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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002807-10 | EudraCT Number | ||
| MK-5592-097 | Other Identifier | Merck Protocol Number |
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This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered intravenously (IV) or orally to immunocompromised pediatric participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3.5 mg/kg POS (2<7 years old) | Experimental | Children 2 to less than 7 years of age will receive POS at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This will be followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they are unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
|
| 4.5 mg/kg POS (2<7 years old) | Experimental | Children 2 to less than 7 years of age will receive POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This will be followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they are unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
|
| 3.5 mg/kg POS (7-17 years old) | Experimental | Children 7 to 17 years of age will receive POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This will be followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they are unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
|
| 4.5 mg/kg POS (7-17 years old) | Experimental | Children 7 to 17 years of age will receive POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This will be followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they are unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole IV solution | Drug | Posaconazole by IV solution twice on Day 1, then once daily on Days 2-10. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose for POS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC from time 0-24 hours post-dose (AUC0-24hr) of posaconazole. A non compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation. | Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
| Maximum Plasma Concentration (Cmax) for POS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cmax of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation. | Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
| Minimum Plasma Concentration (Cmin) for POS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cmin of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation. | Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
| Average Steady-state Plasma Concentration (Cavg) for POS |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event (AE) | 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. |
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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 |
|---|---|---|---|
| 32682946 | Derived | Groll AH, Abdel-Azim H, Lehrnbecher T, Steinbach WJ, Paschke A, Mangin E, Winchell GA, Waskin H, Bruno CJ. Pharmacokinetics and safety of posaconazole intravenous solution and powder for oral suspension in children with neutropenia: an open-label, sequential dose-escalation trial. Int J Antimicrob Agents. 2020 Sep;56(3):106084. doi: 10.1016/j.ijantimicag.2020.106084. Epub 2020 Jul 17. |
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Immunocompromised participants aged 2 to 17 years old, with neutropenia expected to last for at least 7 days following start of study treatment, were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3.5 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| FG001 | 3.5 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| FG002 | 4.5 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| FG003 | 4.5 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| FG004 | 6 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| FG005 | 6 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3.5 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| 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 | Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose for POS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC from time 0-24 hours post-dose (AUC0-24hr) of posaconazole. A non compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation. | All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
|
AEs and SAEs: 14 days after end of treatment (up to day 42); All-Cause Mortality: Up to day 110.
All participants who received at least one dose of study drug. Participants were followed for survival up to 110 days, and deaths that occurred outside of the AE collection time frame were recorded in the Participant Flow. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.
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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 | 3.5 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 21.0 | 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 | May 10, 2017 | Feb 21, 2019 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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|
| 6 mg/kg POS (2<7 years old) | Experimental | Children 2 to less than 7 years of age will receive POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This will be followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they are unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
|
| 6 mg/kg POS (7-17 years old) | Experimental | Children 7 to 17 years of age will receive POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This will be followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they are unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
|
|
| Posaconazole powder for oral suspension | Drug | Posaconazole once daily by PFS for a minimum of 10 days |
|
|
Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cavg of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.
| Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
| Time of Maximum Plasma Concentration (Tmax) for POS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Tmax of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation. | Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
| Total Body Clearance (CL) for POS Administered by IV | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma CL of posaconazole administered by IV. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for participants that received IV treatment. | Any day from Day 7 to Day 10 of therapy (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
| Apparent Total Body Clearance (CL/F) for POS Administered by PFS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma CL/F of posaconazole administered by PFS. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for participants that received PFS treatment. | Any day from Day 7 to Day 10 of therapy (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
| 14 days after end of treatment (Up to 42 days) |
| Number of Participants Who Discontinued Treatment of Study Drug Due to an Adverse Event (AE) | 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | Up to 28 days |
| Death |
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| Physician Decision |
|
| Protocol Violation |
|
| Screen Failure |
|
| Withdrawn by Parent/Guardian |
|
| BG001 | 3.5 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| BG002 | 4.5 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| BG003 | 4.5 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| BG004 | 6 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| BG005 | 6 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Children 2 to less than 7 years of age received posaconazole (POS) at 3.5 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by powder for oral suspension (PFS) for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| OG001 | 3.5 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| OG002 | 4.5 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| OG003 | 4.5 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| OG004 | 6 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
| OG005 | 6 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. |
|
|
| Primary | Maximum Plasma Concentration (Cmax) for POS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cmax of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation. | All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
|
|
|
| Primary | Minimum Plasma Concentration (Cmin) for POS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cmin of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation. | All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
|
|
|
| Primary | Average Steady-state Plasma Concentration (Cavg) for POS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cavg of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation. | All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
|
|
|
| Primary | Time of Maximum Plasma Concentration (Tmax) for POS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Tmax of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation. | All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria. | Posted | Median | Full Range | Hours | Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
|
|
|
| Primary | Total Body Clearance (CL) for POS Administered by IV | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma CL of posaconazole administered by IV. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for participants that received IV treatment. | All treated participants who received at least 7 days of POS IV solution therapy, completed the full POS PK sampling while on POS IV solution, and met pre-specified acceptability criteria. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Any day from Day 7 to Day 10 of therapy (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
|
|
|
| Primary | Apparent Total Body Clearance (CL/F) for POS Administered by PFS | Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma CL/F of posaconazole administered by PFS. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for participants that received PFS treatment. | All treated participants who received at least 7 days of POS PFS therapy, completed the full POS PK sampling while on POS PFS, and met pre-specified acceptability criteria. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Any day from Day 7 to Day 10 of therapy (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion |
|
|
|
| Secondary | Number of Participants With an Adverse Event (AE) | 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | All participants who received at least one dose of study drug. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation. | Posted | Count of Participants | Participants | 14 days after end of treatment (Up to 42 days) |
|
|
|
| Secondary | Number of Participants Who Discontinued Treatment of Study Drug Due to an Adverse Event (AE) | 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 preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. | All participants who received at least one dose of study drug. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
| 1 |
| 14 |
| 3 |
| 14 |
| 13 |
| 14 |
| EG001 | 3.5 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 3.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 3.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. | 0 | 21 | 8 | 21 | 20 | 21 |
| EG002 | 4.5 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. | 0 | 15 | 4 | 15 | 15 | 15 |
| EG003 | 4.5 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 4.5 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 4.5 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. | 0 | 16 | 5 | 16 | 16 | 16 |
| EG004 | 6.0 mg/kg POS (2<7 Years Old) | Children 2 to less than 7 years of age received POS at 6 mg/kg by intravenous (IV) solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. | 1 | 20 | 3 | 20 | 19 | 20 |
| EG005 | 6.0 mg/kg POS (7-17 Years Old) | Children 7 to 17 years of age received POS at 6 mg/kg by IV solution twice on Day 1, then once daily on Days 2-10. This was followed by treatment with 6 mg/kg POS once daily by PFS for a minimum of 10 days; or, if they were unwilling or unable to tolerate POS PFS, continued treatment with POS IV. | 2 | 29 | 8 | 29 | 29 | 29 |
| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hepatic lesion | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Engraftment syndrome | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Enterobacter infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Systemic mycosis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chest wall haematoma | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Venoocclusive disease | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Anal inflammation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lip pruritus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Loose tooth | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oral mucosal exfoliation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Scalloped tongue | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tongue haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tooth loss | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Catheter site oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Granuloma | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Engraftment syndrome | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Graft versus host disease in gastrointestinal tract | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Graft versus host disease in liver | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Graft versus host disease in skin | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Immunodeficiency | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Immunodeficiency common variable | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Serum sickness | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| BK virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Enterobacter bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Hepatitis E | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Human bocavirus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Klebsiella bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Klebsiella infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Proctitis herpes | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Viraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Buttock injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| BK polyomavirus test positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Bacterial test positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood culture positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood immunoglobulin G decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood uric acid decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Cytomegalovirus test positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Drug level increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Fluid balance positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Pulmonary arterial pressure increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Viral test positive | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Vitamin D decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fluid intake reduced | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Magnesium deficiency | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Soft tissue swelling | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypotonia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Intention tremor | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Opisthotonus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Perineal erythema | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Perineal pain | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Testicular oedema | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vulvovaginal inflammation | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Increased viscosity of bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tonsillar exudate | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Macule | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Capillary leak syndrome | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperaemia | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Venoocclusive disease | Vascular disorders | MedDRA 21.0 | 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.
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| PFS |
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| PFS |
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| PFS |
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| PFS |
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