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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5592-104 | Other Identifier | MSD | |
| 2019-002267-10 | EudraCT Number |
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This study will evaluate the safety, efficacy, and pharmacokinetics of posaconazole (POS) intravenous (IV) and oral formulations in pediatric participants 2 to <18 years of age with invasive aspergillosis (IA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posaconazole | Experimental | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole IV | Drug | Posaconazole (POS) 6 mg/kg body weight by IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Treatment-related AEs were determined by the investigator to be related to the drug. The 95% confidence interval (CI) was based on the exact binomial method by Clopper- Pearson. | Up to 14 days after treatment (up to Day 102) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6 | A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Orange County ( Site 1409) | Orange | California | 92868 | United States | ||
| Rady Children's Hospital-San Diego ( Site 1401) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41589852 | Derived | Kang HJ, Arrieta AC, Dhooge C, Kelemen A, Macias-Parra M, Aranda L, Dinikina YV, Kassis I, Cesaro S, Shepherd A, Shah AK, Mackey T, Waskin H, Johnson MG. Phase 2, open-label, noncomparative clinical trial evaluating safety and efficacy of posaconazole in pediatric patients with proven/probable invasive aspergillosis or possible invasive fungal disease. Antimicrob Agents Chemother. 2026 Mar 4;70(3):e0130525. doi: 10.1128/aac.01305-25. Epub 2026 Jan 27. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Male or female participants with a diagnosis of possible, probable, or proven invasive aspergillosis (IA) aged 2 to <18 years were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Age Cohort 1 (2 -< 12 Years Old) | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 2, 2022 |
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| Posaconazole PFS | Drug | Dosing based on weight-band taken orally |
|
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| Posaconazole tablet | Drug | POS tablet 300 mg taken orally |
|
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| Up to week 6 |
| Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12 | A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling. | Up to Week 12 |
| Percentage of Participants Who Have a Relapse of Invasive Aspergillosis (IA) at Any Point After Achieving Favorable Global Clinical Response | In participants who achieved favorable global clinical response, relapse of IA is defined as the re-emergence of clinical, radiographic, or other relevant abnormalities indicating IA. | Up to 28 days post-treatment (up to Day 116) |
| Average Plasma Concentration (Cavg) of POS by Age Cohorts | Steady state Cavg was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cavg parameter values (1 for IV dosing, 1 for oral dosing). | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
| Minimum Plasma Concentration (Cmin) of POS by Age Cohorts | Steady state Cmin was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmin parameter values (1 for IV dosing, 1 for oral dosing). | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
| Maximum Plasma Concentration (Cmax) of POS by Age Cohorts | Steady state Cmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmax parameter values (1 for IV dosing, 1 for oral dosing). | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
| Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Age Cohorts | Steady state AUCtau was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 AUCtau parameter values (1 for IV dosing, 1 for oral dosing). | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
| Time to Reach Cmax (Tmax) of POS by Age Cohorts | Steady state Tmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Tmax parameter values (1 for IV dosing, 1 for oral dosing). | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
| Average Plasma Concentration (Cavg) of POS by Formulation | Steady-state Cavg was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2. | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
| Minimum Plasma Concentration (Cmin) of POS by Formulation | Steady-state Cmin was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2. | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
| Maximum Plasma Concentration (Cmax) of POS by Formulation | Steady-state Cmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2. | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
| Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Formulation | Steady-state AUCtau was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2. | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
| Time to Reach Cmax (Tmax) of POS by Formulation | Steady-state Tmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2. | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
| Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation | Palatability was categorized on the first day (Day 8) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group. Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad. | First day of PFS treatment (Day 8) |
| Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation | Palatability was categorized on the last day (Day 85) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad. | Last day of PFS treatment (Day 85) |
| San Diego |
| California |
| 92123 |
| United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 1402) | Chicago | Illinois | 60611 | United States |
| Washington University ( Site 1403) | St Louis | Missouri | 63110 | United States |
| UCL St Luc ( Site 1000) | Brussels | Bruxelles-Capitale, Region de | 1200 | Belgium |
| UZ Gent ( Site 1002) | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| UZ Leuven ( Site 1001) | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Athens Childrens Hospital Aglaia Kyriakou ( Site 1052) | Athens | Attica | 115 27 | Greece |
| University General Hospital of Thessaloniki "AHEPA" ( Site 1053) | Thessaloniki | Central Macedonia | 546 36 | Greece |
| General Hospital of Thessaloniki "Ippokrateio" ( Site 1050) | Thessaloniki | 546 42 | Greece |
| BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 1101) | Miskolc | Borsod-Abauj Zemplen county | 3526 | Hungary |
| Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 1103) | Budapest | 1089 | Hungary |
| Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 1102) | Budapest | 1097 | Hungary |
| Rambam Medical Center ( Site 1125) | Haifa | 3525408 | Israel |
| Hadassah Ein Karem Hebrew University Medical Center ( Site 1127) | Jerusalem | 9112001 | Israel |
| Chaim Sheba Medical Center ( Site 1126) | Ramat Gan | 5262100 | Israel |
| Sourasky Medical Center ( Site 1128) | Tel Aviv | 6423906 | Israel |
| Ospedale Regina Margherita ( Site 1150) | Torino | 10126 | Italy |
| Azienda Ospedaliera Universitaria Integrata ( Site 1151) | Verona | 37126 | Italy |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 1204) | Monterrey | Nuevo León | 64460 | Mexico |
| Instituto Nacional de Pediatria ( Site 1200) | Mexico City | 04530 | Mexico |
| Instituto Nacional de Enfermedades Neoplásicas ( Site 1251) | Lima | 15038 | Peru |
| Hospital Nacional Edgardo Rebagliati Martins ( Site 1250) | Lima | 15072 | Peru |
| Almazov National Medical Research Centre ( Site 1284) | Saint Petersburg | Leningradskaya Oblast' | 197341 | Russia |
| Dmitry Rogachev National Research Center ( Site 1275) | Moscow | Moscow | 117198 | Russia |
| Institute of Invasive Mycosis ( Site 1282) | Saint Petersburg | Sankt-Peterburg | 194291 | Russia |
| Institute of Child Hematology and Transpl n.a.R.M.Gorbacheva ( Site 1281) | Saint Petersburg | Sankt-Peterburg | 197022 | Russia |
| Seoul National University Hospital ( Site 1326) | Seoul | 03080 | South Korea |
| The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1325) | Seoul | 06591 | South Korea |
| FG001 | Age Cohort 2 (12 -< 18 Years Old) | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Age Cohort 1 (2 -< 12 Years Old) | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation. |
| BG001 | Age Cohort 2 (12 -< 18 Years Old) | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation. |
| BG002 | 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 |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Treatment-related AEs were determined by the investigator to be related to the drug. The 95% confidence interval (CI) was based on the exact binomial method by Clopper- Pearson. | All enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 14 days after treatment (up to Day 102) |
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| Secondary | Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6 | A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling. | Participants who have possible, probable, or proven IA; receive at least 1 dose of study treatment; have at least 1 post-allocation observation subsequent to at least 1 dose of study treatment; and have baseline data for those analyses that require baseline data. | Posted | Number | Percentage of participants | Up to week 6 |
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| Secondary | Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12 | A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling. | Participants who have possible, probable, or proven IA; receive at least 1 dose of study treatment; have at least 1 post-allocation observation subsequent to at least 1 dose of study treatment; and have baseline data for those analyses that require baseline data. | Posted | Number | Percentage of participants | Up to Week 12 |
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| Secondary | Percentage of Participants Who Have a Relapse of Invasive Aspergillosis (IA) at Any Point After Achieving Favorable Global Clinical Response | In participants who achieved favorable global clinical response, relapse of IA is defined as the re-emergence of clinical, radiographic, or other relevant abnormalities indicating IA. | Participants who have possible, probable, or proven IA; receive at least 1 dose of study treatment; have at least 1 post-allocation observation subsequent to at least 1 dose of study treatment; have baseline data for those analyses that require baseline data; and who have achieved a favorable global clinical response at the end of study treatment. | Posted | Number | Percentage of participants | Up to 28 days post-treatment (up to Day 116) |
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| Secondary | Average Plasma Concentration (Cavg) of POS by Age Cohorts | Steady state Cavg was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cavg parameter values (1 for IV dosing, 1 for oral dosing). | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Cavg value | Cavg value |
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| Secondary | Minimum Plasma Concentration (Cmin) of POS by Age Cohorts | Steady state Cmin was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmin parameter values (1 for IV dosing, 1 for oral dosing). | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Cmin value | Cmin value |
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| Secondary | Maximum Plasma Concentration (Cmax) of POS by Age Cohorts | Steady state Cmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmax parameter values (1 for IV dosing, 1 for oral dosing). | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Cmax value | Cmax value |
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| Secondary | Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Age Cohorts | Steady state AUCtau was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 AUCtau parameter values (1 for IV dosing, 1 for oral dosing). | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | AUCtau value | AUCtau value |
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| Secondary | Time to Reach Cmax (Tmax) of POS by Age Cohorts | Steady state Tmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Tmax parameter values (1 for IV dosing, 1 for oral dosing). | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts. | Posted | Median | Full Range | hr. | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Tmax value | Tmax value |
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| Secondary | Average Plasma Concentration (Cavg) of POS by Formulation | Steady-state Cavg was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2. | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
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| Secondary | Minimum Plasma Concentration (Cmin) of POS by Formulation | Steady-state Cmin was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2. | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
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| Secondary | Maximum Plasma Concentration (Cmax) of POS by Formulation | Steady-state Cmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2. | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
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| Secondary | Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Formulation | Steady-state AUCtau was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2. | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
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| Secondary | Time to Reach Cmax (Tmax) of POS by Formulation | Steady-state Tmax was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N > 2. | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation. | Posted | Median | Full Range | hr | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 |
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| Secondary | Percentage of Participants With Different Categories of Palatability After First Day of Treatment With the POS PFS Formulation | Palatability was categorized on the first day (Day 8) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group. Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad. | Participants who completed the palatability questionnaire. Per protocol participants were pooled into a single treatment group. | Posted | Number | Percentage of participants | First day of PFS treatment (Day 8) |
|
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| Secondary | Percentage of Participants With Different Categories of Palatability After Last Day of Treatment With the POS PFS Formulation | Palatability was categorized on the last day (Day 85) on PFS based on responses by participants to a palatability questionnaire. Per protocol participants were pooled into a single treatment group Palatability categories for taste are as follows: Very good; Good; Very bad; Neither good nor bad. | Participants who completed the palatability questionnaire. Per protocol participants were pooled into a single treatment group. | Posted | Number | Percentage of participants | Last day of PFS treatment (Day 85) |
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All-cause mortality (ACM): from enrollment up to 14 days after treatment (up to Day 100), and included those reported beyond the final Day 114 study visit. Adverse events (AEs); from treatment up to 14 days after treatment (up to Day 102).
ACM population analyzed was all enrolled participants. AE population analyzed was all enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Age Cohort 1 (2 -< 12 Years Old) | On Day 1 participants receive 2 administrations of POS 6 mg/kg body weight by IV infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation. | 2 | 14 | 4 | 14 | 12 | 14 |
| EG001 | Age Cohort 2 (12 -< 18 Years Old) | On Day 1 participants receive 2 administrations of POS 6 mg/kg body weight by IV infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation. | 4 | 17 | 8 | 17 | 14 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Administration site extravasation | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Device related sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Gastroenteritis clostridial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Lymphadenitis bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Viral sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Leukaemic infiltration extramedullary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| Nephropathy toxic | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
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| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aplasia | Congenital, familial and genetic disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oculogyric crisis | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion site thrombosis | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Adenovirus interstitial nephritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cytomegalovirus urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infectious disease carrier | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Viraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Viral haemorrhagic cystitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Viruria | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Kidney enlargement | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal haemorrhage | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal tubular disorder | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Genital pain | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Disclosure | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Dec 5, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C101425 | posaconazole |
Not provided
Not provided
Not provided
| Preterm newborn infants (gestational age < 37 wks) |
|
| Newborns (0-27 days) |
|
| Infants and toddlers (28 days-23 months) |
|
| Children (2-11 years) |
|
| Adolescents (12-17 years) |
|
| Adults (18-64 years) |
|
| From 65-84 years |
|
| 85 years and over |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation. |
|
|
On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral formulation, or they may remain on the IV formulation. |
|
|
|
|
| OG002 | Age Cohorts 1 and 2 (2 -< 18 Years Old) | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
|
|
| OG002 | Age Cohorts 1 and 2 (2 -< 18 Years Old) | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
|
|
| OG002 | Age Cohorts 1 and 2 (2 -< 18 Years Old) | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
|
|
| OG002 | Age Cohorts 1 and 2 (2 -< 18 Years Old) | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
|
|
| OG002 | Age Cohorts 1 and 2 (2 -< 18 Years Old) | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
|
|
| OG002 | Age Cohort 1 (2 -< 12 Years Old): Tablet Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG003 | Age Cohort 2 (12 -< 18 Years Old): IV Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG004 | Age Cohort 2 (12 -< 18 Years Old): PFS Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG005 | Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
|
|
| OG002 | Age Cohort 1 (2 -< 12 Years Old): Tablet Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG003 | Age Cohort 2 (12 -< 18 Years Old): IV Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG004 | Age Cohort 2 (12 -< 18 Years Old): PFS Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG005 | Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
|
|
| OG002 | Age Cohort 1 (2 -< 12 Years Old): Tablet Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG003 | Age Cohort 2 (12 -< 18 Years Old): IV Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG004 | Age Cohort 2 (12 -< 18 Years Old): PFS Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG005 | Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
|
|
| OG002 | Age Cohort 1 (2 -< 12 Years Old): Tablet Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG003 | Age Cohort 2 (12 -< 18 Years Old): IV Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG004 | Age Cohort 2 (12 -< 18 Years Old): PFS Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG005 | Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
|
|
| OG002 | Age Cohort 1 (2 -< 12 Years Old): Tablet Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG003 | Age Cohort 2 (12 -< 18 Years Old): IV Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG004 | Age Cohort 2 (12 -< 18 Years Old): PFS Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
| OG005 | Age Cohort 2 (12 -< 18 Years Old): Tablet Formulation | On Day 1 participants receive 2 administrations of posaconazole (POS) 6 mg/kg body weight by intravenous (IV) infusion. On Days 2 through 7, participants receive POS 6 mg/kg body weight once daily by IV infusion. Beginning at Day 8 up to Day 84, participants may transition to receiving an oral (PFS or tablet) formulation, or they may remain on the IV formulation. |
|
|
|
|