{"description":"Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.","eventGroups":[{"description":"Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.","id":"EG000","otherNumAffected":566,"otherNumAtRisk":608,"seriousNumAffected":3,"seriousNumAtRisk":608,"title":"9vHPV Vaccine - Base Study"},{"description":"Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.","id":"EG001","otherNumAffected":197,"otherNumAtRisk":305,"seriousNumAffected":3,"seriousNumAtRisk":305,"title":"Placebo - Base Study"},{"description":"Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.","id":"EG002","otherNumAffected":0,"otherNumAtRisk":99,"seriousNumAffected":2,"seriousNumAtRisk":99,"title":"9vHPV Vaccine - Extension Study"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":52,"numAtRisk":608,"numEvents":67},{"groupId":"EG001","numAffected":12,"numAtRisk":305,"numEvents":13},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":258,"numAtRisk":608,"numEvents":420},{"groupId":"EG001","numAffected":26,"numAtRisk":305,"numEvents":33},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Injection site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":549,"numAtRisk":608,"numEvents":1392},{"groupId":"EG001","numAffected":117,"numAtRisk":305,"numEvents":182},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Injection site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":608,"numEvents":68},{"groupId":"EG001","numAffected":4,"numAtRisk":305,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Injection site pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":298,"numAtRisk":608,"numEvents":558},{"groupId":"EG001","numAffected":18,"numAtRisk":305,"numEvents":27},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Injection site swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":608,"numEvents":50},{"groupId":"EG001","numAffected":10,"numAtRisk":305,"numEvents":10},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":608,"numEvents":55},{"groupId":"EG001","numAffected":19,"numAtRisk":305,"numEvents":20},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":608,"numEvents":34},{"groupId":"EG001","numAffected":6,"numAtRisk":305,"numEvents":8},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":190,"numAtRisk":608,"numEvents":318},{"groupId":"EG001","numAffected":81,"numAtRisk":305,"numEvents":150},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":608,"numEvents":46},{"groupId":"EG001","numAffected":12,"numAtRisk":305,"numEvents":14},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Oropharyngeal pain"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":608,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":305,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":608,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":305,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":608,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":305,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Lumbar vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":608,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":305,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Thoracic vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":608,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":305,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Migraine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":608,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":305,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":608,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":305,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":99,"numEvents":0}],"term":"Abortion induced"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":608,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":305,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 14.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":608,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":305,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":99,"numEvents":1}],"term":"Diarrhoea"}],"timeFrame":"Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study"}