Trial Outcomes & Findings for Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan) (NCT NCT01660334)

Results Overview

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). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.

Recruitment status

COMPLETED

Target enrollment

13 participants

Primary outcome timeframe

16 weeks

Results posted on

2013-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Voriconazole for Scedosporium Disease Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Voriconazole for Scedosporium Disease Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Voriconazole for Scedosporium Disease n=12 Participants Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
Age, Customized <65 years	4 participants n=5 Participants
Age, Customized >=65 years	8 participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

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). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.

Outcome measures

Outcome measures
Measure	Voriconazole for Scedosporium Disease n=12 Participants Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
Number of Participants With Serious Treatment Related Adverse Events.	2 participants

SECONDARY outcome

Timeframe: 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).

The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis. Clinical response of cure was assessed comprehensively by physicians in the three categories, which were "effective", "ineffective", and "not evaluable", based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests.

Outcome measures

Outcome measures
Measure	Voriconazole for Scedosporium Disease n=11 Participants Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.	6 participants

Adverse Events

Voriconazole for Scedosporium Disease

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Voriconazole for Scedosporium Disease n=12 participants at risk Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
Psychiatric disorders Hallucination	8.3% 1/12 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Hallucination, visual	8.3% 1/12 • Number of events 1 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Hepatic function abnormal	8.3% 1/12 • Number of events 1 The frequency of treatment related adverse events during the study.

Other adverse events

Other adverse events
Measure	Voriconazole for Scedosporium Disease n=12 participants at risk Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Hepatic function abnormal	8.3% 1/12 • Number of events 1 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Liver disorder	16.7% 2/12 • Number of events 2 The frequency of treatment related adverse events during the study.
Investigations Gamma-glutamyltransferase increased	8.3% 1/12 • Number of events 1 The frequency of treatment related adverse events during the study.
Investigations Hepatic enzyme increased	8.3% 1/12 • Number of events 1 The frequency of treatment related adverse events during the study.
Investigations Blood alkaline phosphatase increased	8.3% 1/12 • Number of events 1 The frequency of treatment related adverse events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER