A Retrospective Observational Study to Evaluate the Safety and Effectiveness of Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome (LINC7)

LCI699-RECAG-NI-0596

This is a multi-centre, observational, non-comparative, retrospective cohort study designed to evaluate the long-term safety and effectiveness of osilodrostat in non-CD CS patients. Patients treated with oral osilodrostat regardless of the duration of their treatment will be followed retrospectively for up to 36 months after initiating osilodrostat.

2023-01-16

2023-09-30

2023-10-30

Completed

104

Inclusion Criteria: 1. Male and female patients ≥18 years old with diagnosis of CS, except for CD (i.e., an aetiology of adrenal adenoma, adrenocortical carcinoma, adrenal hyperplasia, or ectopic adrenocorticotropic hormone secretion). Patients should have a contemporaneously documented diagnosis of CS as per effective guidelines. 2. Patients treated with osilodrostat between April 2019 and study start date as part of ATU programme or commercialisation. Exclusion Criteria: 1. Patients who participated in a clinical trial anytime during the study period. 2. Patients with Pseudo-Cushing's syndrome, cyclic CS, or iatrogenic CS.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}

2024-04-26