{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Tisotumab vedotin was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (once every 3 weeks). The trial ran until the investigator determined that the participant was no longer benefiting from treatment (ie, disease progression or unacceptable toxicity had occurred), the trial was terminated by the sponsor, or the participant withdrew consent. Each participant received the same dose that they were exposed to in the previous base trial.","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":1,"seriousNumAtRisk":5,"title":"Overall"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":5,"numEvents":5}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Balance disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Retinal exudates"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":2}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Localised infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":3}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Ocular toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Corneal thinning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Punctate keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Venous thrombosis limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Thrombophlebitis superficial"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Peripheral sensorimotor neuropathy"}],"timeFrame":"Day 1 to Week 24 plus 30 days"}