Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT00378560
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2006-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
V501 Efficacy Study in Women Aged 18 to 26 (V501-027)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068857', 'term': 'Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18'}], 'ancestors': [{'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D053918', 'term': 'Papillomavirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination.', 'description': 'The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine.\n\nUnlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'V501', 'description': 'V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6', 'otherNumAtRisk': 480, 'otherNumAffected': 435, 'seriousNumAtRisk': 480, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6', 'otherNumAtRisk': 468, 'otherNumAffected': 396, 'seriousNumAtRisk': 468, 'seriousNumAffected': 65}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 206, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 154, 'numAffected': 99}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site movement impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 867, 'numAffected': 397}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 626, 'numAffected': 316}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 188, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 84, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 40, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 29, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Venipuncture site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Laryngopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Lymph gland infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 59, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 60, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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{'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 3, 'numAffected': 2}, 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'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Urticaria generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 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'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Ovarian abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Drug toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Neck injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 46, 'numAffected': 46}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Ovarian cystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Tonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V501', 'description': 'V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '61.2', 'upperLimit': '97.7'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Relative Risk Reduction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '87.6', 'ciLowerLimit': '59.2', 'ciUpperLimit': '97.6', 'estimateComment': 'Binomial probability conditional on the fixed number of events.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Over 30 months', 'description': 'Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.', 'unitOfMeasure': 'Incidence per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who were not general protocol violators, received all 3 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'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At one month after completed vaccination series (Month 7)', 'description': 'Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.\n\nThe limit of detection of the assay was 7 mMU/ml. 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GMTs and confidence limits below the limit of detection are shown as "11.0".', 'unitOfMeasure': 'Geometric Mean Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range'}, {'type': 'SECONDARY', 'title': 'Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V501', 'description': 'V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6'}], 'classes': [{'categories': [{'measurements': [{'value': '369.0', 'groupId': 'OG000', 'lowerLimit': '335.9', 'upperLimit': '405.4'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '10.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At one month after completed vaccination series (Month 7)', 'description': 'Month 7 HPV cLIA Geometric Mean Titers by vaccine group.\n\nThe limit of detection of the assay was 10 mMU/ml. 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GMTs and confidence limits below the limit of detection are shown as "7.0".'}, {'measure': 'Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)', 'timeFrame': 'At one month after completed vaccination series (Month 7)', 'description': 'Month 7 HPV cLIA Geometric Mean Titers by vaccine group.\n\nThe limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".'}, {'measure': 'Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)', 'timeFrame': 'At one month after completed vaccination series (Month 7)', 'description': 'Month 7 HPV cLIA Geometric Mean Titers by vaccine group.\n\nThe limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".'}, {'measure': 'Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)', 'timeFrame': 'At one month after completed vaccination series (Month 7)', 'description': 'Month 7 HPV cLIA Geometric Mean Titers by vaccine group.\n\nThe limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".'}]}, 'conditionsModule': {'conditions': ['HPV Infections']}, 'referencesModule': {'references': [{'pmid': '23331518', 'type': 'RESULT', 'citation': 'Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7.'}, {'pmid': '32827835', 'type': 'DERIVED', 'citation': 'Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female Subject Aged 18 To 26 Years\n* With 1-4 Lifetime Sexual Partners\n\nExclusion Criteria:\n\n* Male Subject'}, 'identificationModule': {'nctId': 'NCT00378560', 'briefTitle': 'V501 Efficacy Study in Women Aged 18 to 26 (V501-027)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'V501 Phase II Efficacy Study in Women Aged 18 to 26', 'orgStudyIdInfo': {'id': 'V501-027'}, 'secondaryIdInfos': [{'id': '2006_032'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Biological: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Vaccine', 'interventionNames': ['Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine']}], 'interventions': [{'name': 'Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['V501', 'Gardasil'], 'description': 'V501; Gardasil, 0.5 ml injection in 3 dosing regimen', 'armGroupLabels': ['2']}, {'name': 'Comparator: Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo 0.5 ml injection in 3 dosing regimen', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}