Systemic Mycosis
Conditions
Keywords
Systemic Mycosis, Aspergillus infection, Candidiasis, Cryptococcal infections, Japanese, voriconazole, VFEND, Regulatory Post Marketing Commitment Plan.
Brief summary
To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.
Detailed description
All the subjects whom an investigator prescribes the first voriconazole (VFEND) should be registered consecutively until the number of subjects reaches target number in order to extract subjects enrolled into the investigation at random.
Interventions
DRUGVoriconazole
Voriconazole Intravenous Solution 200 mg: Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults. Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg: administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward. Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased. However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily. In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward. Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or Female subjects intend to treat their deep mycosis who are prescribed voriconazole (VFEND) by their Physicians.
Exclusion criteria
* Subject who heve been prescribed voriconazole (VFEND) before.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Responded to Voriconazole Treatment. | 16 weeks | The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis. |
| Number of Participants With the Frequency of Treatment Related Adverse Events. | 16 weeks | Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections. | 16 weeks | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor. |
| Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. | 16 weeks | Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Voriconazole. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. |
| Number of Participants That Responded to Voriconazole Treatment -Severity of Infections. | 16 weeks | Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor. |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Past History. | 16 weeks | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor. |
| Risk Factors for the Frequency of Treatment Related Adverse Events -Gender. | 16 weeks | Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Voriconazole Participants taking Voriconazole according to Japanese Package Insert. | 946 |
| Total | 946 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 31 |
| Overall Study | Protocol Violation | 25 |
Baseline characteristics
| Characteristic | Voriconazole |
|---|---|
| Age, Customized <65 years | 500 participants |
| Age, Customized >=65 years | 446 participants |
| Sex: Female, Male Female | 335 Participants |
| Sex: Female, Male Male | 611 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 201 / 946 |
| serious Total, serious adverse events | 24 / 946 |
Outcome results
Primary
Number of Participants That Responded to Voriconazole Treatment.
The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis.
Time frame: 16 weeks
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole | Number of Participants That Responded to Voriconazole Treatment. | 405 participants |
Primary
Number of Participants With the Frequency of Treatment Related Adverse Events.
Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.
Time frame: 16 weeks
Population: No statistical analysis provided for the frequency of treatment related adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole | Number of Participants With the Frequency of Treatment Related Adverse Events. | 220 participants |
Secondary
Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.
Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.
Time frame: 16 weeks
Population: The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole | Number of Participants That Responded to Voriconazole Treatment -Severity of Infections. | 106 participants |
| Female | Number of Participants That Responded to Voriconazole Treatment -Severity of Infections. | 202 participants |
| Severe Infection | Number of Participants That Responded to Voriconazole Treatment -Severity of Infections. | 97 participants |
Comparison: Statistical Analysis for Risk Factors for the Proportion of Responders to Voriconazole treatment -Severity of infections.p-value: <0.001Chi-squared
Secondary
Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.
Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Voriconazole. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Time frame: 16 weeks
Population: No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole | Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. | 19 events |
Secondary
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.
Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.
Time frame: 16 weeks
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole | Risk Factors for the Frequency of Treatment Related Adverse Events -Gender. | 156 participants |
| Female | Risk Factors for the Frequency of Treatment Related Adverse Events -Gender. | 64 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female in the Frequency of Treatment Related Adverse Events.p-value: =0.03Fisher Exact
Secondary
Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.
Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.
Time frame: 16 weeks
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole | Risk Factors for the Frequency of Treatment Related Adverse Events -Past History. | 77 participants |
| Female | Risk Factors for the Frequency of Treatment Related Adverse Events -Past History. | 142 participants |
Comparison: The risk factor tested was Past History. The null hypothesis is there is no difference between with and without Past History in the Frequency of Treatment Related Adverse Events.p-value: =0.017Fisher Exact
Secondary
Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.
Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Voriconazole | Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections. | 60 participants |
| Female | Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections. | 115 participants |
| Severe Infection | Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections. | 45 participants |
Comparison: The risk factor tested was Severity of infections. The null hypothesis is there is no difference among mild, moderate and severe in the Frequency of Treatment Related Adverse Events.p-value: <0.001Chi-squared