Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01602562
• Collaborator: (none)
• Enrollment: 40
• Locations: 11
• Arm: 1
• Duration (Months): 12.6
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex	Drug: VACV tablets (Adults or pediatrics) or granules (pediatrics)	Phase 3

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Multicenter, Open-label Study to Evaluate Preventive Efficacy for Herpes Simplex Virus Infection and Safety of 256U87 (Valaciclovir Hydrochloride) in Adult and Pediatric Hematopoietic Stem Cell Transplantation Patients
• Study Start Date: May 7, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 24, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: VACV (256U87; valaciclovir hydrochloride) 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.

Drug: VACV tablets (Adults or pediatrics) or granules (pediatrics); 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.; Other Names: 256U87 tablet or granule

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Herpes Simplex Virus (HSV) Infection [From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)]

   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.

Secondary Outcome Measures

1. Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) [From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)]

   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.

2. 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 [Screening (SCR), 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.

3. Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 [Screening (SCR), 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.

4. Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35 [Screening (SCR), 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.

5. Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 [Screening (SCR), Day 14, and Day 35]

   Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35.

6. Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 [Screening (SCR), 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.

7. Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 [Screening (SCR), 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.

8. Mean Red Blood Cell Count at Screening, Day 14, and Day 35 [Screening (SCR), 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.

9. Mean Hemoglobin Values at Screening, Day 14, and Day 35 [Screening (SCR), Day 14, and Day 35]

   Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35.

10. Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 [Screening (SCR), Day 14, and 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.

11. Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 [Screening (SCR), 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.

12. Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 [Baseline; 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.

13. Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 [Baseline; 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.

14. Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 [Screening (SCR) 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who are planning to undergo hematopoietic stem cell transplantation, except cord blood transplantation.

• Patients aged from 1 and above to under 65 at the time of informed consent.

• Patients who can submit their voluntary written informed consent if they are 12 years old and over.

• Patient is male or female. Male patients must be willing to use adequate contraception during the study. Female patients of childbearing potential must agree to consistently perform any of the contraceptive methods.

• QTc <450 msec, or QTc <480 msec in patients with bundle branch block. (values based on either single ECG values or triplicate ECG averaged QTc values)

• Liver test (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2x upper limit of normal (ULN); alkaline phosphatase (Al-P)and total bilirubin <=1.5xULN (total bilirubin >1.5xULN is acceptable if direct bilirubin <35%).

Exclusion Criteria:

• Patients with a history of HSCT.

• Patients who are judged to be in the following condition by the investigator (or subinvestigator): the clinical severity of malabsorption syndrome, vomiting, mucositis or other gastrointestinal dysfunction is so serious that orally administered VACV can not be absorbed.

• Patients who have known nucleoside analogs hypersensitivity.

• Patients who have a concurrent or past history of renal function disorder (serum creatinine >=1.5x ULN).

• Patients who have serious complication (eg, other malignant tumours, cardiac disorder, juvenile diabetes).

• Patients who are currently treated with the prohibited concomitant drugs.

• Patients with evidence of chronic hepatitis B or C.

• Patients with AIDS or patients infected with HIV.

• Patients who were given other trial products within 30 days before initiation of administration of this trial product or those who intend to participate in other clinical trials.

• Patients who are pregnant or probably pregnant.

• Patients who can not follow the protocol because of psychological, family, social or geological reasons.

• Patients are not allowed to participate in this clinical trial if the investigator (or subinvestigator) judges that their participation is inappropriate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Aichi		Japan	446-8602
2	GSK Investigational Site	Aichi		Japan	453-8511
3	GSK Investigational Site	Aichi		Japan	466-8560
4	GSK Investigational Site	Hiroshima		Japan	734-8551
5	GSK Investigational Site	Hyogo		Japan	650-0047
6	GSK Investigational Site	Hyogo		Japan	654-0081
7	GSK Investigational Site	Kagoshima		Japan	890-8520
8	GSK Investigational Site	Kanagawa		Japan	259-1143
9	GSK Investigational Site	Osaka		Japan	594-1101
10	GSK Investigational Site	Saitama		Japan	339-8551
11	GSK Investigational Site	Tokyo		Japan	162-8655

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01602562
• Other Study ID Numbers: 116100
• First Posted: May 21, 2012
• Last Update Posted: Aug 17, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Herpes simplex infection; valaciclovir; herpes simplex virus; hematopoietic stem cell transplantation
• Additional relevant MeSH terms: Herpes Simplex; Valacyclovir

Study Results

Participant Flow

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Period Title: Overall Study
STARTED	21	19
COMPLETED	16	16
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets	Total
Arm/Group Description	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).	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).	Total of all reporting groups
Overall Participants	21	19	40
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	48.6 (14.32)	7.5 (4.69)	29.1 (23.40)
Sex: Female, Male (Count of Participants)
Female	9 42.9%	7 36.8%	16 40%
Male	12 57.1%	12 63.2%	24 60%
Race/Ethnicity, Customized (Number) [Number]
Asian - Japanese Heritage	21 100%	19 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Herpes Simplex Virus (HSV) Infection
Description	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.
Time Frame	From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
Number [Participants]	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adult Participants: VACV 500 mg Tablet
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; 0.00 to 16.11
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value reflects the percentage of participants with an HSV infection.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pediatric Participants: VACV 500 mg Granules/Tablets
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; 0.00 to 17.65
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value reflects the percentage of participants with an HSV infection.

2. Secondary Outcome

Title	Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
Description	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.
Time Frame	From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)

Outcome Measure Data

Analysis Population Description

Safety Population: All participants who received VACV more than once.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
Any AE	13 61.9%	11 57.9%
Any SAE	2 9.5%	1 5.3%

3. Secondary Outcome

Title	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
Description	Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35.
Time Frame	Screening (SCR), Day 14, and Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
ALP, SCR, n=21, 19	247.1 (105.09)	598.8 (132.37)
ALP, Day 14, n=18, 17	358.7 (206.04)	456.7 (206.98)
ALP, Day 35, n=16, 16	314.9 (111.65)	519.9 (183.83)
ALT, SCR, n=21, 19	23.7 (10.98)	20.7 (12.55)
ALT, Day 14, n=18, 17	53.2 (63.38)	62.1 (84.64)
ALT, Day 35, n=16, 16	58.9 (36.92)	62.0 (76.59)
AST, SCR, n=21, 19	23.2 (9.01)	27.1 (9.62)
AST, Day 14, n=18, 17	39.8 (39.82)	35.0 (34.88)
AST, Day 35, n=16, 16	45.1 (19.12)	54.0 (48.96)
CPK, SCR, n=21, 19	65.1 (70.37)	72.0 (40.63)
CPK, Day 14, n=18, 17	20.5 (9.88)	27.4 (28.85)
CPK, Day 35, n=16, 16	42.1 (26.74)	38.4 (26.48)
GGT, SCR, n=21, 19	47.2 (34.94)	24.8 (24.74)
GGT, Day 14, n=18, 17	118.4 (113.63)	27.5 (10.61)
GGT, Day 35, n=16, 16	90.3 (70.96)	50.7 (43.34)
LD, SCR, n=21, 19	251.8 (179.06)	213.3 (77.51)
LD, Day 14, n=18, 17	215.4 (68.15)	210.6 (103.09)
LD, Day 35, n=16, 16	256.7 (65.92)	255.9 (92.84)

4. Secondary Outcome

Title	Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35
Description	Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, Day 14, and Day 35.
Time Frame	Screening (SCR), Day 14, and Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
Direct bilirubin, SCR, n=21, 19	2.931 (1.8843)	2.970 (1.8769)
Direct bilirubin, Day 14, n=18, 17	7.410 (11.5234)	3.923 (3.0688)
Direct bilirubin, Day 35, n=16, 16	2.351 (0.8550)	2.565 (1.2488)
Total bilirubin, SCR, n=21, 19	8.224 (5.4242)	8.190 (3.9728)
Total bilirubin, Day 14, n=18, 17	12.540 (14.8264)	9.858 (8.6251)
Total bilirubin, Day 35, n=16, 16	6.306 (1.9466)	6.733 (3.1512)
Creatinine, SCR, n=21, 19	62.6798 (19.71123)	30.1025 (10.12416)
Creatinine, Day 14, n=18, 17	46.7047 (16.31214)	25.5320 (12.84039)
Creatinine, Day 35, n=16, 16	58.7860 (18.83010)	33.3710 (19.49749)
Uric acid, SCR, n=21, 19	276.1571 (80.38764)	259.5206 (63.88405)
Uric acid, Day 14, n=18, 17	133.1691 (62.35442)	137.5038 (56.34464)
Uric acid, Day 35, n=16, 16	255.0205 (96.37167)	238.6635 (101.47400)

5. Secondary Outcome

Title	Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35
Description	Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35.
Time Frame	Screening (SCR), Day 14, and Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
Cholesterol, SCR, n=21, 19	4.8149 (1.33518)	4.1703 (0.70625)
Cholesterol, Day 14, n=18, 17	4.0255 (1.06483)	3.5504 (1.25610)
Cholesterol, Day 35, n=16, 16	5.5324 (1.45536)	4.1279 (1.01828)
Chloride, SCR, n=21, 19	105.2 (2.83)	103.3 (2.21)
Chloride, Day 14, n=18, 17	104.4 (4.06)	105.0 (2.06)
Chloride, Day 35, n=16, 16	106.0 (2.99)	104.0 (2.31)
Glucose, SCR, n=21, 19	5.8127 (1.38621)	6.0214 (1.83355)
Glucose, Day 14, n=18, 17	7.2656 (2.31056)	6.0996 (2.13721)
Glucose, Day 35, n=16, 16	6.4808 (1.35160)	5.7800 (1.41869)
Potassium, SCR, n=21, 19	4.08 (0.402)	4.01 (0.283)
Potassium, Day 14, n=18, 17	3.93 (0.457)	4.34 (0.449)
Potassium, Day 35, n=16, 16	4.31 (0.521)	4.09 (0.359)
Sodium, SCR, n=21, 19	142.0 (1.92)	140.2 (1.92)
Sodium, Day 14, n=18, 17	140.3 (4.16)	139.2 (1.55)
Sodium, Day 35, n=16, 16	141.8 (2.29)	139.3 (1.39)
Triglycerides, SCR, n=21, 19	2.0760 (1.30955)	1.3489 (0.75044)
Triglycerides, Day 14, n=18, 17	1.8789 (0.95581)	1.4185 (1.02762)
Triglycerides, Day 35, n=16, 16	2.9486 (1.49324)	1.6646 (1.04585)
Urea/BUN, SCR, n=21, 19	4.2721 (1.61486)	3.6903 (0.93331)
Urea/BUN, Day 14, n=18, 17	4.8274 (3.76473)	3.1332 (1.35997)
Urea/BUN, Day 35, n=16, 16	3.7619 (1.72437)	4.1657 (1.99412)

6. Secondary Outcome

Title	Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35
Description	Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35.
Time Frame	Screening (SCR), Day 14, and Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
Albumin, SCR, n=21, 19	41.0 (3.07)	41.5 (2.04)
Albumin, Day 14, n=18, 17	34.6 (3.87)	39.1 (3.04)
Albumin, Day 35, n=16, 16	40.8 (3.34)	40.9 (3.02)
Total protein, SCR, n=21, 19	64.2 (5.83)	66.2 (5.34)
Total protein, Day 14, n=18, 17	57.6 (5.76)	62.7 (5.08)
Total protein, Day 35, n=16, 16	62.9 (4.75)	65.3 (5.84)

7. Secondary Outcome

Title	Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35
Description	Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35.
Time Frame	Screening (SCR), Day 14, and Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
Basophils, SCR, n=21,19	1.05 (1.473)	0.49 (0.470)
Basophils, Day 14, n=16, 16	0.69 (1.661)	0.14 (0.352)
Basophils, Day 35, n=16, 15	1.09 (0.903)	0.59 (0.380)
Eosinophils, SCR, n=21, 19	3.67 (4.754)	2.06 (1.974)
Eosinophils, Day 14, n=16, 16	0.79 (2.770)	0.59 (1.517)
Eosinophils, Day 35, n=16, 15	4.10 (2.672)	7.51 (10.357)
Lymphocytes, SCR, n=21,19	32.72 (16.104)	38.94 (21.616)
Lymphocytes, Day 14, n=16, 16	13.61 (8.897)	16.73 (17.909)
Lymphocytes, Day 35, n=16, 15	37.08 (15.496)	30.85 (20.338)
Monocytes, SCR, n=21,19	7.90 (3.337)	10.99 (7.565)
Monocytes, Day 14, n=16, 16	15.32 (7.263)	17.33 (12.061)
Monocytes, Day 35, n=16, 15	14.54 (6.609)	13.33 (7.021)
Total neutrophils, SCR, n=21,19	54.46 (15.003)	47.52 (22.667)
Total neutrophils, Day 14, n=16, 16	63.53 (18.117)	62.21 (23.273)
Total neutrophils, Day 35, n=16, 15	42.76 (13.336)	47.63 (20.745)

8. Secondary Outcome

Title	Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35
Description	Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35.
Time Frame	Screening (SCR), Day 14, and Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
Platelet count, SCR, n=21,19	190.2 (126.32)	167.7 (98.15)
Platelet count, Day 14, n=18, 17	40.3 (20.73)	58.2 (37.41)
Platelet count, Day 35, n=16, 16	139.4 (79.29)	119.0 (89.31)
WBC count, SCR, n=21,19	4.01 (1.842)	3.03 (1.873)
WBC count, Day 14, n=16, 12	3.46 (2.955)	2.23 (2.403)
WBC count, Day 35, n=16, 14	5.00 (3.524)	3.71 (2.189)

9. Secondary Outcome

Title	Mean Red Blood Cell Count at Screening, Day 14, and Day 35
Description	Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35.
Time Frame	Screening (SCR), Day 14, and Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
SCR, n=21,19	3.165 (0.7583)	3.293 (0.6529)
Day 14, n=18, 17	2.932 (0.3479)	2.908 (0.3854)
Day 35, n=16, 16	3.297 (0.5021)	3.073 (0.4797)

10. Secondary Outcome

Title	Mean Hemoglobin Values at Screening, Day 14, and Day 35
Description	Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35.
Time Frame	Screening (SCR), Day 14, and Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
SCR, n=21,19	101.6 (24.84)	99.3 (17.94)
Day 14, n=18, 17	91.6 (10.02)	85.1 (12.10)
Day 35, n=16, 16	106.5 (16.36)	94.4 (15.23)

11. Secondary Outcome

Title	Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35
Description	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.
Time Frame	Screening (SCR), Day 14, and 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
UB, Neg, SCR, n=21, 19	21 100%	19 100%
UB, Neg, Day 14, n=18, 17	18 85.7%	17 89.5%
UB, Neg, Day 35, n=16, 16	16 76.2%	16 84.2%
UOB, Neg, SCR, n=21, 19	19 90.5%	19 100%
UOB, 2+, SCR, n=21, 19	2 9.5%	0 0%
UOB, Neg, Day 14, n=18, 17	14 66.7%	14 73.7%
UOB, Trace, Day 14, n=18, 17	2 9.5%	2 10.5%
UOB, 1+, Day 14, n=18, 17	2 9.5%	0 0%
UOB, 3+, Day 14, n=18, 17	0 0%	1 5.3%
UOB, Neg, Day 35, n=16, 16	12 57.1%	16 84.2%
UOB, Trace, Day 35, n=16, 16	1 4.8%	0 0%
UOB, 1+, Day 35, n=16, 16	2 9.5%	0 0%
UOB, 3+, Day 35, n=16, 16	1 4.8%	0 0%
UG, Neg, SCR, n=21, 19	19 90.5%	19 100%
UG, Trace, SCR, n=21, 19	2 9.5%	0 0%
UG, Neg, Day 14, n=18, 17	14 66.7%	17 89.5%
UG, Trace, Day 14, n=18, 17	1 4.8%	0 0%
UG, 1+, Day 14, n=18, 17	1 4.8%	0 0%
UG, 2+, Day 14, n=18, 17	1 4.8%	0 0%
UG, 3+, Day 14, n=18, 17	1 4.8%	0 0%
UG, Neg, Day 35, n=16, 16	15 71.4%	16 84.2%
UG, Trace, Day 35, n=16, 16	1 4.8%	0 0%
UK, Neg, SCR, n=21, 19	21 100%	19 100%
UK, Neg, Day 14, n=18, 17	17 81%	17 89.5%
UK, 1+, Day 14, n=18, 17	1 4.8%	0 0%
UK, Neg, Day 35, n=16, 16	16 76.2%	15 78.9%
UK, 1+, Day 35, n=16, 16	0 0%	1 5.3%
UP, Neg, SCR, n=21, 19	19 90.5%	14 73.7%
UP, Trace, SCR, n=21, 19	0 0%	4 21.1%
UP, 1+, SCR, n=21, 19	0 0%	1 5.3%
UP, 2+, SCR, n=21, 19	2 9.5%	0 0%
UP, Neg, Day 14, n=18, 17	9 42.9%	12 63.2%
UP, Trace, Day 14, n=18, 17	5 23.8%	4 21.1%
UP, 1+, Day 14, n=18, 17	2 9.5%	0 0%
UP, 2+, Day 14, n=18, 17	2 9.5%	1 5.3%
UP, Neg, Day 35, n=16, 16	13 61.9%	13 68.4%
UP, Trace, Day 35, n=16, 16	2 9.5%	1 5.3%
UP, 1+, Day 35, n=16, 16	1 4.8%	2 10.5%
UUG, Trace, SCR, n=21, 19	19 90.5%	19 100%
UUG, 2+, SCR, n=21, 19	2 9.5%	0 0%
UUG, Trace, Day 14, n=18, 17	17 81%	15 78.9%
UUG, 1+, Day 14, n=18, 17	1 4.8%	0 0%
UUG, 2+, Day 14, n=18, 17	0 0%	1 5.3%
UUG, 3+, Day 14, n=18, 17	0 0%	1 5.3%
UUG, Trace, Day 35, n=16, 16	16 76.2%	15 78.9%
UUG, 3+, Day 35, n=16, 16	0 0%	1 5.3%

12. Secondary Outcome

Title	Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35
Description	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.
Time Frame	Screening (SCR), Day 14, and Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
SCR, n=21, 19	1.0146 (0.00705)	1.0188 (0.00912)
Day 14, n=18, 17	1.0158 (0.00628)	1.0155 (0.00685)
Day 35, n=16, 16	1.0137 (0.00572)	1.0153 (0.00642)

13. Secondary Outcome

Title	Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35
Description	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.
Time Frame	Baseline; Days 0, 7, 14, 21, and 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
SBP, Day 0, n=21, 19	-1.8 (18.23)	-4.7 (16.85)
SBP, Day 7, n=19, 17	0.9 (18.88)	-6.1 (16.34)
SBP, Day 14, n=18, 17	4.3 (20.68)	-7.6 (18.61)
SBP, Day 21, n=17, 17	-1.4 (14.98)	-7.0 (13.88)
SBP, Day 35, n=16, 16	2.8 (20.14)	-4.5 (15.08)
DBP, Day 0, n=21, 19	-2.7 (16.04)	-1.8 (13.63)
DBP, Day 7, n=19, 17	1.6 (16.37)	0.3 (13.87)
DBP, Day 14, n=18, 17	3.4 (18.29)	-5.9 (14.69)
DBP, Day 21, n=17, 17	1.5 (11.41)	-1.2 (11.91)
DBP, Day 35, n=16, 16	4.7 (14.74)	-1.1 (11.20)

14. Secondary Outcome

Title	Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35
Description	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.
Time Frame	Baseline; Days 0, 7, 14, 21, and 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
Day 0, n=21, 19	1.1 (13.66)	-1.0 (17.15)
Day 7, n=19, 17	13.3 (14.41)	3.8 (20.42)
Day 14, n=18, 17	12.5 (14.70)	3.6 (25.47)
Day 21, n=17, 17	16.4 (14.54)	1.8 (21.14)
Day 35, n=16, 16	19.2 (18.99)	3.6 (23.60)

15. Secondary Outcome

Title	Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35
Description	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.
Time Frame	Screening (SCR) and Day 35

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Adult Participants: VACV 500 mg Tablet	Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).	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).
Measure Participants	21	19
SCR, Normal, n=21, 19	16 76.2%	19 100%
SCR, NCS, n=21, 19	5 23.8%	0 0%
SCR, CS, n=21, 19	0 0%	0 0%
SCR, NR, n=21, 19	0 0%	0 0%
Day 35, Normal, n=16, 16	15 71.4%	13 68.4%
Day 35, NCS, n=16, 16	1 4.8%	2 10.5%
Day 35, CS, n=16, 16	0 0%	0 0%
Day 35, NR, n=16, 16	0 0%	1 5.3%

Adverse Events

Time Frame	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).
Adverse Event Reporting Description	SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received VACV more than once.
Arm/Group Title	Adult Participants: VACV 500 mg Tablet		Pediatric Participants: VACV 500 mg Granules/Tablets
Arm/Group Description	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).		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).
All Cause Mortality
	Adult Participants: VACV 500 mg Tablet		Pediatric Participants: VACV 500 mg Granules/Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Adult Participants: VACV 500 mg Tablet		Pediatric Participants: VACV 500 mg Granules/Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)		1/19 (5.3%)
Hepatobiliary disorders
Liver injury	0/21 (0%)		1/19 (5.3%)
Respiratory, thoracic and mediastinal disorders
Lung disorder	1/21 (4.8%)		0/19 (0%)
Skin and subcutaneous tissue disorders
Toxic skin eruption	1/21 (4.8%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Adult Participants: VACV 500 mg Tablet		Pediatric Participants: VACV 500 mg Granules/Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/21 (61.9%)		11/19 (57.9%)
Blood and lymphatic system disorders
Thrombocytopenia	3/21 (14.3%)		4/19 (21.1%)
Febrile neutropenia	6/21 (28.6%)		0/19 (0%)
Anaemia	2/21 (9.5%)		3/19 (15.8%)
Leukopenia	0/21 (0%)		4/19 (21.1%)
Neutropenia	0/21 (0%)		3/19 (15.8%)
Lymphopenia	0/21 (0%)		2/19 (10.5%)
Coagulopathy	0/21 (0%)		1/19 (5.3%)
Cardiac disorders
Arrhythmia	1/21 (4.8%)		0/19 (0%)
Tachycardia	0/21 (0%)		1/19 (5.3%)
Ear and labyrinth disorders
Tinnitus	0/21 (0%)		1/19 (5.3%)
Eye disorders
Diplopia	1/21 (4.8%)		0/19 (0%)
Dry eye	0/21 (0%)		1/19 (5.3%)
Eye pruritus	0/21 (0%)		1/19 (5.3%)
Retinal haemorrhage	0/21 (0%)		1/19 (5.3%)
Gastrointestinal disorders
Diarrhoea	8/21 (38.1%)		4/19 (21.1%)
Nausea	5/21 (23.8%)		3/19 (15.8%)
Vomiting	3/21 (14.3%)		5/19 (26.3%)
Stomatitis	4/21 (19%)		2/19 (10.5%)
Abdominal pain	2/21 (9.5%)		3/19 (15.8%)
Constipation	2/21 (9.5%)		3/19 (15.8%)
Abdominal pain upper	1/21 (4.8%)		1/19 (5.3%)
Proctalgia	2/21 (9.5%)		0/19 (0%)
Tongue coated	0/21 (0%)		2/19 (10.5%)
Anal fissure	1/21 (4.8%)		0/19 (0%)
Anorectal discomfort	1/21 (4.8%)		0/19 (0%)
Cheilitis	1/21 (4.8%)		0/19 (0%)
Dry mouth	1/21 (4.8%)		0/19 (0%)
Gastritis erosive	1/21 (4.8%)		0/19 (0%)
Gastrointestinal mucosal disorder	0/21 (0%)		1/19 (5.3%)
Gingival swelling	0/21 (0%)		1/19 (5.3%)
Haematochezia	0/21 (0%)		1/19 (5.3%)
Haemorrhoids	0/21 (0%)		1/19 (5.3%)
Ileus	0/21 (0%)		1/19 (5.3%)
Mouth haemorrhage	1/21 (4.8%)		0/19 (0%)
Oral discomfort	1/21 (4.8%)		0/19 (0%)
Oral disorder	1/21 (4.8%)		0/19 (0%)
Oral pain	0/21 (0%)		1/19 (5.3%)
Parotid gland enlargement	1/21 (4.8%)		0/19 (0%)
Periproctitis	0/21 (0%)		1/19 (5.3%)
General disorders
Fatigue	5/21 (23.8%)		2/19 (10.5%)
Chest pain	0/21 (0%)		1/19 (5.3%)
Chills	0/21 (0%)		1/19 (5.3%)
Feeling abnormal	1/21 (4.8%)		0/19 (0%)
Oedema	1/21 (4.8%)		0/19 (0%)
Oedema peripheral	0/21 (0%)		1/19 (5.3%)
Hepatobiliary disorders
Hepatic function abnormal	1/21 (4.8%)		0/19 (0%)
Liver injury	1/21 (4.8%)		0/19 (0%)
Immune system disorders
Bone marrow transplant rejection	1/21 (4.8%)		0/19 (0%)
Graft versus host disease in skin	1/21 (4.8%)		0/19 (0%)
Infections and infestations
Nasopharyngitis	1/21 (4.8%)		2/19 (10.5%)
Bacteraemia	2/21 (9.5%)		0/19 (0%)
Sepsis	1/21 (4.8%)		1/19 (5.3%)
Acute sinusitis	0/21 (0%)		1/19 (5.3%)
Bronchitis	0/21 (0%)		1/19 (5.3%)
Device related infection	0/21 (0%)		1/19 (5.3%)
Folliculitis	1/21 (4.8%)		0/19 (0%)
Molluscum contagiosum	0/21 (0%)		1/19 (5.3%)
Injury, poisoning and procedural complications
Contusion	0/21 (0%)		1/19 (5.3%)
Excoriation	1/21 (4.8%)		0/19 (0%)
Laceration	0/21 (0%)		1/19 (5.3%)
Investigations
Alanine aminotransferase increased	1/21 (4.8%)		4/19 (21.1%)
Aspartate aminotransferase increased	1/21 (4.8%)		4/19 (21.1%)
Amylase increased	0/21 (0%)		3/19 (15.8%)
Blood bilirubin increased	2/21 (9.5%)		1/19 (5.3%)
C-reactive protein increased	0/21 (0%)		3/19 (15.8%)
Blood urine present	0/21 (0%)		2/19 (10.5%)
Hepatic enzyme increased	2/21 (9.5%)		0/19 (0%)
Occult blood	0/21 (0%)		2/19 (10.5%)
Antithrombin III decreased	0/21 (0%)		1/19 (5.3%)
Blood creatinine increased	1/21 (4.8%)		0/19 (0%)
Blood magnesium decreased	1/21 (4.8%)		0/19 (0%)
Blood potassium decreased	1/21 (4.8%)		0/19 (0%)
Blood pressure increased	0/21 (0%)		1/19 (5.3%)
Blood sodium increased	1/21 (4.8%)		0/19 (0%)
Glucose urine present	0/21 (0%)		1/19 (5.3%)
Platelet count decreased	1/21 (4.8%)		0/19 (0%)
Red blood cell count decreased	1/21 (4.8%)		0/19 (0%)
Urine output decreased	0/21 (0%)		1/19 (5.3%)
Weight decreased	0/21 (0%)		1/19 (5.3%)
White blood cell count decreased	1/21 (4.8%)		0/19 (0%)
Pyrexia	2/21 (9.5%)		3/19 (15.8%)
Metabolism and nutrition disorders
Decreased appetite	7/21 (33.3%)		2/19 (10.5%)
Fluid retention	3/21 (14.3%)		0/19 (0%)
Hyponatraemia	0/21 (0%)		3/19 (15.8%)
Hyperglycaemia	2/21 (9.5%)		0/19 (0%)
Hypomagnesaemia	2/21 (9.5%)		0/19 (0%)
Diabetes mellitus	1/21 (4.8%)		0/19 (0%)
Hypoalbuminaemia	0/21 (0%)		1/19 (5.3%)
Hypoproteinaemia	0/21 (0%)		1/19 (5.3%)
Musculoskeletal and connective tissue disorders
Back pain	3/21 (14.3%)		0/19 (0%)
Bone pain	1/21 (4.8%)		0/19 (0%)
Groin pain	0/21 (0%)		1/19 (5.3%)
Limb discomfort	0/21 (0%)		1/19 (5.3%)
Musculoskeletal chest pain	1/21 (4.8%)		0/19 (0%)
Musculoskeletal discomfort	1/21 (4.8%)		0/19 (0%)
Neck pain	0/21 (0%)		1/19 (5.3%)
Pain in extremity	0/21 (0%)		1/19 (5.3%)
Nervous system disorders
Headache	2/21 (9.5%)		2/19 (10.5%)
Dysgeusia	1/21 (4.8%)		0/19 (0%)
Head discomfort	1/21 (4.8%)		0/19 (0%)
Hypoaesthesia	0/21 (0%)		1/19 (5.3%)
Peripheral sensory neuropathy	1/21 (4.8%)		0/19 (0%)
Sensory disturbance	1/21 (4.8%)		0/19 (0%)
Psychiatric disorders
Insomnia	4/21 (19%)		0/19 (0%)
Delirium	1/21 (4.8%)		0/19 (0%)
Renal and urinary disorders
Dysuria	1/21 (4.8%)		1/19 (5.3%)
Hypertonic bladder	1/21 (4.8%)		0/19 (0%)
Renal impairment	1/21 (4.8%)		0/19 (0%)
Reproductive system and breast disorders
Metrorrhagia	1/21 (4.8%)		0/19 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	4/21 (19%)		1/19 (5.3%)
Epistaxis	2/21 (9.5%)		2/19 (10.5%)
Cough	0/21 (0%)		2/19 (10.5%)
Dyspnoea	0/21 (0%)		1/19 (5.3%)
Hiccups	1/21 (4.8%)		0/19 (0%)
Hyperventilation	0/21 (0%)		1/19 (5.3%)
Oropharyngeal discomfort	1/21 (4.8%)		0/19 (0%)
Pharyngeal erythema	1/21 (4.8%)		0/19 (0%)
Pulmonary oedema	1/21 (4.8%)		0/19 (0%)
Rhinorrhoea	1/21 (4.8%)		0/19 (0%)
Skin and subcutaneous tissue disorders
Rash	3/21 (14.3%)		1/19 (5.3%)
Urticaria	1/21 (4.8%)		2/19 (10.5%)
Alopecia	0/21 (0%)		2/19 (10.5%)
Pruritus	0/21 (0%)		2/19 (10.5%)
Dermatitis bullous	0/21 (0%)		1/19 (5.3%)
Dry skin	0/21 (0%)		1/19 (5.3%)
Erythema	1/21 (4.8%)		0/19 (0%)
Palmar erythema	0/21 (0%)		1/19 (5.3%)
Petechiae	0/21 (0%)		1/19 (5.3%)
Rash maculo-papular	1/21 (4.8%)		0/19 (0%)
Skin ulcer	0/21 (0%)		1/19 (5.3%)
Xeroderma	1/21 (4.8%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.