Trial Outcomes & Findings for Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (NCT NCT01151085)

Last Updated: 2013-08-08

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). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.

Recruitment status

COMPLETED

Target enrollment

1002 participants

Primary outcome timeframe

16 weeks

Results posted on

2013-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	Voriconazole Participants taking Voriconazole according to Japanese Package Insert.
Overall Study STARTED	1002
Overall Study COMPLETED	946
Overall Study NOT COMPLETED	56

Reasons for withdrawal

Reasons for withdrawal
Measure	Voriconazole Participants taking Voriconazole according to Japanese Package Insert.
Overall Study Lost to Follow-up	31
Overall Study Protocol Violation	25

Baseline Characteristics

Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Voriconazole n=946 Participants Participants taking Voriconazole according to Japanese Package Insert.
Age, Customized <65 years	500 participants n=5 Participants
Age, Customized >=65 years	446 participants n=5 Participants
Sex: Female, Male Female	335 Participants n=5 Participants
Sex: Female, Male Male	611 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: No statistical analysis provided for the frequency of treatment related adverse events.

Outcome measures

Outcome measures
Measure	Voriconazole n=946 Participants Participants taking Voriconazole according to Japanese Package Insert.	Female Female Participants taking Voriconazole according to Japanese Package Insert.	Severe Infection Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
Number of Participants With the Frequency of Treatment Related Adverse Events.	220 participants	—	—

PRIMARY 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 subjects for efficacy analysis.

Outcome measures

Outcome measures
Measure	Voriconazole n=558 Participants Participants taking Voriconazole according to Japanese Package Insert.	Female Female Participants taking Voriconazole according to Japanese Package Insert.	Severe Infection Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
Number of Participants That Responded to Voriconazole Treatment.	405 participants	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: No statistical analysis provided for the number of the 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.

Outcome measures

Outcome measures
Measure	Voriconazole n=946 Participants Participants taking Voriconazole according to Japanese Package Insert.	Female Female Participants taking Voriconazole according to Japanese Package Insert.	Severe Infection Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.	19 events	—	—

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.

Outcome measures

Outcome measures
Measure	Voriconazole n=611 Participants Participants taking Voriconazole according to Japanese Package Insert.	Female n=335 Participants Female Participants taking Voriconazole according to Japanese Package Insert.	Severe Infection Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.	156 participants	64 participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Voriconazole n=229 Participants Participants taking Voriconazole according to Japanese Package Insert.	Female n=412 Participants Female Participants taking Voriconazole according to Japanese Package Insert.	Severe Infection n=305 Participants Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.	60 participants	115 participants	45 participants

SECONDARY outcome

Timeframe: 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.

Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.

Outcome measures

Outcome measures
Measure	Voriconazole n=271 Participants Participants taking Voriconazole according to Japanese Package Insert.	Female n=673 Participants Female Participants taking Voriconazole according to Japanese Package Insert.	Severe Infection Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.	77 participants	142 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).

Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.

Outcome measures

Outcome measures
Measure	Voriconazole n=129 Participants Participants taking Voriconazole according to Japanese Package Insert.	Female n=269 Participants Female Participants taking Voriconazole according to Japanese Package Insert.	Severe Infection n=160 Participants Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.	106 participants	202 participants	97 participants

Adverse Events

Voriconazole

Serious events: 24 serious events

Other events: 201 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Voriconazole n=946 participants at risk Participants taking Voriconazole according to Japanese Package Insert.
Blood and lymphatic system disorders Thrombocytopenia	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Metabolism and nutrition disorders Hyperammonaemia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Metabolism and nutrition disorders Hyponatraemia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Nervous system disorders Hepatic encephalopathy	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Nervous system disorders Dizziness	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Eye disorders Photophobia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Jaundice	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Hepatic function abnormal	0.42% 4/946 • Number of events 4 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Liver disorder	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Renal and urinary disorders Renal failure acute	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Renal and urinary disorders Renal impairment	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Renal and urinary disorders Renal disorder	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Renal and urinary disorders Renal failure	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
General disorders Drug interaction	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Investigations Hepatic enzyme increased	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Investigations Blood alkaline phosphatase increased	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.

Other adverse events

Other adverse events
Measure	Voriconazole n=946 participants at risk Participants taking Voriconazole according to Japanese Package Insert.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Rash	0.74% 7/946 • Number of events 7 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Drug eruption	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Urticaria	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Musculoskeletal and connective tissue disorders Back pain	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Renal and urinary disorders Renal impairment	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Renal and urinary disorders Renal disorder	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Congenital, familial and genetic disorders Colour blindness	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
General disorders Feeling abnormal	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Malaise	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Pyrexia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Oedema	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
General disorders Oedema peripheral	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Investigations Aspartate aminotransferase increased	0.85% 8/946 • Number of events 8 The frequency of treatment related adverse events during the study.
Investigations Alanine aminotransferase increased	0.63% 6/946 • Number of events 6 The frequency of treatment related adverse events during the study.
Investigations Gamma-glutamyltransferase increased	1.7% 16/946 • Number of events 16 The frequency of treatment related adverse events during the study.
Investigations Liver function test abnormal	0.53% 5/946 • Number of events 5 The frequency of treatment related adverse events during the study.
Investigations Hepatic enzyme increased	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Investigations Blood alkaline phosphatase increased	1.2% 11/946 • Number of events 11 The frequency of treatment related adverse events during the study.
Investigations Blood creatinine increased	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Investigations Blood creatine increased	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Investigations Blood bilirubin increased	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Investigations Blood lactate dehydrogenase increased	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Investigations Blood urea increased	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Investigations Neutrophil count decreased	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Investigations White blood cell count decreased	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Blood and lymphatic system disorders Thrombocytopenia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Blood and lymphatic system disorders Neutropenia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Blood and lymphatic system disorders Leukopenia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Metabolism and nutrition disorders Hyperphosphatasaemia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Metabolism and nutrition disorders Hyperkalaemia	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Metabolism and nutrition disorders Decreased appetite	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Metabolism and nutrition disorders Hypokalaemia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Hallucination	1.2% 11/946 • Number of events 11 The frequency of treatment related adverse events during the study.
Psychiatric disorders Hallucination, visual	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Psychiatric disorders Hallucination, auditory	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Confusional state	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Disorientation	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Anxiety	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Insomnia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Psychiatric disorders Delirium	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Nervous system disorders Altered state of consciousness	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Nervous system disorders Hypoaesthesia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Nervous system disorders Memory impairment	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Nervous system disorders Tremor	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Nervous system disorders Headache	0.42% 4/946 • Number of events 4 The frequency of treatment related adverse events during the study.
Nervous system disorders Dizziness	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Nervous system disorders Neuropathy peripheral	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Eye disorders Eyelid disorder	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Eye disorders Colour blindness acquired	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Eye disorders Visual impairment	0.95% 9/946 • Number of events 9 The frequency of treatment related adverse events during the study.
Eye disorders Chromatopsia	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Eye disorders Vision blurred	0.63% 6/946 • Number of events 6 The frequency of treatment related adverse events during the study.
Eye disorders Photophobia	1.5% 14/946 • Number of events 14 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Nausea	0.32% 3/946 • Number of events 3 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Gastric ulcer	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Lip dry	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Abdominal discomfort	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Gastrointestinal disorders Vomiting	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Hepatic function abnormal	6.0% 57/946 • Number of events 57 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Liver disorder	2.7% 26/946 • Number of events 26 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Hepatobiliary disease	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Hepatobiliary disorders Hyperbilirubinaemia	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Pruritus	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.21% 2/946 • Number of events 2 The frequency of treatment related adverse events during the study.
Skin and subcutaneous tissue disorders Blister	0.11% 1/946 • Number of events 1 The frequency of treatment related adverse events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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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