{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50"}]}],"title":"Thrombocytopenia: Grade 3/4 After Day 1 Dosing"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"}]}],"title":"Thrombocytopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"}]}],"title":"Thrombocytopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Thrombocytopenia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"75"}]}],"title":"Neutropenia: Grade 3/4 After Day 1 Dosing"},{"categories":[{"measurements":[{"groupId":"OG000","value":"36"}]}],"title":"Neutropenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Neutropenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Neutropenia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"75"}]}],"title":"Lymphopenia: Grade 3/4 After Day 1 Dosing"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"}]}],"title":"Lymphopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"}]}],"title":"Lymphopenia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Lymphopenia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"36"}]}],"title":"Anaemia: Grade 3/4 After Day 1 Dosing"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Anaemia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 30"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Anaemia: Initial Grade 3/4 Not Recovered to <= Grade 2 by Day 60"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Anaemia: Grade 3/4 > Day 60 (After Initial Recovery of Grade 3/4 within Day 60)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"82"}],"units":"Participants"}],"description":"Number of participants with treatment-emergent AESIs: prolonged and recurrent cytopenias were reported. AESIs include the anticipated risks of treatment with study drug and events that may be related to multiple sclerosis comorbidities. It included Thrombocytopenia, Neutropenia, Lymphopenia, and Anaemia. Treatment-emergent AESIs were defined as any AESI 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 AESI that was considered related to study intervention regardless of the start date of the event; or any AESI that was present at baseline but worsens in toxicity grade or was subsequently considered related to study intervention by the investigator. Severity was assessed using 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 Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias","type":"SECONDARY","unitOfMeasure":"Participants"}