Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-01 @ 5:52 PM
Study NCT ID:
NCT00779766
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
2008-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], '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'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'At the time of the event-triggered analysis at Month 24, some safety results remain blinded and are not presented here since the study is still ongoing. These results will be updated once they become available.'}}, 'adverseEventsModule': {'timeFrame': 'SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination', 'description': 'Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.', 'eventGroups': [{'id': 'EG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.', 'otherNumAtRisk': 3026, 'deathsNumAtRisk': 3026, 'otherNumAffected': 2786, 'seriousNumAtRisk': 3026, 'deathsNumAffected': 0, 'seriousNumAffected': 56}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.', 'otherNumAtRisk': 3025, 'deathsNumAtRisk': 3025, 'otherNumAffected': 2548, 'seriousNumAtRisk': 3025, 'deathsNumAffected': 3, 'seriousNumAffected': 81}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 276}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 290}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3005, 'numAffected': 2634}, {'groupId': 'EG001', 'numAtRisk': 3001, 'numAffected': 2166}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3005, 'numAffected': 838}, {'groupId': 'EG001', 'numAtRisk': 3001, 'numAffected': 517}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3005, 'numAffected': 853}, {'groupId': 'EG001', 'numAtRisk': 3001, 'numAffected': 408}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3005, 'numAffected': 270}, {'groupId': 'EG001', 'numAtRisk': 3001, 'numAffected': 213}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3005, 'numAffected': 1142}, {'groupId': 'EG001', 'numAtRisk': 3001, 'numAffected': 1018}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3005, 'numAffected': 409}, {'groupId': 'EG001', 'numAtRisk': 3001, 'numAffected': 473}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3005, 'numAffected': 691}, {'groupId': 'EG001', 'numAtRisk': 3001, 'numAffected': 690}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3005, 'numAffected': 523}, {'groupId': 'EG001', 'numAtRisk': 3001, 'numAffected': 360}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3005, 'numAffected': 749}, {'groupId': 'EG001', 'numAtRisk': 3001, 'numAffected': 703}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Breast cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ectopic pregnancy with intrauterine device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ovarian cyst torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abortion spontaneous complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 5}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Premature baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 5}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Umbilical cord around neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cleft lip and palate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Congenital torticollis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Foetal death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Low birth weight baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neonatal pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neonatal respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Premature separation of placenta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Stillbirth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Teratoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abortion spontaneous incomplete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abortion threatened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Adenoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Angiomyolipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Benign gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blighted ovum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Breast fibroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Chondrodystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diaphragmatic hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Foetal distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, 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'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gestational diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gestational hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypersplenism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'IgA nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Imminent abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pelvic adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pelvic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pituitary tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Placental insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary hypoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Trisomy 21', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urethral cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Uterine cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vascular rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3026, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3025, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2775', 'groupId': 'OG000'}, {'value': '2764', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. 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Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Sero negative, DNA negative HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2497', 'groupId': 'OG000'}, {'value': '2502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2320', 'groupId': 'OG000'}, {'value': '2314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative, HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2775', 'groupId': 'OG000'}, {'value': '2764', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative, HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2677', 'groupId': 'OG000'}, {'value': '2672', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative, HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2738', 'groupId': 'OG000'}, {'value': '2731', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 24', 'description': 'CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable subjects for whom efficacy data were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2803', 'groupId': 'OG000'}, {'value': '2799', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. 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Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Sero negative, DNA negative HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2522', 'groupId': 'OG000'}, {'value': '2531', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1958', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2320', 'groupId': 'OG000'}, {'value': '2314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative, HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2803', 'groupId': 'OG000'}, {'value': '2799', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative, HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2705', 'groupId': 'OG000'}, {'value': '2707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative, HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 48', 'description': 'CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2805', 'groupId': 'OG000'}, {'value': '2802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Sero negative, DNA negative HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2524', 'groupId': 'OG000'}, {'value': '2535', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1959', 'groupId': 'OG000'}, {'value': '1909', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2346', 'groupId': 'OG000'}, {'value': '2344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2805', 'groupId': 'OG000'}, {'value': '2802', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2707', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2768', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 57', 'description': 'CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2804', 'groupId': 'OG000'}, {'value': '2801', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Sero negative, DNA negative HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2523', 'groupId': 'OG000'}, {'value': '2534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1958', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2345', 'groupId': 'OG000'}, {'value': '2344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16/18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2804', 'groupId': 'OG000'}, {'value': '2801', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 72', 'description': 'CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2807', 'groupId': 'OG000'}, {'value': '2802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Sero negative, DNA negative HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2497', 'groupId': 'OG000'}, {'value': '2502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1935', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2321', 'groupId': 'OG000'}, {'value': '2314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2776', 'groupId': 'OG000'}, {'value': '2764', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2677', 'groupId': 'OG000'}, {'value': '2672', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2740', 'groupId': 'OG000'}, {'value': '2731', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2519', 'groupId': 'OG000'}, {'value': '2527', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1953', 'groupId': 'OG000'}, {'value': '1905', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2341', 'groupId': 'OG000'}, {'value': '2337', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2397', 'groupId': 'OG000'}, {'value': '2424', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2230', 'groupId': 'OG000'}, {'value': '2241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1859', 'groupId': 'OG000'}, {'value': '1830', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2525', 'groupId': 'OG000'}, {'value': '2535', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1958', 'groupId': 'OG000'}, {'value': '1909', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2347', 'groupId': 'OG000'}, {'value': '2344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2807', 'groupId': 'OG000'}, {'value': '2802', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2708', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2770', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2524', 'groupId': 'OG000'}, {'value': '2534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1957', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2346', 'groupId': 'OG000'}, {'value': '2344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1806', 'groupId': 'OG000'}, {'value': '2801', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2707', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'DNA negative HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2769', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 24,48, 57 and 72', 'description': 'HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered. - DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2762', 'groupId': 'OG000'}, {'value': '2748', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Sero negative, DNA negative HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2332', 'groupId': 'OG000'}, {'value': '2326', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1810', 'groupId': 'OG000'}, {'value': '1747', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2168', 'groupId': 'OG000'}, {'value': '2154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2596', 'groupId': 'OG000'}, {'value': '2569', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2509', 'groupId': 'OG000'}, {'value': '2488', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2565', 'groupId': 'OG000'}, {'value': '2537', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2464', 'groupId': 'OG000'}, {'value': '2474', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1915', 'groupId': 'OG000'}, {'value': '1864', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2290', 'groupId': 'OG000'}, {'value': '2288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2742', 'groupId': 'OG000'}, {'value': '2728', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2647', 'groupId': 'OG000'}, {'value': '2639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2694', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2480', 'groupId': 'OG000'}, {'value': '2488', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1928', 'groupId': 'OG000'}, {'value': '1875', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2306', 'groupId': 'OG000'}, {'value': '2298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2759', 'groupId': 'OG000'}, {'value': '2744', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2663', 'groupId': 'OG000'}, {'value': '2655', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2723', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2483', 'groupId': 'OG000'}, {'value': '2492', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1929', 'groupId': 'OG000'}, {'value': '1876', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2309', 'groupId': 'OG000'}, {'value': '2303', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2762', 'groupId': 'OG000'}, {'value': '2748', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2666', 'groupId': 'OG000'}, {'value': '2659', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Overall HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2726', 'groupId': 'OG000'}, {'value': '2714', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months. Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2702', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Sero negative, DNA negative HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '1091', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '799', 'groupId': 'OG000'}, {'value': '768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1034', 'groupId': 'OG000'}, {'value': '1014', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}, {'value': '1257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1261', 'groupId': 'OG000'}, {'value': '1216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1285', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2397', 'groupId': 'OG000'}, {'value': '2424', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1859', 'groupId': 'OG000'}, {'value': '1830', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2230', 'groupId': 'OG000'}, {'value': '2241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2668', 'groupId': 'OG000'}, {'value': '2673', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2575', 'groupId': 'OG000'}, {'value': '2587', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2633', 'groupId': 'OG000'}, {'value': '2639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2425', 'groupId': 'OG000'}, {'value': '2455', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1880', 'groupId': 'OG000'}, {'value': '1856', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2257', 'groupId': 'OG000'}, {'value': '2269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2699', 'groupId': 'OG000'}, {'value': '2706', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2604', 'groupId': 'OG000'}, {'value': '2620', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2664', 'groupId': 'OG000'}, {'value': '2672', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2428', 'groupId': 'OG000'}, {'value': '2458', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1882', 'groupId': 'OG000'}, {'value': '1857', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2258', 'groupId': 'OG000'}, {'value': '2273', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2702', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2607', 'groupId': 'OG000'}, {'value': '2622', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2666', 'groupId': 'OG000'}, {'value': '2675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months. Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA). Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2812', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2677', 'groupId': 'OG000'}, {'value': '2672', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2740', 'groupId': 'OG000'}, {'value': '2731', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2745', 'groupId': 'OG000'}, {'value': '2733', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2738', 'groupId': 'OG000'}, {'value': '2733', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2753', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2716', 'groupId': 'OG000'}, {'value': '2723', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2751', 'groupId': 'OG000'}, {'value': '2751', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2712', 'groupId': 'OG000'}, {'value': '2708', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2626', 'groupId': 'OG000'}, {'value': '2615', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2741', 'groupId': 'OG000'}, {'value': '2730', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2730', 'groupId': 'OG000'}, {'value': '2718', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2771', 'groupId': 'OG000'}, {'value': '2746', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2737', 'groupId': 'OG000'}, {'value': '2715', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2732', 'groupId': 'OG000'}, {'value': '2734', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2780', 'groupId': 'OG000'}, {'value': '2773', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2780', 'groupId': 'OG000'}, {'value': '2774', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2780', 'groupId': 'OG000'}, {'value': '2774', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '313', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2780', 'groupId': 'OG000'}, {'value': '2774', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '323', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2702', 'groupId': 'OG000'}, {'value': '2702', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2770', 'groupId': 'OG000'}, {'value': '2762', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2763', 'groupId': 'OG000'}, {'value': '2763', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2789', 'groupId': 'OG000'}, {'value': '2783', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2742', 'groupId': 'OG000'}, {'value': '2752', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2777', 'groupId': 'OG000'}, {'value': '2781', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2736', 'groupId': 'OG000'}, {'value': '2736', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2650', 'groupId': 'OG000'}, {'value': '2644', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2755', 'groupId': 'OG000'}, {'value': '2748', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2797', 'groupId': 'OG000'}, {'value': '2776', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2763', 'groupId': 'OG000'}, {'value': '2745', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2758', 'groupId': 'OG000'}, {'value': '2764', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2806', 'groupId': 'OG000'}, {'value': '2803', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2806', 'groupId': 'OG000'}, {'value': '2804', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2806', 'groupId': 'OG000'}, {'value': '2804', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '536', 'groupId': 'OG000'}, {'value': '591', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2806', 'groupId': 'OG000'}, {'value': '2804', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '552', 'groupId': 'OG000'}, {'value': '646', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2708', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2770', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2776', 'groupId': 'OG000'}, {'value': '2770', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2769', 'groupId': 'OG000'}, {'value': '2771', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2795', 'groupId': 'OG000'}, {'value': '2791', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2748', 'groupId': 'OG000'}, {'value': '2760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2783', 'groupId': 'OG000'}, {'value': '2789', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2742', 'groupId': 'OG000'}, {'value': '2743', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2656', 'groupId': 'OG000'}, {'value': '2652', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2772', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2761', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2806', 'groupId': 'OG000'}, {'value': '2784', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2769', 'groupId': 'OG000'}, {'value': '2752', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2772', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2812', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2812', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2812', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '692', 'groupId': 'OG000'}, {'value': '800', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2812', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '710', 'groupId': 'OG000'}, {'value': '862', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2707', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2769', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2775', 'groupId': 'OG000'}, {'value': '2769', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2768', 'groupId': 'OG000'}, {'value': '2770', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2794', 'groupId': 'OG000'}, {'value': '2790', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2747', 'groupId': 'OG000'}, {'value': '2759', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2782', 'groupId': 'OG000'}, {'value': '2788', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2741', 'groupId': 'OG000'}, {'value': '2742', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2655', 'groupId': 'OG000'}, {'value': '2651', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2771', 'groupId': 'OG000'}, {'value': '2766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2760', 'groupId': 'OG000'}, {'value': '2755', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2802', 'groupId': 'OG000'}, {'value': '2783', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2768', 'groupId': 'OG000'}, {'value': '2751', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2763', 'groupId': 'OG000'}, {'value': '2771', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2811', 'groupId': 'OG000'}, {'value': '2810', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2811', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2811', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '744', 'groupId': 'OG000'}, {'value': '852', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2811', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '764', 'groupId': 'OG000'}, {'value': '914', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2509', 'groupId': 'OG000'}, {'value': '2488', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2565', 'groupId': 'OG000'}, {'value': '2537', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2568', 'groupId': 'OG000'}, {'value': '2540', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2562', 'groupId': 'OG000'}, {'value': '2539', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2585', 'groupId': 'OG000'}, {'value': '2558', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2540', 'groupId': 'OG000'}, {'value': '2532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2573', 'groupId': 'OG000'}, {'value': '2559', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2544', 'groupId': 'OG000'}, {'value': '2514', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2466', 'groupId': 'OG000'}, {'value': '2438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2566', 'groupId': 'OG000'}, {'value': '2538', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2553', 'groupId': 'OG000'}, {'value': '2526', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2591', 'groupId': 'OG000'}, {'value': '2551', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2564', 'groupId': 'OG000'}, {'value': '2521', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2558', 'groupId': 'OG000'}, {'value': '2540', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2600', 'groupId': 'OG000'}, {'value': '2576', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2600', 'groupId': 'OG000'}, {'value': '2577', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2600', 'groupId': 'OG000'}, {'value': '2577', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2600', 'groupId': 'OG000'}, {'value': '2577', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2647', 'groupId': 'OG000'}, {'value': '2639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2694', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2714', 'groupId': 'OG000'}, {'value': '2698', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2705', 'groupId': 'OG000'}, {'value': '2696', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2730', 'groupId': 'OG000'}, {'value': '2718', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2684', 'groupId': 'OG000'}, {'value': '2686', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2718', 'groupId': 'OG000'}, {'value': '2717', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2684', 'groupId': 'OG000'}, {'value': '2669', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2598', 'groupId': 'OG000'}, {'value': '2587', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2709', 'groupId': 'OG000'}, {'value': '2693', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2698', 'groupId': 'OG000'}, {'value': '2684', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2738', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2678', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2703', 'groupId': 'OG000'}, {'value': '2698', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2747', 'groupId': 'OG000'}, {'value': '2736', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2747', 'groupId': 'OG000'}, {'value': '2737', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2747', 'groupId': 'OG000'}, {'value': '2737', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2663', 'groupId': 'OG000'}, {'value': '2655', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2723', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2731', 'groupId': 'OG000'}, {'value': '2714', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2722', 'groupId': 'OG000'}, {'value': '2712', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2747', 'groupId': 'OG000'}, {'value': '2734', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2701', 'groupId': 'OG000'}, {'value': '2702', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2735', 'groupId': 'OG000'}, {'value': '2733', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2699', 'groupId': 'OG000'}, {'value': '2685', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2612', 'groupId': 'OG000'}, {'value': '2602', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2726', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2715', 'groupId': 'OG000'}, {'value': '2699', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2755', 'groupId': 'OG000'}, {'value': '2726', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2723', 'groupId': 'OG000'}, {'value': '2694', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2720', 'groupId': 'OG000'}, {'value': '2714', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2752', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2753', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2753', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2753', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2666', 'groupId': 'OG000'}, {'value': '2659', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2726', 'groupId': 'OG000'}, {'value': '2714', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2734', 'groupId': 'OG000'}, {'value': '2718', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2725', 'groupId': 'OG000'}, {'value': '2716', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}, {'value': '2738', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2703', 'groupId': 'OG000'}, {'value': '2706', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2738', 'groupId': 'OG000'}, {'value': '2737', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2702', 'groupId': 'OG000'}, {'value': '2688', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2614', 'groupId': 'OG000'}, {'value': '2606', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2728', 'groupId': 'OG000'}, {'value': '2712', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2718', 'groupId': 'OG000'}, {'value': '2703', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2758', 'groupId': 'OG000'}, {'value': '2730', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2726', 'groupId': 'OG000'}, {'value': '2697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2723', 'groupId': 'OG000'}, {'value': '2718', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '381', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '382', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2717', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1261', 'groupId': 'OG000'}, {'value': '1216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1285', 'groupId': 'OG000'}, {'value': '1242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1283', 'groupId': 'OG000'}, {'value': '1239', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1287', 'groupId': 'OG000'}, {'value': '1248', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1298', 'groupId': 'OG000'}, {'value': '1255', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1272', 'groupId': 'OG000'}, {'value': '1234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1292', 'groupId': 'OG000'}, {'value': '1246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1281', 'groupId': 'OG000'}, {'value': '1229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1240', 'groupId': 'OG000'}, {'value': '1193', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1283', 'groupId': 'OG000'}, {'value': '1246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1273', 'groupId': 'OG000'}, {'value': '1238', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1298', 'groupId': 'OG000'}, {'value': '1246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1289', 'groupId': 'OG000'}, {'value': '1238', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1281', 'groupId': 'OG000'}, {'value': '1240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1305', 'groupId': 'OG000'}, {'value': '1261', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1305', 'groupId': 'OG000'}, {'value': '1262', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1305', 'groupId': 'OG000'}, {'value': '1262', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1305', 'groupId': 'OG000'}, {'value': '1262', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2575', 'groupId': 'OG000'}, {'value': '2587', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2633', 'groupId': 'OG000'}, {'value': '2639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2640', 'groupId': 'OG000'}, {'value': '2643', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2632', 'groupId': 'OG000'}, {'value': '2643', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2655', 'groupId': 'OG000'}, {'value': '2662', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2611', 'groupId': 'OG000'}, {'value': '2632', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2643', 'groupId': 'OG000'}, {'value': '2661', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2610', 'groupId': 'OG000'}, {'value': '2615', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2527', 'groupId': 'OG000'}, {'value': '2538', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2635', 'groupId': 'OG000'}, {'value': '2639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2626', 'groupId': 'OG000'}, {'value': '2629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2663', 'groupId': 'OG000'}, {'value': '2654', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2633', 'groupId': 'OG000'}, {'value': '2624', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2629', 'groupId': 'OG000'}, {'value': '2643', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2672', 'groupId': 'OG000'}, {'value': '2680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2672', 'groupId': 'OG000'}, {'value': '2681', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2672', 'groupId': 'OG000'}, {'value': '2681', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2672', 'groupId': 'OG000'}, {'value': '2681', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2604', 'groupId': 'OG000'}, {'value': '2620', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2664', 'groupId': 'OG000'}, {'value': '2672', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2671', 'groupId': 'OG000'}, {'value': '2676', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2663', 'groupId': 'OG000'}, {'value': '2675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2686', 'groupId': 'OG000'}, {'value': '2695', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2641', 'groupId': 'OG000'}, {'value': '2664', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2674', 'groupId': 'OG000'}, {'value': '2694', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2639', 'groupId': 'OG000'}, {'value': '2647', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2553', 'groupId': 'OG000'}, {'value': '2569', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2665', 'groupId': 'OG000'}, {'value': '2672', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2656', 'groupId': 'OG000'}, {'value': '2661', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2694', 'groupId': 'OG000'}, {'value': '2687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2662', 'groupId': 'OG000'}, {'value': '2657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2659', 'groupId': 'OG000'}, {'value': '2675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2703', 'groupId': 'OG000'}, {'value': '2713', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2717', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2717', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2717', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2607', 'groupId': 'OG000'}, {'value': '2622', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2666', 'groupId': 'OG000'}, {'value': '2675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2674', 'groupId': 'OG000'}, {'value': '2679', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2666', 'groupId': 'OG000'}, {'value': '2678', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2689', 'groupId': 'OG000'}, {'value': '2698', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2643', 'groupId': 'OG000'}, {'value': '2667', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2677', 'groupId': 'OG000'}, {'value': '2697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2642', 'groupId': 'OG000'}, {'value': '2650', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2555', 'groupId': 'OG000'}, {'value': '2571', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2667', 'groupId': 'OG000'}, {'value': '2675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2659', 'groupId': 'OG000'}, {'value': '2664', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2697', 'groupId': 'OG000'}, {'value': '2690', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2665', 'groupId': 'OG000'}, {'value': '2660', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2662', 'groupId': 'OG000'}, {'value': '2678', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2716', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2717', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2717', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2717', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 24,48, 57 and 72', 'description': 'Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2803', 'groupId': 'OG000'}, {'value': '2802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Sero negative, DNA negative HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2494', 'groupId': 'OG000'}, {'value': '2502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1935', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2318', 'groupId': 'OG000'}, {'value': '2314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2772', 'groupId': 'OG000'}, {'value': '2763', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2674', 'groupId': 'OG000'}, {'value': '2671', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2736', 'groupId': 'OG000'}, {'value': '2730', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2520', 'groupId': 'OG000'}, {'value': '2531', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1957', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2342', 'groupId': 'OG000'}, {'value': '2340', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2801', 'groupId': 'OG000'}, {'value': '2799', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2703', 'groupId': 'OG000'}, {'value': '2707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2522', 'groupId': 'OG000'}, {'value': '2535', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1958', 'groupId': 'OG000'}, {'value': '1909', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2344', 'groupId': 'OG000'}, {'value': '2344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2803', 'groupId': 'OG000'}, {'value': '2802', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2705', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2521', 'groupId': 'OG000'}, {'value': '2534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1957', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2343', 'groupId': 'OG000'}, {'value': '2344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2802', 'groupId': 'OG000'}, {'value': '2801', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2704', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. US).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2674', 'groupId': 'OG000'}, {'value': '2671', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2736', 'groupId': 'OG000'}, {'value': '2730', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2741', 'groupId': 'OG000'}, {'value': '2732', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2734', 'groupId': 'OG000'}, {'value': '2732', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2760', 'groupId': 'OG000'}, {'value': '2752', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2712', 'groupId': 'OG000'}, {'value': '2722', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2747', 'groupId': 'OG000'}, {'value': '2750', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2709', 'groupId': 'OG000'}, {'value': '2707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2622', 'groupId': 'OG000'}, {'value': '2614', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2737', 'groupId': 'OG000'}, {'value': '2730', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2726', 'groupId': 'OG000'}, {'value': '2717', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2745', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2733', 'groupId': 'OG000'}, {'value': '2714', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2728', 'groupId': 'OG000'}, {'value': '2733', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2776', 'groupId': 'OG000'}, {'value': '2772', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2776', 'groupId': 'OG000'}, {'value': '2773', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2776', 'groupId': 'OG000'}, {'value': '2773', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2776', 'groupId': 'OG000'}, {'value': '2773', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2703', 'groupId': 'OG000'}, {'value': '2707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2770', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2763', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2789', 'groupId': 'OG000'}, {'value': '2788', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2742', 'groupId': 'OG000'}, {'value': '2757', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2777', 'groupId': 'OG000'}, {'value': '2786', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2737', 'groupId': 'OG000'}, {'value': '2741', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2650', 'groupId': 'OG000'}, {'value': '2649', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2755', 'groupId': 'OG000'}, {'value': '2753', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2797', 'groupId': 'OG000'}, {'value': '2781', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2763', 'groupId': 'OG000'}, {'value': '2750', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2758', 'groupId': 'OG000'}, {'value': '2769', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2806', 'groupId': 'OG000'}, {'value': '2808', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2806', 'groupId': 'OG000'}, {'value': '2809', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2806', 'groupId': 'OG000'}, {'value': '2809', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2806', 'groupId': 'OG000'}, {'value': '2809', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2705', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2772', 'groupId': 'OG000'}, {'value': '2770', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}, {'value': '2771', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2791', 'groupId': 'OG000'}, {'value': '2791', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2744', 'groupId': 'OG000'}, {'value': '2760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2789', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2739', 'groupId': 'OG000'}, {'value': '2743', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2652', 'groupId': 'OG000'}, {'value': '2652', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2768', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2757', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2799', 'groupId': 'OG000'}, {'value': '2784', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}, {'value': '2752', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2760', 'groupId': 'OG000'}, {'value': '2772', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2704', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2771', 'groupId': 'OG000'}, {'value': '2769', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2770', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2790', 'groupId': 'OG000'}, {'value': '2790', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2743', 'groupId': 'OG000'}, {'value': '2759', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2778', 'groupId': 'OG000'}, {'value': '2788', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2738', 'groupId': 'OG000'}, {'value': '2742', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2651', 'groupId': 'OG000'}, {'value': '2651', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2756', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2798', 'groupId': 'OG000'}, {'value': '2783', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2764', 'groupId': 'OG000'}, {'value': '2751', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2759', 'groupId': 'OG000'}, {'value': '2771', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2807', 'groupId': 'OG000'}, {'value': '2810', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2807', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2807', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '309', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2807', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '313', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2805', 'groupId': 'OG000'}, {'value': '2802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Sero negative, DNA negative HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2497', 'groupId': 'OG000'}, {'value': '2502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2320', 'groupId': 'OG000'}, {'value': '2314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2775', 'groupId': 'OG000'}, {'value': '2764', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2677', 'groupId': 'OG000'}, {'value': '2672', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2738', 'groupId': 'OG000'}, {'value': '2731', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2522', 'groupId': 'OG000'}, {'value': '2531', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1958', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2344', 'groupId': 'OG000'}, {'value': '2340', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2803', 'groupId': 'OG000'}, {'value': '2799', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2705', 'groupId': 'OG000'}, {'value': '2707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2524', 'groupId': 'OG000'}, {'value': '2535', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1959', 'groupId': 'OG000'}, {'value': '1909', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2346', 'groupId': 'OG000'}, {'value': '2344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2805', 'groupId': 'OG000'}, {'value': '2802', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2707', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2768', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2523', 'groupId': 'OG000'}, {'value': '2534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1958', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2345', 'groupId': 'OG000'}, {'value': '2344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2804', 'groupId': 'OG000'}, {'value': '2801', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2805', 'groupId': 'OG000'}, {'value': '2802', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Sero negative, DNA negative HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2497', 'groupId': 'OG000'}, {'value': '2502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2320', 'groupId': 'OG000'}, {'value': '2314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2775', 'groupId': 'OG000'}, {'value': '2764', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2677', 'groupId': 'OG000'}, {'value': '2672', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2738', 'groupId': 'OG000'}, {'value': '2731', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2522', 'groupId': 'OG000'}, {'value': '2531', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1958', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2344', 'groupId': 'OG000'}, {'value': '2340', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2803', 'groupId': 'OG000'}, {'value': '2799', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2705', 'groupId': 'OG000'}, {'value': '2707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2524', 'groupId': 'OG000'}, {'value': '2535', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1959', 'groupId': 'OG000'}, {'value': '1909', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2346', 'groupId': 'OG000'}, {'value': '2344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2805', 'groupId': 'OG000'}, {'value': '2802', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2707', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2768', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2523', 'groupId': 'OG000'}, {'value': '2534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1958', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Sero negative, DNA negative HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2345', 'groupId': 'OG000'}, {'value': '2344', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16/18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2804', 'groupId': 'OG000'}, {'value': '2801', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Overall, HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2810', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2677', 'groupId': 'OG000'}, {'value': '2672', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2738', 'groupId': 'OG000'}, {'value': '2731', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2744', 'groupId': 'OG000'}, {'value': '2733', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2737', 'groupId': 'OG000'}, {'value': '2733', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2763', 'groupId': 'OG000'}, {'value': '2753', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2714', 'groupId': 'OG000'}, {'value': '2723', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}, {'value': '2751', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2711', 'groupId': 'OG000'}, {'value': '2708', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2624', 'groupId': 'OG000'}, {'value': '2615', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2739', 'groupId': 'OG000'}, {'value': '2731', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2729', 'groupId': 'OG000'}, {'value': '2718', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2770', 'groupId': 'OG000'}, {'value': '2746', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2736', 'groupId': 'OG000'}, {'value': '2715', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2731', 'groupId': 'OG000'}, {'value': '2734', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2773', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2774', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2774', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2774', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2705', 'groupId': 'OG000'}, {'value': '2707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2772', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2791', 'groupId': 'OG000'}, {'value': '2788', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2743', 'groupId': 'OG000'}, {'value': '2757', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2786', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2739', 'groupId': 'OG000'}, {'value': '2741', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2651', 'groupId': 'OG000'}, {'value': '2649', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2768', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2757', 'groupId': 'OG000'}, {'value': '2753', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2799', 'groupId': 'OG000'}, {'value': '2781', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}, {'value': '2750', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2760', 'groupId': 'OG000'}, {'value': '2769', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2808', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2809', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2809', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2809', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2707', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2768', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2774', 'groupId': 'OG000'}, {'value': '2770', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2771', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2793', 'groupId': 'OG000'}, {'value': '2791', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2745', 'groupId': 'OG000'}, {'value': '2760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2781', 'groupId': 'OG000'}, {'value': '2789', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2741', 'groupId': 'OG000'}, {'value': '2743', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2653', 'groupId': 'OG000'}, {'value': '2652', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2770', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2759', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2801', 'groupId': 'OG000'}, {'value': '2784', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2752', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2762', 'groupId': 'OG000'}, {'value': '2772', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2810', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2810', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2810', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2810', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2773', 'groupId': 'OG000'}, {'value': '2769', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2770', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2792', 'groupId': 'OG000'}, {'value': '2790', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2744', 'groupId': 'OG000'}, {'value': '2759', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2780', 'groupId': 'OG000'}, {'value': '2788', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2740', 'groupId': 'OG000'}, {'value': '2742', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2652', 'groupId': 'OG000'}, {'value': '2651', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2769', 'groupId': 'OG000'}, {'value': '2766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2758', 'groupId': 'OG000'}, {'value': '2755', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2800', 'groupId': 'OG000'}, {'value': '2783', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2751', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2761', 'groupId': 'OG000'}, {'value': '2771', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2809', 'groupId': 'OG000'}, {'value': '2810', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2809', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2809', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2809', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2810', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2677', 'groupId': 'OG000'}, {'value': '2672', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2738', 'groupId': 'OG000'}, {'value': '2731', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2744', 'groupId': 'OG000'}, {'value': '2733', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2737', 'groupId': 'OG000'}, {'value': '2733', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2763', 'groupId': 'OG000'}, {'value': '2753', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2714', 'groupId': 'OG000'}, {'value': '2723', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2750', 'groupId': 'OG000'}, {'value': '2751', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2711', 'groupId': 'OG000'}, {'value': '2708', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2624', 'groupId': 'OG000'}, {'value': '2615', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2739', 'groupId': 'OG000'}, {'value': '2731', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2729', 'groupId': 'OG000'}, {'value': '2718', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2770', 'groupId': 'OG000'}, {'value': '2746', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2736', 'groupId': 'OG000'}, {'value': '2715', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2731', 'groupId': 'OG000'}, {'value': '2734', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2773', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2774', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2774', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2774', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2705', 'groupId': 'OG000'}, {'value': '2707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2772', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2791', 'groupId': 'OG000'}, {'value': '2788', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2743', 'groupId': 'OG000'}, {'value': '2757', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2779', 'groupId': 'OG000'}, {'value': '2786', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2739', 'groupId': 'OG000'}, {'value': '2741', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2651', 'groupId': 'OG000'}, {'value': '2649', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2768', 'groupId': 'OG000'}, {'value': '2765', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2757', 'groupId': 'OG000'}, {'value': '2753', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2799', 'groupId': 'OG000'}, {'value': '2781', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2765', 'groupId': 'OG000'}, {'value': '2750', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2760', 'groupId': 'OG000'}, {'value': '2769', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2808', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2809', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2809', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2808', 'groupId': 'OG000'}, {'value': '2809', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2707', 'groupId': 'OG000'}, {'value': '2710', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2768', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2774', 'groupId': 'OG000'}, {'value': '2770', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2771', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2793', 'groupId': 'OG000'}, {'value': '2791', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2745', 'groupId': 'OG000'}, {'value': '2760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2781', 'groupId': 'OG000'}, {'value': '2789', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2741', 'groupId': 'OG000'}, {'value': '2743', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2653', 'groupId': 'OG000'}, {'value': '2652', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2770', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2759', 'groupId': 'OG000'}, {'value': '2756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2801', 'groupId': 'OG000'}, {'value': '2784', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2752', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2762', 'groupId': 'OG000'}, {'value': '2772', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2810', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2810', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2810', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2810', 'groupId': 'OG000'}, {'value': '2812', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2706', 'groupId': 'OG000'}, {'value': '2709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV-18 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2767', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2773', 'groupId': 'OG000'}, {'value': '2769', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV-33 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2770', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV-35 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2792', 'groupId': 'OG000'}, {'value': '2790', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-39 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2744', 'groupId': 'OG000'}, {'value': '2759', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2780', 'groupId': 'OG000'}, {'value': '2788', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-51 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2740', 'groupId': 'OG000'}, {'value': '2742', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-52 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2652', 'groupId': 'OG000'}, {'value': '2651', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV-56 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2769', 'groupId': 'OG000'}, {'value': '2766', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-58 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2758', 'groupId': 'OG000'}, {'value': '2755', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV-59 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2800', 'groupId': 'OG000'}, {'value': '2783', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-66 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2766', 'groupId': 'OG000'}, {'value': '2751', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV-68 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2761', 'groupId': 'OG000'}, {'value': '2771', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV-31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2809', 'groupId': 'OG000'}, {'value': '2810', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'HPV-16/18/31/33/45 M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2809', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'HRW-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2809', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'HR-HPV M72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2809', 'groupId': 'OG000'}, {'value': '2811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Any Pain - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2439', 'groupId': 'OG000'}, {'value': '1815', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1650', 'groupId': 'OG000'}, {'value': '1062', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2934', 'groupId': 'OG000'}, {'value': '2951', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1499', 'groupId': 'OG000'}, {'value': '918', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2934', 'groupId': 'OG000'}, {'value': '2951', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2634', 'groupId': 'OG000'}, {'value': '2166', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '512', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '350', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness - 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Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. 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Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '449', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2934', 'groupId': 'OG000'}, {'value': '2951', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2934', 'groupId': 'OG000'}, {'value': '2951', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2934', 'groupId': 'OG000'}, {'value': '2951', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': '>37.0°C Fever - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '480', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}]}]}, {'title': '>37.0°C Fever - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}]}, {'title': '>37.0°C Fever - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2934', 'groupId': 'OG000'}, {'value': '2951', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}]}, {'title': '>37.0°C Fever - 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Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2934', 'groupId': 'OG000'}, {'value': '2951', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '588', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2934', 'groupId': 'OG000'}, {'value': '2951', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2934', 'groupId': 'OG000'}, {'value': '2951', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2983', 'groupId': 'OG000'}, {'value': '2987', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2934', 'groupId': 'OG000'}, {'value': '2951', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3005', 'groupId': 'OG000'}, {'value': '3001', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0 degrees Celsius) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination, Related = symptoms assessed by the investigator as causally related to study vaccination, Grade 3 symptoms = prevented normal activity, Grade 3 urticaria = distributed on at least 4 body areas.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Any Arthralgia - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'OG000'}, {'value': '1825', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1838', 'groupId': 'OG000'}, {'value': '1806', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'OG000'}, {'value': '1825', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1838', 'groupId': 'OG000'}, {'value': '1806', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'OG000'}, {'value': '1825', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1838', 'groupId': 'OG000'}, {'value': '1806', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '509', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'OG000'}, {'value': '1825', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1838', 'groupId': 'OG000'}, {'value': '1806', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue - 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Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'OG000'}, {'value': '1825', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1838', 'groupId': 'OG000'}, {'value': '1806', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue - 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Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'OG000'}, {'value': '1825', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1838', 'groupId': 'OG000'}, {'value': '1806', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1863', 'groupId': 'OG000'}, {'value': '1825', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1838', 'groupId': 'OG000'}, {'value': '1806', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1879', 'groupId': 'OG000'}, {'value': '1831', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1124', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. 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Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1124', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1124', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1118', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}, {'value': '1143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1124', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1124', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1118', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}, {'value': '1143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1124', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1124', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1118', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}, {'value': '1143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1124', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1124', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1118', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}, {'value': '1143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1124', 'groupId': 'OG000'}, {'value': '1167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Any Arthralgia - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia - 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Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '>37.0°C Fever - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '>37.0°C Fever - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '>37.0°C Fever - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '>37.0°C Fever - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': '>39.0°C Fever - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '>39.0°C Fever - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '>39.0°C Fever - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '>39.0°C Fever - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria - Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3026', 'groupId': 'OG000'}, {'value': '3025', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '793', 'groupId': 'OG000'}, {'value': '775', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within Days 0-29 after vaccination', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1892', 'groupId': 'OG000'}, {'value': '1843', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '497', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within Days 0-29 after vaccination', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1131', 'groupId': 'OG000'}, {'value': '1179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within Days 0-29 after vaccination', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within Days 0-29 after vaccination', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3026', 'groupId': 'OG000'}, {'value': '3025', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Month 72', 'description': 'SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Medically Significant Conditions (MSC) Regardless of Causal Relationship to Vaccination and Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3026', 'groupId': 'OG000'}, {'value': '3025', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1892', 'groupId': 'OG000'}, {'value': '1843', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1131', 'groupId': 'OG000'}, {'value': '1179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '837', 'groupId': 'OG000'}, {'value': '853', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Live infant NO ACA', 'categories': [{'measurements': [{'value': '648', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}]}, {'title': 'Live infant CA', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elective termination NO ACA', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}, {'title': 'Elective termination CA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic pregnancy', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Spontaneous abortion NO ACA', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Stillbirth NO ACA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Stillbirth CA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lost to follow up', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Pregnancy ongoing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '555', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Live infant NO ACA', 'categories': [{'measurements': [{'value': '436', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}]}, {'title': 'Live infant CA', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elective termination NO ACA', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Elective termination CA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic pregnancy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Spontaneous abortion NO ACA', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Spontaneous abortion CA [Month 24]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stillbirth NO ACA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Stillbirth CA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lost to follow up', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Pregnancy ongoing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and MIssing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule'}], 'classes': [{'title': 'Live infant NO ACA', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}]}, {'title': 'Live infant CA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elective termination NO ACA', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Elective termination CA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic pregnancy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Spontaneous abortion NO ACA', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Stillbirth NO ACA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Stillbirth CA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lost to follow up', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Pregnancy ongoing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and Missing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Live infant NO ACA', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Live infant CA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elective termination NO ACA', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Elective termination CA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic pregnancy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Spontaneous abortion NO ACA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stillbirth NO ACA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stillbirth CA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lost to follow up', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pregnancy ongoing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': '≥8 EL.U/mL, sero- [pre-vaccination]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥8 EL.U/mL, sero+ [pre-vaccination]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': '≥8 EL.U/mL, sero- [Month 7]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': '≥8 EL.U/mL, sero+ [Month 7]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': '≥8 EL.U/mL, sero-, [Month12]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': '≥8 EL.U/mL, sero+, [Month12]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': '≥8 EL.U/mL, sero-, [Month24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': '≥8 EL.U/mL, sero+, [Month24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': '≥19 EL.U/mL, sero-, [Month 36]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '≥19 EL.U/mL, sero+, [Month 36]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': '≥19 EL.U/mL, sero-, [Month 48]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '≥19 EL.U/mL, sero+, [Month 48]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': '≥19 EL.U/mL, sero-, [Month 72]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '≥19 EL.U/mL, sero+, [Month 72]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Months 0 (PRE), 7, 12, 24, 36, 48 and 72', 'description': 'HPV-16 assay cut-off value was defined as greater than or equal to (≥) 8 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and ≥ 19 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 8 EL.U/mL prior to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': '≥ 7 EL.U/mL, sero- PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥ 7 EL.U/mL, sero+ PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': '≥ 7 EL.U/mL, sero- [Month 7]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '≥ 7 EL.U/mL, sero+ [Month 7]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': '≥ 7 EL.U/mL, sero- [Month 12]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': '≥ 7 EL.U/mL, sero+ [Month 12]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': '≥ 7 EL.U/mL, sero- [Month 24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': '≥ 7 EL.U/mL, sero+ [Month 24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': '≥ 18 EL.U/mL, sero- [Month 36]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '≥ 18 EL.U/mL, sero+ [Month 36]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '≥ 18 EL.U/mL, sero- [Month 48]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '≥ 18 EL.U/mL, sero+ [Month 48]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '≥ 18 EL.U/mL, sero- [Month 72]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '≥ 18 EL.U/mL, sero+ [Month 72]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Months 0 (PRE), 7, 12, 24, 36, 48 and 72', 'description': 'HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at PRE vaccination, Month 7, 12 and 24 and ≥ 18 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL and 18 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 7 EL.U/mL and 18 EL.U/mL prior to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'HPV-16, sero- [pre-vaccination]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '4.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '4.0'}]}]}, {'title': 'HPV-16, sero- [Month 7]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6964.3', 'groupId': 'OG000', 'lowerLimit': '6164.3', 'upperLimit': '7868.2'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.1'}]}]}, {'title': 'HPV-16, sero-, [Month 12]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3451.3', 'groupId': 'OG000', 'lowerLimit': '3055.5', 'upperLimit': '3898.4'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '5.4'}]}]}, {'title': 'HPV-16, sero-, [Month 24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1253.2', 'groupId': 'OG000', 'lowerLimit': '1120.6', 'upperLimit': '1401.5'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '5.0'}]}]}, {'title': 'HPV-16, sero-, [Month 36]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1074.6', 'groupId': 'OG000', 'lowerLimit': '958.0', 'upperLimit': '1205.4'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '10.1'}]}]}, {'title': 'HPV-16, sero-, [Month 48]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '828.4', 'groupId': 'OG000', 'lowerLimit': '728.4', 'upperLimit': '942.2'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '11.5'}]}]}, {'title': 'HPV-16, sero-, [Month 72]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '678.1', 'groupId': 'OG000', 'lowerLimit': '552.9', 'upperLimit': '831.5'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '9.7', 'upperLimit': '11.4'}]}]}, {'title': 'HPV-16, sero+ [pre-vaccination]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000', 'lowerLimit': '22.7', 'upperLimit': '33.0'}, {'value': '25.2', 'groupId': 'OG001', 'lowerLimit': '21.1', 'upperLimit': '30.1'}]}]}, {'title': 'HPV-16, sero+ [Month 7]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5672.0', 'groupId': 'OG000', 'lowerLimit': '4661.9', 'upperLimit': '6900.9'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '31.9'}]}]}, {'title': 'HPV-16, sero+, [Month 12]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3219.8', 'groupId': 'OG000', 'lowerLimit': '2593.3', 'upperLimit': '3997.7'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '23.2', 'upperLimit': '35.1'}]}]}, {'title': 'HPV-16, sero+, [Month 24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1317.7', 'groupId': 'OG000', 'lowerLimit': '1094.4', 'upperLimit': '1586.5'}, {'value': '19.7', 'groupId': 'OG001', 'lowerLimit': '16.1', 'upperLimit': '24.1'}]}]}, {'title': 'HPV-16, sero+, [Month 36]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1290.3', 'groupId': 'OG000', 'lowerLimit': '1071.7', 'upperLimit': '1553.5'}, {'value': '24.6', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '31.2'}]}]}, {'title': 'HPV-16, sero+, [Month 48]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1006.0', 'groupId': 'OG000', 'lowerLimit': '817.9', 'upperLimit': '1237.2'}, {'value': '25.1', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '31.4'}]}]}, {'title': 'HPV-16, sero+, [Month 72]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '724.4', 'groupId': 'OG000', 'lowerLimit': '503.1', 'upperLimit': '1043.0'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '13.5', 'upperLimit': '22.3'}]}]}, {'title': 'HPV-18, sero- [pre-vaccination]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '3.5'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '3.5'}]}]}, {'title': 'HPV-18, sero- [Month 7]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3357.4', 'groupId': 'OG000', 'lowerLimit': '2974.7', 'upperLimit': '3789.4'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '4.2'}]}]}, {'title': 'HPV-18, sero-, [Month 12]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1318.9', 'groupId': 'OG000', 'lowerLimit': '1166.2', 'upperLimit': '1491.4'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '4.5'}]}]}, {'title': 'HPV-18, sero-, [Month 24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '711.7', 'groupId': 'OG000', 'lowerLimit': '629.6', 'upperLimit': '804.6'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '5.4'}]}]}, {'title': 'HPV-18, sero-, [Month 36]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '525.1', 'groupId': 'OG000', 'lowerLimit': '467.2', 'upperLimit': '590.3'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '10.1'}]}]}, {'title': 'HPV-18, sero-, [Month 48]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '387.7', 'groupId': 'OG000', 'lowerLimit': '342.6', 'upperLimit': '438.8'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '10.3'}]}]}, {'title': 'HPV-18, sero-, [Month 72]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '343.7', 'groupId': 'OG000', 'lowerLimit': '291.9', 'upperLimit': '404.8'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '11.0'}]}]}, {'title': 'HPV-18, sero+ [pre-vaccination]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '24.1'}, {'value': '25.8', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '34.1'}]}]}, {'title': 'HPV-18, sero+ [Month 7]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3200.2', 'groupId': 'OG000', 'lowerLimit': '2690.8', 'upperLimit': '3806.1'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '36.9'}]}]}, {'title': 'HPV-18, sero+, [Month 12]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1152.9', 'groupId': 'OG000', 'lowerLimit': '932.3', 'upperLimit': '1425.6'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '30.0'}]}]}, {'title': 'HPV-18, sero+, [Month 24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '831.6', 'groupId': 'OG000', 'lowerLimit': '659.5', 'upperLimit': '1048.7'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '31.8'}]}]}, {'title': 'HPV-18, sero+, [Month 36]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '601.8', 'groupId': 'OG000', 'lowerLimit': '465.4', 'upperLimit': '778.0'}, {'value': '33.4', 'groupId': 'OG001', 'lowerLimit': '22.4', 'upperLimit': '49.8'}]}]}, {'title': 'HPV-18, sero+, [Month 48]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '523.0', 'groupId': 'OG000', 'lowerLimit': '403.8', 'upperLimit': '677.5'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '18.3', 'upperLimit': '35.4'}]}]}, {'title': 'HPV-18, sero+, [Month 72]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '420.0', 'groupId': 'OG000', 'lowerLimit': '278.9', 'upperLimit': '632.4'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '42.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'at Months 0 (PRE), 7, 12, 24, 36, 48 and 72', 'description': 'Titers were expressed as geometric mean titers calculated on all subjects, HPV-16 assay cut-off value was defined as greater than or equal to 8 EL.U/mL at Months 0, 7, 12 and 24 and greater than or equal to 19 EL.U/mL at Months 36, 48 and 72. HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at Month 0, 7, 12 and 24 and ≥ 18 EL.U/mL at Months 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ the assay cut-off value prior to vaccination.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}], 'periods': [{'title': 'Month 24', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3026'}, {'groupId': 'FG001', 'numSubjects': '3025'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2694'}, {'groupId': 'FG001', 'numSubjects': '2693'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '332'}, {'groupId': 'FG001', 'numSubjects': '332'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '162'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}, {'title': 'Month 48', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2703'}, {'groupId': 'FG001', 'numSubjects': '2727'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2529'}, {'groupId': 'FG001', 'numSubjects': '2559'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '168'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Month 72', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2319'}, {'groupId': 'FG001', 'numSubjects': '2347'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2134'}, {'groupId': 'FG001', 'numSubjects': '2158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '189'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This record provides the end-of-study analysis, including analyses at Month 24, 48, 57 and 72.', 'preAssignmentDetails': 'Out of the 6081 subjects enrolled, 2 did not have any subject or vaccine number allocated and 28 did not receive any study vaccine dose, hence only 6051 subjects started the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3026', 'groupId': 'BG000'}, {'value': '3025', 'groupId': 'BG001'}, {'value': '6051', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'spread': '1.70', 'groupId': 'BG000'}, {'value': '23.0', 'spread': '1.75', 'groupId': 'BG001'}, {'value': '23.0', 'spread': '1.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3026', 'groupId': 'BG000'}, {'value': '3025', 'groupId': 'BG001'}, {'value': '6051', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - Chinese Heritage', 'categories': [{'measurements': [{'value': '3026', 'groupId': 'BG000'}, {'value': '3025', 'groupId': 'BG001'}, {'value': '6051', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6081}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-03', 'studyFirstSubmitDate': '2008-10-23', 'resultsFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2008-10-23', 'lastUpdatePostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-04-12', 'studyFirstPostDateStruct': {'date': '2008-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24', 'timeFrame': 'At Month 24', 'description': 'CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.'}, {'measure': 'Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48', 'timeFrame': 'At Month 48', 'description': 'CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.'}, {'measure': 'Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57', 'timeFrame': 'At Month 57', 'description': 'CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.'}, {'measure': 'Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72', 'timeFrame': 'At Month 72', 'description': 'CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18', 'timeFrame': 'At Months 24,48, 57 and 72', 'description': 'HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered. - DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.'}, {'measure': 'Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months. Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.'}, {'measure': 'Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months. Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA). Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.'}, {'measure': 'Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.'}, {'measure': 'Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.'}, {'measure': 'Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type', 'timeFrame': 'At Months 24,48, 57 and 72', 'description': 'Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.'}, {'measure': 'Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. US).'}, {'measure': 'Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.'}, {'measure': 'Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.'}, {'measure': 'Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.'}, {'measure': 'Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.'}, {'measure': 'Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type', 'timeFrame': 'At Months 24, 48, 57 and 72', 'description': 'CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.'}, {'measure': 'Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade, Grade 3 Pain = pain that prevented normal activity, Grade 3 Swelling or Redness = swelling or redness above (\\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.'}, {'measure': 'Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Swelling or Redness = swelling/redness above (\\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.'}, {'measure': 'Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity, Grade 3 Swelling or Redness = swelling/redness above (\\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.'}, {'measure': 'Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade, Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination'}, {'measure': 'Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0 degrees Celsius) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination, Related = symptoms assessed by the investigator as causally related to study vaccination, Grade 3 symptoms = prevented normal activity, Grade 3 urticaria = distributed on at least 4 body areas.'}, {'measure': 'Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas.'}, {'measure': 'Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas'}, {'measure': 'Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'timeFrame': 'Within 7 days (Days 0-6) after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas'}, {'measure': 'Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within Days 0-29 after vaccination', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline', 'timeFrame': 'Within Days 0-29 after vaccination', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'timeFrame': 'Within Days 0-29 after vaccination', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'timeFrame': 'Within Days 0-29 after vaccination', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 0 to Month 72', 'description': 'SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.'}, {'measure': 'Number of Subjects With Medically Significant Conditions (MSC) Regardless of Causal Relationship to Vaccination and Intensity', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.'}, {'measure': 'Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.'}, {'measure': 'Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.'}, {'measure': 'Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.'}, {'measure': 'Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.'}, {'measure': 'Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and MIssing.'}, {'measure': 'Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and Missing.'}, {'measure': 'Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline', 'timeFrame': 'From Day 0 to Month 72', 'description': 'Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.'}, {'measure': 'Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status', 'timeFrame': 'at Months 0 (PRE), 7, 12, 24, 36, 48 and 72', 'description': 'HPV-16 assay cut-off value was defined as greater than or equal to (≥) 8 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and ≥ 19 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 8 EL.U/mL prior to vaccination.'}, {'measure': 'Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status', 'timeFrame': 'at Months 0 (PRE), 7, 12, 24, 36, 48 and 72', 'description': 'HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at PRE vaccination, Month 7, 12 and 24 and ≥ 18 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL and 18 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 7 EL.U/mL and 18 EL.U/mL prior to vaccination.'}, {'measure': 'Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status', 'timeFrame': 'at Months 0 (PRE), 7, 12, 24, 36, 48 and 72', 'description': 'Titers were expressed as geometric mean titers calculated on all subjects, HPV-16 assay cut-off value was defined as greater than or equal to 8 EL.U/mL at Months 0, 7, 12 and 24 and greater than or equal to 19 EL.U/mL at Months 36, 48 and 72. HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at Month 0, 7, 12 and 24 and ≥ 18 EL.U/mL at Months 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ the assay cut-off value prior to vaccination.'}]}, 'conditionsModule': {'keywords': ['Human papillomavirus', 'vaccine', 'cervical cancer', 'cervical infection'], 'conditions': ['Infections, Papillomavirus']}, 'referencesModule': {'availIpds': [{'id': '107638', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107638', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107638', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107638', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107638', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107638', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107638', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '24740547', 'type': 'BACKGROUND', 'citation': 'Zhao FH, Zhu FC, Chen W, Li J, Hu YM, Hong Y, Zhang YJ, Pan QJ, Zhu JH, Zhang X, Chen Y, Tang H, Zhang H, Durand C, Datta SK, Struyf F, Bi D; HPV-039 study group. Baseline prevalence and type distribution of human papillomavirus in healthy Chinese women aged 18-25 years enrolled in a clinical trial. Int J Cancer. 2014 Dec 1;135(11):2604-11. doi: 10.1002/ijc.28896. Epub 2014 May 20.'}, {'pmid': '24740596', 'type': 'BACKGROUND', 'citation': 'Zhu FC, Chen W, Hu YM, Hong Y, Li J, Zhang X, Zhang YJ, Pan QJ, Zhao FH, Yu JX, Zhang YS, Yang X, Zhang CF, Tang H, Zhang H, Lebacq M, David MP, Datta SK, Struyf F, Bi D, Descamps D; HPV-039 study group. Efficacy, immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese women aged 18-25 years: results from a randomized controlled trial. Int J Cancer. 2014 Dec 1;135(11):2612-22. doi: 10.1002/ijc.28897. Epub 2014 May 20.'}, {'pmid': '27998015', 'type': 'BACKGROUND', 'citation': 'Zhu FC, Hu SY, Hong Y, Hu YM, Zhang X, Zhang YJ, Pan QJ, Zhang WH, Zhao FH, Zhang CF, Yang X, Yu JX, Zhu J, Zhu Y, Chen F, Zhang Q, Wang H, Wang C, Bi J, Xue S, Shen L, Zhang YS, He Y, Tang H, Karkada N, Suryakiran P, Bi D, Struyf F. Efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine in Chinese women aged 18-25 years: event-triggered analysis of a randomized controlled trial. Cancer Med. 2017 Jan;6(1):12-25. doi: 10.1002/cam4.869. Epub 2016 Dec 20.'}, {'pmid': '41276263', 'type': 'DERIVED', 'citation': 'Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.'}, {'pmid': '40452051', 'type': 'DERIVED', 'citation': 'Chen S, Du Q, Yin J, Xu X, Chen W, Pan Q, Zhang X, Hong Y, Zhang W, Liu B, Cui J, Hu S, Zhao F. HPV genotyping agreement between paired cervical cytological sample and biopsy across lesion severity and vaccination. Virol J. 2025 Jun 2;22(1):176. doi: 10.1186/s12985-025-02791-x.'}, {'pmid': '34939897', 'type': 'DERIVED', 'citation': 'Welby S, Rosillon D, Feng Y, Borys D. Progression from human papillomavirus (HPV) infection to cervical lesion or clearance in women (18-25 years): Natural history study in the control arm subjects of AS04-HPV-16/18 vaccine efficacy study in China between 2008 and 2016. Expert Rev Vaccines. 2022 Mar;21(3):407-413. doi: 10.1080/14760584.2022.2021077. Epub 2022 Jan 24.'}, {'pmid': '33198657', 'type': 'DERIVED', 'citation': 'Zhao S, Hu S, Xu X, Zhang X, Pan Q, Chen F, Zhao F. Impact of HPV-16/18 AS04-adjuvanted vaccine on preventing subsequent infection and disease after excision treatment: post-hoc analysis from a randomized controlled trial. BMC Infect Dis. 2020 Nov 16;20(1):846. doi: 10.1186/s12879-020-05560-z.'}, {'pmid': '33180670', 'type': 'DERIVED', 'citation': 'Hu S, Xu X, Zhu F, Hong Y, Hu Y, Zhang X, Pan Q, Zhang W, Zhang C, Yang X, Yu J, Zhu J, Zhu Y, Chen F, Zhao S, Karkada N, Tang H, Bi D, Struyf F, Zhao F. Efficacy of the AS04-adjuvanted HPV-16/18 vaccine in young Chinese women with oncogenic HPV infection at baseline: post-hoc analysis of a randomized controlled trial. Hum Vaccin Immunother. 2021 Apr 3;17(4):955-964. doi: 10.1080/21645515.2020.1829411. Epub 2020 Nov 12.'}, {'pmid': '32780946', 'type': 'DERIVED', 'citation': 'Hu Y, Zhang X, He Y, Ma Z, Xie Y, Lu X, Xu Y, Zhang Y, Jiang Y, Xiao H, Struyf F, Folschweiller N, Jiang J, Poncelet S, Karkada N, Jastorff A, Borys D. Long-term persistence of immune response to the AS04-adjuvanted HPV-16/18 vaccine in Chinese girls aged 9-17 years: Results from an 8-9-year follow-up phase III open-label study. Asia Pac J Clin Oncol. 2020 Dec;16(6):392-399. doi: 10.1111/ajco.13398. Epub 2020 Aug 11.'}, {'pmid': '31824976', 'type': 'DERIVED', 'citation': 'Chen J, Gopala K, Akarsh PK, Struyf F, Rosillon D. Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine. Open Forum Infect Dis. 2019 Dec 4;6(12):ofz486. doi: 10.1093/ofid/ofz486. eCollection 2019 Dec.'}, {'pmid': '31305011', 'type': 'DERIVED', 'citation': 'Zhu FC, Hu SY, Hong Y, Hu YM, Zhang X, Zhang YJ, Pan QJ, Zhang WH, Zhao FH, Zhang CF, Yang X, Yu JX, Zhu J, Zhu Y, Chen F, Zhang Q, Wang H, Wang C, Bi J, Xue S, Shen L, Zhang YS, He Y, Tang H, Karkada N, Suryakiran P, Bi D, Struyf F. Efficacy, immunogenicity and safety of the AS04-HPV-16/18 vaccine in Chinese women aged 18-25 years: End-of-study results from a phase II/III, randomised, controlled trial. Cancer Med. 2019 Oct;8(14):6195-6211. doi: 10.1002/cam4.2399. Epub 2019 Jul 15.'}, {'pmid': '25424785', 'type': 'DERIVED', 'citation': 'Zhu F, Li J, Hu Y, Zhang X, Yang X, Zhao H, Wang J, Yang J, Xia G, Dai Q, Tang H, Suryakiran P, Datta SK, Descamps D, Bi D, Struyf F. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years. Hum Vaccin Immunother. 2014;10(7):1795-806. doi: 10.4161/hv.28702.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter study in which women are planned to receive either the HPV vaccine or control. Study participation will last approximately 72 months and involves a total of thirteen or fourteen scheduled visits.\n\nOriginally, the study was planned for 24 months. It was then extended for 2 more years with 4 additional visits (study end at Month 48).\n\nThe protocol posting has been updated as the study was extended by additional 2 years with two or three additional visits (study end at Month 72) for subjects who consent to participate in the extension.', 'detailedDescription': 'This protocol posting has been updated following protocol amendment 6 dated 24 April 2014.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Chinese females between and including 18 and 25 years of age at the time of the first vaccination.\n* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.\n* Written informed consent obtained from the subject prior to enrolment.\n* Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.\n* Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test.\n* Subjects must be of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination and agree to continue such precautions for 2 months after completion of the vaccination series.\n* Subject must have one single intact cervix.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.\n* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e., Days 0-29) the first dose of vaccine.\n* Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).\n* A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.\n* Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.\n* Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period.\n* Previous administration of components of the investigational vaccine.\n* History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.\n* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine.\n* Hypersensitivity to latex.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Acute disease at the time of enrolment.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.\n* History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.'}, 'identificationModule': {'nctId': 'NCT00779766', 'briefTitle': "Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects", 'orgStudyIdInfo': {'id': '107638'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.', 'interventionNames': ['Biological: HPV GSK 580299 vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.', 'interventionNames': ['Biological: Placebo control']}], 'interventions': [{'name': 'HPV GSK 580299 vaccine', 'type': 'BIOLOGICAL', 'description': 'Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.', 'armGroupLabels': ['Cervarix Group']}, {'name': 'Placebo control', 'type': 'BIOLOGICAL', 'description': 'Subjects were planned to receive three doses of the placebo control administered intramuscularly according to a 0, 1, 6 month vaccination schedule.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '213200', 'city': 'Jintan', 'state': 'Jiangsu', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.75, 'lon': 119.58333}}, {'city': 'Lianshui', 'state': 'Jiangsu', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.77, 'lon': 119.26389}}, {'zip': '221006', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '224500', 'city': 'Yancheng', 'state': 'Jiangsu', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.3575, 'lon': 120.1573}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicalstudydatarequest.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD is available via the Clinical Study Data Request site (click on the link provided below).', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}