{"description":"All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \\> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":144,"description":"Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.\n\nquadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine\n\nlaboratory biomarker analysis","id":"EG000","otherNumAffected":59,"otherNumAtRisk":144,"seriousNumAffected":5,"seriousNumAtRisk":144,"title":"Vaccination"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":144}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":144}],"term":"Injection site reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":144}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":144}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":144}],"term":"Skin and subcutaneous tissue disorder - other, specify"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":144,"numEvents":2}],"term":"Skin infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":144,"numEvents":1}],"term":"Gum infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":144,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":144,"numEvents":1}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Homicidal ideation","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":144,"numEvents":1}],"term":"Psychiatric disorders - other, specify"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":144,"numEvents":3}],"term":"Suicidal ideation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":144,"numEvents":2}],"term":"Suicide attempt"}],"timeFrame":"From enrollment through 2 years after the first injection of Gardasil."}