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Trial record 26 of 58 for:    "Aspergillosis" | "Cytochrome P-450 CYP3A Inhibitors"

Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)

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ClinicalTrials.gov Identifier: NCT02180165
Recruitment Status : Completed
First Posted : July 2, 2014
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aspergillosis
Interventions Drug: Posaconazole
Drug: Voriconazole
Enrollment 116
Recruitment Details This study was conducted in male and female Japanese participants with deep-seated fungal infection.
Pre-assignment Details  
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description Participants with chronic pulmonary aspergillosis or with fusariosis or zygomycosis, received 300 mg posaconazole oral tablet (or 300 mg intravenous [IV] solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days Participants with aspergillosis or with fusariosis or zygomycosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days Participants with aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Period Title: Overall Study
Started [1] 15 7 63 31
Treated Participants 15 7 62 31
Type of Aspergillosis 15 [2] 7 [2] 57 [3] 27 [3]
Completed [4] 4 6 34 25
Not Completed 11 1 29 6
Reason Not Completed
Not Treated             0             0             1             0
Adverse Event             7             0             18             3
Lack of Efficacy             0             1             3             2
Physician Decision             1             0             5             0
Withdrawal by Subject             3             0             2             1
[1]
Randomized participants
[2]
Chronic Pulmonary Aspergillosis
[3]
Invasive Aspergillosis and Chronic Pulmonary Aspergillosis
[4]
Completed Through Day 84
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole Total
Hide Arm/Group Description Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days Participants from cohort 2 with invasive aspergillosis and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days Participants from cohort 2 with invasive aspergillosis and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days Total of all reporting groups
Overall Number of Baseline Participants 15 7 57 27 106
Hide Baseline Analysis Population Description
Cohort 1: All randomized and treated participants with chronic pulmonary aspergillosis; Cohort 2: All randomized and treated participants with invasive aspergillosis and chronic pulmonary aspergillosis
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 7 participants 57 participants 27 participants 106 participants
64.3  (9.5) 69.9  (4.5) 65.6  (12.3) 58.2  (13.9) 63.8  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 7 participants 57 participants 27 participants 106 participants
Female
3
  20.0%
3
  42.9%
3
   5.3%
2
   7.4%
11
  10.4%
Male
12
  80.0%
4
  57.1%
54
  94.7%
25
  92.6%
95
  89.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 7 participants 57 participants 27 participants 106 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
15
 100.0%
7
 100.0%
57
 100.0%
27
 100.0%
106
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With an Adverse Event
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor’s product is also an AE.
Time Frame Up to approximately Day 98
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 1: All randomized participants with chronic pulmonary aspergillosis who received at least one dose of study treatment. Cohort 2: All randomized participants with invasive aspergillosis and chronic pulmonary aspergillosis who received at least one dose of study treatment.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 15 7 57 27
Measure Type: Count of Participants
Unit of Measure: Participants
15
 100.0%
6
  85.7%
57
 100.0%
27
 100.0%
2.Secondary Outcome
Title Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42
Hide Description Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by the clinical adjudication committee (CAC). The 95% confidence interval (CI) is based on the Clopper-Pearson exact method.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 5 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
40.0
(5.3 to 85.3)
100
(29.2 to 100)
3.Secondary Outcome
Title Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84
Hide Description Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 5 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
60.0
(14.7 to 94.7)
100
(29.2 to 100)
4.Secondary Outcome
Title Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42
Hide Description Successful treatment (or successful overall response) is defined as favorable response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 48 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
56.3
(41.2 to 70.5)
87.0
(66.4 to 97.2)
5.Secondary Outcome
Title Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84
Hide Description Successful treatment (or successful overall response) is defined as favorable response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 48 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
58.3
(43.2 to 72.4)
87.0
(66.4 to 97.2)
6.Secondary Outcome
Title Percentage of Participants With Successful Overall Response for Invasive Aspergillosis and Chronic Pulmonary Aspergillosis in Cohort 2 at End of Trial (Day 84)
Hide Description Successful treatment (or successful overall response) for invasive aspergillosis is defined as complete response and partial response to treatment assessed by CAC. Successful treatment (or successful overall response) for chronic pulmonary aspergillosis is defined as favorable response to treatment.The 95% CI is based on the Clopper-Pearson exact method.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis or chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 53 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
58.5
(44.1 to 71.9)
88.5
(69.8 to 97.6)
7.Secondary Outcome
Title Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 42
Hide Description Zygomycosis is an infection caused by zygomycete fungi. Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2, posaconazole treatment only, diagnosed by CAC with proven or probable zygomycosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1, and cohort 2 voriconazole treatment were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with zygomycosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 3 0
Measure Type: Number
Unit of Measure: Percentage of participants
66.7
8.Secondary Outcome
Title Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 84
Hide Description Zygomycosis is an infection caused by zygomycete fungi. Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2, posaconazole treatment only, diagnosed by CAC with proven or probable zygomycosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1, and cohort 2 voriconazole treatment were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with zygomycosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 3 0
Measure Type: Number
Unit of Measure: Percentage of participants
100
9.Secondary Outcome
Title Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 as Assessed by the Clinical Investigator
Hide Description Successful treatment (or successful overall response) for invasive aspergillosis is defined as complete response and partial response to treatment assessed by the clinical investigator.The 95% CI is based on the Clopper-Pearson exact method.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 5 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
80.0
(28.4 to 99.5)
66.7
(9.4 to 99.2)
10.Secondary Outcome
Title Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 as Assessed by the Clinical Investigator
Hide Description Successful treatment (or successful overall response) for chronic pulmonary aspergillosis is defined as favorable response to treatment assessed by the clinical investigator.The 95% CI is based on the Clopper-Pearson exact method.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 48 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
60.4
(45.3 to 74.2)
78.3
(56.3 to 92.5)
11.Secondary Outcome
Title Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 42
Hide Description A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, and a clinical response of improvement is defined as improvement of attributable signs and symptoms of disease as assessed by the CAC.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 5 3
Measure Type: Number
Unit of Measure: Percentage of participants
Resolution 60.0 0
Improvement 20.0 66.7
12.Secondary Outcome
Title Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 84
Hide Description A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, and a clinical response of improvement is defined as improvement of attributable signs and symptoms of disease as assessed by the CAC.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 5 3
Measure Type: Number
Unit of Measure: Percentage of participants
Resolution 60.0 33.3
Improvement 20.0 33.3
13.Secondary Outcome
Title Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 42
Hide Description A radiological response of resolution is defined as resolution of radiological lesions, and a radiological response of improvement is defined as major reduction in size of radiological lesions as assessed by the CAC.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 5 3
Measure Type: Number
Unit of Measure: Percentage of participants
Resolution 0 0
Improvement 40.0 100
14.Secondary Outcome
Title Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 84
Hide Description A radiological response of resolution is defined as resolution of radiological lesions, and a radiological response of improvement is defined as major reduction in size of radiological lesions as assessed by the CAC.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 5 3
Measure Type: Number
Unit of Measure: Percentage of participants
Resolution 0 0
Improvement 60.0 100
15.Secondary Outcome
Title Percentage of Participants With Invasive Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42
Hide Description A mycological response of eradication is defined as fungus detected from culture or microscopy at the screening is eradicated at the time of evaluation (including presumed eradication), as assessed by the CAC.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 5 3
Measure Type: Number
Unit of Measure: Percentage of participants
20.0 0
16.Secondary Outcome
Title Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 42
Hide Description A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, as assessed by the CAC.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 48 23
Measure Type: Number
Unit of Measure: Percentage of participants
43.8 73.9
17.Secondary Outcome
Title Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 84
Hide Description A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, as assessed by the CAC.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 48 23
Measure Type: Number
Unit of Measure: Percentage of participants
45.8 82.6
18.Secondary Outcome
Title Percentage of Participants With Chronic Pulmonary Aspergillosis With Radiological Response of Resolution in Cohort 2 at Day 42
Hide Description A radiological response of resolution is defined as resolution of radiological lesions, as assessed by the CAC.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 48 23
Measure Type: Number
Unit of Measure: Percentage of participants
58.3 87.0
19.Secondary Outcome
Title Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42
Hide Description A mycological response of eradication is defined as fungus detected from culture or microscopy at the screening is eradicated at the time of evaluation (including presumed eradication), as assessed by the CAC.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 48 23
Measure Type: Number
Unit of Measure: Percentage of participants
33.3 21.7
20.Secondary Outcome
Title Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 84
Hide Description A mycological response of eradication is defined as fungus detected from culture or microscopy at the screening is eradicated at the time of evaluation (including presumed eradication), as assessed by the CAC.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description:
Participants with chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg posaconazole oral tablet (or 300 mg IV solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
Participants from cohort 2 with invasive and chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
Overall Number of Participants Analyzed 0 0 48 23
Measure Type: Number
Unit of Measure: Percentage of participants
35.4 21.7
Time Frame Up to approximately Day 98
Adverse Event Reporting Description All randomized participants who received at least one dose of study treatment.
 
Arm/Group Title Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Hide Arm/Group Description Participants with chronic pulmonary aspergillosis or with fusariosis or zygomycosis, received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days Participants with chronic pulmonary aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days Participants with aspergillosis or with fusariosis or zygomycosis,received 300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days. Participants with fusariosis or zygomycosis, were also assigned to this treatment group Participants with aspergillosis received 300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
All-Cause Mortality
Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/15 (6.67%)      1/7 (14.29%)      6/62 (9.68%)      0/31 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/15 (20.00%)      2/7 (28.57%)      28/62 (45.16%)      3/31 (9.68%)    
Blood and lymphatic system disorders         
Febrile neutropenia  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Cardiac disorders         
Cardiac failure  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Cardiac failure congestive  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Cor pulmonale  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
General disorders         
Chest pain  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Malaise  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Multiple organ dysfunction syndrome  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Pyrexia  1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/62 (3.23%)  2 1/31 (3.23%)  1
Infections and infestations         
Blister infected  1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/62 (0.00%)  0 0/31 (0.00%)  0
Bronchitis  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 1/31 (3.23%)  1
Bronchopulmonary aspergillosis  1  1/15 (6.67%)  1 1/7 (14.29%)  1 0/62 (0.00%)  0 0/31 (0.00%)  0
Nasopharyngitis  1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/62 (0.00%)  0 1/31 (3.23%)  1
Osteomyelitis  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Pneumonia  1  2/15 (13.33%)  2 0/7 (0.00%)  0 7/62 (11.29%)  7 0/31 (0.00%)  0
Pneumonia bacterial  1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/62 (3.23%)  2 0/31 (0.00%)  0
Pyelonephritis  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Sepsis  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Staphylococcal bacteraemia  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Injury, poisoning and procedural complications         
Spinal compression fracture  1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/62 (0.00%)  0 0/31 (0.00%)  0
Investigations         
Neutrophil count decreased  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
White blood cell count decreased  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  2 1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders         
Arthritis  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Joint effusion  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Gastric cancer  1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/62 (0.00%)  0 1/31 (3.23%)  1
Lung cancer metastatic  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Squamous cell carcinoma of lung  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Nervous system disorders         
Loss of consciousness  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/62 (3.23%)  2 0/31 (0.00%)  0
Haemoptysis  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 1/31 (3.23%)  1
Hypercapnia  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Hypoxia  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Interstitial lung disease  1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/62 (3.23%)  2 0/31 (0.00%)  0
Pneumonia aspiration  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Respiratory failure  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Posaconazole Cohort 1: Voriconazole Cohort 2: Posaconazole Cohort 2: Voriconazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      6/7 (85.71%)      58/62 (93.55%)      31/31 (100.00%)    
Blood and lymphatic system disorders         
Anaemia  1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/62 (3.23%)  2 2/31 (6.45%)  2
Eosinophilia  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Eye disorders         
Blepharitis  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Colour blindness acquired  1  0/15 (0.00%)  0 2/7 (28.57%)  2 0/62 (0.00%)  0 3/31 (9.68%)  3
Dry eye  1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/62 (0.00%)  0 0/31 (0.00%)  0
Photophobia  1  0/15 (0.00%)  0 2/7 (28.57%)  2 5/62 (8.06%)  5 9/31 (29.03%)  9
Vision blurred  1  1/15 (6.67%)  1 1/7 (14.29%)  1 0/62 (0.00%)  0 3/31 (9.68%)  3
Visual impairment  1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/62 (0.00%)  0 4/31 (12.90%)  5
Gastrointestinal disorders         
Abdominal pain upper  1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/62 (0.00%)  0 0/31 (0.00%)  0
Constipation  1  2/15 (13.33%)  2 1/7 (14.29%)  1 11/62 (17.74%)  12 5/31 (16.13%)  5
Dental caries  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 1/31 (3.23%)  1
Diarrhoea  1  2/15 (13.33%)  2 2/7 (28.57%)  2 4/62 (6.45%)  4 2/31 (6.45%)  2
Lip dry  1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/62 (3.23%)  2 2/31 (6.45%)  2
Nausea  1  2/15 (13.33%)  2 1/7 (14.29%)  1 5/62 (8.06%)  5 0/31 (0.00%)  0
Oral dysaesthesia  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Stomatitis  1  0/15 (0.00%)  0 0/7 (0.00%)  0 5/62 (8.06%)  5 0/31 (0.00%)  0
Vomiting  1  0/15 (0.00%)  0 1/7 (14.29%)  1 3/62 (4.84%)  3 1/31 (3.23%)  1
General disorders         
Malaise  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  1 1/31 (3.23%)  2
Oedema peripheral  1  2/15 (13.33%)  2 0/7 (0.00%)  0 5/62 (8.06%)  6 1/31 (3.23%)  1
Pyrexia  1  5/15 (33.33%)  5 0/7 (0.00%)  0 18/62 (29.03%)  19 1/31 (3.23%)  1
Thirst  1  2/15 (13.33%)  2 0/7 (0.00%)  0 1/62 (1.61%)  1 1/31 (3.23%)  1
Hepatobiliary disorders         
Hepatic function abnormal  1  1/15 (6.67%)  1 0/7 (0.00%)  0 13/62 (20.97%)  14 6/31 (19.35%)  6
Hepatobiliary disease  1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/62 (0.00%)  0 2/31 (6.45%)  2
Infections and infestations         
Bronchiolitis  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Cellulitis  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  2 0/31 (0.00%)  0
Device related infection  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Nasopharyngitis  1  2/15 (13.33%)  3 2/7 (28.57%)  2 1/62 (1.61%)  2 4/31 (12.90%)  6
Periodontitis  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Pharyngitis  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  1 1/31 (3.23%)  1
Pneumonia  1  0/15 (0.00%)  0 1/7 (14.29%)  2 3/62 (4.84%)  3 1/31 (3.23%)  1
Pneumonia bacterial  1  0/15 (0.00%)  0 0/7 (0.00%)  0 4/62 (6.45%)  4 1/31 (3.23%)  1
Upper respiratory tract infection  1  2/15 (13.33%)  2 0/7 (0.00%)  0 2/62 (3.23%)  2 0/31 (0.00%)  0
Urinary tract infection  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Injury, poisoning and procedural complications         
Ligament sprain  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  2/15 (13.33%)  3 0/7 (0.00%)  0 7/62 (11.29%)  7 2/31 (6.45%)  3
Aspartate aminotransferase increased  1  2/15 (13.33%)  3 2/7 (28.57%)  2 8/62 (12.90%)  8 2/31 (6.45%)  4
Blood alkaline phosphatase increased  1  0/15 (0.00%)  0 4/7 (57.14%)  4 3/62 (4.84%)  3 1/31 (3.23%)  1
Blood creatinine increased  1  0/15 (0.00%)  0 2/7 (28.57%)  3 3/62 (4.84%)  4 1/31 (3.23%)  1
Blood potassium decreased  1  1/15 (6.67%)  2 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
C-reactive protein increased  1  0/15 (0.00%)  0 0/7 (0.00%)  0 5/62 (8.06%)  5 0/31 (0.00%)  0
Electrocardiogram QT prolonged  1  1/15 (6.67%)  1 1/7 (14.29%)  1 6/62 (9.68%)  6 1/31 (3.23%)  1
Electrocardiogram ST segment elevation  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Gamma-glutamyltransferase increased  1  0/15 (0.00%)  0 1/7 (14.29%)  1 1/62 (1.61%)  1 3/31 (9.68%)  3
Liver function test increased  1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/62 (1.61%)  1 2/31 (6.45%)  2
Platelet count decreased  1  0/15 (0.00%)  0 0/7 (0.00%)  0 5/62 (8.06%)  5 2/31 (6.45%)  3
Renal function test abnormal  1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/62 (0.00%)  0 0/31 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  4/15 (26.67%)  4 0/7 (0.00%)  0 10/62 (16.13%)  11 0/31 (0.00%)  0
Hyperkalaemia  1  0/15 (0.00%)  0 2/7 (28.57%)  2 1/62 (1.61%)  1 1/31 (3.23%)  1
Hyperuricaemia  1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/62 (0.00%)  0 0/31 (0.00%)  0
Hypoalbuminaemia  1  1/15 (6.67%)  1 0/7 (0.00%)  0 3/62 (4.84%)  3 0/31 (0.00%)  0
Hypoglycaemia  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Hypokalaemia  1  3/15 (20.00%)  3 0/7 (0.00%)  0 13/62 (20.97%)  13 1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders         
Pain in extremity  1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/62 (3.23%)  2 2/31 (6.45%)  2
Periarthritis  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Nervous system disorders         
Dizziness  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Dysgeusia  1  1/15 (6.67%)  1 1/7 (14.29%)  1 0/62 (0.00%)  0 2/31 (6.45%)  3
Headache  1  0/15 (0.00%)  0 1/7 (14.29%)  1 3/62 (4.84%)  3 0/31 (0.00%)  0
Parosmia  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Psychiatric disorders         
Delirium  1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/62 (0.00%)  0 3/31 (9.68%)  3
Hallucination  1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/62 (0.00%)  0 3/31 (9.68%)  3
Insomnia  1  1/15 (6.67%)  1 0/7 (0.00%)  0 2/62 (3.23%)  2 6/31 (19.35%)  6
Renal and urinary disorders         
Pollakiuria  1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/62 (0.00%)  0 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  1 2/31 (6.45%)  2
Epistaxis  1  1/15 (6.67%)  1 0/7 (0.00%)  0 2/62 (3.23%)  2 1/31 (3.23%)  1
Haemoptysis  1  1/15 (6.67%)  1 0/7 (0.00%)  0 2/62 (3.23%)  2 0/31 (0.00%)  0
Oropharyngeal pain  1  1/15 (6.67%)  1 0/7 (0.00%)  0 3/62 (4.84%)  4 0/31 (0.00%)  0
Pleural effusion  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Upper respiratory tract inflammation  1  0/15 (0.00%)  0 1/7 (14.29%)  1 1/62 (1.61%)  1 1/31 (3.23%)  1
Skin and subcutaneous tissue disorders         
Dermatitis contact  1  2/15 (13.33%)  2 0/7 (0.00%)  0 0/62 (0.00%)  0 1/31 (3.23%)  2
Dry skin  1  0/15 (0.00%)  0 0/7 (0.00%)  0 4/62 (6.45%)  4 0/31 (0.00%)  0
Erythema  1  2/15 (13.33%)  2 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Erythema nodosum  1  1/15 (6.67%)  1 0/7 (0.00%)  0 1/62 (1.61%)  1 0/31 (0.00%)  0
Perivascular dermatitis  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Photosensitivity reaction  1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/62 (0.00%)  0 2/31 (6.45%)  2
Pruritus  1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/62 (0.00%)  0 0/31 (0.00%)  0
Rash  1  2/15 (13.33%)  2 0/7 (0.00%)  0 4/62 (6.45%)  4 2/31 (6.45%)  2
Skin irritation  1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/62 (0.00%)  0 0/31 (0.00%)  0
Vascular disorders         
Hypertension  1  3/15 (20.00%)  3 0/7 (0.00%)  0 11/62 (17.74%)  11 1/31 (3.23%)  1
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02180165     History of Changes
Other Study ID Numbers: 5592-101
142639 ( Registry Identifier: JAPIC-CTI )
MK-5592-101 ( Other Identifier: Merck Protocol Number )
First Submitted: July 1, 2014
First Posted: July 2, 2014
Results First Submitted: December 19, 2018
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019