| Primary | Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender | A case of HZ was defined as new unilateral pain (broadly defined to include allodynia and pruritus) accompanied by unilateral rash and no alternative diagnosis. Age ranges were 50-54, 55-59, 60-64, 65-69, 70-74, 75-79 and greater than or equal to (≥) 80 years. The incidence rate was expressed as the number of HZ cases per (/) 1000 person-years. | The analysis was performed on the HZ cases occurring in the total population covered by the participating general practitioners (GPs). | Posted | | Mean | 95% Confidence Interval | Number of HZ cases/1000 person-years | | Day 0 to 2 years | | | | ID | Title | Description |
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| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
| | | Title | Denominators | Categories |
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| Female, 50-54 | | | | Female, 55-59 | |
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| Secondary | Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall | PHN persistence refers to pain occurring or persisting from Day 90 to Day 270 after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. | The analysis was performed on the HZ cases (with completed questionnaires up to Day 270) occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Number | 95% Confidence Interval | Percentage of PHN cases | | At Day 90, 180 and 270 after onset of HZ | | | | ID | Title | Description |
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| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | General Medical History of Cases With HZ, Overall | General medical history focused on characteristics such as patient pre-existing condition and diseases (local trauma, diabetes mellitus, liver disease, alcoholism, renal failure/dialysis, emotional problems, stress or depression, blood malignancy, solid malignancy, hematopoetic cell/ bone marrow transplant, solid organ transplantation, HIV infection, hepatitis C under active therapy, autoimmune disease active and under therapy, other). | The analysis was performed on the HZ cases occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Number | | Percentage of HZ cases | | Between Day 0 and Day 270. | | | | ID | Title | Description |
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| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Other General Medical History Characteristics for HZ Cases, Overall | Other general medical history characteristics referred to arterial problems, cerebral problems, gastric problems, gastric problems, prostate problems (arterial hypertension and allergic rhinitis, arterial hypertension and pacemaker, arteriopathy and past nun-Hodgkin lymphoma, atrial fibrillation, bronchopathy, cerebral thrombosis, cholecyst, chronic cerebral ischemia, chronic leukemia, chronic obstructive pulmonary disease, epilepsy, gastric lymphoma, gastropathy, hypertension, hypertension and hypothyroidism after surgery, hypertension dyslipidemia and hyperthyroidism, hypothyroidism hypertension, polycythaemia, polycythaemia from 10 years, prostate neoplasm, prostate oral anticoagulant therapy cardiopathy, prostatic cancer, right feet arthralgia, thrombocytopenia, vasculopathy chronic brain). | The analysis was performed on the HZ cases occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Number | | Percentage of HZ cases | | Between Day 0 and Day 270. | | | | ID | Title | Description |
|---|
| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Clinical Information of Cases With HZ, Overall | Clinical information of HZ cases referred to experience of any symptoms before rash, actual symptoms before rash (SBR), any complications at initial visit. | The analysis was performed on the HZ cases occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Number | | Percentage of HZ cases | | Between Day 0 and Day 270 | | | | ID | Title | Description |
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| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Complications Related to HZ Cases, Overall | HZ related complications refer to cutaneous complications (Varicella Zoster Virus [VZV] dissemination, Bacterial superinfection), ocular (Loss of corneal sensation, Keratitis, Scleritis, Uveitis, Iridocyclitis), neurological (Meningo-encephalitis, Cranial nerve palsies, Peripheral nerve palsies, Ramsay-Hunt syndrome, Persistent HZ-related Pain), visceral [Neural extension of VZV infection (bronchitis, esophagitis,cystitis), VZV dissemination (pneumonia, arthritis, hepatitis] and other. | The analysis was performed on the HZ cases occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Number | | Percentage of HZ complications | | Between Day 0 and Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Other Complications Related to HZ Cases, Overall | HZ related other complications refer to axillary lympagenopathy, burning sensation, hypoacusis, itching and rectum pain. | The analysis was performed on the HZ cases occurring in the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Number | | Percentage of HZ complications | | Between Day 0 and Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Direct Medical Costs, Direct Non-medical Costs and Indirect Costs | Cost data related to HZ included medication, procedures and referral to hospital/specialist for direct medical costs, transport for direct non-medical costs and missed time from work, sick certificate for the indirect costs. | The analysis was performed on the HZ subjects from the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Mean | Standard Deviation | Euro | | Up to Day 90 | | | | ID | Title | Description |
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| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Worst Pain Assessment in HZ Subjects | The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset. | The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Mean | Standard Deviation | Scores on a scale | | At Day 90 | | | | ID | Title | Description |
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| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Average Pain Assessment in HZ Subjects | The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset. | The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Mean | Standard Deviation | Scores on a scale | | At Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory | PHN persistence refers to pain occurring or persisting between 90-270 days after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. | The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Mean | Standard Deviation | Scores on a scale | | At Day 0, 15, 30, 60, 90 | | | | ID | Title | Description |
|---|
| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits | EuroQoL-Five Digits (EQ-5D) is a standardised instrument for use as a measure of health outcome and is designed for self-completion by respondents. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index/scale goes from 0 (worst health state) to 1 (perfect health state). | The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Mean | Standard Deviation | Scores on a scale | | At Day 0, 15, 30, 60, 90 | | | | ID | Title | Description |
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| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | PHN Direct Medical Costs, Direct Non-medical Costs and Indirect Costs by Payer/Societal Perspective | Cost data related to HZ included medication, procedures and referral to hospital/specialist for direct medical costs, transport for direct non-medical costs and missed time from work, sick certificate for the indirect costs. | The analysis was performed on the PHN subjects from the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Mean | Standard Deviation | Euro | | Between Day 90 and Day 270 | | | | ID | Title | Description |
|---|
| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Worst Pain Assessment in PHN Subjects | The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset. | The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Mean | Standard Deviation | Scores on a scale | | At Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Average Pain Assessment in PHN Subjects | The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. The ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset. | The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Mean | Standard Deviation | Scores on a scale | | At Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory | PHN persistence refers to pain occurring or persisting between 90-270 days after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. | The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who met all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Mean | Standard Deviation | Scores on a scale | | At Day 0, 15, 30, 60, 90 | | | | ID | Title | Description |
|---|
| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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| Secondary | Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits | EuroQoL-Five Digits (EQ-5D) is a standardised instrument for use as a measure of health outcome and is designed for self-completion by respondents. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was 0 (worst health state) to 1 (best health state). | The analysis was performed on the According-To-Protocol cohort (ATP) which included all evaluable patients (i.e. those who mett all eligibility criteria and complied with the study procedures defined in the protocol). | Posted | | Mean | Standard Deviation | Scores on a scale | | At Day 0, 15, 30, 60, 90 | | | | ID | Title | Description |
|---|
| OG000 | Herpes Zoster Group | Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode. |
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