表48。Applicant – Subject Incidence of Serious Treatment-emergent Adverse Events by System Organ Class and Preferred Term for > 1% of Subjects Overall (Safety Analysis Set) (Study 20200491 Primary Analysis) ....................................................................................................... 209 Table 49.申请人 - 首选术语的严重不良事件（总体至少发生在1％的受试者中） - 单一疗法 - 研究20200491、20200040和单一疗法研究20160323（安全分析集）（安全分析集）90天安全更新........FDA Analysis of Serious Adverse Events ≥3% .............................................................. 212 Table 51.申请人 - 不良事件，导致塔拉塔马布通过首选术语（至少在2个受试者中发生） - 单一疗法 - 研究20200491，20200040和单一疗法研究20160323（安全分析集）（安全分析集）申请人 - 不良事件，导致塔拉塔马州通过首选期限（至少在2个主题中发生） - 单一疗法 - 研究20200491、20200040和单一疗法研究20160323（安全分析集）（安全分析集）90天安全更新... 215表53。Applicant – Summary of Adverse Events – Monotherapy – Studies 20200491, 20200040 and Monotherapy Cohorts of Study 20160323 (Safety Analysis Set) ....................... 221 Table 54.Applicant – Adverse Reactions (≥ 15%) in Subjects with SCLC Who Received Tarlatamab 10 mg in Study 20200491 a ....................................................................................... 222 Table 55.Applicant – Summary of Adverse Events – Monotherapy – Studies 20200491, 20200040 and Monotherapy Cohorts of Study 20160323 (Safety Analysis Set) 90-Day Safety Update......................................................................................................................................... 224 Table 56 FDA Analysis of Select Laboratory Abnormalities (≥ 20%) That Worsened from Baseline in Patients with ES - SCLC in Study DeLLphi-300 and Study DeLLphi-301 .................................. 228 Table 57 FDA Analysis of CRS and neurologic toxicity, including ICANS .................................... 238 Table 58.Analysis of Adverse Events by Sex .............................................................................. 242 Table 59.按年龄组分析不良事件............................................................................................................................................................................................................................................................................................................................................................... 242表60。分析种族的不良事件..................................................................................................................................................................................................................................................................................................................................... 243表61推荐的剂量和imdelltra（tarlatamab）的时间表（Tarlatamab） - 拟议的标签257表62咬合分子中CRS和ICAN的风险缓解和ICAS的发生率 ..................................................................................................................................................... 258 Table 63.Summary of Tarlatamab PK geometric mean (CV%) following IV administration of Tarlatamab in Cycle 2 (Study 20160323) .................................................................................... 277 Table 64.在研究20200491中，静脉注射10 mg或100mg Q2W方案后，静脉注射10 mg或100mg Q2W方案后，几何平均值（CV％）塔拉氏症峰和槽血清浓度摘要。..................................................................................................................... 279 Table 65 Summary of Demographics, Clinical Characteristics and Baseline Covariates ............ 292 Table 66 Parameter Estimates for the Final Model .................................................................... 294 Table 67 Bootstrap Estimates and 95% Confidence Intervals .................................................... 295 Table 68 Pharmacokinetic Parameters of Tarlatamab 1/10 mg Q2W in Patients with SCLC in Study 20200491.......................................................................................................................... 301 Table 69 Exposure comparison between the Applicant's proposed retreatment plan after dose delay and the treatment plan with no dose delay ..................................................................... 302