Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-03 @ 9:28 PM
Study NCT ID:
NCT03671369
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2018-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', '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}, 'limitationsAndCaveats': {'description': "Statistical significance of AEs incidence proportion by baseline background factor wasn't planned in statistical analysis plan. As per Ministry of Food and Drug Safety regulation, additional analysis was done to determine what factors may affect AEs incidence in Korea routine clinical practice. Study design didn't include stratification or adjustment to account for baseline factors in analysis. Study findings are to be interpreted with caution considering clinical plausibility and significance."}}, 'adverseEventsModule': {'timeFrame': 'Non-serious adverse events: From Day 1 up to 30 days (post dose 1, dose 2 and dose 3 vaccination). SAEs: From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6).', 'description': 'Data was collected based on the Total Vaccinated Cohort.', 'eventGroups': [{'id': 'EG000', 'title': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.', 'otherNumAtRisk': 669, 'deathsNumAtRisk': 669, 'otherNumAffected': 144, 'seriousNumAtRisk': 669, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 68, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 34, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Functional gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Keratosis pilaris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Swelling of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 669, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.72', 'groupId': 'OG000', 'lowerLimit': '14.33', 'upperLimit': '21.54'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to 30 days (post dose 1 vaccination)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.\n\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.77', 'groupId': 'OG000', 'lowerLimit': '15.01', 'upperLimit': '23.01'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to 30 days (post dose 2 vaccination)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.\n\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received two doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.'}, {'type': 'PRIMARY', 'title': 'Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '14.92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to 30 days (post dose 3 vaccination)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.\n\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Safety cohort, which included all subjects with data available at the specified time point who received three doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With AEs by Maximum Intensity Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '457', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 up to 30 days (post dose 1 vaccination)', 'description': "An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With AEs by Maximum Intensity Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 up to 30 days (post dose 2 vaccination)', 'description': "An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received two doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With AEs by Maximum Intensity Post Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 up to 30 days (post dose 3 vaccination)', 'description': "An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Safety cohort, which included all participants with data available at the specified time point who received three doses of vaccine as per the protocol and who reported adverse events even though they have not completed 30-days follow-up period after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '662', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.'}], 'classes': [{'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fatal Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Safety cohort, which included all participants who received at least one dose of vaccine as per the protocol and who reported adverse events even though they have not completed 30 days follow up period after vaccination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '669'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '378'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '291'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '289'}]}, {'type': 'Not willing to be vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 29 centers in Republic of Korea.', 'preAssignmentDetails': 'Out of 670 subjects enrolled in the study, 1 subject did not receive any vaccine and therefore was not included in any analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.92', 'spread': '2.75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '646', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Korean', 'categories': [{'measurements': [{'value': '664', 'groupId': 'BG000'}]}]}, {'title': 'Non-Korean', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-14', 'size': 971225, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-16T09:57', 'hasProtocol': True}, {'date': '2018-12-06', 'size': 313484, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-16T09:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 670}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2018-08-30', 'resultsFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-20', 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 1', 'timeFrame': 'From Day 1 up to 30 days (post dose 1 vaccination)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.\n\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.'}, {'measure': 'Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 2', 'timeFrame': 'From Day 1 up to 30 days (post dose 2 vaccination)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.\n\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.'}, {'measure': 'Percentage (%) of Subjects With Adverse Events (AEs) Post Dose 3', 'timeFrame': 'From Day 1 up to 30 days (post dose 3 vaccination)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.\n\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The percentage of subjects with AEs was calculated by dividing the number of subjects with adverse events by the number of subjects in each total number of Cervarix doses vaccinated in Total Safety Cohort, and multiplied by 100.'}, {'measure': 'Number of Participants With AEs by Maximum Intensity Post Dose 1', 'timeFrame': 'From Day 1 up to 30 days (post dose 1 vaccination)', 'description': "An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement."}, {'measure': 'Number of Participants With AEs by Maximum Intensity Post Dose 2', 'timeFrame': 'From Day 1 up to 30 days (post dose 2 vaccination)', 'description': "An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement."}, {'measure': 'Number of Participants With AEs by Maximum Intensity Post Dose 3', 'timeFrame': 'From Day 1 up to 30 days (post dose 3 vaccination)', 'description': "An AE with maximum intensity are equivalent to severe AEs category (AEs which prevented normal everyday activities in a young child. Such an AE would, for example, prevent attendance at school/kindergarten/a day-care centre and can cause the parent(s)/Legally Acceptable Representative(s) to seek medical advice). The physician assessed the maximum intensity that occurred over the duration of the event for all AEs recorded during the PMS. The assessment was based on the physician's clinical judgement."}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) and Fatal SAEs', 'timeFrame': 'From Day 1 to 30 days after the last vaccine dose administered (at Month 0 or Month 2 or Month 6)', 'description': 'A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human Papillomavirus Vaccine', 'Adverse events after vaccination', 'Safety', 'Serious adverse events after vaccination'], 'conditions': ['Neoplasms, Rectal']}, 'referencesModule': {'references': [{'pmid': '36896702', 'type': 'DERIVED', 'citation': 'Eun BW, Bahar E, Xavier S, Kim H, Borys D. Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017-2021). Hum Vaccin Immunother. 2023 Dec 31;19(1):2184756. doi: 10.1080/21645515.2023.2184756. Epub 2023 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (PI) in Korea in a real health care setting over a period of 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Korean male and female subjects aged 9-25 years, who are eligible for the series of Cervarix vaccination, according to the locally approved PI.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject or/and subjects whose parent(s)/Legally Acceptable Representative(s) \\[LAR(s)\\], in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Korean male or female subjects aged 9-25 years who are eligible for the series of Cervarix according to the locally approved PI.\n* Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.\n\nExclusion Criteria:\n\n* At the time of PMS entry, the contraindications and precautions of use indicated in the locally approved PI. PI should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved PI must be implemented immediately.\n* Subjects who had previous administration of a HPV vaccine other than Cervarix will not be enrolled into the study.\n* Subjects who are not eligible for vaccination with Cervarix according to the medical judgement of physician.\n* Child in care.'}, 'identificationModule': {'nctId': 'NCT03671369', 'briefTitle': "A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Post-marketing Surveillance of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix When Administered According to the Approved Prescribing Information in Korea", 'orgStudyIdInfo': {'id': '208710'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cervarix Group', 'description': 'The study group comprised of 9-25 year-old male and female subjects who were administered with 3 doses of Cervarix vaccine, according to a 0, 1, and 6 months schedule, as per locally approved prescribing information (PI) in Korea. The 9-14 years old subjects were vaccinated with 2 doses, according to a 0 and 6-12 months schedule. In the 2-dose schedule, if the second dose was administered before 5 months after the first dose, the third dose vaccination was required. In the 3 doses schedule, if the vaccination schedule required flexibility, the second dose was administered between 1 and 2.5 months and the third dose was administered between 5 and 12 months after the first dose.', 'interventionNames': ['Other: Safety data collection (following routine vaccination) by a continuous surveillance method.']}], 'interventions': [{'name': 'Safety data collection (following routine vaccination) by a continuous surveillance method.', 'type': 'OTHER', 'description': "This study assesses the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine in terms of frequency and intensity of adverse events (AEs) and serious adverse events (SAEs) when administered routinely in male and female subjects aged between 9 and 25 years, according to the approved Prescribing Information in Korea.\n\nAll AEs reported during the 30-day post-vaccination follow-up period (Day 1 to Day 30) and all SAEs reported through the study period from dose 1 up to 30 days after the last dose administered during the post-marketing surveillance (PMS) were collected as part of safety data in this PMS.", 'armGroupLabels': ['Cervarix Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47863', 'city': 'Busan', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '32580', 'city': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'GSK Investigational Site'}, {'zip': '42274', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '32555', 'city': 'Gongju-si, Chungcheongnam-do', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.45556, 'lon': 127.12472}}, {'zip': '62220', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '11813', 'city': 'Gyeonggi-do', 'country': 'South 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