Trial Outcomes & Findings for Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients (NCT NCT01602562)

Last Updated: 2018-08-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)

Results posted on

2018-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	21	19
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).
Overall Study Adverse Event	3	1
Overall Study Physician Decision	1	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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 n=40 Participants Total of all reporting groups
Age, Continuous	48.6 Years STANDARD_DEVIATION 14.32 • n=93 Participants	7.5 Years STANDARD_DEVIATION 4.69 • n=4 Participants	29.1 Years STANDARD_DEVIATION 23.40 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	7 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	21 Participants n=93 Participants	19 Participants n=4 Participants	40 Participants n=27 Participants

PRIMARY outcome

Timeframe: From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)

Population: 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.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Number of Participants With a Herpes Simplex Virus (HSV) Infection	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)

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

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.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Any AE	13 Participants	11 Participants
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Any SAE	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Screening (SCR), Day 14, and Day 35

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 for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.

Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35.

Outcome measures

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Direct bilirubin, SCR, n=21, 19	2.931 Micromoles per liter (µmol/L) Standard Deviation 1.8843	2.970 Micromoles per liter (µmol/L) Standard Deviation 1.8769
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Direct bilirubin, Day 14, n=18, 17	7.410 Micromoles per liter (µmol/L) Standard Deviation 11.5234	3.923 Micromoles per liter (µmol/L) Standard Deviation 3.0688
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Direct bilirubin, Day 35, n=16, 16	2.351 Micromoles per liter (µmol/L) Standard Deviation 0.8550	2.565 Micromoles per liter (µmol/L) Standard Deviation 1.2488
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Total bilirubin, SCR, n=21, 19	8.224 Micromoles per liter (µmol/L) Standard Deviation 5.4242	8.190 Micromoles per liter (µmol/L) Standard Deviation 3.9728
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Total bilirubin, Day 14, n=18, 17	12.540 Micromoles per liter (µmol/L) Standard Deviation 14.8264	9.858 Micromoles per liter (µmol/L) Standard Deviation 8.6251
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Total bilirubin, Day 35, n=16, 16	6.306 Micromoles per liter (µmol/L) Standard Deviation 1.9466	6.733 Micromoles per liter (µmol/L) Standard Deviation 3.1512
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Creatinine, SCR, n=21, 19	62.6798 Micromoles per liter (µmol/L) Standard Deviation 19.71123	30.1025 Micromoles per liter (µmol/L) Standard Deviation 10.12416
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Creatinine, Day 14, n=18, 17	46.7047 Micromoles per liter (µmol/L) Standard Deviation 16.31214	25.5320 Micromoles per liter (µmol/L) Standard Deviation 12.84039
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Creatinine, Day 35, n=16, 16	58.7860 Micromoles per liter (µmol/L) Standard Deviation 18.83010	33.3710 Micromoles per liter (µmol/L) Standard Deviation 19.49749
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Uric acid, SCR, n=21, 19	276.1571 Micromoles per liter (µmol/L) Standard Deviation 80.38764	259.5206 Micromoles per liter (µmol/L) Standard Deviation 63.88405
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Uric acid, Day 14, n=18, 17	133.1691 Micromoles per liter (µmol/L) Standard Deviation 62.35442	137.5038 Micromoles per liter (µmol/L) Standard Deviation 56.34464
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 Uric acid, Day 35, n=16, 16	255.0205 Micromoles per liter (µmol/L) Standard Deviation 96.37167	238.6635 Micromoles per liter (µmol/L) Standard Deviation 101.47400

SECONDARY outcome

Timeframe: 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.

Outcome measures

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 Albumin, SCR, n=21, 19	41.0 Grams per liter (G/L) Standard Deviation 3.07	41.5 Grams per liter (G/L) Standard Deviation 2.04
Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 Albumin, Day 14, n=18, 17	34.6 Grams per liter (G/L) Standard Deviation 3.87	39.1 Grams per liter (G/L) Standard Deviation 3.04
Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 Albumin, Day 35, n=16, 16	40.8 Grams per liter (G/L) Standard Deviation 3.34	40.9 Grams per liter (G/L) Standard Deviation 3.02
Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 Total protein, SCR, n=21, 19	64.2 Grams per liter (G/L) Standard Deviation 5.83	66.2 Grams per liter (G/L) Standard Deviation 5.34
Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 Total protein, Day 14, n=18, 17	57.6 Grams per liter (G/L) Standard Deviation 5.76	62.7 Grams per liter (G/L) Standard Deviation 5.08
Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 Total protein, Day 35, n=16, 16	62.9 Grams per liter (G/L) Standard Deviation 4.75	65.3 Grams per liter (G/L) Standard Deviation 5.84

SECONDARY outcome

Timeframe: 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.

Outcome measures

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 Platelet count, SCR, n=21,19	190.2 giga (10^9) per liter (GI/L) Standard Deviation 126.32	167.7 giga (10^9) per liter (GI/L) Standard Deviation 98.15
Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 Platelet count, Day 14, n=18, 17	40.3 giga (10^9) per liter (GI/L) Standard Deviation 20.73	58.2 giga (10^9) per liter (GI/L) Standard Deviation 37.41
Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 Platelet count, Day 35, n=16, 16	139.4 giga (10^9) per liter (GI/L) Standard Deviation 79.29	119.0 giga (10^9) per liter (GI/L) Standard Deviation 89.31
Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 WBC count, SCR, n=21,19	4.01 giga (10^9) per liter (GI/L) Standard Deviation 1.842	3.03 giga (10^9) per liter (GI/L) Standard Deviation 1.873
Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 WBC count, Day 14, n=16, 12	3.46 giga (10^9) per liter (GI/L) Standard Deviation 2.955	2.23 giga (10^9) per liter (GI/L) Standard Deviation 2.403
Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 WBC count, Day 35, n=16, 14	5.00 giga (10^9) per liter (GI/L) Standard Deviation 3.524	3.71 giga (10^9) per liter (GI/L) Standard Deviation 2.189

SECONDARY outcome

Timeframe: Screening (SCR), Day 14, and Day 35

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.

Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Mean Red Blood Cell Count at Screening, Day 14, and Day 35 SCR, n=21,19	3.165 tera (10^12) per liter (TI/L) Standard Deviation 0.7583	3.293 tera (10^12) per liter (TI/L) Standard Deviation 0.6529
Mean Red Blood Cell Count at Screening, Day 14, and Day 35 Day 14, n=18, 17	2.932 tera (10^12) per liter (TI/L) Standard Deviation 0.3479	2.908 tera (10^12) per liter (TI/L) Standard Deviation 0.3854
Mean Red Blood Cell Count at Screening, Day 14, and Day 35 Day 35, n=16, 16	3.297 tera (10^12) per liter (TI/L) Standard Deviation 0.5021	3.073 tera (10^12) per liter (TI/L) Standard Deviation 0.4797

SECONDARY outcome

Timeframe: Screening (SCR), Day 14, and Day 35

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.

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

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Mean Hemoglobin Values at Screening, Day 14, and Day 35 SCR, n=21,19	101.6 Grams per liter (G/L) Standard Deviation 24.84	99.3 Grams per liter (G/L) Standard Deviation 17.94
Mean Hemoglobin Values at Screening, Day 14, and Day 35 Day 14, n=18, 17	91.6 Grams per liter (G/L) Standard Deviation 10.02	85.1 Grams per liter (G/L) Standard Deviation 12.10
Mean Hemoglobin Values at Screening, Day 14, and Day 35 Day 35, n=16, 16	106.5 Grams per liter (G/L) Standard Deviation 16.36	94.4 Grams per liter (G/L) Standard Deviation 15.23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UB, Neg, SCR, n=21, 19	21 Participants	19 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UB, Neg, Day 14, n=18, 17	18 Participants	17 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UB, Neg, Day 35, n=16, 16	16 Participants	16 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UOB, Neg, SCR, n=21, 19	19 Participants	19 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UOB, 2+, SCR, n=21, 19	2 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UOB, Neg, Day 14, n=18, 17	14 Participants	14 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UOB, Trace, Day 14, n=18, 17	2 Participants	2 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UOB, 1+, Day 14, n=18, 17	2 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UOB, 3+, Day 14, n=18, 17	0 Participants	1 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UOB, Neg, Day 35, n=16, 16	12 Participants	16 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UOB, Trace, Day 35, n=16, 16	1 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UOB, 1+, Day 35, n=16, 16	2 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UOB, 3+, Day 35, n=16, 16	1 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UG, Neg, SCR, n=21, 19	19 Participants	19 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UG, Trace, SCR, n=21, 19	2 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UG, Neg, Day 14, n=18, 17	14 Participants	17 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UG, Trace, Day 14, n=18, 17	1 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UG, 1+, Day 14, n=18, 17	1 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UG, 2+, Day 14, n=18, 17	1 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UG, 3+, Day 14, n=18, 17	1 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UG, Neg, Day 35, n=16, 16	15 Participants	16 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UG, Trace, Day 35, n=16, 16	1 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UK, Neg, SCR, n=21, 19	21 Participants	19 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UK, Neg, Day 14, n=18, 17	17 Participants	17 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UK, 1+, Day 14, n=18, 17	1 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UK, Neg, Day 35, n=16, 16	16 Participants	15 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UK, 1+, Day 35, n=16, 16	0 Participants	1 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, Neg, SCR, n=21, 19	19 Participants	14 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, Trace, SCR, n=21, 19	0 Participants	4 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, 1+, SCR, n=21, 19	0 Participants	1 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, 2+, SCR, n=21, 19	2 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, Neg, Day 14, n=18, 17	9 Participants	12 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, Trace, Day 14, n=18, 17	5 Participants	4 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, 1+, Day 14, n=18, 17	2 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, 2+, Day 14, n=18, 17	2 Participants	1 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, Neg, Day 35, n=16, 16	13 Participants	13 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, Trace, Day 35, n=16, 16	2 Participants	1 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UP, 1+, Day 35, n=16, 16	1 Participants	2 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UUG, Trace, SCR, n=21, 19	19 Participants	19 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UUG, 2+, SCR, n=21, 19	2 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UUG, Trace, Day 14, n=18, 17	17 Participants	15 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UUG, 1+, Day 14, n=18, 17	1 Participants	0 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UUG, 2+, Day 14, n=18, 17	0 Participants	1 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UUG, 3+, Day 14, n=18, 17	0 Participants	1 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UUG, Trace, Day 35, n=16, 16	16 Participants	15 Participants
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 UUG, 3+, Day 35, n=16, 16	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Screening (SCR), Day 14, and Day 35

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.

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.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 SCR, n=21, 19	1.0146 ratio Standard Deviation 0.00705	1.0188 ratio Standard Deviation 0.00912
Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 Day 14, n=18, 17	1.0158 ratio Standard Deviation 0.00628	1.0155 ratio Standard Deviation 0.00685
Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 Day 35, n=16, 16	1.0137 ratio Standard Deviation 0.00572	1.0153 ratio Standard Deviation 0.00642

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 SBP, Day 0, n=21, 19	-1.8 Millimeters of mercury Standard Deviation 18.23	-4.7 Millimeters of mercury Standard Deviation 16.85
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 SBP, Day 7, n=19, 17	0.9 Millimeters of mercury Standard Deviation 18.88	-6.1 Millimeters of mercury Standard Deviation 16.34
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 SBP, Day 14, n=18, 17	4.3 Millimeters of mercury Standard Deviation 20.68	-7.6 Millimeters of mercury Standard Deviation 18.61
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 SBP, Day 21, n=17, 17	-1.4 Millimeters of mercury Standard Deviation 14.98	-7.0 Millimeters of mercury Standard Deviation 13.88
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 SBP, Day 35, n=16, 16	2.8 Millimeters of mercury Standard Deviation 20.14	-4.5 Millimeters of mercury Standard Deviation 15.08
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 DBP, Day 0, n=21, 19	-2.7 Millimeters of mercury Standard Deviation 16.04	-1.8 Millimeters of mercury Standard Deviation 13.63
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 DBP, Day 7, n=19, 17	1.6 Millimeters of mercury Standard Deviation 16.37	0.3 Millimeters of mercury Standard Deviation 13.87
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 DBP, Day 14, n=18, 17	3.4 Millimeters of mercury Standard Deviation 18.29	-5.9 Millimeters of mercury Standard Deviation 14.69
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 DBP, Day 21, n=17, 17	1.5 Millimeters of mercury Standard Deviation 11.41	-1.2 Millimeters of mercury Standard Deviation 11.91
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 DBP, Day 35, n=16, 16	4.7 Millimeters of mercury Standard Deviation 14.74	-1.1 Millimeters of mercury Standard Deviation 11.20

SECONDARY outcome

Timeframe: Baseline; Days 0, 7, 14, 21, and 35

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.

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.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 Day 0, n=21, 19	1.1 Beats per minute Standard Deviation 13.66	-1.0 Beats per minute Standard Deviation 17.15
Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 Day 7, n=19, 17	13.3 Beats per minute Standard Deviation 14.41	3.8 Beats per minute Standard Deviation 20.42
Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 Day 14, n=18, 17	12.5 Beats per minute Standard Deviation 14.70	3.6 Beats per minute Standard Deviation 25.47
Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 Day 21, n=17, 17	16.4 Beats per minute Standard Deviation 14.54	1.8 Beats per minute Standard Deviation 21.14
Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 Day 35, n=16, 16	19.2 Beats per minute Standard Deviation 18.99	3.6 Beats per minute Standard Deviation 23.60

SECONDARY outcome

Timeframe: Screening (SCR) and Day 35

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.

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.

Outcome measures

Outcome measures
Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 SCR, Normal, n=21, 19	16 Participants	19 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 SCR, NCS, n=21, 19	5 Participants	0 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 SCR, CS, n=21, 19	0 Participants	0 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 SCR, NR, n=21, 19	0 Participants	0 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 Day 35, Normal, n=16, 16	15 Participants	13 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 Day 35, NCS, n=16, 16	1 Participants	2 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 Day 35, CS, n=16, 16	0 Participants	0 Participants
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 Day 35, NR, n=16, 16	0 Participants	1 Participants

Adverse Events

Adult Participants: VACV 500 mg Tablet

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Pediatric Participants: VACV 500 mg Granules/Tablets

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adult Participants: VACV 500 mg Tablet n=21 participants at risk 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: VACV 500 mg Granules/Tablets n=19 participants at risk 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).
Hepatobiliary disorders Liver injury	0.00% 0/21 • 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.	5.3% 1/19 • 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.
Respiratory, thoracic and mediastinal disorders Lung disorder	4.8% 1/21 • 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.	0.00% 0/19 • 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.
Skin and subcutaneous tissue disorders Toxic skin eruption	4.8% 1/21 • 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.	0.00% 0/19 • 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.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

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

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

Measure	Adult Participants: VACV 500 mg Tablet n=21 Participants 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: VACV 500 mg Granules/Tablets n=19 Participants 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).
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Basophils, SCR, n=21,19	1.05 Percentage of cells in blood Standard Deviation 1.473	0.49 Percentage of cells in blood Standard Deviation 0.470
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Basophils, Day 14, n=16, 16	0.69 Percentage of cells in blood Standard Deviation 1.661	0.14 Percentage of cells in blood Standard Deviation 0.352
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Basophils, Day 35, n=16, 15	1.09 Percentage of cells in blood Standard Deviation 0.903	0.59 Percentage of cells in blood Standard Deviation 0.380
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Eosinophils, SCR, n=21, 19	3.67 Percentage of cells in blood Standard Deviation 4.754	2.06 Percentage of cells in blood Standard Deviation 1.974
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Eosinophils, Day 14, n=16, 16	0.79 Percentage of cells in blood Standard Deviation 2.770	0.59 Percentage of cells in blood Standard Deviation 1.517
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Eosinophils, Day 35, n=16, 15	4.10 Percentage of cells in blood Standard Deviation 2.672	7.51 Percentage of cells in blood Standard Deviation 10.357
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Lymphocytes, SCR, n=21,19	32.72 Percentage of cells in blood Standard Deviation 16.104	38.94 Percentage of cells in blood Standard Deviation 21.616
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Lymphocytes, Day 14, n=16, 16	13.61 Percentage of cells in blood Standard Deviation 8.897	16.73 Percentage of cells in blood Standard Deviation 17.909
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Lymphocytes, Day 35, n=16, 15	37.08 Percentage of cells in blood Standard Deviation 15.496	30.85 Percentage of cells in blood Standard Deviation 20.338
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Monocytes, SCR, n=21,19	7.90 Percentage of cells in blood Standard Deviation 3.337	10.99 Percentage of cells in blood Standard Deviation 7.565
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Monocytes, Day 14, n=16, 16	15.32 Percentage of cells in blood Standard Deviation 7.263	17.33 Percentage of cells in blood Standard Deviation 12.061
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Monocytes, Day 35, n=16, 15	14.54 Percentage of cells in blood Standard Deviation 6.609	13.33 Percentage of cells in blood Standard Deviation 7.021
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Total neutrophils, SCR, n=21,19	54.46 Percentage of cells in blood Standard Deviation 15.003	47.52 Percentage of cells in blood Standard Deviation 22.667
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Total neutrophils, Day 14, n=16, 16	63.53 Percentage of cells in blood Standard Deviation 18.117	62.21 Percentage of cells in blood Standard Deviation 23.273
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 Total neutrophils, Day 35, n=16, 15	42.76 Percentage of cells in blood Standard Deviation 13.336	47.63 Percentage of cells in blood Standard Deviation 20.745