Description of Relugolix Use in Patients With Prostate Cancer Within the VHA

Primary outcomes

1. Number of Participants According to Geographic Region

   Time frame: Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this study

   The number of participants according to geographic regions of the United States (South, West, Northeast and Midwest) as documented during baseline period were reported in this outcome measure. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

2. Number of Participants According to Index Year

   Time frame: At Index date (anytime between 18-Dec-2020 to 31-Dec- 2023 [approximately 3 years]; available data observed retrospectively over 178 days in this study

   Number of participants according to index year (2020, 2021, 2022 and 2023) were reported in this outcome measure. The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

3. Time From First Observed Prostate Cancer Diagnosis Date to the Index Date

   Time frame: From prostate cancer diagnosis to index date (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this study

   Time from the first observed prostate cancer date to the index date was evaluated. All data available prior to the index date were used. The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis. Participants with a diagnosis of prostate cancer between 01-Jan-2006 to 31-Dec-2023 were considered.

4. Number of Participants According to Type of Previous Treatments Received

   Time frame: Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this study

   Number of participants according to treatments received previously such as pain medication, androgen receptor pathway inhibitor, androgen deprivation therapy, chronic oral corticosteroid use, non-steroidal anti-androgen, radiotherapy, olaparib, prostatectomy and chemotherapy in the baseline period were reported in this outcome measure. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis. One participant could have received more than 1 treatment.

5. Number of Participants According to Metastasis Status

   Time frame: Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this study

   Number of participants according to metastasis status (metastatic prostate cancer and non-metastatic prostate cancer) were reported in this outcome measure. Metastatic prostate cancer was defined as having evidence of during the baseline period or within 90 days after the index date. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

6. Number of Participants According to Site of Metastasis

   Time frame: Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this study

   Number of participants with a metastatic diagnosis at the sites: bone only, node only, bone and node, viscera and other (urinary organs, genital organs, skin, kidney, adrenal, brain, spinal, and other nervous system), were reported among participants with metastatic prostate cancer. Metastatic prostate cancer was defined as having evidence of metastasis any time prior to the index date or within 90 days after the index date. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

7. Number of Participants According to Androgen Deprivation Therapy (ADT) Status

   Time frame: Any time prior to index date including baseline period (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this study

   ADT naïve was defined as having no records of any systemic ADT ever based on all available data prior to the index date (i.e., including baseline period data and any available data prior to the baseline period). Systemic ADT included luteinizing hormone-releasing hormone (LHRH) agonists and gonadotropin-releasing hormone (GnRH) antagonists (i.e., degarelix, relugolix, goserelin, histrelin, leuprolide, triptorelin). ADT experienced was defined as having any records of systemic ADT based on all available data prior to the index date (i.e., including baseline period data and any available data prior to the baseline period). Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

8. Prostate-Specific Antigen (PSA) Value at 180 Days Prior to Index Date

   Time frame: 180 days prior to Index date; data observed retrospectively over 178 days in this study

   The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed PC diagnosis.

9. Testosterone Value at 180 Days Prior to Index Date

   Time frame: 180 days prior to Index date; data observed retrospectively over 178 days in this study

   The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed PC diagnosis.

10. Mean National Cancer Institute (NCI) Charlson Comorbidity Index (CCI) Score

    Time frame: Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this study

    CCI based on various comorbid conditions such as myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. CCI score range was from 0 to 14, where "0"= low comorbid condition and "14"= high comorbid condition, higher scores indicated more comorbidity. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

11. Number of Participants According to Comorbidities

    Time frame: Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this study

    Number of participants according to comorbidities (hypertension, hyperlipidemia, diabetes, major adverse cardiovascular event, depression, congestive heart failure, sexual dysfunction, chronic obstructive pulmonary disease, anxiety, cognitive impairment, urinary tract infection, myocardial infarction, arrhythmia, stroke, acute coronary syndrome, angina pectoris, inflammatory bowel disease, hot flashes) were reported in this outcome measure. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis. One participant could have more than one comorbidity.