For example, a missing relatedness will be assumed to be certainly related ; a missing severity will be assumed to be severe and so on. All AEs will be coded using the latest version of MedDRA. The severity of AEs will be coded using CTCAE v5.0. All TEAEs will be summarized and presented in the listings by the number of patients reporting an event, the percentage of patients with that event, and the grade, duration, and relationship to treatment. Percentages will be based on the number of patients who received each treatment during the study. The incidence of SAEs, including death, and AEs leading to study treatment discontinuation will also be tabulated. 7.6.4.2. Laboratory Test R esults For all laboratory tests with continuous results, absolute value and change fro m baseline will be summarized by visit and treatment group. For laboratory tests with categorical results, shift from baseline will be summarized by visit and treatment group. Shift tables for laboratory test results by severity will be produced and, for a subset of tests to be specified in the study SAP, separate shift tables indicating hyper - and hypodirectionality of change will be produced. Shift tables for urine dipstick test results by grade may also be produced as appropriate. Clinically significant laboratory test results will be flagged and listed.