{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"ADA positive at any visit (ADA prevalence)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Treatment-emergent ADA positive (ADA incidence)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Treatment-boosted ADA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Treatment-induced ADA (ADA positive post-baseline only)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"ADA positive at baseline only"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"ADA positive post-baseline and positive at baseline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Persistently positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Transiently positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"nAb positive at any visit"}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"}],"units":"Participants"}],"description":"Serum sampling for ADA assessment was conducted utilizing a tiered approach (screen, confirm, titer). ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA (or ADA incidence) was defined as the sum of treatment-induced ADA and treatment-boosted ADA (defined as baseline positive ADA titer that was boosted to ≥4-fold during the study period). Persistently positive was defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks between first and last positive, or an ADA positive result at the last available assessment. Transiently positive was defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The presence of nAb was tested for all ADA positive samples. Results are reported as number of patients with ADA responses to tremelimumab for each indicated category.","groups":[{"description":"During Chemotherapy:\n\nPatients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nPost-Chemotherapy:\n\nPatients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.","id":"OG000","title":"China Cohort: D + T + EP"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The China ADA evaluable patients included those in the China safety analysis set who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. ADA for tremelimumab was performed for the D + T + EP group only. The denominator was tremelimumab ADA evaluable patients.","reportingStatus":"POSTED","timeFrame":"Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of IP (ie, tremelimumab). Assessed at the China cohort second analysis DCO (02 November 2020).","title":"Number of Patients With ADA Response to Tremelimumab in the China Cohort","type":"SECONDARY","unitOfMeasure":"Participants"}