{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 1: Mild"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Grade 2: Moderate"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}],"title":"Grade 3: Severe"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"}]}],"title":"Grade 4: Life-threatening"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Grade 5: Death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"82"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as any AE that occurs on or after the start of cilta-cel OOS infusion through 100 days after the cilta-cel OOS infusion or the start of subsequent anti-myeloma therapy, whichever was earlier; or any AE that is considered related to study intervention regardless of the start date of the event; or any AE that was present at baseline (Day 1, pre-infusion of cilta-cel OOS) but worsens in toxicity grade or was subsequently considered related to study intervention by the investigator. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to adverse event.","groups":[{"description":"Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \\[mg/m\\^2\\] intravenous \\[IV\\] infusion and fludarabine 30 mg/m\\^2 IV infusion daily, for 3 days \\[Day -7 to Day -5\\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\\*10\\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\\*10\\^6 CAR-positive viable T cells/kg to 1.0\\*10\\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.","id":"OG000","title":"Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The all treated analysis set included all participants who received study intervention (cilta-cel OOS).","reportingStatus":"POSTED","timeFrame":"From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)","title":"Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity","type":"SECONDARY","unitOfMeasure":"Participants"}