1/233 (0.4%) | |
Bone marrow failure | 2/233 (0.9%) | |
Febrile neutropenia | 5/233 (2.1%) | |
Immune thrombocytopenic purpura | 1/233 (0.4%) | |
Thrombotic microangiopathy | 1/233 (0.4%) | |
Cardiac disorders | ||
Arrhythmia | 1/233 (0.4%) | |
Cardiac failure | 1/233 (0.4%) | |
Cardiac failure acute | 1/233 (0.4%) | |
Cardiac failure chronic | 1/233 (0.4%) | |
Gastrointestinal disorders | ||
Diarrhoea | 1/233 (0.4%) | |
Gastrointestinal haemorrhage | 1/233 (0.4%) | |
Pancreatitis acute | 1/233 (0.4%) | |
General disorders | ||
Generalised oedema | 1/233 (0.4%) | |
Mucosal inflammation | 1/233 (0.4%) | |
Multiple organ dysfunction syndrome | 1/233 (0.4%) | |
Hepatobiliary disorders | ||
Cholecystitis | 1/233 (0.4%) | |
Hepatic function abnormal | 1/233 (0.4%) | |
Hepatitis acute | 1/233 (0.4%) | |
Venoocclusive liver disease | 2/233 (0.9%) | |
Immune system disorders | ||
Acute graft versus host disease | 3/233 (1.3%) | |
Acute graft versus host disease in intestine | 1/233 (0.4%) | |
Acute graft versus host disease in liver | 1/233 (0.4%) | |
Cytokine storm | 1/233 (0.4%) | |
Engraftment syndrome | 1/233 (0.4%) | |
Graft versus host disease | 12/233 (5.2%) | |
Graft versus host disease in lung | 2/233 (0.9%) | |
Primary amyloidosis | 1/233 (0.4%) | |
Infections and infestations | ||
Adenovirus infection | 1/233 (0.4%) | |
Pneumonia influenzal | 1/233 (0.4%) | |
Cytomegalovirus viraemia | 1/233 (0.4%) | |
Staphylococcal sepsis | 1/233 (0.4%) | |
Herpes virus infection | 1/233 (0.4%) | |
Meningoencephalitis herpetic | 1/233 (0.4%) | |
Bacteraemia | 1/233 (0.4%) | |
Psoas abscess | 1/233 (0.4%) | |
Tooth infection | 1/233 (0.4%) | |
Systemic candida | 1/233 (0.4%) | |
Systemic mycosis | 1/233 (0.4%) | |
Sepsis | 1/233 (0.4%) | |
Pneumonia | 3/233 (1.3%) | |
Lung abscess | 1/233 (0.4%) | |
Injury, poisoning and procedural complications | ||
Engraft failure | 1/233 (0.4%) | |
Investigations | ||
Aspartate aminotransferase increased | 1/233 (0.4%) | |
Blood bilirubin increased | 3/233 (1.3%) | |
Blood creatinine increased | 2/233 (0.9%) | |
Blood urea increased | 1/233 (0.4%) | |
Neutrophil count decreased | 3/233 (1.3%) | |
Platelet count decreased | 2/233 (0.9%) | |
Metabolism and nutrition disorders | ||
Tumour lysis syndrome | 2/233 (0.9%) | |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Acute lymphocytic leukaemia recurrent | 1/233 (0.4%) | |
Acute myeloid leukaemia | 1/233 (0.4%) | |
Chronic myeloid leukaemia recurrent | 1/233 (0.4%) | |
Lymphoma | 1/233 (0.4%) | |
Myelodysplastic syndrome | 2/233 (0.9%) | |
Neoplasm progression | 1/233 (0.4%) | |
Nervous system disorders | ||
Cerebrovascular accident | 1/233 (0.4%) | |
Headache | 1/233 (0.4%) | |
Parkinsonism | 1/233 (0.4%) | |
Renal and urinary disorders | ||
Acute kidney injury | 2/233 (0.9%) | |
Nephrotic syndrome | 1/233 (0.4%) | |
Renal disorder | 1/233 (0.4%) | |
Renal failure | 1/233 (0.4%) | |
Renal impairment | 4/233 (1.7%) | |
Respiratory, thoracic and mediastinal disorders | ||
Hypercapnia | 1/233 (0.4%) | |
Idiopathic pneumonia syndrome | 1/233 (0.4%) | |
Pneumomediastinum | 1/233 (0.4%) | |
Pulmonary congestion | 1/233 (0.4%) | |
Respiratory failure | 1/233 (0.4%) | |
Skin and subcutaneous tissue disorders | ||
Subcutaneous emphysema | 1/233 (0.4%) | |
Vascular disorders | ||
Shock | 1/233 (0.4%) | |
Other (Not Including Serious) Adverse Events |
||
VFEND (Voriconazole) | ||
Affected / at Risk (%) | # Events | |
Total | 229/233 (98.3%) | |
Blood and lymphatic system disorders | ||
Febrile neutropenia | 38/233 (16.3%) | |
Hepatobiliary disorders | ||
Liver disorder | 14/233 (6%) | |
Immune system disorders | ||
Graft versus host disease | 43/233 (18.5%) | |
Infections and infestations | ||
Cytomegalovirus viraemia | 11/233 (4.7%) | |
Investigations | ||
Aspartate aminotransferase increased | 24/233 (10.3%) | |
Alanine aminotransferase increased | 24/233 (10.3%) | |
Gamma-glutamyltransferase increased | 30/233 (12.9%) | |
Platelet count decreased | 14/233 (6%) | |
Blood alkaline phosphatase increased | 19/233 (8.2%) | |
White blood cell count decreased | 12/233 (5.2%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer, Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
- A1501106