Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT01077856
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2010-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
GARDASIL™ Vaccine Impact in Population Study (V501-033)
Sponsor:
Organization:
Raw JSON
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Any information identified by the sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Per protocol, adverse events were not collected as part of the study database; therefore, none were collected and the number at risk is zero', 'eventGroups': [{'id': 'EG000', 'title': 'Denmark Participants', 'description': 'All Denmark study participants', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Norway Participants', 'description': 'All Norway study participants', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sweden Participants', 'description': 'All Sweden study participants', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2531060', 'groupId': 'OG000'}, {'value': '2521944', 'groupId': 'OG001'}, {'value': '2509417', 'groupId': 'OG002'}, {'value': '2513941', 'groupId': 'OG003'}, {'value': '2504258', 'groupId': 'OG004'}, {'value': '2495192', 'groupId': 'OG005'}]}, {'units': 'cases', 'counts': [{'value': '4156', 'groupId': 'OG000'}, {'value': '4827', 'groupId': 'OG001'}, {'value': '5463', 'groupId': 'OG002'}, {'value': '6041', 'groupId': 'OG003'}, {'value': '5587', 'groupId': 'OG004'}, {'value': '5709', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2007, After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Denmark Participants 2008 After Gardasil Licensure'}, {'id': 'OG003', 'title': 'Denmark Participants 2009 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Denmark Participants 2010 After Gardasil Licensure'}, {'id': 'OG005', 'title': 'Denmark Participants 2011 After Gardasil Licensure'}], 'classes': [{'categories': [{'measurements': [{'value': '164.2', 'groupId': 'OG000'}, {'value': '191.4', 'groupId': 'OG001'}, {'value': '217.7', 'groupId': 'OG002'}, {'value': '240.3', 'groupId': 'OG003'}, {'value': '223.1', 'groupId': 'OG004'}, {'value': '228.8', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. 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The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.'}, {'type': 'PRIMARY', 'title': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3264205', 'groupId': 'OG000'}, {'value': '3262783', 'groupId': 'OG001'}, {'value': '2628908', 'groupId': 'OG002'}, {'value': '2627821', 'groupId': 'OG003'}, {'value': '2639206', 'groupId': 'OG004'}, {'value': '2642110', 'groupId': 'OG005'}]}, {'units': 'cases', 'counts': [{'value': '4596', 'groupId': 'OG000'}, {'value': '5041', 'groupId': 'OG001'}, {'value': '5129', 'groupId': 'OG002'}, {'value': '4945', 'groupId': 'OG003'}, {'value': '5318', 'groupId': 'OG004'}, {'value': '6061', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Sweden Participants 2007, After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Sweden Participants 2008 After Gardasil Licensure'}, {'id': 'OG003', 'title': 'Sweden Participants 2009 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2010 After Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 After Gardasil Licensure'}], 'classes': [{'categories': [{'measurements': [{'value': '140.8', 'groupId': 'OG000'}, {'value': '154.5', 'groupId': 'OG001'}, {'value': '195.1', 'groupId': 'OG002'}, {'value': '188.1', 'groupId': 'OG003'}, {'value': '201.5', 'groupId': 'OG004'}, {'value': '229.4', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women \\>26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'cases', 'denomUnitsSelected': 'cases', 'populationDescription': 'The analysis population was the entire population of qualifying women \\>26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.'}, {'type': 'PRIMARY', 'title': 'Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '299', 'groupId': 'OG003'}, {'value': '390', 'groupId': 'OG004'}, {'value': '304', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'title': 'Overall CIN', 'categories': [{'measurements': [{'value': '164.2', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.0'}, {'value': '230.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '133.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '149.6', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '142.6', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '2.6'}, {'value': '200.3', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '2.9'}]}]}, {'title': 'HPV 6/11/16/18-related CIN', 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000'}, {'value': '115.0', 'groupId': 'OG001'}, {'value': '70.1', 'groupId': 'OG002'}, {'value': '75.1', 'groupId': 'OG003'}, {'value': '73.9', 'groupId': 'OG004'}, {'value': '106.2', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants of all ages with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'title': 'Overall CIN', 'categories': [{'measurements': [{'value': '133.4', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.0'}, {'value': '198.6', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '71.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '76.1', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '94.1', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '2.6'}, {'value': '156.8', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '2.9'}]}]}, {'title': 'HPV 6/11/16/18-related CIN', 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}, {'value': '117.2', 'groupId': 'OG001'}, {'value': '50.9', 'groupId': 'OG002'}, {'value': '41.6', 'groupId': 'OG003'}, {'value': '56.6', 'groupId': 'OG004'}, {'value': '102.9', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\<=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}, {'value': '266', 'groupId': 'OG003'}, {'value': '287', 'groupId': 'OG004'}, {'value': '211', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'title': 'Overall CIN', 'categories': [{'measurements': [{'value': '179.5', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.0'}, {'value': '251.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '172.6', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '196.2', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '140.8', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '2.6'}, {'value': '228.3', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '2.9'}]}]}, {'title': 'HPV 6/11/16/18-related CIN', 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000'}, {'value': '114.3', 'groupId': 'OG001'}, {'value': '85.3', 'groupId': 'OG002'}, {'value': '97.3', 'groupId': 'OG003'}, {'value': '68.7', 'groupId': 'OG004'}, {'value': '108.2', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\>26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'title': 'Overall CIN', 'categories': [{'measurements': [{'value': '133.4', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '42.3'}, {'value': '198.6', 'groupId': 'OG001', 'lowerLimit': '32.5', 'upperLimit': '43.6'}, {'value': '71.3', 'groupId': 'OG002', 'lowerLimit': '26.6', 'upperLimit': '37.7'}, {'value': '76.1', 'groupId': 'OG003', 'lowerLimit': '30.7', 'upperLimit': '41.8'}, {'value': '94.1', 'groupId': 'OG004', 'lowerLimit': '32.1', 'upperLimit': '41.9'}, {'value': '156.8', 'groupId': 'OG005', 'lowerLimit': '29.8', 'upperLimit': '40.9'}]}]}, {'title': 'CIN not related to HPV 16/18', 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001'}, {'value': '17.0', 'groupId': 'OG002'}, {'value': '30.0', 'groupId': 'OG003'}, {'value': '34.7', 'groupId': 'OG004'}, {'value': '45.5', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\<=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}, {'value': '266', 'groupId': 'OG003'}, {'value': '287', 'groupId': 'OG004'}, {'value': '211', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'title': 'Overall CIN', 'categories': [{'measurements': [{'value': '179.5', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '42.3'}, {'value': '251.3', 'groupId': 'OG001', 'lowerLimit': '32.5', 'upperLimit': '43.6'}, {'value': '172.6', 'groupId': 'OG002', 'lowerLimit': '26.6', 'upperLimit': '37.7'}, {'value': '196.2', 'groupId': 'OG003', 'lowerLimit': '30.7', 'upperLimit': '41.8'}, {'value': '140.8', 'groupId': 'OG004', 'lowerLimit': '32.1', 'upperLimit': '41.9'}, {'value': '228.3', 'groupId': 'OG005', 'lowerLimit': '29.8', 'upperLimit': '40.9'}]}]}, {'title': 'CIN not related to HPV 16/18', 'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '57.5', 'groupId': 'OG002'}, {'value': '70.0', 'groupId': 'OG003'}, {'value': '52.0', 'groupId': 'OG004'}, {'value': '86.5', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\>26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants of All Ages', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '185', 'groupId': 'OG003'}, {'value': '148', 'groupId': 'OG004'}, {'value': '126', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'title': 'Overall cervical cancer', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.0'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '11.7', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '11.7', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '8.4', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '2.6'}, {'value': '8.7', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '2.9'}]}]}, {'title': 'HPV 6/11/16/18-related cervical cancer', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}, {'value': '7.4', 'groupId': 'OG002'}, {'value': '7.7', 'groupId': 'OG003'}, {'value': '5.2', 'groupId': 'OG004'}, {'value': '6.3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants <=26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'title': 'Overall cervical cancer', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.0'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '2.6'}, {'value': '1.0', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '2.9'}]}]}, {'title': 'HPV 6/11/16/18-related cervical cancer', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}, {'value': '1.4', 'groupId': 'OG003'}, {'value': '0.5', 'groupId': 'OG004'}, {'value': '0.75', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\<=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants >26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}, {'value': '142', 'groupId': 'OG004'}, {'value': '118', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'title': 'Overall cervical cancer', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.0'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '18.6', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '18.2', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '13.3', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '2.6'}, {'value': '13.6', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '2.9'}]}]}, {'title': 'HPV 6/11/16/18-related cervical cancer', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}, {'value': '11.7', 'groupId': 'OG002'}, {'value': '11.8', 'groupId': 'OG003'}, {'value': '8.2', 'groupId': 'OG004'}, {'value': '9.8', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\>26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'title': 'Overall cervical cancer', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '42.3'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '32.5', 'upperLimit': '43.6'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '26.6', 'upperLimit': '37.7'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '30.7', 'upperLimit': '41.8'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '32.1', 'upperLimit': '41.9'}, {'value': '1.0', 'groupId': 'OG005', 'lowerLimit': '29.8', 'upperLimit': '40.9'}]}]}, {'title': 'Cervical cancer not related to HPV 16/18', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.1', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\<=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}, {'value': '142', 'groupId': 'OG004'}, {'value': '118', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'title': 'Overall cervical cancer', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.0'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '18.6', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '18.2', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '13.3', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '2.6'}, {'value': '13.6', 'groupId': 'OG005', 'lowerLimit': '0.2', 'upperLimit': '2.9'}]}]}, {'title': 'Cervical cancer not related to HPV 16/18', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '3.5', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}, {'value': '2.8', 'groupId': 'OG004'}, {'value': '2.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.', 'unitOfMeasure': 'Cases per 100,000 women', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\>26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Incidence of HPV-related Histologically Confirmed Female Genital Diseases, Including Vulvar and Vaginal Cancer and Their High-grade Precursors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'The incidence of HPV-related histologically confirmed female genital diseases, including vulvar and vaginal cancer and their high-grade precursors was to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of this endpoint was not planned nor were the data collected. Thus, the number of participants analyzed is zero.'}, {'type': 'PRIMARY', 'title': 'Prevalence of HPV 6/11/16/18 Infection in Participants <=26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '831', 'groupId': 'OG000'}, {'value': '1043', 'groupId': 'OG001'}, {'value': '1055', 'groupId': 'OG002'}, {'value': '1011', 'groupId': 'OG003'}, {'value': '968', 'groupId': 'OG004'}, {'value': '996', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000', 'lowerLimit': '17.6', 'upperLimit': '23.2'}, {'value': '14.2', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '16.5'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '24.1', 'upperLimit': '29.5'}, {'value': '22.6', 'groupId': 'OG003', 'lowerLimit': '20.0', 'upperLimit': '25.3'}, {'value': '19.0', 'groupId': 'OG004', 'lowerLimit': '16.6', 'upperLimit': '21.6'}, {'value': '13.4', 'groupId': 'OG005', 'lowerLimit': '11.3', 'upperLimit': '15.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\<=26 years of age with liquid-based cytology samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Prevalence of HPV 6/11/16/18 Infection in Participants >26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1486', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}, {'value': '958', 'groupId': 'OG002'}, {'value': '1217', 'groupId': 'OG003'}, {'value': '1196', 'groupId': 'OG004'}, {'value': '1006', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '7.6'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '6.2'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '7.2'}, {'value': '6.2', 'groupId': 'OG003', 'lowerLimit': '4.9', 'upperLimit': '7.7'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '4.4', 'upperLimit': '7.1'}, {'value': '7.7', 'groupId': 'OG005', 'lowerLimit': '6.1', 'upperLimit': '9.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\>26 years of age with liquid-based cytology samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants <=26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '831', 'groupId': 'OG000'}, {'value': '1043', 'groupId': 'OG001'}, {'value': '1055', 'groupId': 'OG002'}, {'value': '1011', 'groupId': 'OG003'}, {'value': '968', 'groupId': 'OG004'}, {'value': '996', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '22.7', 'upperLimit': '28.7'}, {'value': '22.8', 'groupId': 'OG001', 'lowerLimit': '20.3', 'upperLimit': '25.5'}, {'value': '27.5', 'groupId': 'OG002', 'lowerLimit': '24.8', 'upperLimit': '30.3'}, {'value': '23.5', 'groupId': 'OG003', 'lowerLimit': '21.0', 'upperLimit': '26.3'}, {'value': '21.2', 'groupId': 'OG004', 'lowerLimit': '18.6', 'upperLimit': '23.9'}, {'value': '24.6', 'groupId': 'OG005', 'lowerLimit': '22.0', 'upperLimit': '27.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\<=26 years of age with liquid-based cytology samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants >26 Years of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1486', 'groupId': 'OG000'}, {'value': '1026', 'groupId': 'OG001'}, {'value': '958', 'groupId': 'OG002'}, {'value': '1217', 'groupId': 'OG003'}, {'value': '1196', 'groupId': 'OG004'}, {'value': '1006', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG001', 'title': 'Denmark Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG002', 'title': 'Norway Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG003', 'title': 'Norway Participants 2011 to 2012 After Gardasil Licensure'}, {'id': 'OG004', 'title': 'Sweden Participants 2004 to 2006 Before Gardasil Licensure'}, {'id': 'OG005', 'title': 'Sweden Participants 2011 to 2012 After Gardasil Licensure'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '14.4'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '10.9'}, {'value': '9.6', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '11.6'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '7.6', 'upperLimit': '10.9'}, {'value': '9.0', 'groupId': 'OG004', 'lowerLimit': '7.5', 'upperLimit': '10.8'}, {'value': '11.0', 'groupId': 'OG005', 'lowerLimit': '9.2', 'upperLimit': '13.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was participants \\>26 years of age with liquid-based cytology samples analyzed for HPV types'}, {'type': 'PRIMARY', 'title': 'Percentage of Live Born Babies With a Major Congenital Anomaly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '320891', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '306290', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '543738', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Babies Born to Denmark Participants Who Received Gardasil', 'description': 'Live babies born between 2007 and 2011 to Denmark participants who received Gardasil during pregnancy'}, {'id': 'OG001', 'title': 'Babies Born to Denmark Participants', 'description': 'Live babies born between 2007 and 2011 to Denmark participants in the general population, including participants who did and did not receive Gardasil'}, {'id': 'OG002', 'title': 'Babies Born to Norway Participants Who Received Gardasil', 'description': 'Live babies born between 2007 and 2011 to Norway participants who received Gardasil during pregnancy'}, {'id': 'OG003', 'title': 'Babies Born to Norway Participants', 'description': 'Live babies born between 2007 and 2011 to Norway participants in the general population, including participants who did and did not receive Gardasil'}, {'id': 'OG004', 'title': 'Babies Born to Sweden Participants Who Received Gardasil', 'description': 'Live babies born between 2007 and 2011 to Sweden participants who received Gardasil during pregnancy'}, {'id': 'OG005', 'title': 'Babies Born to Sweden Participants', 'description': 'Live babies born between 2007 and 2011 to Sweden participants in the general population, including participants who did and did not received Gardasil'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}, {'value': '4.3', 'groupId': 'OG002'}, {'value': '2.9', 'groupId': 'OG003'}, {'value': '2.9', 'groupId': 'OG004'}, {'value': '3.0', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Standardized Prevalence Ratio (SPR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '0.89', 'ciUpperLimit': '2.00', 'estimateComment': 'SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Standardized Prevalence Ratio (SPR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '0.00', 'ciUpperLimit': '4.77', 'estimateComment': 'SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Standardized Prevalence Ratio (SPR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.00', 'ciUpperLimit': '2.02', 'estimateComment': 'SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years after Gardasil licensure (2007 to 2011)', 'description': 'The percentage of live born babies with major congenital anomalies (MCA) born to women vaccinated with Gardasil during pregnancy and to women in the general population was assessed. For Denmark and Sweden diagnoses of congenital anomaly within 1 year of birth are included; for Norway diagnoses at birth are included.', 'unitOfMeasure': 'Percentage of babies with a MCA', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population represents the babies born to participating mothers, instead of female participants, because the number of babies represents the denominator for the percentage calculation, not female participants (i.e., mothers)'}, {'type': 'SECONDARY', 'title': 'Incidence of Cervical Intraepithelial Neoplasia by Gardasil Vaccination Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants Who Received Gardasil', 'description': 'Denmark participants who received Gardasil on or before March 2012'}, {'id': 'OG001', 'title': 'Denmark Participants Who Did Not Receive Gardasil'}, {'id': 'OG002', 'title': 'Norway Participants Who Received Gardasil', 'description': 'Norway participants who received Gardasil on or before March 2012'}, {'id': 'OG003', 'title': 'Norway Participants Who Did Not Receive Gardasil'}, {'id': 'OG004', 'title': 'Sweden Participants Who Received Gardasil', 'description': 'Sweden participants who received Gardasil on or before March 2012'}, {'id': 'OG005', 'title': 'Sweden Participants Who Did Not Receive Gardasil'}], 'timeFrame': 'Four years to 5 years after Gardasil licensure (2011 to 2012)', 'description': 'The incidence of CIN by Gardasil vaccination status was to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.'}, {'type': 'SECONDARY', 'title': 'Incidence of Cervical Cancer by Gardasil Vaccination Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants Who Received Gardasil', 'description': 'Denmark participants who received Gardasil on or before March 2012'}, {'id': 'OG001', 'title': 'Denmark Participants Who Did Not Receive Gardasil'}, {'id': 'OG002', 'title': 'Norway Participants Who Received Gardasil', 'description': 'Norway participants who received Gardasil on or before March 2012'}, {'id': 'OG003', 'title': 'Norway Participants Who Did Not Receive Gardasil'}, {'id': 'OG004', 'title': 'Sweden Participants Who Received Gardasil', 'description': 'Sweden participants who received Gardasil on or before March 2012'}, {'id': 'OG005', 'title': 'Sweden Participants Who Did Not Receive Gardasil'}], 'timeFrame': 'Four years to 5 years after Gardasil licensure (2011 to 2012)', 'description': 'The incidence of other cervical cancers by Gardasil vaccination status was to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.'}, {'type': 'SECONDARY', 'title': 'Incidence of Other HPV-related Genital Diseases by Gardasil Vaccination Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants Who Received Gardasil', 'description': 'Denmark participants who received Gardasil on or before March 2012'}, {'id': 'OG001', 'title': 'Denmark Participants Who Did Not Receive Gardasil'}, {'id': 'OG002', 'title': 'Norway Participants Who Received Gardasil', 'description': 'Norway participants who received Gardasil on or before March 2012'}, {'id': 'OG003', 'title': 'Norway Participants Who Did Not Receive Gardasil'}, {'id': 'OG004', 'title': 'Sweden Participants Who Received Gardasil', 'description': 'Sweden participants who received Gardasil on or before March 2012'}, {'id': 'OG005', 'title': 'Sweden Participants Who Did Not Receive Gardasil'}], 'timeFrame': 'Four years to 5 years after Gardasil licensure (2011 to 2012)', 'description': 'The incidence of other HPV-related genital diseases, including vulvar and vaginal cancers, by Gardasil vaccination status was to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.'}, {'type': 'SECONDARY', 'title': 'Prevalence of HPV 6, 11, 16, and 18 Infection by Gardasil Vaccination Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Denmark Participants Who Received Gardasil', 'description': 'Denmark participants who received Gardasil on or before March 2012'}, {'id': 'OG001', 'title': 'Denmark Participants Who Did Not Receive Gardasil'}, {'id': 'OG002', 'title': 'Norway Participants Who Received Gardasil', 'description': 'Norway participants who received Gardasil on or before March 2012'}, {'id': 'OG003', 'title': 'Norway Participants Who Did Not Receive Gardasil'}, {'id': 'OG004', 'title': 'Sweden Participants Who Received Gardasil', 'description': 'Sweden participants who received Gardasil on or before March 2012'}, {'id': 'OG005', 'title': 'Sweden Participants Who Did Not Receive Gardasil'}], 'timeFrame': 'Four years to 5 years after Gardasil licensure (2011 to 2012)', 'description': 'The percentage of participants with liquid-based cervical cytology samples positive for HPV 6, 11, 16, and 18 was to be analyzed by Gardasil vaccination status.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Denmark Participants', 'description': 'Participants in Denmark who completed the first survey (before licensure of GARDASIL)'}, {'id': 'FG001', 'title': 'Norway Participants', 'description': 'Participants in Norway who completed the first survey (before licensure of GARDASIL)'}, {'id': 'FG002', 'title': 'Sweden Participants', 'description': 'Participants in Sweden who completed the first survey (before licensure of GARDASIL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22199'}, {'groupId': 'FG001', 'numSubjects': '16604'}, {'groupId': 'FG002', 'numSubjects': '15713'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22199'}, {'groupId': 'FG001', 'numSubjects': '16604'}, {'groupId': 'FG002', 'numSubjects': '15713'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22199', 'groupId': 'BG000'}, {'value': '16604', 'groupId': 'BG001'}, {'value': '15713', 'groupId': 'BG002'}, {'value': '54516', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Denmark Participants', 'description': 'Participants in Denmark who completed the first survey (before licensure of GARDASIL)'}, {'id': 'BG001', 'title': 'Norway Participants', 'description': 'Participants in Norway who completed the first survey (before licensure of GARDASIL)'}, {'id': 'BG002', 'title': 'Sweden Participants', 'description': 'Participants in Sweden who completed the first survey (before licensure of GARDASIL)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'groupId': 'BG000', 'lowerLimit': '24.3', 'upperLimit': '39.0'}, {'value': '31.0', 'groupId': 'BG001', 'lowerLimit': '24.0', 'upperLimit': '38.0'}, {'value': '33.2', 'groupId': 'BG002', 'lowerLimit': '26.1', 'upperLimit': '39.5'}, {'value': '32.0', 'groupId': 'BG003', 'lowerLimit': '24.8', 'upperLimit': '39.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22199', 'groupId': 'BG000'}, {'value': '16604', 'groupId': 'BG001'}, {'value': '15713', 'groupId': 'BG002'}, {'value': '54516', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who took the first survey given before Gardasil licensure'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue, cervical cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54516}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2014-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2010-02-26', 'resultsFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2010-02-26', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-05', 'studyFirstPostDateStruct': {'date': '2010-03-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.'}, {'measure': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Denmark', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women \\<=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.'}, {'measure': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Denmark', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women \\>26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.'}, {'measure': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Norway', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.'}, {'measure': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Norway', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women \\<=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.'}, {'measure': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Norway', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women \\>26 years of age were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.'}, {'measure': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Sweden', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.'}, {'measure': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Sweden', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women \\<=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.'}, {'measure': 'Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Sweden', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women \\>26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.'}, {'measure': 'Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.'}, {'measure': 'Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.'}, {'measure': 'Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.'}, {'measure': 'Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.'}, {'measure': 'Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.'}, {'measure': 'Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants of All Ages', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.'}, {'measure': 'Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants <=26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.'}, {'measure': 'Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants >26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.'}, {'measure': 'Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.'}, {'measure': 'Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.'}, {'measure': 'Incidence of HPV-related Histologically Confirmed Female Genital Diseases, Including Vulvar and Vaginal Cancer and Their High-grade Precursors', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'The incidence of HPV-related histologically confirmed female genital diseases, including vulvar and vaginal cancer and their high-grade precursors was to be assessed.'}, {'measure': 'Prevalence of HPV 6/11/16/18 Infection in Participants <=26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.'}, {'measure': 'Prevalence of HPV 6/11/16/18 Infection in Participants >26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.'}, {'measure': 'Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants <=26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.'}, {'measure': 'Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants >26 Years of Age', 'timeFrame': 'Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)', 'description': 'All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.'}, {'measure': 'Percentage of Live Born Babies With a Major Congenital Anomaly', 'timeFrame': 'Up to 5 years after Gardasil licensure (2007 to 2011)', 'description': 'The percentage of live born babies with major congenital anomalies (MCA) born to women vaccinated with Gardasil during pregnancy and to women in the general population was assessed. For Denmark and Sweden diagnoses of congenital anomaly within 1 year of birth are included; for Norway diagnoses at birth are included.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Cervical Intraepithelial Neoplasia by Gardasil Vaccination Status', 'timeFrame': 'Four years to 5 years after Gardasil licensure (2011 to 2012)', 'description': 'The incidence of CIN by Gardasil vaccination status was to be assessed.'}, {'measure': 'Incidence of Cervical Cancer by Gardasil Vaccination Status', 'timeFrame': 'Four years to 5 years after Gardasil licensure (2011 to 2012)', 'description': 'The incidence of other cervical cancers by Gardasil vaccination status was to be assessed.'}, {'measure': 'Incidence of Other HPV-related Genital Diseases by Gardasil Vaccination Status', 'timeFrame': 'Four years to 5 years after Gardasil licensure (2011 to 2012)', 'description': 'The incidence of other HPV-related genital diseases, including vulvar and vaginal cancers, by Gardasil vaccination status was to be assessed.'}, {'measure': 'Prevalence of HPV 6, 11, 16, and 18 Infection by Gardasil Vaccination Status', 'timeFrame': 'Four years to 5 years after Gardasil licensure (2011 to 2012)', 'description': 'The percentage of participants with liquid-based cervical cytology samples positive for HPV 6, 11, 16, and 18 was to be analyzed by Gardasil vaccination status.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['congenital anomaly', 'pregnancy', 'GARDASIL®', 'Nordic', 'population-based'], 'conditions': ['Human Papillomavirus Infections']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=V501-033&kw=V501-033&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '20451636', 'type': 'BACKGROUND', 'citation': 'Bonanni P, Cohet C, Kjaer SK, Latham NB, Lambert PH, Reisinger K, Haupt RM. A summary of the post-licensure surveillance initiatives for GARDASIL/SILGARD. Vaccine. 2010 Jul 5;28(30):4719-30. doi: 10.1016/j.vaccine.2010.04.070. Epub 2010 May 6.'}, {'pmid': '24552678', 'type': 'RESULT', 'citation': 'Baldur-Felskov B, Dehlendorff C, Munk C, Kjaer SK. Early impact of human papillomavirus vaccination on cervical neoplasia--nationwide follow-up of young Danish women. J Natl Cancer Inst. 2014 Mar;106(3):djt460. doi: 10.1093/jnci/djt460. Epub 2014 Feb 19.'}, {'pmid': '32990181', 'type': 'DERIVED', 'citation': 'Nygard M, Hansen BT, Kjaer SK, Hortlund M, Tryggvadottir L, Munk C, Lagheden C, Sigurdardottir LG, Campbell S, Liaw KL, Dillner J. Human papillomavirus genotype-specific risks for cervical intraepithelial lesions. Hum Vaccin Immunother. 2021 Apr 3;17(4):972-981. doi: 10.1080/21645515.2020.1814097. Epub 2020 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the impact of GARDASIL™ human papillomavirus (HPV) vaccine in the general female population by utilizing nationwide registry databases in the participating Nordic countries.', 'detailedDescription': 'Time perspective: The study will be conducted using data collected both retrospectively/concurrently from registries and prospectively by questionnaire survey.\n\nBaseline survey data were collected during a prior study from 2004-2005.\n\nSafety Monitoring: An expert panel on teratology consisting of one teratologist from each of the participating countries will review all available medical records related to any congenital anomalies to search for any emerging patterns that may be indicative of an association between GARDASIL™ exposure in the mother and the subsequent congenital anomalies in the babies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Registry data from the Population, Cervical Cancer Screening, Pathology, Cancer, and Death registries; Survey: Questionnaire sent to random sampling of women from the Central Population Registry Database; HPV Data: liquid-based cytology and histology samples from hospitals in participating countries', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: - Registry Data: \\* Female residents of participating Nordic countries who were alive on January 1st in the year the data will be used for analysis - Survey Data: --Female residents alive in the participating countries on July 1, 2011 --Women must provide consent to use questionnaire data and to link data to other registry databases - Cervical Sample Collection: --For HPV data in the general population: cervical samples from residents of the participating countries who are 45 years and under collected between 2006 and 2007, or in 2011-2012 --For HPV data in lesional samples: cervical samples from women with a diagnosis of CIN or cervical cancer between 2004-2006 and 2011-2012 Exclusion Criteria: - Registry Data: \\* Women who participated in Protocol V501-015 (NCT00092534) and are included in the Long-Term Follow-Up study - Survey Data: --Women under 18 or above age 45 on July 1, 2011 --Women who participated in Protocol V501-015 and are included in the Long-Term Follow-Up study - Cervical Sample Collection: --Samples from women who participated in Protocol V501-015 and are included in the Long-Term Follow-Up study --Samples with inadequate integrity for HPV testing'}, 'identificationModule': {'nctId': 'NCT01077856', 'acronym': 'VIP', 'briefTitle': 'GARDASIL™ Vaccine Impact in Population Study (V501-033)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'GARDASIL™ Vaccine Impact in Population Study', 'orgStudyIdInfo': {'id': 'V501-033'}, 'secondaryIdInfos': [{'id': '2010_018', 'type': 'OTHER', 'domain': 'Merck Registration Number'}, {'id': 'EP08014.033', 'type': 'OTHER', 'domain': 'Merck Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-Vaccine', 'description': 'Registry, survey, and HPV status data from 2004-2006'}, {'label': 'Post-Vaccine', 'description': 'Registry, survey, and HPV status data from 2011-2012'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Danish Cancer Society', 'class': 'OTHER'}, {'name': 'Union for International Cancer Control', 'class': 'OTHER'}, {'name': 'Norwegian Institute of Public Health', 'class': 'OTHER_GOV'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}