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| ID | Type | Description | Link |
|---|---|---|---|
| 142639 | Registry Identifier | JAPIC-CTI | |
| MK-5592-101 | Other Identifier | Merck Protocol Number |
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The primary objective of this study is to assess and compare the safety of posaconazole with voriconazole in Japanese participants with aspergillosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Posaconazole | Experimental | 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 |
|
| Cohort 1: Voriconazole | Active Comparator | 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 |
|
| Cohort 2: Posaconazole | Experimental | 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 |
|
| Cohort 2: Voriconazole | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole | Drug | 300 mg posaconazole twice on Day 1, either by oral tablet or IV solution; followed by 300 mg once daily for up to 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event | 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. | Up to approximately Day 98 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 | 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. | Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | "Kohno S, Izumikawa K, Yoshida M, Okada F, Mori T, Najima Y, Waskin H, Shizuya T, Fukuhara T, Adachi N, Niki Y. A Randomized, Active-controlled, Open-label, Comparative Study to Assess the Safety and Efficacy of Posaconazole in Japanese Subjects with Deep-seated Fungal Infection. Nihon Ishinkin Gakkai Zasshi. 2020; 61(1):1-11. PDF file: https://www.jstage.jst.go.jp/article/ishinkin/61/1/61_19-00015/_pdf/-char/ja Web page: https://www.jstage.jst.go.jp/article/ishinkin/61/1/61_19-00015/_article/-char/ja" |
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This study was conducted in male and female Japanese participants with deep-seated fungal infection.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Posaconazole | 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 |
| FG001 | Cohort 1: Voriconazole | 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 |
| FG002 | Cohort 2: Posaconazole | 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 |
| FG003 | Cohort 2: Voriconazole | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Posaconazole | 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 |
| BG001 | Cohort 1: Voriconazole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With an Adverse Event | 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. | 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. | Posted | Count of Participants | Participants | Up to approximately Day 98 |
|
Up to approximately Day 98
All randomized participants who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Posaconazole | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2017 | Dec 19, 2018 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Voriconazole | Drug | 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 |
|
| Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84 | 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. | Day 84 |
| Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42 | 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. | Day 42 |
| Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 | 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. | Day 84 |
| Percentage of Participants With Successful Overall Response for Invasive Aspergillosis and Chronic Pulmonary Aspergillosis in Cohort 2 at End of Trial (Day 84) | 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. | Day 84 |
| Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 42 | 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. | Day 42 |
| Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 84 | 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. | Day 84 |
| Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 as Assessed by the Clinical Investigator | 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. | Day 42 |
| Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 as Assessed by the Clinical Investigator | 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. | Day 84 |
| Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 42 | 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. | Day 42 |
| Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 84 | 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. | Day 84 |
| Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 42 | 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. | Day 42 |
| Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 84 | 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. | Day 84 |
| Percentage of Participants With Invasive Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42 | 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. | Day 42 |
| Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 42 | A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, as assessed by the CAC. | Day 42 |
| Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 84 | A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, as assessed by the CAC. | Day 84 |
| Percentage of Participants With Chronic Pulmonary Aspergillosis With Radiological Response of Resolution in Cohort 2 at Day 42 | A radiological response of resolution is defined as resolution of radiological lesions, as assessed by the CAC. | Day 42 |
| Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42 | 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. | Day 42 |
| Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 84 | 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. | Day 84 |
| Adverse Event |
|
| Lack of Efficacy |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
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 |
| BG002 | Cohort 2: Posaconazole | 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 |
| BG003 | Cohort 2: Voriconazole | 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 |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | Cohort 1: Posaconazole | 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 |
| OG001 | Cohort 1: Voriconazole | 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 |
| OG002 | Cohort 2: Posaconazole | 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 |
| OG003 | Cohort 2: Voriconazole | 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 |
|
|
| Secondary | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 42 |
|
|
|
| Secondary | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 84 |
|
|
|
| Secondary | Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 42 |
|
|
|
| Secondary | Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 84 |
|
|
|
| Secondary | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis and Chronic Pulmonary Aspergillosis in Cohort 2 at End of Trial (Day 84) | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 84 |
|
|
|
| Secondary | Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 42 | 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. | 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. | Posted | Number | Percentage of participants | Day 42 |
|
|
|
| Secondary | Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 84 | 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. | 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. | Posted | Number | Percentage of participants | Day 84 |
|
|
|
| Secondary | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 as Assessed by the Clinical Investigator | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 42 |
|
|
|
| Secondary | Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 as Assessed by the Clinical Investigator | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 84 |
|
|
|
| Secondary | Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 42 | 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. | 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. | Posted | Number | Percentage of participants | Day 42 |
|
|
|
| Secondary | Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 84 | 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. | 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. | Posted | Number | Percentage of participants | Day 84 |
|
|
|
| Secondary | Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 42 | 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. | 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. | Posted | Number | Percentage of participants | Day 42 |
|
|
|
| Secondary | Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 84 | 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. | 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. | Posted | Number | Percentage of participants | Day 84 |
|
|
|
| Secondary | Percentage of Participants With Invasive Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42 | 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. | 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. | Posted | Number | Percentage of participants | Day 42 |
|
|
|
| Secondary | Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 42 | A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, as assessed by the CAC. | 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. | Posted | Number | Percentage of participants | Day 42 |
|
|
|
| Secondary | Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 84 | A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, as assessed by the CAC. | 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. | Posted | Number | Percentage of participants | Day 84 |
|
|
|
| Secondary | Percentage of Participants With Chronic Pulmonary Aspergillosis With Radiological Response of Resolution in Cohort 2 at Day 42 | A radiological response of resolution is defined as resolution of radiological lesions, as assessed by the CAC. | 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. | Posted | Number | Percentage of participants | Day 42 |
|
|
|
| Secondary | Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42 | 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. | 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. | Posted | Number | Percentage of participants | Day 42 |
|
|
|
| Secondary | Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 84 | 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. | 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. | Posted | Number | Percentage of participants | Day 84 |
|
|
|
| 1 |
| 15 |
| 3 |
| 15 |
| 15 |
| 15 |
| EG001 | Cohort 1: Voriconazole | 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 | 1 | 7 | 2 | 7 | 6 | 7 |
| EG002 | Cohort 2: Posaconazole | 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 | 6 | 62 | 28 | 62 | 58 | 62 |
| EG003 | Cohort 2: Voriconazole | 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 | 0 | 31 | 3 | 31 | 31 | 31 |
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Blister infected | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Colour blindness acquired | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Electrocardiogram ST segment elevation | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Renal function test abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Perivascular dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
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.