{"description":"The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.","eventGroups":[{"deathsNumAffected":133,"deathsNumAtRisk":227,"description":"Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.","id":"EG000","otherNumAffected":224,"otherNumAtRisk":227,"seriousNumAffected":69,"seriousNumAtRisk":227,"title":"Dacomitinib"},{"deathsNumAffected":152,"deathsNumAtRisk":224,"description":"Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.","id":"EG001","otherNumAffected":217,"otherNumAtRisk":224,"seriousNumAffected":53,"seriousNumAtRisk":224,"title":"Gefitinib"},{"deathsNumAffected":1,"deathsNumAtRisk":11,"description":"DCO was the protocol-defined cutoff at 48 months from first dosing of the last enrolled participant (13 May 2019). At the DCO, 11 participants were ongoing in the dacomitinib arm and continued study treatment until disease progression, intolerable toxicities, withdrawal, death, or study terminated by sponsor, whichever occurred first. The 11 participants were analyzed for adverse events after LPLV on 27 Jan 2022.","id":"EG002","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":4,"seriousNumAtRisk":11,"title":"Dacomitinib (Ongoing at DCO)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":227},{"groupId":"EG001","numAffected":18,"numAtRisk":224},{"groupId":"EG002","numAffected":5,"numAtRisk":11}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":199,"numAtRisk":227},{"groupId":"EG001","numAffected":125,"numAtRisk":224},{"groupId":"EG002","numAffected":10,"numAtRisk":11}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":99,"numAtRisk":227},{"groupId":"EG001","numAffected":41,"numAtRisk":224},{"groupId":"EG002","numAffected":6,"numAtRisk":11}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":227},{"groupId":"EG001","numAffected":50,"numAtRisk":224},{"groupId":"EG002","numAffected":3,"numAtRisk":11}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":227},{"groupId":"EG001","numAffected":29,"numAtRisk":224},{"groupId":"EG002","numAffected":2,"numAtRisk":11}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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