Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 1:24 PM
Study NCT ID:
NCT01772160
Status:
COMPLETED
Last Update Posted:
2020-05-22
First Post:
2013-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Estimate the Burden of Herpes Zoster (HZ) and Post-herpetic Neuralgia (PHN) in Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Not applicable as serious and other adverse events were not monitored in this study', 'description': 'Serious and other adverse events were not monitored in this study as this a non-interventional study based on pre-existing medical records obtained from a network of general practitioners.There was no assessment of AEs related to any treatment or vaccination in this study, as only burden of Herpes Zoster disease was assessed. Complications and clinical information of HZ cases presented in outcome measures 5-7 and deaths reported in participant flow are obtained from pre-existing medical records.', 'eventGroups': [{'id': 'EG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 394, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Female, 50-54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.19', 'groupId': 'OG000', 'lowerLimit': '3.84', 'upperLimit': '6.86'}]}]}, {'title': 'Female, 55-59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.29', 'groupId': 'OG000', 'lowerLimit': '4.75', 'upperLimit': '8.17'}]}]}, {'title': 'Female, 60-64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '3.55', 'upperLimit': '6.83'}]}]}, {'title': 'Female, 65-69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.19', 'groupId': 'OG000', 'lowerLimit': '7.22', 'upperLimit': '11.54'}]}]}, {'title': 'Female, 70-74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.51', 'groupId': 'OG000', 'lowerLimit': '5.64', 'upperLimit': '9.79'}]}]}, {'title': 'Female, 75-79', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.72', 'groupId': 'OG000', 'lowerLimit': '8.37', 'upperLimit': '13.52'}]}]}, {'title': 'Female, ≥ 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.06', 'groupId': 'OG000', 'lowerLimit': '5.69', 'upperLimit': '8.65'}]}]}, {'title': 'Male, 50-54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.71', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '2.82'}]}]}, {'title': 'Male, 55-59', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.91', 'groupId': 'OG000', 'lowerLimit': '1.85', 'upperLimit': '4.37'}]}]}, {'title': 'Male, 60-64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.35', 'groupId': 'OG000', 'lowerLimit': '2.98', 'upperLimit': '6.15'}]}]}, {'title': 'Male, 65-69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.95', 'groupId': 'OG000', 'lowerLimit': '6.86', 'upperLimit': '11.47'}]}]}, {'title': 'Male, 70-74', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.33', 'groupId': 'OG000', 'lowerLimit': '7.05', 'upperLimit': '12.12'}]}]}, {'title': 'Male, 75-79', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.18', 'groupId': 'OG000', 'lowerLimit': '5.10', 'upperLimit': '9.81'}]}]}, {'title': 'Male, ≥ 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.20', 'groupId': 'OG000', 'lowerLimit': '5.48', 'upperLimit': '9.29'}]}]}, {'title': 'Overall incidence of HZ cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.46', 'groupId': 'OG000', 'lowerLimit': '5.99', 'upperLimit': '6.95'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 to 2 years', 'description': '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.', 'unitOfMeasure': 'Number of HZ cases/1000 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the HZ cases occurring in the total population covered by the participating general practitioners (GPs).'}, {'type': 'SECONDARY', 'title': 'Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Overall PHN cases, Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.66', 'groupId': 'OG000', 'lowerLimit': '8.46', 'upperLimit': '15.54'}]}]}, {'title': 'Overall PHN cases, Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.86', 'groupId': 'OG000', 'lowerLimit': '17.66', 'upperLimit': '71.14'}]}]}, {'title': 'Overall PHN cases, Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '19.41', 'upperLimit': '99.37'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 90, 180 and 270 after onset of HZ', 'description': "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'.", 'unitOfMeasure': 'Percentage of PHN cases', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'General Medical History of Cases With HZ, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Pre-existing condition, Yes', 'categories': [{'measurements': [{'value': '32.74', 'groupId': 'OG000'}]}]}, {'title': 'Pre-existing condition, No', 'categories': [{'measurements': [{'value': '67.26', 'groupId': 'OG000'}]}]}, {'title': 'Pre-existing condition, Missing Confirmed', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Local Trauma', 'categories': [{'measurements': [{'value': '3.91', 'groupId': 'OG000'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '35.94', 'groupId': 'OG000'}]}]}, {'title': 'Liver disease', 'categories': [{'measurements': [{'value': '4.69', 'groupId': 'OG000'}]}]}, {'title': 'Alcoholism', 'categories': [{'measurements': [{'value': '2.34', 'groupId': 'OG000'}]}]}, {'title': 'Renal failure/dialysis', 'categories': [{'measurements': [{'value': '7.03', 'groupId': 'OG000'}]}]}, {'title': 'Emotional problems, stress or depression', 'categories': [{'measurements': [{'value': '32.03', 'groupId': 'OG000'}]}]}, {'title': 'Blood malignancy', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'Solid malignancy', 'categories': [{'measurements': [{'value': '3.91', 'groupId': 'OG000'}]}]}, {'title': 'Hematopoetic cell/ bone marrow transplant', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Solid organ transplantation', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'HIV infection', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'Hepatitis C under active therapy', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'Autoimmune disease active and under therapy', 'categories': [{'measurements': [{'value': '5.47', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 0 and Day 270.', 'description': '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).', 'unitOfMeasure': 'Percentage of HZ cases', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Other General Medical History Characteristics for HZ Cases, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Arterial hypertension and allergic rhinitis', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Arterial hypertension and pacemaker', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Arteriopathy and past non-Hodgkin lymphoma', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Bronchopathy', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Cerebral thrombosis', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Cholecyst', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Chronic cerebral ischemia', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Chronic leukemia', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Chronic obstructive pulmonary disease', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Epilepsy', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Gastric lymphoma', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Gastropathy', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension and hypothyroidism after surgery', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension dyslipidemia and hyperthyroidism', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Hypothyroidism hypertension', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Polycythaemia', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Polycythaemia from 10 years', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Prostate neoplasm', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Prostate oral anticoagulant therapy cardiopathy', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Prostatic cancer', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Right feet arthralgia', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'Vasculopathy chronic brain', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 0 and Day 270.', 'description': '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).', 'unitOfMeasure': 'Percentage of HZ cases', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Clinical Information of Cases With HZ, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Any symptoms before rash, Yes', 'categories': [{'measurements': [{'value': '73.66', 'groupId': 'OG000'}]}]}, {'title': 'Any symptoms before rash, No', 'categories': [{'measurements': [{'value': '26.34', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Prodromal pain', 'categories': [{'measurements': [{'value': '82.64', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Fever', 'categories': [{'measurements': [{'value': '5.90', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Malaise', 'categories': [{'measurements': [{'value': '29.17', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Other:Ailment to the touch', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Other:Burning sensation', 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Other:Dysesthesia', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Other:Fever sensation', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Other:Itching feeling of internal heat', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Other:Itching', 'categories': [{'measurements': [{'value': '6.25', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Other:Paresthesia', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Other:Pain in right eyelid', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Other:Pain in upper arms', 'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'SBR, Other:Sweating', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Any complications at initial visit, Yes', 'categories': [{'measurements': [{'value': '16.62', 'groupId': 'OG000'}]}]}, {'title': 'Any complications at initial visit, No', 'categories': [{'measurements': [{'value': '83.38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 0 and Day 270', 'description': 'Clinical information of HZ cases referred to experience of any symptoms before rash, actual symptoms before rash (SBR), any complications at initial visit.', 'unitOfMeasure': 'Percentage of HZ cases', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Complications Related to HZ Cases, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'VZV dissemination', 'categories': [{'measurements': [{'value': '44.62', 'groupId': 'OG000'}]}]}, {'title': 'Bacterial superinfection', 'categories': [{'measurements': [{'value': '7.69', 'groupId': 'OG000'}]}]}, {'title': 'Loss of corneal sensation', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Keratitis', 'categories': [{'measurements': [{'value': '10.77', 'groupId': 'OG000'}]}]}, {'title': 'Scleritis', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Uveitis', 'categories': [{'measurements': [{'value': '4.62', 'groupId': 'OG000'}]}]}, {'title': 'Iridocyclitis', 'categories': [{'measurements': [{'value': '1.54', 'groupId': 'OG000'}]}]}, {'title': 'Meningo-encephalitis', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Cranial nerve palsies', 'categories': [{'measurements': [{'value': '3.08', 'groupId': 'OG000'}]}]}, {'title': 'Peripheral nerve palsies', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Ramsay-Hunt syndrome', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Persistent HZ-related Pain', 'categories': [{'measurements': [{'value': '64.62', 'groupId': 'OG000'}]}]}, {'title': 'Neural extension of VZV infection', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia, arthritis, hepatitis', 'categories': [{'measurements': [{'value': '1.54', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7.69', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 0 and Day 270', 'description': '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.', 'unitOfMeasure': 'Percentage of HZ complications', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Other Complications Related to HZ Cases, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Axillary lymphadenopathy', 'categories': [{'measurements': [{'value': '20.00', 'groupId': 'OG000'}]}]}, {'title': 'Burning sensation', 'categories': [{'measurements': [{'value': '20.00', 'groupId': 'OG000'}]}]}, {'title': 'Hypoacusis', 'categories': [{'measurements': [{'value': '20.00', 'groupId': 'OG000'}]}]}, {'title': 'Itching', 'categories': [{'measurements': [{'value': '20.00', 'groupId': 'OG000'}]}]}, {'title': 'Rectum pain', 'categories': [{'measurements': [{'value': '20.00', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 0 and Day 270', 'description': 'HZ related other complications refer to axillary lympagenopathy, burning sensation, hypoacusis, itching and rectum pain.', 'unitOfMeasure': 'Percentage of HZ complications', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Direct Medical Costs, Direct Non-medical Costs and Indirect Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Direct Medical Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '189', 'spread': '377', 'groupId': 'OG000'}]}]}, {'title': 'Productivity Loss - Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2124', 'spread': '1965', 'groupId': 'OG000'}]}]}, {'title': 'Productivity Loss - Caregiver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82', 'spread': '105', 'groupId': 'OG000'}]}]}, {'title': 'Transport', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'spread': '54', 'groupId': 'OG000'}]}]}, {'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '297', 'spread': '730', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 90', 'description': '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.', 'unitOfMeasure': 'Euro', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Worst Pain Assessment in HZ Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 90', 'description': "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.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Average Pain Assessment in HZ Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '1.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 90', 'description': "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.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '3.478', 'spread': '2.707', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '2.742', 'spread': '2.749', 'groupId': 'OG000'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '1.823', 'spread': '2.459', 'groupId': 'OG000'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '1.026', 'spread': '1.931', 'groupId': 'OG000'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '0.578', 'spread': '1.471', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 0, 15, 30, 60, 90', 'description': "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'.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '0.748', 'spread': '0.207', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '0.801', 'spread': '0.198', 'groupId': 'OG000'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '0.849', 'spread': '0.207', 'groupId': 'OG000'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '0.901', 'spread': '0.175', 'groupId': 'OG000'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '0.935', 'spread': '0.140', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 0, 15, 30, 60, 90', 'description': '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).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'PHN Direct Medical Costs, Direct Non-medical Costs and Indirect Costs by Payer/Societal Perspective', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'PHN, Payer', 'categories': [{'measurements': [{'value': '176', 'spread': '179', 'groupId': 'OG000'}]}]}, {'title': 'PHN, Societal', 'categories': [{'measurements': [{'value': '426', 'spread': '663', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between Day 90 and Day 270', 'description': '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.', 'unitOfMeasure': 'Euro', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Worst Pain Assessment in PHN Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 90', 'description': "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.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Average Pain Assessment in PHN Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '2.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 90', 'description': "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.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '5.967', 'spread': '2.550', 'groupId': 'OG000'}]}]}, {'title': 'Day15', 'categories': [{'measurements': [{'value': '6.062', 'spread': '2.385', 'groupId': 'OG000'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '5.553', 'spread': '2.600', 'groupId': 'OG000'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '4.315', 'spread': '2.550', 'groupId': 'OG000'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '3.671', 'spread': '2.145', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 0, 15, 30, 60, 90', 'description': "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'.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '0.592', 'spread': '0.227', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '0.582', 'spread': '0.284', 'groupId': 'OG000'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '0.542', 'spread': '0.317', 'groupId': 'OG000'}]}]}, {'title': 'Day 60', 'categories': [{'measurements': [{'value': '0.688', 'spread': '0.275', 'groupId': 'OG000'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '0.732', 'spread': '0.202', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Day 0, 15, 30, 60, 90', 'description': '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).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '394'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '346'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Eligibility criteria not fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Consent withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Migrated / moved from the study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'Out of 395 subjects originally enrolled in this study, 1 subject was excluded due to protocol violation, hence only 394 were included in the Total Cohort.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69.3', 'spread': '11.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '238', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '156', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 395}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2016-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-08', 'studyFirstSubmitDate': '2013-01-17', 'resultsFirstSubmitDate': '2018-09-19', 'studyFirstSubmitQcDate': '2013-01-17', 'lastUpdatePostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-08', 'studyFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender', 'timeFrame': 'Day 0 to 2 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall', 'timeFrame': 'At Day 90, 180 and 270 after onset of HZ', 'description': "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'."}, {'measure': 'General Medical History of Cases With HZ, Overall', 'timeFrame': 'Between Day 0 and Day 270.', 'description': '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).'}, {'measure': 'Other General Medical History Characteristics for HZ Cases, Overall', 'timeFrame': 'Between Day 0 and Day 270.', 'description': '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).'}, {'measure': 'Clinical Information of Cases With HZ, Overall', 'timeFrame': 'Between Day 0 and Day 270', 'description': 'Clinical information of HZ cases referred to experience of any symptoms before rash, actual symptoms before rash (SBR), any complications at initial visit.'}, {'measure': 'Complications Related to HZ Cases, Overall', 'timeFrame': 'Between Day 0 and Day 270', 'description': '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.'}, {'measure': 'Other Complications Related to HZ Cases, Overall', 'timeFrame': 'Between Day 0 and Day 270', 'description': 'HZ related other complications refer to axillary lympagenopathy, burning sensation, hypoacusis, itching and rectum pain.'}, {'measure': 'Direct Medical Costs, Direct Non-medical Costs and Indirect Costs', 'timeFrame': 'Up to Day 90', 'description': '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.'}, {'measure': 'Worst Pain Assessment in HZ Subjects', 'timeFrame': 'At Day 90', 'description': "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."}, {'measure': 'Average Pain Assessment in HZ Subjects', 'timeFrame': 'At Day 90', 'description': "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."}, {'measure': 'Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory', 'timeFrame': 'At Day 0, 15, 30, 60, 90', 'description': "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'."}, {'measure': 'Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits', 'timeFrame': 'At Day 0, 15, 30, 60, 90', 'description': '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).'}, {'measure': 'PHN Direct Medical Costs, Direct Non-medical Costs and Indirect Costs by Payer/Societal Perspective', 'timeFrame': 'Between Day 90 and Day 270', 'description': '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.'}, {'measure': 'Worst Pain Assessment in PHN Subjects', 'timeFrame': 'At Day 90', 'description': "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."}, {'measure': 'Average Pain Assessment in PHN Subjects', 'timeFrame': 'At Day 90', 'description': "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."}, {'measure': 'Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory', 'timeFrame': 'At Day 0, 15, 30, 60, 90', 'description': "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'."}, {'measure': 'Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits', 'timeFrame': 'At Day 0, 15, 30, 60, 90', 'description': '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).'}]}, 'conditionsModule': {'keywords': ['Adults', 'Italy', 'Herpes Zoster', 'Complications', 'Quality of life', 'Surveillance', 'Burden', 'Cost', 'Incidence'], 'conditions': ['Herpes Zoster', 'Herpes Zoster Vaccine']}, 'referencesModule': {'references': [{'pmid': '31193254', 'type': 'BACKGROUND', 'citation': 'Salvetti A, Ferrari V, Garofalo R, Gazzaniga P, Guerroni A, Metrucci A, Sessa A, Severi ML, Nati G, Ruggeri M, Rossi A, Cappellari L, Gopala K, Tosatto R, Simone B. Incidence of herpes zoster and postherpetic neuralgia in Italian adults aged >/=50 years: A prospective study. Prev Med Rep. 2019 Apr 24;14:100882. doi: 10.1016/j.pmedr.2019.100882. eCollection 2019 Jun.'}, {'pmid': '30793003', 'type': 'DERIVED', 'citation': 'Matthews S, De Maria A, Passamonti M, Ristori G, Loiacono I, Puggina A, Curran D. The Economic Burden and Impact on Quality of Life of Herpes Zoster and Postherpetic Neuralgia in Individuals Aged 50 Years or Older in Italy. Open Forum Infect Dis. 2019 Jan 12;6(2):ofz007. doi: 10.1093/ofid/ofz007. eCollection 2019 Feb.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect data on the incidence, complications, economic burden and impact on the quality of life in adults aged ≥ 50 years with HZ disease in Italy.', 'detailedDescription': 'The surveillance/recruitment period will take approximately 2 years and once the enrolment of HZ patients has ended, the study will continue for a maximum of 9 months to allow for completion of the follow-up of potential PHN cases.\n\nThe data will be captured at protocol specified time-points based on the time of enrolment of each subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult population, male or female aged ≥ 50 years of age presenting with a HZ episode.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female ≥ 50 years of age at the time of study enrolment presenting with acute HZ.\n* HZ diagnosis for this HZ episode:\n\n * Is his/her first outpatient diagnosis (i.e. initial consultation), OR\n * Took place at another site/centre (e.g. emergency room or Dermatologist/Specialist practice) provided the HZ diagnosis is not more than 7 days before the initial visit for the present study (i.e. secondary consultation).\n* Written informed consent obtained from the patient.\n* Ability to comply with study procedures.\n\nExclusion Criteria:\n\n• Patient participating in another clinical study (participation in another observational, non-interventional trial is allowed).'}, 'identificationModule': {'nctId': 'NCT01772160', 'briefTitle': 'Study to Estimate the Burden of Herpes Zoster (HZ) and Post-herpetic Neuralgia (PHN) in Italy', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Population Based Surveillance to Estimate the Burden of Herpes Zoster and Post-herpetic Neuralgia in Italy', 'orgStudyIdInfo': {'id': '116208'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Herpes Zoster Group', 'description': 'Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'HZ/PHN booklet, HZ/PHN file and logbook. HZ/PHN booklet will be completed by the patient and the HZ/PHN file and logbook will be completed by the participating general practitioner.', 'armGroupLabels': ['Herpes Zoster Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73020', 'city': 'Cavallino (LE)', 'state': 'Apulia', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.3102, 'lon': 18.20221}}, {'zip': '73043', 'city': 'Copertino (LE)', 'state': 'Apulia', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.26821, 'lon': 18.0543}}, {'zip': '73020', 'city': 'Cutrofiano (LE)', 'state': 'Apulia', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.12616, 'lon': 18.2026}}, {'zip': '73013', 'city': 'Galatina (LE)', 'state': 'Apulia', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.17416, 'lon': 18.17032}}, {'zip': '73035', 'city': 'Montesano S. (LE)', 'state': 'Apulia', 'country': 'Italy', 'facility': 'GSK Investigational Site'}, {'zip': '73052', 'city': 'Parabita (LE)', 'state': 'Apulia', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.05139, 'lon': 18.12651}}, {'zip': '73040', 'city': 'Specchia (LE)', 'state': 'Apulia', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.93913, 'lon': 18.29784}}, {'zip': '80125', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80126', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '00141', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00142', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 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'geoPoint': {'lat': 45.85578, 'lon': 8.86823}}, {'zip': '21020', 'city': 'Comerio (VA)', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.84191, 'lon': 8.74207}}, {'zip': '21054', 'city': 'Fagnano Olona (VA)', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.66977, 'lon': 8.85994}}, {'zip': '21030', 'city': 'Ghirla Valganna (VA)', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site'}, {'zip': '21040', 'city': 'Induno Olona (VA)', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.84571, 'lon': 8.84056}}, {'zip': '21018', 'city': 'Sesto Calende (VA)', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.72608, 'lon': 8.63397}}, {'zip': '21052', 'city': 'Solbiate Olona (VA)', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.65028, 'lon': 8.88198}}, {'zip': '21100', 'city': 'Varese', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '15121', 'city': 'Alessandria', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'zip': '15065', 'city': 'Frugarolo (AL)', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.83924, 'lon': 8.68165}}, {'zip': '15026', 'city': 'Oviglio (AL)', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.86125, 'lon': 8.48774}}, {'zip': '15045', 'city': 'Sale (AL)', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.97932, 'lon': 8.80963}}, {'zip': '15050', 'city': 'Villalvernia (AL)', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.81387, 'lon': 8.85532}}, {'zip': '58031', 'city': 'Arcidosso (GR)', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.87162, 'lon': 11.53599}}, {'zip': '52100', 'city': 'Arezzo', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}, {'zip': '58045', 'city': 'Civitella Paganico (GR)', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.99408, 'lon': 11.28116}}, {'zip': '58022', 'city': 'Follonica (GR)', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.92779, 'lon': 10.76451}}, {'zip': '58100', 'city': 'Grosseto', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.76296, 'lon': 11.10941}}, {'zip': '52046', 'city': 'Lucignano (AR)', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.27259, 'lon': 11.74599}}, {'zip': '58015', 'city': 'Orbetello (GR)', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.44158, 'lon': 11.2214}}, {'zip': '58029', 'city': 'Sassofortino (GR)', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.0258, 'lon': 11.11138}}, {'zip': '06125', 'city': 'Perugia', 'state': 'Umbria', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '06126', 'city': 'Perugia', 'state': 'Umbria', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Perugia', 'state': 'Umbria', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '06134', 'city': 'Ripa (PG)', 'state': 'Umbria', 'country': 'Italy', 'facility': 'GSK Investigational Site'}, {'city': 'Alessano (LE)', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.89381, 'lon': 18.33221}}, {'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicalstudydatarequest.com/Posting.aspx?ID=20346', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}