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The purpose of this study is to evaluate the preventive efficacy for HSV infection and safety of valaciclovir (VACV) in the adult and pediatric HSCT patients.
This clinical study is a multicenter open-label study on the adult and pediatric hematopoietic stem cell transplantation (HSCT) patients. The primary objective is to confirm the preventive efficacy for herpes simplex virus (HSV) infection of 256U87 (VACV: valaciclovir) due to the treatment before or immediately after hematopoietic stem cell transplantation. The secondary objective is to confirm the safety of VACV in the case of its use for such a purpose.
This clinical study consists of the following two periods: the screening period lasting 7 days at the longest and the administration period from 7 days before HSCT to 35 days after HSCT (43 days in total). During the administration period, adult patients are orally given a VACV tablet twice daily, while pediatric patients are orally given VACV granules twice daily at a dose of 25 mg/kg b.w. (maximum dose per treatment: 500 mg). Pediatric patients weighing 40 kg or over may be orally given a VACV tablet twice daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VACV (256U87; valaciclovir hydrochloride) | Experimental | Adult patients (16-65 years): A VACV tablet (containing 500mg of valaciclovir) is orally given twice daily. Pediatric patients (1-16 years): VACV granules are orally given at a dose of 25 mg/kg b.w. twice daily. The maximum dose per treatment is limited to 500 mg. Pediatric patients weighing 40 kg or over may be orally given a VACV tablet (containing 500 mg of valaciclovir) twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VACV tablets (Adults or pediatrics) or granules (pediatrics) | Drug | A white to slightly yellowish white film coated tablet contains 556 mg of valaciclovir hydrochloride (500 mg of valaciclovir)). VACV granules have no or slightly specific odor. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Herpes Simplex Virus (HSV) Infection | Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed. | From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 446-8602 | Japan | |||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 116100 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Participants: VACV 500 mg Tablet | Adult participants (between 16 and 65 years of age) received a valaciclovir hydrochloride (VACV) tablet containing 500 milligrams (mg) of valaciclovir orally twice daily for 43 days, from 7 days before hematopoietic stem cell transplantation (HSCT) to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT). |
| FG001 | Pediatric Participants: VACV 500 mg Granules/Tablets | Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kilogram (kg) body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Participants: VACV 500 mg Tablet | Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Herpes Simplex Virus (HSV) Infection | Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed. | Full Analysis Set (FAS): all participants who were given VACV more than once and who could provide data evaluable with respect to the occurrence of HSV infection. | Posted | Number | Participants | From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT) |
|
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until the end of the treatment (up to Day 43).
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received VACV more than once.
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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 | Adult Participants: VACV 500 mg Tablet | Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver injury | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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|
| From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT) |
| Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LD) Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35. | Screening (SCR), Day 14, and Day 35 |
| Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, Day 14, and Day 35. | Screening (SCR), Day 14, and Day 35 |
| Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35. | Screening (SCR), Day 14, and Day 35 |
| Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35. | Screening (SCR), Day 14, and Day 35 |
| Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35. | Screening (SCR), Day 14, and Day 35 |
| Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35. | Screening (SCR), Day 14, and Day 35 |
| Mean Red Blood Cell Count at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35. | Screening (SCR), Day 14, and Day 35 |
| Mean Hemoglobin Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35. | Screening (SCR), Day 14, and Day 35 |
| Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 | Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), urine protein (UP), and urine urobilinogen (UUG). The dipstick is a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, and 3+ (in order of increasing levels). Data are reported as the number of participants who had Neg, Trace, 1+, 2+, and 3+ levels at Screening, Day 14, and Day 35. If a category has not been reported for a specific parameter, then no participants were measured in that category. | Screening (SCR), Day 14, and 35 |
| Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Screening (SCR), Day 14, and Day 35 |
| Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 | Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; Days 0, 7, 14, 21, and 35 |
| Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 | Heart rate is defined as the number of heartbeats per unit of time. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; Days 0, 7, 14, 21, and 35 |
| Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening and Day 35 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator. | Screening (SCR) and Day 35 |
| Aichi |
| 453-8511 |
| Japan |
| GSK Investigational Site | Aichi | 466-8560 | Japan |
| GSK Investigational Site | Hiroshima | 734-8551 | Japan |
| GSK Investigational Site | Hyōgo | 650-0047 | Japan |
| GSK Investigational Site | Hyōgo | 654-0081 | Japan |
| GSK Investigational Site | Kagoshima | 890-8520 | Japan |
| GSK Investigational Site | Kanagawa | 259-1143 | Japan |
| GSK Investigational Site | Osaka | 594-1101 | Japan |
| GSK Investigational Site | Saitama | 339-8551 | Japan |
| GSK Investigational Site | Tokyo | 162-8655 | Japan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 116100 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116100 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116100 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Withdrawal by Subject |
|
| BG001 |
| Pediatric Participants: VACV 500 mg Granules/Tablets |
Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG001 | Pediatric Participants: VACV 500 mg Granules/Tablets | Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT). |
|
|
|
| Secondary | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs. | Safety Population: All participants who received VACV more than once. | Posted | Number | Participants | From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT) |
|
|
|
| Secondary | Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LD) Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | International units per liter (IU/L) | Screening (SCR), Day 14, and Day 35 |
|
|
|
| Secondary | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, Day 14, and Day 35. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | Micromoles per liter (µmol/L) | Screening (SCR), Day 14, and Day 35 |
|
|
|
| Secondary | Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Screening (SCR), Day 14, and Day 35 |
|
|
|
| Secondary | Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | Grams per liter (G/L) | Screening (SCR), Day 14, and Day 35 |
|
|
|
| Secondary | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | Percentage of cells in blood | Screening (SCR), Day 14, and Day 35 |
|
|
|
| Secondary | Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | giga (10^9) per liter (GI/L) | Screening (SCR), Day 14, and Day 35 |
|
|
|
| Secondary | Mean Red Blood Cell Count at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | tera (10^12) per liter (TI/L) | Screening (SCR), Day 14, and Day 35 |
|
|
|
| Secondary | Mean Hemoglobin Values at Screening, Day 14, and Day 35 | Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | Grams per liter (G/L) | Screening (SCR), Day 14, and Day 35 |
|
|
|
| Secondary | Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 | Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), urine protein (UP), and urine urobilinogen (UUG). The dipstick is a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, and 3+ (in order of increasing levels). Data are reported as the number of participants who had Neg, Trace, 1+, 2+, and 3+ levels at Screening, Day 14, and Day 35. If a category has not been reported for a specific parameter, then no participants were measured in that category. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Number | Participants | Screening (SCR), Day 14, and 35 |
|
|
|
| Secondary | Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | ratio | Screening (SCR), Day 14, and Day 35 |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 | Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline; Days 0, 7, 14, 21, and 35 |
|
|
|
| Secondary | Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 | Heart rate is defined as the number of heartbeats per unit of time. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Mean | Standard Deviation | Beats per minute | Baseline; Days 0, 7, 14, 21, and 35 |
|
|
|
| Secondary | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening and Day 35 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. | Posted | Number | Participants | Screening (SCR) and Day 35 |
|
|
|
| 2 |
| 21 |
| 13 |
| 21 |
| EG001 | Pediatric Participants: VACV 500 mg Granules/Tablets | Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT). | 1 | 19 | 11 | 19 |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tongue coated | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal mucosal disorder | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Periproctitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Occult blood | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Antithrombin III decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Liver injury | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Bone marrow transplant rejection | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Graft versus host disease in skin | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| ALP, Day 35, n=16, 16 |
|
| ALT, SCR, n=21, 19 |
|
| ALT, Day 14, n=18, 17 |
|
| ALT, Day 35, n=16, 16 |
|
| AST, SCR, n=21, 19 |
|
| AST, Day 14, n=18, 17 |
|
| AST, Day 35, n=16, 16 |
|
| CPK, SCR, n=21, 19 |
|
| CPK, Day 14, n=18, 17 |
|
| CPK, Day 35, n=16, 16 |
|
| GGT, SCR, n=21, 19 |
|
| GGT, Day 14, n=18, 17 |
|
| GGT, Day 35, n=16, 16 |
|
| LD, SCR, n=21, 19 |
|
| LD, Day 14, n=18, 17 |
|
| LD, Day 35, n=16, 16 |
|
| Direct bilirubin, Day 35, n=16, 16 |
|
| Total bilirubin, SCR, n=21, 19 |
|
| Total bilirubin, Day 14, n=18, 17 |
|
| Total bilirubin, Day 35, n=16, 16 |
|
| Creatinine, SCR, n=21, 19 |
|
| Creatinine, Day 14, n=18, 17 |
|
| Creatinine, Day 35, n=16, 16 |
|
| Uric acid, SCR, n=21, 19 |
|
| Uric acid, Day 14, n=18, 17 |
|
| Uric acid, Day 35, n=16, 16 |
|
| Cholesterol, Day 35, n=16, 16 |
|
| Chloride, SCR, n=21, 19 |
|
| Chloride, Day 14, n=18, 17 |
|
| Chloride, Day 35, n=16, 16 |
|
| Glucose, SCR, n=21, 19 |
|
| Glucose, Day 14, n=18, 17 |
|
| Glucose, Day 35, n=16, 16 |
|
| Potassium, SCR, n=21, 19 |
|
| Potassium, Day 14, n=18, 17 |
|
| Potassium, Day 35, n=16, 16 |
|
| Sodium, SCR, n=21, 19 |
|
| Sodium, Day 14, n=18, 17 |
|
| Sodium, Day 35, n=16, 16 |
|
| Triglycerides, SCR, n=21, 19 |
|
| Triglycerides, Day 14, n=18, 17 |
|
| Triglycerides, Day 35, n=16, 16 |
|
| Urea/BUN, SCR, n=21, 19 |
|
| Urea/BUN, Day 14, n=18, 17 |
|
| Urea/BUN, Day 35, n=16, 16 |
|
| Albumin, Day 35, n=16, 16 |
|
| Total protein, SCR, n=21, 19 |
|
| Total protein, Day 14, n=18, 17 |
|
| Total protein, Day 35, n=16, 16 |
|
| Basophils, Day 35, n=16, 15 |
|
| Eosinophils, SCR, n=21, 19 |
|
| Eosinophils, Day 14, n=16, 16 |
|
| Eosinophils, Day 35, n=16, 15 |
|
| Lymphocytes, SCR, n=21,19 |
|
| Lymphocytes, Day 14, n=16, 16 |
|
| Lymphocytes, Day 35, n=16, 15 |
|
| Monocytes, SCR, n=21,19 |
|
| Monocytes, Day 14, n=16, 16 |
|
| Monocytes, Day 35, n=16, 15 |
|
| Total neutrophils, SCR, n=21,19 |
|
| Total neutrophils, Day 14, n=16, 16 |
|
| Total neutrophils, Day 35, n=16, 15 |
|
| Platelet count, Day 35, n=16, 16 |
|
| WBC count, SCR, n=21,19 |
|
| WBC count, Day 14, n=16, 12 |
|
| WBC count, Day 35, n=16, 14 |
|
| Day 35, n=16, 16 |
|
| Day 35, n=16, 16 |
|
| UB, Neg, Day 35, n=16, 16 |
|
| UOB, Neg, SCR, n=21, 19 |
|
| UOB, 2+, SCR, n=21, 19 |
|
| UOB, Neg, Day 14, n=18, 17 |
|
| UOB, Trace, Day 14, n=18, 17 |
|
| UOB, 1+, Day 14, n=18, 17 |
|
| UOB, 3+, Day 14, n=18, 17 |
|
| UOB, Neg, Day 35, n=16, 16 |
|
| UOB, Trace, Day 35, n=16, 16 |
|
| UOB, 1+, Day 35, n=16, 16 |
|
| UOB, 3+, Day 35, n=16, 16 |
|
| UG, Neg, SCR, n=21, 19 |
|
| UG, Trace, SCR, n=21, 19 |
|
| UG, Neg, Day 14, n=18, 17 |
|
| UG, Trace, Day 14, n=18, 17 |
|
| UG, 1+, Day 14, n=18, 17 |
|
| UG, 2+, Day 14, n=18, 17 |
|
| UG, 3+, Day 14, n=18, 17 |
|
| UG, Neg, Day 35, n=16, 16 |
|
| UG, Trace, Day 35, n=16, 16 |
|
| UK, Neg, SCR, n=21, 19 |
|
| UK, Neg, Day 14, n=18, 17 |
|
| UK, 1+, Day 14, n=18, 17 |
|
| UK, Neg, Day 35, n=16, 16 |
|
| UK, 1+, Day 35, n=16, 16 |
|
| UP, Neg, SCR, n=21, 19 |
|
| UP, Trace, SCR, n=21, 19 |
|
| UP, 1+, SCR, n=21, 19 |
|
| UP, 2+, SCR, n=21, 19 |
|
| UP, Neg, Day 14, n=18, 17 |
|
| UP, Trace, Day 14, n=18, 17 |
|
| UP, 1+, Day 14, n=18, 17 |
|
| UP, 2+, Day 14, n=18, 17 |
|
| UP, Neg, Day 35, n=16, 16 |
|
| UP, Trace, Day 35, n=16, 16 |
|
| UP, 1+, Day 35, n=16, 16 |
|
| UUG, Trace, SCR, n=21, 19 |
|
| UUG, 2+, SCR, n=21, 19 |
|
| UUG, Trace, Day 14, n=18, 17 |
|
| UUG, 1+, Day 14, n=18, 17 |
|
| UUG, 2+, Day 14, n=18, 17 |
|
| UUG, 3+, Day 14, n=18, 17 |
|
| UUG, Trace, Day 35, n=16, 16 |
|
| UUG, 3+, Day 35, n=16, 16 |
|
| Day 35, n=16, 16 |
|
| SBP, Day 14, n=18, 17 |
|
| SBP, Day 21, n=17, 17 |
|
| SBP, Day 35, n=16, 16 |
|
| DBP, Day 0, n=21, 19 |
|
| DBP, Day 7, n=19, 17 |
|
| DBP, Day 14, n=18, 17 |
|
| DBP, Day 21, n=17, 17 |
|
| DBP, Day 35, n=16, 16 |
|
| Day 14, n=18, 17 |
|
| Day 21, n=17, 17 |
|
| Day 35, n=16, 16 |
|
| SCR, CS, n=21, 19 |
|
| SCR, NR, n=21, 19 |
|
| Day 35, Normal, n=16, 16 |
|
| Day 35, NCS, n=16, 16 |
|
| Day 35, CS, n=16, 16 |
|
| Day 35, NR, n=16, 16 |
|