9.5.1.1 Analysis of Adverse Events All AEs will be analyzed in terms of descriptive statistics and qualitative analysis. Adverse events will be listed for each subject and summarized by system organ class (SOC) and preferred term according to the latest version of MedDRA. In addition, summaries of AEs by severity and relationship to IP will be presented. All safety and tolerability data recorded during the study will be listed and summarized over time, as appropriate. For the purpose of summaries and listings , the durations of AEs will be calculated as follows: (stop [day ] – start [day]) + 1 day, which yields the number of days on which the AE was pr esent. Treatment emergent AEs are defined as AEs that first occurred or worsened in severity after the first administration of the IP. Adverse event summaries will include incidence of TEAEs, SAEs including deaths, AEs that led to IP discontinuation, AEs b y maximum severity and relationship to IP, and temporally infusion related AEs. The version of the MedDRA that is current on the date of study initiation will be used throughout conduct and data analysis. All summaries will be presented by MedDRA SOC and preferred term for each treatment group.