A Post-authorization Safety Study to Evaluate the Safety of Multiple Myeloma Patients Treated with Ciltacabtagene Autoleucel

Data sources

• Data sources (types):
  Other

  Spontaneous reports of suspected adverse drug reactions
• Data sources (types), other:
  - Prospective patient-based data collection; - The primary data source for this study will be the medical records of each patient who provided a signed informed consent form. Other data sources may also include analyses from tumor samples of patients developing second primary malignancies or adverse events spontaneously reported to the sponsor, where available.

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No