Safety Profile

The safety profile of PLUVICTO + BSOC was evaluated in the large phase 3 VISION trial

Adverse reactions occurring at a ≥5% incidence in patients who received PLUVICTO + BSOC compared with BSOC in VISION^1,*

Clinically relevant adverse reactions in <5% of patients who received PLUVICTO plus BSOC included dry eye, vertigo, and pancytopenia (including bicytopenia).

BSOC, best standard of care.

*National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
^a Peripheral edema includes peripheral edema, fluid retention, and fluid overload.
^b Dry mouth includes dry mouth, aptyalism, and dry throat.
^c Vomiting includes vomiting and retching.
^d Abdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, abdominal tenderness, and gastrointestinal pain.
^e Urinary tract infection includes urinary tract infection, cystitis, and cystitis bacterial.
^f Acute kidney injury includes blood creatinine increased, acute kidney injury, renal failure, and blood urea increased.
^g Dysgeusia includes dysgeusia and taste disorder.

12% of patients discontinued PLUVICTO due to any treatment-related adverse events vs 8% with BSOC alone^1,2

Select laboratory abnormalities (≥10%) that worsened from baseline in patients who received PLUVICTO plus BSOC (between arm difference of ≥5% all grades) in VISION¹

^a The denominator used to calculate the rate for each laboratory parameter varied from 506 to 529 based on the number of patients with a baseline value and at least 1 posttreatment value.
^b The denominator used to calculate the rate for each laboratory parameter varied from 194 to 198 based on the number of patients with a baseline value and at least 1 posttreatment value.
^c No grade 4 laboratory abnormalities worsening from baseline were reported.

No unexpected laboratory abnormalities were reported in the VISION trial.