Varicella
Conditions
Brief summary
The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of valaciclovir in pediatric patients with chickenpox
Interventions
DRUGValaciclovir
Sponsors
GlaxoSmithKline
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients with chickenpox (aged less than 15 years old).
Exclusion criteria
* Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Serious Adverse Event | 1 month | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Indicated Adverse Drug Reactions | 1 month | An adverse drug reaction (ADR) is an adverse event whose causal relationship to study drug was not ruled out by the reporting physician. An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all ADRs occurring during the course of the study, please also see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record. |
| Number of Participants With Any Unexpected Adverse Drug Reactions | 1 month | An unexpected adverse drug reaction is an adverse event whose casual relationship to the study drug is not ruled out by the reporting physician and also is not listed in a package insert of the drug. |
| Number of Participants Classified as Effective and Not Effective | 1 month | The course of symptoms was comprehensively assessed by the investigator on a four-category scale (Improved, Unchanged, Worsen, and Unassessable) before and after the initiation of valaciclovir therapy. Improved was regarded as Effective, and Unchanged and Worsen were regarded as Not effective. The two participants classifed as Not effective were classified as Unchanged. |
Participant flow
Pre-assignment details
This post-marketing surveillance (PMS) study was designed to evaluate the safety and efficacy of valaciclovir in pediatric participants with chickenpox.
Participants by arm
| Arm | Count |
|---|---|
| Valaciclovir VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily. | 369 |
| Total | 369 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | No Visit after the First Visit | 7 |
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Valaciclovir |
|---|---|
| Age, Customized >=1 month to <1 year | 16 Participants |
| Age, Customized >=1 to <7 years | 311 Participants |
| Age, Customized >=7 to <=13 years | 42 Participants |
| Race/Ethnicity, Customized Japanese | 369 participants |
| Sex: Female, Male Female | 156 Participants |
| Sex: Female, Male Male | 213 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 369 |
| serious Total, serious adverse events | 0 / 369 |
Outcome results
Primary
Number of Participants With Any Serious Adverse Event
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record.
Time frame: 1 month
Population: Intent-to-Treat Safety Population: all participants to whom the drug was administered, excluding 10 withdrawal participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valaciclovir | Number of Participants With Any Serious Adverse Event | 0 participants |
Secondary
Number of Participants Classified as Effective and Not Effective
The course of symptoms was comprehensively assessed by the investigator on a four-category scale (Improved, Unchanged, Worsen, and Unassessable) before and after the initiation of valaciclovir therapy. Improved was regarded as Effective, and Unchanged and Worsen were regarded as Not effective. The two participants classifed as Not effective were classified as Unchanged.
Time frame: 1 month
Population: Efficacy Analysis Set: all participants assessed for efficacy who completed all study visits; 7 participants did not undergo an efficacy evaluation, and 13 participants failed to visit after the first visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Valaciclovir | Number of Participants Classified as Effective and Not Effective | Effective | 347 participants |
| Valaciclovir | Number of Participants Classified as Effective and Not Effective | Not effective | 2 participants |
Secondary
Number of Participants With Any Unexpected Adverse Drug Reactions
An unexpected adverse drug reaction is an adverse event whose casual relationship to the study drug is not ruled out by the reporting physician and also is not listed in a package insert of the drug.
Time frame: 1 month
Population: ITT Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valaciclovir | Number of Participants With Any Unexpected Adverse Drug Reactions | 0 participants |
Secondary
Number of Participants With the Indicated Adverse Drug Reactions
An adverse drug reaction (ADR) is an adverse event whose causal relationship to study drug was not ruled out by the reporting physician. An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all ADRs occurring during the course of the study, please also see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record.
Time frame: 1 month
Population: ITT Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Valaciclovir | Number of Participants With the Indicated Adverse Drug Reactions | Urticaria | 2 participants |
| Valaciclovir | Number of Participants With the Indicated Adverse Drug Reactions | Diarrhoea | 1 participants |