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The term \"BCG unresponsive\" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with CIS within 12 months of their last intravesical treatment with BCG or relapsed with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.","id":"EG000","otherNumAffected":101,"otherNumAtRisk":107,"seriousNumAffected":10,"seriousNumAtRisk":107,"title":"Carcinoma in Situ (CIS)"},{"deathsNumAffected":5,"deathsNumAtRisk":50,"description":"Patients had at entry, confirmed by a pathology report Ta/T1 high-grade disease without concomitant CIS and were \"BCG unresponsive\" which referred to patients with high-grade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG. The term \"BCG unresponsive\" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with high-grade Ta/T1 high-grade disease without concomitant CIS within 12 months of their last intravesical treatment with BCG or relapsed with high- grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.","id":"EG001","otherNumAffected":45,"otherNumAtRisk":50,"seriousNumAffected":9,"seriousNumAtRisk":50,"title":"Papillary Disease (Without Concomitant CIS)"},{"deathsNumAffected":26,"deathsNumAtRisk":157,"description":"Total Treatment-Emergent Adverse Events (TEAE) in the Study.","id":"EG002","otherNumAffected":146,"otherNumAtRisk":157,"seriousNumAffected":19,"seriousNumAtRisk":157,"title":"Total TEAE"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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