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Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients

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ClinicalTrials.gov Identifier: NCT01602562
Recruitment Status : Completed
First Posted : May 21, 2012
Results First Posted : February 24, 2014
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Herpes Simplex
Intervention Drug: VACV tablets (Adults or pediatrics) or granules (pediatrics)
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adult Participants: VACV 500 mg Tablet Pediatric Participants: VACV 500 mg Granules/Tablets
Hide 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
Reason Not Completed
Adverse Event             3             1
Physician Decision             1             1
Withdrawal by Subject             1             1
Arm/Group Title Adult Participants: VACV 500 mg Tablet Pediatric Participants: VACV 500 mg Granules/Tablets Total
Hide 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 Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 40 participants
48.6  (14.32) 7.5  (4.69) 29.1  (23.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
9
  42.9%
7
  36.8%
16
  40.0%
Male
12
  57.1%
12
  63.2%
24
  60.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian - Japanese Heritage Number Analyzed 21 participants 19 participants 40 participants
21 19 40
1.Primary Outcome
Title Number of Participants With a Herpes Simplex Virus (HSV) Infection
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Measure Type: Number
Unit of Measure: Participants
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adult Participants: VACV 500 mg Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
0.00 to 16.11
Estimation Comments The estimated value reflects the percentage of participants with an HSV infection.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pediatric Participants: VACV 500 mg Granules/Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
0.00 to 17.65
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)
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Measure Type: Number
Unit of Measure: Participants
Any AE 13 11
Any SAE 2 1
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: International units per liter (IU/L)
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter (µmol/L)
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Grams per liter (G/L)
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Percentage of cells in blood
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: giga (10^9) per liter (GI/L)
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: tera (10^12) per liter (TI/L)
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
Hide 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
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Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Grams per liter (G/L)
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
Hide 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
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Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Measure Type: Number
Unit of Measure: Participants
UB, Neg, SCR, n=21, 19 21 19
UB, Neg, Day 14, n=18, 17 18 17
UB, Neg, Day 35, n=16, 16 16 16
UOB, Neg, SCR, n=21, 19 19 19
UOB, 2+, SCR, n=21, 19 2 0
UOB, Neg, Day 14, n=18, 17 14 14
UOB, Trace, Day 14, n=18, 17 2 2
UOB, 1+, Day 14, n=18, 17 2 0
UOB, 3+, Day 14, n=18, 17 0 1
UOB, Neg, Day 35, n=16, 16 12 16
UOB, Trace, Day 35, n=16, 16 1 0
UOB, 1+, Day 35, n=16, 16 2 0
UOB, 3+, Day 35, n=16, 16 1 0
UG, Neg, SCR, n=21, 19 19 19
UG, Trace, SCR, n=21, 19 2 0
UG, Neg, Day 14, n=18, 17 14 17
UG, Trace, Day 14, n=18, 17 1 0
UG, 1+, Day 14, n=18, 17 1 0
UG, 2+, Day 14, n=18, 17 1 0
UG, 3+, Day 14, n=18, 17 1 0
UG, Neg, Day 35, n=16, 16 15 16
UG, Trace, Day 35, n=16, 16 1 0
UK, Neg, SCR, n=21, 19 21 19
UK, Neg, Day 14, n=18, 17 17 17
UK, 1+, Day 14, n=18, 17 1 0
UK, Neg, Day 35, n=16, 16 16 15
UK, 1+, Day 35, n=16, 16 0 1
UP, Neg, SCR, n=21, 19 19 14
UP, Trace, SCR, n=21, 19 0 4
UP, 1+, SCR, n=21, 19 0 1
UP, 2+, SCR, n=21, 19 2 0
UP, Neg, Day 14, n=18, 17 9 12
UP, Trace, Day 14, n=18, 17 5 4
UP, 1+, Day 14, n=18, 17 2 0
UP, 2+, Day 14, n=18, 17 2 1
UP, Neg, Day 35, n=16, 16 13 13
UP, Trace, Day 35, n=16, 16 2 1
UP, 1+, Day 35, n=16, 16 1 2
UUG, Trace, SCR, n=21, 19 19 19
UUG, 2+, SCR, n=21, 19 2 0
UUG, Trace, Day 14, n=18, 17 17 15
UUG, 1+, Day 14, n=18, 17 1 0
UUG, 2+, Day 14, n=18, 17 0 1
UUG, 3+, Day 14, n=18, 17 0 1
UUG, Trace, Day 35, n=16, 16 16 15
UUG, 3+, Day 35, n=16, 16 0 1
12.Secondary Outcome
Title Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35
Hide 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
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Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: ratio
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
Hide 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
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Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
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
Hide 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
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Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: Beats per minute
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
Hide 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
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Hide 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
Hide 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).
Overall Number of Participants Analyzed 21 19
Measure Type: Number
Unit of Measure: Participants
SCR, Normal, n=21, 19 16 19
SCR, NCS, n=21, 19 5 0
SCR, CS, n=21, 19 0 0
SCR, NR, n=21, 19 0 0
Day 35, Normal, n=16, 16 15 13
Day 35, NCS, n=16, 16 1 2
Day 35, CS, n=16, 16 0 0
Day 35, NR, n=16, 16 0 1
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adult Participants: VACV 500 mg Tablet Pediatric Participants: VACV 500 mg Granules/Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   2/21 (9.52%)   1/19 (5.26%) 
Hepatobiliary disorders     
Liver injury  1  0/21 (0.00%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Lung disorder  1  1/21 (4.76%)  0/19 (0.00%) 
Skin and subcutaneous tissue disorders     
Toxic skin eruption  1  1/21 (4.76%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adult Participants: VACV 500 mg Tablet Pediatric Participants: VACV 500 mg Granules/Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   13/21 (61.90%)   11/19 (57.89%) 
Blood and lymphatic system disorders     
Thrombocytopenia  1  3/21 (14.29%)  4/19 (21.05%) 
Febrile neutropenia  1  6/21 (28.57%)  0/19 (0.00%) 
Anaemia  1  2/21 (9.52%)  3/19 (15.79%) 
Leukopenia  1  0/21 (0.00%)  4/19 (21.05%) 
Neutropenia  1  0/21 (0.00%)  3/19 (15.79%) 
Lymphopenia  1  0/21 (0.00%)  2/19 (10.53%) 
Coagulopathy  1  0/21 (0.00%)  1/19 (5.26%) 
Cardiac disorders     
Arrhythmia  1  1/21 (4.76%)  0/19 (0.00%) 
Tachycardia  1  0/21 (0.00%)  1/19 (5.26%) 
Ear and labyrinth disorders     
Tinnitus  1  0/21 (0.00%)  1/19 (5.26%) 
Eye disorders     
Diplopia  1  1/21 (4.76%)  0/19 (0.00%) 
Dry eye  1  0/21 (0.00%)  1/19 (5.26%) 
Eye pruritus  1  0/21 (0.00%)  1/19 (5.26%) 
Retinal haemorrhage  1  0/21 (0.00%)  1/19 (5.26%) 
Gastrointestinal disorders     
Diarrhoea  1  8/21 (38.10%)  4/19 (21.05%) 
Nausea  1  5/21 (23.81%)  3/19 (15.79%) 
Vomiting  1  3/21 (14.29%)  5/19 (26.32%) 
Stomatitis  1  4/21 (19.05%)  2/19 (10.53%) 
Abdominal pain  1  2/21 (9.52%)  3/19 (15.79%) 
Constipation  1  2/21 (9.52%)  3/19 (15.79%) 
Abdominal pain upper  1  1/21 (4.76%)  1/19 (5.26%) 
Proctalgia  1  2/21 (9.52%)  0/19 (0.00%) 
Tongue coated  1  0/21 (0.00%)  2/19 (10.53%) 
Anal fissure  1  1/21 (4.76%)  0/19 (0.00%) 
Anorectal discomfort  1  1/21 (4.76%)  0/19 (0.00%) 
Cheilitis  1  1/21 (4.76%)  0/19 (0.00%) 
Dry mouth  1  1/21 (4.76%)  0/19 (0.00%) 
Gastritis erosive  1  1/21 (4.76%)  0/19 (0.00%) 
Gastrointestinal mucosal disorder  1  0/21 (0.00%)  1/19 (5.26%) 
Gingival swelling  1  0/21 (0.00%)  1/19 (5.26%) 
Haematochezia  1  0/21 (0.00%)  1/19 (5.26%) 
Haemorrhoids  1  0/21 (0.00%)  1/19 (5.26%) 
Ileus  1  0/21 (0.00%)  1/19 (5.26%) 
Mouth haemorrhage  1  1/21 (4.76%)  0/19 (0.00%) 
Oral discomfort  1  1/21 (4.76%)  0/19 (0.00%) 
Oral disorder  1  1/21 (4.76%)  0/19 (0.00%) 
Oral pain  1  0/21 (0.00%)  1/19 (5.26%) 
Parotid gland enlargement  1  1/21 (4.76%)  0/19 (0.00%) 
Periproctitis  1  0/21 (0.00%)  1/19 (5.26%) 
General disorders     
Fatigue  1  5/21 (23.81%)  2/19 (10.53%) 
Chest pain  1  0/21 (0.00%)  1/19 (5.26%) 
Chills  1  0/21 (0.00%)  1/19 (5.26%) 
Feeling abnormal  1  1/21 (4.76%)  0/19 (0.00%) 
Oedema  1  1/21 (4.76%)  0/19 (0.00%) 
Oedema peripheral  1  0/21 (0.00%)  1/19 (5.26%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  1/21 (4.76%)  0/19 (0.00%) 
Liver injury  1  1/21 (4.76%)  0/19 (0.00%) 
Immune system disorders     
Bone marrow transplant rejection  1  1/21 (4.76%)  0/19 (0.00%) 
Graft versus host disease in skin  1  1/21 (4.76%)  0/19 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  1/21 (4.76%)  2/19 (10.53%) 
Bacteraemia  1  2/21 (9.52%)  0/19 (0.00%) 
Sepsis  1  1/21 (4.76%)  1/19 (5.26%) 
Acute sinusitis  1  0/21 (0.00%)  1/19 (5.26%) 
Bronchitis  1  0/21 (0.00%)  1/19 (5.26%) 
Device related infection  1  0/21 (0.00%)  1/19 (5.26%) 
Folliculitis  1  1/21 (4.76%)  0/19 (0.00%) 
Molluscum contagiosum  1  0/21 (0.00%)  1/19 (5.26%) 
Injury, poisoning and procedural complications     
Contusion  1  0/21 (0.00%)  1/19 (5.26%) 
Excoriation  1  1/21 (4.76%)  0/19 (0.00%) 
Laceration  1  0/21 (0.00%)  1/19 (5.26%) 
Investigations     
Alanine aminotransferase increased  1  1/21 (4.76%)  4/19 (21.05%) 
Aspartate aminotransferase increased  1  1/21 (4.76%)  4/19 (21.05%) 
Amylase increased  1  0/21 (0.00%)  3/19 (15.79%) 
Blood bilirubin increased  1  2/21 (9.52%)  1/19 (5.26%) 
C-reactive protein increased  1  0/21 (0.00%)  3/19 (15.79%) 
Blood urine present  1  0/21 (0.00%)  2/19 (10.53%) 
Hepatic enzyme increased  1  2/21 (9.52%)  0/19 (0.00%) 
Occult blood  1  0/21 (0.00%)  2/19 (10.53%) 
Antithrombin III decreased  1  0/21 (0.00%)  1/19 (5.26%) 
Blood creatinine increased  1  1/21 (4.76%)  0/19 (0.00%) 
Blood magnesium decreased  1  1/21 (4.76%)  0/19 (0.00%) 
Blood potassium decreased  1  1/21 (4.76%)  0/19 (0.00%) 
Blood pressure increased  1  0/21 (0.00%)  1/19 (5.26%) 
Blood sodium increased  1  1/21 (4.76%)  0/19 (0.00%) 
Glucose urine present  1  0/21 (0.00%)  1/19 (5.26%) 
Platelet count decreased  1  1/21 (4.76%)  0/19 (0.00%) 
Red blood cell count decreased  1  1/21 (4.76%)  0/19 (0.00%) 
Urine output decreased  1  0/21 (0.00%)  1/19 (5.26%) 
Weight decreased  1  0/21 (0.00%)  1/19 (5.26%) 
White blood cell count decreased  1  1/21 (4.76%)  0/19 (0.00%) 
Pyrexia  1  2/21 (9.52%)  3/19 (15.79%) 
Metabolism and nutrition disorders     
Decreased appetite  1  7/21 (33.33%)  2/19 (10.53%) 
Fluid retention  1  3/21 (14.29%)  0/19 (0.00%) 
Hyponatraemia  1  0/21 (0.00%)  3/19 (15.79%) 
Hyperglycaemia  1  2/21 (9.52%)  0/19 (0.00%) 
Hypomagnesaemia  1  2/21 (9.52%)  0/19 (0.00%) 
Diabetes mellitus  1  1/21 (4.76%)  0/19 (0.00%) 
Hypoalbuminaemia  1  0/21 (0.00%)  1/19 (5.26%) 
Hypoproteinaemia  1  0/21 (0.00%)  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  3/21 (14.29%)  0/19 (0.00%) 
Bone pain  1  1/21 (4.76%)  0/19 (0.00%) 
Groin pain  1  0/21 (0.00%)  1/19 (5.26%) 
Limb discomfort  1  0/21 (0.00%)  1/19 (5.26%) 
Musculoskeletal chest pain  1  1/21 (4.76%)  0/19 (0.00%) 
Musculoskeletal discomfort  1  1/21 (4.76%)  0/19 (0.00%) 
Neck pain  1  0/21 (0.00%)  1/19 (5.26%) 
Pain in extremity  1  0/21 (0.00%)  1/19 (5.26%) 
Nervous system disorders     
Headache  1  2/21 (9.52%)  2/19 (10.53%) 
Dysgeusia  1  1/21 (4.76%)  0/19 (0.00%) 
Head discomfort  1  1/21 (4.76%)  0/19 (0.00%) 
Hypoaesthesia  1  0/21 (0.00%)  1/19 (5.26%) 
Peripheral sensory neuropathy  1  1/21 (4.76%)  0/19 (0.00%) 
Sensory disturbance  1  1/21 (4.76%)  0/19 (0.00%) 
Psychiatric disorders     
Insomnia  1  4/21 (19.05%)  0/19 (0.00%) 
Delirium  1  1/21 (4.76%)  0/19 (0.00%) 
Renal and urinary disorders     
Dysuria  1  1/21 (4.76%)  1/19 (5.26%) 
Hypertonic bladder  1  1/21 (4.76%)  0/19 (0.00%) 
Renal impairment  1  1/21 (4.76%)  0/19 (0.00%) 
Reproductive system and breast disorders     
Metrorrhagia  1  1/21 (4.76%)  0/19 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  4/21 (19.05%)  1/19 (5.26%) 
Epistaxis  1  2/21 (9.52%)  2/19 (10.53%) 
Cough  1  0/21 (0.00%)  2/19 (10.53%) 
Dyspnoea  1  0/21 (0.00%)  1/19 (5.26%) 
Hiccups  1  1/21 (4.76%)  0/19 (0.00%) 
Hyperventilation  1  0/21 (0.00%)  1/19 (5.26%) 
Oropharyngeal discomfort  1  1/21 (4.76%)  0/19 (0.00%) 
Pharyngeal erythema  1  1/21 (4.76%)  0/19 (0.00%) 
Pulmonary oedema  1  1/21 (4.76%)  0/19 (0.00%) 
Rhinorrhoea  1  1/21 (4.76%)  0/19 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  3/21 (14.29%)  1/19 (5.26%) 
Urticaria  1  1/21 (4.76%)  2/19 (10.53%) 
Alopecia  1  0/21 (0.00%)  2/19 (10.53%) 
Pruritus  1  0/21 (0.00%)  2/19 (10.53%) 
Dermatitis bullous  1  0/21 (0.00%)  1/19 (5.26%) 
Dry skin  1  0/21 (0.00%)  1/19 (5.26%) 
Erythema  1  1/21 (4.76%)  0/19 (0.00%) 
Palmar erythema  1  0/21 (0.00%)  1/19 (5.26%) 
Petechiae  1  0/21 (0.00%)  1/19 (5.26%) 
Rash maculo-papular  1  1/21 (4.76%)  0/19 (0.00%) 
Skin ulcer  1  0/21 (0.00%)  1/19 (5.26%) 
Xeroderma  1  1/21 (4.76%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01602562     History of Changes
Other Study ID Numbers: 116100
First Submitted: May 17, 2012
First Posted: May 21, 2012
Results First Submitted: January 9, 2014
Results First Posted: February 24, 2014
Last Update Posted: August 17, 2018