Herpes Simplex
Conditions
Keywords
Herpes simplex infection, valaciclovir, herpes simplex virus, hematopoietic stem cell transplantation
Brief summary
The purpose of this study is to evaluate the preventive efficacy for HSV infection and safety of valaciclovir (VACV) in the adult and pediatric HSCT patients.
Detailed description
This clinical study is a multicenter open-label study on the adult and pediatric hematopoietic stem cell transplantation (HSCT) patients. The primary objective is to confirm the preventive efficacy for herpes simplex virus (HSV) infection of 256U87 (VACV: valaciclovir) due to the treatment before or immediately after hematopoietic stem cell transplantation. The secondary objective is to confirm the safety of VACV in the case of its use for such a purpose. This clinical study consists of the following two periods: the screening period lasting 7 days at the longest and the administration period from 7 days before HSCT to 35 days after HSCT (43 days in total). During the administration period, adult patients are orally given a VACV tablet twice daily, while pediatric patients are orally given VACV granules twice daily at a dose of 25 mg/kg b.w. (maximum dose per treatment: 500 mg). Pediatric patients weighing 40 kg or over may be orally given a VACV tablet twice daily.
Interventions
DRUGVACV tablets (Adults or pediatrics) or granules (pediatrics)
A white to slightly yellowish white film coated tablet contains 556 mg of valaciclovir hydrochloride (500 mg of valaciclovir)). VACV granules have no or slightly specific odor.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are planning to undergo hematopoietic stem cell transplantation, except cord blood transplantation. * Patients aged from 1 and above to under 65 at the time of informed consent. * Patients who can submit their voluntary written informed consent if they are 12 years old and over. * Patient is male or female. Male patients must be willing to use adequate contraception during the study. Female patients of childbearing potential must agree to consistently perform any of the contraceptive methods. * QTc \<450 msec, or QTc \<480 msec in patients with bundle branch block. (values based on either single ECG values or triplicate ECG averaged QTc values) * Liver test (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2x upper limit of normal (ULN); alkaline phosphatase (Al-P)and total bilirubin \<=1.5xULN (total bilirubin \>1.5xULN is acceptable if direct bilirubin \<35%).
Exclusion criteria
* Patients with a history of HSCT. * Patients who are judged to be in the following condition by the investigator (or subinvestigator): the clinical severity of malabsorption syndrome, vomiting, mucositis or other gastrointestinal dysfunction is so serious that orally administered VACV can not be absorbed. * Patients who have known nucleoside analogs hypersensitivity. * Patients who have a concurrent or past history of renal function disorder (serum creatinine \>=1.5x ULN). * Patients who have serious complication (eg, other malignant tumours, cardiac disorder, juvenile diabetes). * Patients who are currently treated with the prohibited concomitant drugs. * Patients with evidence of chronic hepatitis B or C. * Patients with AIDS or patients infected with HIV. * Patients who were given other trial products within 30 days before initiation of administration of this trial product or those who intend to participate in other clinical trials. * Patients who are pregnant or probably pregnant. * Patients who can not follow the protocol because of psychological, family, social or geological reasons. * Patients are not allowed to participate in this clinical trial if the investigator (or subinvestigator) judges that their participation is inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Herpes Simplex Virus (HSV) Infection | From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT) | Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LD) Values at Screening, Day 14, and Day 35 | Screening (SCR), Day 14, and Day 35 | Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35. |
| Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Screening (SCR), Day 14, and Day 35 | Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, Day 14, and Day 35. |
| Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35 | Screening (SCR), Day 14, and Day 35 | Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35. |
| Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 | Screening (SCR), Day 14, and Day 35 | Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35. |
| Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Screening (SCR), Day 14, and Day 35 | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35. |
| Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 | Screening (SCR), Day 14, and Day 35 | Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35. |
| Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT) | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs. |
| Mean Hemoglobin Values at Screening, Day 14, and Day 35 | Screening (SCR), Day 14, and Day 35 | Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35. |
| Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 | Screening (SCR), Day 14, and 35 | Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), urine protein (UP), and urine urobilinogen (UUG). The dipstick is a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, and 3+ (in order of increasing levels). Data are reported as the number of participants who had Neg, Trace, 1+, 2+, and 3+ levels at Screening, Day 14, and Day 35. If a category has not been reported for a specific parameter, then no participants were measured in that category. |
| Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 | Screening (SCR), Day 14, and Day 35 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population. |
| Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 | Baseline; Days 0, 7, 14, 21, and 35 | Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 | Baseline; Days 0, 7, 14, 21, and 35 | Heart rate is defined as the number of heartbeats per unit of time. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | Screening (SCR) and Day 35 | The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening and Day 35 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator. |
| Mean Red Blood Cell Count at Screening, Day 14, and Day 35 | Screening (SCR), Day 14, and Day 35 | Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adult Participants: VACV 500 mg Tablet Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT). | 21 |
| Pediatric Participants: VACV 500 mg Granules/Tablets Pediatric participants (between 1 and \<16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT). | 19 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Adult Participants: VACV 500 mg Tablet | Pediatric Participants: VACV 500 mg Granules/Tablets | Total |
|---|---|---|---|
| Age, Continuous | 48.6 Years STANDARD_DEVIATION 14.32 | 7.5 Years STANDARD_DEVIATION 4.69 | 29.1 Years STANDARD_DEVIATION 23.4 |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 21 | 11 / 19 |
| serious Total, serious adverse events | 2 / 21 | 1 / 19 |
Outcome results
Primary
Number of Participants With a Herpes Simplex Virus (HSV) Infection
Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adult Participants: VACV 500 mg Tablet | Number of Participants With a Herpes Simplex Virus (HSV) Infection | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With a Herpes Simplex Virus (HSV) Infection | 0 Participants |
95% CI: [0, 16.11]
95% CI: [0, 17.65]
Secondary
Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35
Heart rate is defined as the number of heartbeats per unit of time. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 14.7 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 | Day 35, n=16, 16 | 3.6 Beats per minute | Standard Deviation 23.6 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 | Day 0, n=21, 19 | -1.0 Beats per minute | Standard Deviation 17.15 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 | Day 7, n=19, 17 | 3.8 Beats per minute | Standard Deviation 20.42 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 | Day 14, n=18, 17 | 3.6 Beats per minute | Standard Deviation 25.47 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 | Day 21, n=17, 17 | 1.8 Beats per minute | Standard Deviation 21.14 |
Secondary
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35
Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: 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 for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | -5.9 Millimeters of mercury | Standard Deviation 14.69 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | -1.8 Millimeters of mercury | Standard Deviation 13.63 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | -4.5 Millimeters of mercury | Standard Deviation 15.08 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | -4.7 Millimeters of mercury | Standard Deviation 16.85 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | -1.1 Millimeters of mercury | Standard Deviation 11.2 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | -6.1 Millimeters of mercury | Standard Deviation 16.34 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0.3 Millimeters of mercury | Standard Deviation 13.87 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | -7.6 Millimeters of mercury | Standard Deviation 18.61 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | -1.2 Millimeters of mercury | Standard Deviation 11.91 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | -7.0 Millimeters of mercury | Standard Deviation 13.88 |
Secondary
Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35
Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 | Total protein, Day 35, n=16, 16 | 65.3 Grams per liter (G/L) | Standard Deviation 5.84 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 | Albumin, SCR, n=21, 19 | 41.5 Grams per liter (G/L) | Standard Deviation 2.04 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 | Albumin, Day 14, n=18, 17 | 39.1 Grams per liter (G/L) | Standard Deviation 3.04 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 | Albumin, Day 35, n=16, 16 | 40.9 Grams per liter (G/L) | Standard Deviation 3.02 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 | Total protein, SCR, n=21, 19 | 66.2 Grams per liter (G/L) | Standard Deviation 5.34 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 | Total protein, Day 14, n=18, 17 | 62.7 Grams per liter (G/L) | Standard Deviation 5.08 |
Secondary
Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LD) Values at Screening, Day 14, and Day 35
Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 27.5 International units per liter (IU/L) | Standard Deviation 10.61 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 598.8 International units per liter (IU/L) | Standard Deviation 132.37 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 72.0 International units per liter (IU/L) | Standard Deviation 40.63 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 456.7 International units per liter (IU/L) | Standard Deviation 206.98 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 255.9 International units per liter (IU/L) | Standard Deviation 92.84 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 519.9 International units per liter (IU/L) | Standard Deviation 183.83 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 27.4 International units per liter (IU/L) | Standard Deviation 28.85 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 20.7 International units per liter (IU/L) | Standard Deviation 12.55 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 50.7 International units per liter (IU/L) | Standard Deviation 43.34 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 62.1 International units per liter (IU/L) | Standard Deviation 84.64 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 38.4 International units per liter (IU/L) | Standard Deviation 26.48 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 62.0 International units per liter (IU/L) | Standard Deviation 76.59 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 210.6 International units per liter (IU/L) | Standard Deviation 103.09 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 27.1 International units per liter (IU/L) | Standard Deviation 9.62 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 24.8 International units per liter (IU/L) | Standard Deviation 24.74 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 35.0 International units per liter (IU/L) | Standard Deviation 34.88 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 213.3 International units per liter (IU/L) | Standard Deviation 77.51 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 54.0 International units per liter (IU/L) | Standard Deviation 48.96 |
Secondary
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35
Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 2.77 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Total neutrophils, Day 35, n=16, 15 | 47.63 Percentage of cells in blood | Standard Deviation 20.745 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Basophils, SCR, n=21,19 | 0.49 Percentage of cells in blood | Standard Deviation 0.47 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Basophils, Day 14, n=16, 16 | 0.14 Percentage of cells in blood | Standard Deviation 0.352 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Basophils, Day 35, n=16, 15 | 0.59 Percentage of cells in blood | Standard Deviation 0.38 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Eosinophils, SCR, n=21, 19 | 2.06 Percentage of cells in blood | Standard Deviation 1.974 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Eosinophils, Day 14, n=16, 16 | 0.59 Percentage of cells in blood | Standard Deviation 1.517 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Eosinophils, Day 35, n=16, 15 | 7.51 Percentage of cells in blood | Standard Deviation 10.357 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Lymphocytes, SCR, n=21,19 | 38.94 Percentage of cells in blood | Standard Deviation 21.616 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Lymphocytes, Day 14, n=16, 16 | 16.73 Percentage of cells in blood | Standard Deviation 17.909 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Lymphocytes, Day 35, n=16, 15 | 30.85 Percentage of cells in blood | Standard Deviation 20.338 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Monocytes, SCR, n=21,19 | 10.99 Percentage of cells in blood | Standard Deviation 7.565 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Monocytes, Day 14, n=16, 16 | 17.33 Percentage of cells in blood | Standard Deviation 12.061 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Monocytes, Day 35, n=16, 15 | 13.33 Percentage of cells in blood | Standard Deviation 7.021 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Total neutrophils, SCR, n=21,19 | 47.52 Percentage of cells in blood | Standard Deviation 22.667 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 | Total neutrophils, Day 14, n=16, 16 | 62.21 Percentage of cells in blood | Standard Deviation 23.273 |
Secondary
Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35
Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 1.3516 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 4.34 Millimoles per liter (mmol/L) | Standard Deviation 0.449 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 4.1703 Millimoles per liter (mmol/L) | Standard Deviation 0.70625 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 3.6903 Millimoles per liter (mmol/L) | Standard Deviation 0.93331 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 3.5504 Millimoles per liter (mmol/L) | Standard Deviation 1.2561 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 4.09 Millimoles per liter (mmol/L) | Standard Deviation 0.359 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 4.1279 Millimoles per liter (mmol/L) | Standard Deviation 1.01828 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1.4185 Millimoles per liter (mmol/L) | Standard Deviation 1.02762 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 103.3 Millimoles per liter (mmol/L) | Standard Deviation 2.21 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 140.2 Millimoles per liter (mmol/L) | Standard Deviation 1.92 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 105.0 Millimoles per liter (mmol/L) | Standard Deviation 2.06 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 4.1657 Millimoles per liter (mmol/L) | Standard Deviation 1.99412 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 104.0 Millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 139.2 Millimoles per liter (mmol/L) | Standard Deviation 1.55 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 6.0214 Millimoles per liter (mmol/L) | Standard Deviation 1.83355 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1.6646 Millimoles per liter (mmol/L) | Standard Deviation 1.04585 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 6.0996 Millimoles per liter (mmol/L) | Standard Deviation 2.13721 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 139.3 Millimoles per liter (mmol/L) | Standard Deviation 1.39 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 5.7800 Millimoles per liter (mmol/L) | Standard Deviation 1.41869 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 3.1332 Millimoles per liter (mmol/L) | Standard Deviation 1.35997 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 4.01 Millimoles per liter (mmol/L) | Standard Deviation 0.283 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1.3489 Millimoles per liter (mmol/L) | Standard Deviation 0.75044 |
Secondary
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35
Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, Day 14, and Day 35.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 0.855 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 18.8301 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Uric acid, Day 14, n=18, 17 | 137.5038 Micromoles per liter (µmol/L) | Standard Deviation 56.34464 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Direct bilirubin, SCR, n=21, 19 | 2.970 Micromoles per liter (µmol/L) | Standard Deviation 1.8769 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Creatinine, SCR, n=21, 19 | 30.1025 Micromoles per liter (µmol/L) | Standard Deviation 10.12416 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Direct bilirubin, Day 14, n=18, 17 | 3.923 Micromoles per liter (µmol/L) | Standard Deviation 3.0688 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Uric acid, SCR, n=21, 19 | 259.5206 Micromoles per liter (µmol/L) | Standard Deviation 63.88405 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Direct bilirubin, Day 35, n=16, 16 | 2.565 Micromoles per liter (µmol/L) | Standard Deviation 1.2488 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Creatinine, Day 14, n=18, 17 | 25.5320 Micromoles per liter (µmol/L) | Standard Deviation 12.84039 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Total bilirubin, SCR, n=21, 19 | 8.190 Micromoles per liter (µmol/L) | Standard Deviation 3.9728 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Uric acid, Day 35, n=16, 16 | 238.6635 Micromoles per liter (µmol/L) | Standard Deviation 101.474 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Total bilirubin, Day 14, n=18, 17 | 9.858 Micromoles per liter (µmol/L) | Standard Deviation 8.6251 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Creatinine, Day 35, n=16, 16 | 33.3710 Micromoles per liter (µmol/L) | Standard Deviation 19.49749 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 | Total bilirubin, Day 35, n=16, 16 | 6.733 Micromoles per liter (µmol/L) | Standard Deviation 3.1512 |
Secondary
Mean Hemoglobin Values at Screening, Day 14, and Day 35
Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Hemoglobin Values at Screening, Day 14, and Day 35 | Day 35, n=16, 16 | 94.4 Grams per liter (G/L) | Standard Deviation 15.23 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Hemoglobin Values at Screening, Day 14, and Day 35 | SCR, n=21,19 | 99.3 Grams per liter (G/L) | Standard Deviation 17.94 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Hemoglobin Values at Screening, Day 14, and Day 35 | Day 14, n=18, 17 | 85.1 Grams per liter (G/L) | Standard Deviation 12.1 |
Secondary
Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35
Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 | WBC count, Day 14, n=16, 12 | 2.23 giga (10^9) per liter (GI/L) | Standard Deviation 2.403 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 | Platelet count, SCR, n=21,19 | 167.7 giga (10^9) per liter (GI/L) | Standard Deviation 98.15 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 | WBC count, SCR, n=21,19 | 3.03 giga (10^9) per liter (GI/L) | Standard Deviation 1.873 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 | Platelet count, Day 14, n=18, 17 | 58.2 giga (10^9) per liter (GI/L) | Standard Deviation 37.41 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 | WBC count, Day 35, n=16, 14 | 3.71 giga (10^9) per liter (GI/L) | Standard Deviation 2.189 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 | Platelet count, Day 35, n=16, 16 | 119.0 giga (10^9) per liter (GI/L) | Standard Deviation 89.31 |
Secondary
Mean Red Blood Cell Count at Screening, Day 14, and Day 35
Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Red Blood Cell Count at Screening, Day 14, and Day 35 | SCR, n=21,19 | 3.293 tera (10^12) per liter (TI/L) | Standard Deviation 0.6529 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Red Blood Cell Count at Screening, Day 14, and Day 35 | Day 14, n=18, 17 | 2.908 tera (10^12) per liter (TI/L) | Standard Deviation 0.3854 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Red Blood Cell Count at Screening, Day 14, and Day 35 | Day 35, n=16, 16 | 3.073 tera (10^12) per liter (TI/L) | Standard Deviation 0.4797 |
Secondary
Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 | SCR, n=21, 19 | 1.0146 ratio | Standard Deviation 0.00705 |
| Adult Participants: VACV 500 mg Tablet | Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 | Day 14, n=18, 17 | 1.0158 ratio | Standard Deviation 0.00628 |
| Adult Participants: VACV 500 mg Tablet | Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 | Day 35, n=16, 16 | 1.0137 ratio | Standard Deviation 0.00572 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 | SCR, n=21, 19 | 1.0188 ratio | Standard Deviation 0.00912 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 | Day 14, n=18, 17 | 1.0155 ratio | Standard Deviation 0.00685 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 | Day 35, n=16, 16 | 1.0153 ratio | Standard Deviation 0.00642 |
Secondary
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any AE | 13 Participants |
| Adult Participants: VACV 500 mg Tablet | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any SAE | 2 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any AE | 11 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) | Any SAE | 1 Participants |
Secondary
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35
The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening and Day 35 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | Day 35, NCS, n=16, 16 | 1 Participants |
| Adult Participants: VACV 500 mg Tablet | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | SCR, NR, n=21, 19 | 0 Participants |
| Adult Participants: VACV 500 mg Tablet | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | SCR, NCS, n=21, 19 | 5 Participants |
| Adult Participants: VACV 500 mg Tablet | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | Day 35, Normal, n=16, 16 | 15 Participants |
| Adult Participants: VACV 500 mg Tablet | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | Day 35, CS, n=16, 16 | 0 Participants |
| Adult Participants: VACV 500 mg Tablet | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | SCR, CS, n=21, 19 | 0 Participants |
| Adult Participants: VACV 500 mg Tablet | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | Day 35, NR, n=16, 16 | 0 Participants |
| Adult Participants: VACV 500 mg Tablet | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | SCR, Normal, n=21, 19 | 16 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | Day 35, NR, n=16, 16 | 1 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | Day 35, Normal, n=16, 16 | 13 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | Day 35, NCS, n=16, 16 | 2 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | SCR, Normal, n=21, 19 | 19 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | SCR, NCS, n=21, 19 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | SCR, CS, n=21, 19 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | SCR, NR, n=21, 19 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 | Day 35, CS, n=16, 16 | 0 Participants |
Secondary
Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35
Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), urine protein (UP), and urine urobilinogen (UUG). The dipstick is a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, and 3+ (in order of increasing levels). Data are reported as the number of participants who had Neg, Trace, 1+, 2+, and 3+ levels at Screening, Day 14, and Day 35. If a category has not been reported for a specific parameter, then no participants were measured in that category.
Time frame: Screening (SCR), Day 14, 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 for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Adult Participants: VACV 500 mg Tablet | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 19 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 15 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 14 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 4 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 12 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 4 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 19 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 17 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 16 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 17 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 16 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 2 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 15 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 0 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 1 Participants |
| Pediatric Participants: VACV 500 mg Granules/Tablets | 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 | 15 Participants |