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The purpose of this study is to collect pharmacokinetic (PK) information related to how well intravenous Posaconazole (POS IV), is distributed in the body and to determine the safety and tolerability of this new formulation. In addition, the PK, safety, and tolerability of switching from taking POS IV to taking Posaconazole Oral Suspension (POS Oral) will be evaluated. The data collected in this study will be compared to data collected in previous studies.
Individuals who have been diagnosed by their physicians with a blood disease or cancer that can affect their infection-fighting white blood cells will be asked to participate in the trial. Since these blood diseases and their treatments can weaken the immune system, they may put these individuals at a high risk for getting a serious fungal infection of their internal organs or blood (invasive fungal infection). As these fungal infections can be hard to detect early and can be life-threatening, many physicians believe that individuals diagnosed with these diseases should receive antifungal therapy to try to lower their risk of getting this type of infection.
Enrollment into this study will take place in several stages (cohorts). The determination of which cohort an individual will be asked to participate in is based on which cohort is open at the site at the time the individual is approached to consider study participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POS IV 200 mg single dose (Cohort 0) | Active Comparator | POS 200 mg IV single dose infused over 1.5 hours on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0) |
|
| Dextrose 5% in water (Cohort 0) | Placebo Comparator | Placebo IV single dose infused over 1.5 hours on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0) |
|
| POS IV 200 mg BID (Cohort 1) | Experimental | POS 200 mg IV infused over 1.5 hours BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1) |
|
| POS IV 300 mg BID (Cohort 2) | Experimental | POS 300 mg IV infused over 1.5 hours BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability. |
|
| POS IV 300 mg BID (Cohort 3) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single Dose Trough Concentration of IV Posaconazole (Cmin) | Blood samples were collected from participants for the determination of plasma POS concentration. | 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2) |
| Steady State Trough Concentration of IV Posaconazole (Cmin) | Blood samples were collected from participants for the determination of plasma POS concentration. | 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| Single Dose Maximum Concentration of IV Posaconazole (Cmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2) |
| Steady State Maximum Concentration of IV Posaconazole (Cmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| Single Dose Time of Observed Maximum Concentration of IV Posaconazole (Tmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0 and 1) |
| Steady State Time of Observed Maximum Concentration of IV Posaconazole (Tmax) | Blood samples were collected from participants for the determination of plasma POS concentration. |
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Inclusion Criteria:
Adult subjects greater than or equal to 18 years of age (weighing greater than 34 kg [75 lb]), of either sex and of any race/ethnicity.
Disease definition for each subject: Anticipated (likely to develop within 3 days to 5 days) or documented prolonged neutropenia (absolute neutrophil count [ANC] <500/mm^3 [0.5 x 10^9/L]) at Baseline and likely to last for at least 7 days due to:
Disease definition for each Cohort 3 subject: In addition to subjects defined above, allogeneic hematopoietic stem cell transplant (HSCT) subjects may be randomized in either the pre-engraftment period (i.e., after they have received their conditioning regimen for the transplant, but while they are still neutropenic) or in the post-engraftment period if they are receiving immunosuppressive therapy for prevention or treatment of graft-versus-host disease (e.g., steroids, tacrolimus, cyclosporin, mycophenolate mofetil, and antithymocyte globulin).
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24733463 | Result | Maertens J, Cornely OA, Ullmann AJ, Heinz WJ, Krishna G, Patino H, Caceres M, Kartsonis N, Waskin H, Robertson MN. Phase 1B study of the pharmacokinetics and safety of posaconazole intravenous solution in patients at risk for invasive fungal disease. Antimicrob Agents Chemother. 2014 Jul;58(7):3610-7. doi: 10.1128/AAC.02686-13. Epub 2014 Apr 14. | |
| 28961714 |
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All participants who started the study were eligible to enter the follow-up phase, whether or not they completed the treatment phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Posaconazole (POS) 200 mg IV Single Dose (Cohort 0) | POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0) |
| FG001 | Placebo IV Single Dose (Cohort 0) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
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POS 300 mg IV infused over 1.5 hours BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28, or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability. |
|
|
| Dextrose 5% in water | Drug |
|
|
| Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| Single Dose Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC) | Blood samples were collected from participants for the determination of plasma POS concentration. | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2) |
| Steady State Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC) | Blood samples were collected from participants for the determination of plasma POS concentration. | Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| Steady State Average Concentration of IV Posaconazole (Cavg) | Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (24 hours). | Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| Steady State Total Body Clearance of IV Posaconazole (CL) | Blood samples were collected from participants for the determination of plasma POS concentration. | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| Steady State Trough Concentration of Oral Posaconazole (Cmin) | Blood samples were collected from participants for the determination of plasma POS concentration. | 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
| Steady State Maximum Concentration of Oral Posaconazole (Cmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
| Steady State Time of Observed Maximum Concentration of Oral Posaconazole (Tmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
| Steady State Area Under the Concentration Versus Time Curve of Oral Posaconazole (AUC) | Blood samples were collected from participants for the determination of plasma POS concentration. | Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
| Steady State Average Concentration of Oral Posaconazole (Cavg) | Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (12 hours). | Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
| Steady State Apparent Total Body Clearance of Oral Posaconazole (CL/F) | Blood samples were collected from participants for the determination of plasma POS concentration. | Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
| Cornely OA, Robertson MN, Haider S, Grigg A, Geddes M, Aoun M, Heinz WJ, Raad I, Schanz U, Meyer RG, Hammond SP, Mullane KM, Ostermann H, Ullmann AJ, Zimmerli S, Van Iersel MLPS, Hepler DA, Waskin H, Kartsonis NA, Maertens J. Pharmacokinetics and safety results from the Phase 3 randomized, open-label, study of intravenous posaconazole in patients at risk of invasive fungal disease. J Antimicrob Chemother. 2017 Dec 1;72(12):3406-3413. doi: 10.1093/jac/dkx263. |
Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0) |
| FG002 | POS 200 mg IV BID (Cohort 1) | POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1) |
| FG003 | POS 300 mg IV BID (Cohort 2) | POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability. |
| FG004 | POS 300 mg IV BID (Cohort 3) | POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability. |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up Phase |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | POS 200 mg IV Single Dose (Cohort 0) | POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0) |
| BG001 | Placebo IV Single Dose (Cohort 0) | Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0) |
| BG002 | POS 200 mg IV BID (Cohort 1) | POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1) |
| BG003 | POS 300 mg IV BID (Cohort 2) | POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability. |
| BG004 | POS 300 mg IV BID (Cohort 3) | POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Single Dose Trough Concentration of IV Posaconazole (Cmin) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2) |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Steady State Trough Concentration of IV Posaconazole (Cmin) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. | Posted | Mean | Standard Deviation | ng/mL | 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| |||||||||||||||||||||||||||||||||
| Primary | Single Dose Maximum Concentration of IV Posaconazole (Cmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2) |
| |||||||||||||||||||||||||||||||||
| Primary | Steady State Maximum Concentration of IV Posaconazole (Cmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. | Posted | Mean | Standard Deviation | ng/mL | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| |||||||||||||||||||||||||||||||||
| Primary | Single Dose Time of Observed Maximum Concentration of IV Posaconazole (Tmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure. | Posted | Median | Full Range | Hours | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0 and 1) |
| |||||||||||||||||||||||||||||||||
| Primary | Steady State Time of Observed Maximum Concentration of IV Posaconazole (Tmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. | Posted | Median | Full Range | Hours | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
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| Primary | Single Dose Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure. | Posted | Mean | Standard Deviation | hour*ng/mL | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2) |
| |||||||||||||||||||||||||||||||||
| Primary | Steady State Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. | Posted | Mean | Standard Deviation | hour*ng/mL | Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| |||||||||||||||||||||||||||||||||
| Primary | Steady State Average Concentration of IV Posaconazole (Cavg) | Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (24 hours). | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. | Posted | Mean | Standard Deviation | ng/mL | Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| |||||||||||||||||||||||||||||||||
| Primary | Steady State Total Body Clearance of IV Posaconazole (CL) | Blood samples were collected from participants for the determination of plasma POS concentration. | CL for posaconazole was not calculated in this study because it was collected in other studies more appropriate for evaluation of this parameter. | Posted | Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Steady State Trough Concentration of Oral Posaconazole (Cmin) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
| |||||||||||||||||||||||||||||||||
| Primary | Steady State Maximum Concentration of Oral Posaconazole (Cmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
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| Primary | Steady State Time of Observed Maximum Concentration of Oral Posaconazole (Tmax) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure. | Posted | Median | Full Range | Hours | Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
| |||||||||||||||||||||||||||||||||
| Primary | Steady State Area Under the Concentration Versus Time Curve of Oral Posaconazole (AUC) | Blood samples were collected from participants for the determination of plasma POS concentration. | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure. | Posted | Mean | Standard Deviation | hour*ng/mL | Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
| |||||||||||||||||||||||||||||||||
| Primary | Steady State Average Concentration of Oral Posaconazole (Cavg) | Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (12 hours). | The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
| |||||||||||||||||||||||||||||||||
| Primary | Steady State Apparent Total Body Clearance of Oral Posaconazole (CL/F) | Blood samples were collected from participants for the determination of plasma POS concentration. | CL/F for posaconazole was not calculated in this study because it was collected in other studies more appropriate for evaluation of this parameter | Posted | Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2) |
|
Up to Day 14 (Cohort 0); Up to Day 35 (Cohorts 1, 2, and 3)
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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 | POS 200 mg IV Single Dose (Cohort 0) | POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0) | 2 | 10 | 10 | 10 | ||
| EG001 | Placebo IV Single Dose (Cohort 0) | Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0) | 2 | 11 | 11 | 11 | ||
| EG002 | POS 200 mg IV BID (Cohort 1) | POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1) | 4 | 21 | 20 | 21 | ||
| EG003 | POS 300 mg IV BID (Cohort 2 and 3) | POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2); POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability. | 71 | 237 | 229 | 237 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Asthenia | General disorders | MedDRA 16.0 |
| ||
| Multi-organ failure | General disorders | MedDRA 16.0 |
| ||
| Pyrexia | General disorders | MedDRA 16.0 |
| ||
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 16.0 |
| ||
| Hepatitis | Hepatobiliary disorders | MedDRA 16.0 |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.0 |
| ||
| Graft versus host disease | Immune system disorders | MedDRA 16.0 |
| ||
| Graft versus host disease in intestine | Immune system disorders | MedDRA 16.0 |
| ||
| Graft versus host disease in lung | Immune system disorders | MedDRA 16.0 |
| ||
| Graft versus host disease in skin | Immune system disorders | MedDRA 16.0 |
| ||
| Aspergillosis | Infections and infestations | MedDRA 16.0 |
| ||
| Bacteraemia | Infections and infestations | MedDRA 16.0 |
| ||
| Bacterial sepsis | Infections and infestations | MedDRA 16.0 |
| ||
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 |
| ||
| Cellulitis | Infections and infestations | MedDRA 16.0 |
| ||
| Cytomegalovirus infection | Infections and infestations | MedDRA 16.0 |
| ||
| Enterococcal bacteraemia | Infections and infestations | MedDRA 16.0 |
| ||
| Escherichia sepsis | Infections and infestations | MedDRA 16.0 |
| ||
| Meningoencephalitis bacterial | Infections and infestations | MedDRA 16.0 |
| ||
| Oral herpes | Infections and infestations | MedDRA 16.0 |
| ||
| Pneumonia | Infections and infestations | MedDRA 16.0 |
| ||
| Pulmonary mycosis | Infections and infestations | MedDRA 16.0 |
| ||
| Rotavirus infection | Infections and infestations | MedDRA 16.0 |
| ||
| Sepsis | Infections and infestations | MedDRA 16.0 |
| ||
| Septic shock | Infections and infestations | MedDRA 16.0 |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 |
| ||
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 16.0 |
| ||
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 16.0 |
| ||
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 |
| ||
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 16.0 |
| ||
| Blood bilirubin increased | Investigations | MedDRA 16.0 |
| ||
| Smear cervix abnormal | Investigations | MedDRA 16.0 |
| ||
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
| ||
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
| ||
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
| ||
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
| ||
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
| ||
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
| ||
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
| ||
| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.0 |
| ||
| Encephalopathy | Nervous system disorders | MedDRA 16.0 |
| ||
| Headache | Nervous system disorders | MedDRA 16.0 |
| ||
| Myelitis transverse | Nervous system disorders | MedDRA 16.0 |
| ||
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 16.0 |
| ||
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 16.0 |
| ||
| VIIth nerve paralysis | Nervous system disorders | MedDRA 16.0 |
| ||
| Renal failure | Renal and urinary disorders | MedDRA 16.0 |
| ||
| Renal failure acute | Renal and urinary disorders | MedDRA 16.0 |
| ||
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Tonsillectomy | Surgical and medical procedures | MedDRA 16.0 |
| ||
| Hypotension | Vascular disorders | MedDRA 16.0 |
| ||
| Venoocclusive disease | Vascular disorders | MedDRA 16.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 |
| ||
| Angina pectoris | Cardiac disorders | MedDRA 16.0 |
| ||
| Atrial flutter | Cardiac disorders | MedDRA 16.0 |
| ||
| Sinus tachycardia | Cardiac disorders | MedDRA 16.0 |
| ||
| Tachycardia | Cardiac disorders | MedDRA 16.0 |
| ||
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 |
| ||
| Dry eye | Eye disorders | MedDRA 16.0 |
| ||
| Eye haemorrhage | Eye disorders | MedDRA 16.0 |
| ||
| Ocular hyperaemia | Eye disorders | MedDRA 16.0 |
| ||
| Visual impairment | Eye disorders | MedDRA 16.0 |
| ||
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Anal fistula | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Enteritis | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Gingival bleeding | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Haematochezia | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Ileus paralytic | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Oedema mouth | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Oral disorder | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Tongue coated | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Tongue disorder | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 |
| ||
| Catheter site erythema | General disorders | MedDRA 16.0 |
| ||
| Catheter site haematoma | General disorders | MedDRA 16.0 |
| ||
| Catheter site pain | General disorders | MedDRA 16.0 |
| ||
| Chills | General disorders | MedDRA 16.0 |
| ||
| Fatigue | General disorders | MedDRA 16.0 |
| ||
| Infusion site extravasation | General disorders | MedDRA 16.0 |
| ||
| Injection site inflammation | General disorders | MedDRA 16.0 |
| ||
| Mucosal inflammation | General disorders | MedDRA 16.0 |
| ||
| Oedema | General disorders | MedDRA 16.0 |
| ||
| Oedema peripheral | General disorders | MedDRA 16.0 |
| ||
| Pyrexia | General disorders | MedDRA 16.0 |
| ||
| Cholestasis | Hepatobiliary disorders | MedDRA 16.0 |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.0 |
| ||
| Atypical pneumonia | Infections and infestations | MedDRA 16.0 |
| ||
| Bacteraemia | Infections and infestations | MedDRA 16.0 |
| ||
| Cellulitis | Infections and infestations | MedDRA 16.0 |
| ||
| Device related infection | Infections and infestations | MedDRA 16.0 |
| ||
| Enterococcal infection | Infections and infestations | MedDRA 16.0 |
| ||
| Infection | Infections and infestations | MedDRA 16.0 |
| ||
| Oral herpes | Infections and infestations | MedDRA 16.0 |
| ||
| Otitis media | Infections and infestations | MedDRA 16.0 |
| ||
| Pneumonia bacterial | Infections and infestations | MedDRA 16.0 |
| ||
| Pseudomonas infection | Infections and infestations | MedDRA 16.0 |
| ||
| Puncture site infection | Infections and infestations | MedDRA 16.0 |
| ||
| Sepsis | Infections and infestations | MedDRA 16.0 |
| ||
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 16.0 |
| ||
| Staphylococcal infection | Infections and infestations | MedDRA 16.0 |
| ||
| Streptococcal bacteraemia | Infections and infestations | MedDRA 16.0 |
| ||
| Streptococcal infection | Infections and infestations | MedDRA 16.0 |
| ||
| Tonsillitis | Infections and infestations | MedDRA 16.0 |
| ||
| Urinary tract infection | Infections and infestations | MedDRA 16.0 |
| ||
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 16.0 |
| ||
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 |
| ||
| Antithrombin III decreased | Investigations | MedDRA 16.0 |
| ||
| Blood creatinine increased | Investigations | MedDRA 16.0 |
| ||
| Weight increased | Investigations | MedDRA 16.0 |
| ||
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Fluid retention | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 16.0 |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
| ||
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
| ||
| Dizziness | Nervous system disorders | MedDRA 16.0 |
| ||
| Dysgeusia | Nervous system disorders | MedDRA 16.0 |
| ||
| Headache | Nervous system disorders | MedDRA 16.0 |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
| ||
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
| ||
| Haematoma | Vascular disorders | MedDRA 16.0 |
| ||
| Hypertension | Vascular disorders | MedDRA 16.0 |
| ||
| Hypotension | Vascular disorders | MedDRA 16.0 |
| ||
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 16.0 |
| ||
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 |
| ||
| Paraesthesia | Nervous system disorders | MedDRA 16.0 |
| ||
| Sensory loss | Nervous system disorders | MedDRA 16.0 |
| ||
| Anxiety | Psychiatric disorders | MedDRA 16.0 |
| ||
| Confusional state | Psychiatric disorders | MedDRA 16.0 |
| ||
| Hallucination | Psychiatric disorders | MedDRA 16.0 |
| ||
| Insomnia | Psychiatric disorders | MedDRA 16.0 |
| ||
| Nervousness | Psychiatric disorders | MedDRA 16.0 |
| ||
| Urinary retention | Renal and urinary disorders | MedDRA 16.0 |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 16.0 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
| ||
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
| ||
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
| ||
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
| ||
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
|
The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Cllinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C101425 | posaconazole |
| D005947 | Glucose |
| D014867 | Water |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
Not provided
Not provided
| Adverse Event |
|
| Administrative |
|
| Withdrawal by Subject |
|
| Progression of disease |
|
| Treatment failure |
|
| Male |
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| Units | Counts |
|---|---|
| Participants |
|