Safety in nmCRPC

Established safety profile1

Adverse reactions (all grades) with ≥10% incidence in the ERLEADA® + ADT arm that occurred with at least 2% greater frequency than in the placebo + ADT arm in the SPARTAN study1

Adverse Reactions ERLEADA® + ADT
Placebo + ADT
Fatigue 39% 28%
Hypertension 25% 20%
Rash 25% 6%
Diarrhea 20% 15%
Nausea 18% 16%
Weight decreased 16% 6%
Arthralgia 16% 8%
Fall 16% 9%
Hot flush 14% 9%
Decreased appetite 12% 9%
Fracture 12% 7%
Peripheral edema 11% 9%

Grades 3 and 4 adverse reactions in the SPARTAN study1

Adverse Reactions ERLEADA® + ADT
Placebo + ADT
Hypertension 14% 12%
Rash 5.2% 0.3%
Fracture 2.7% 0.8%
Fall 1.7% 0.8%
Weight decreased 1.1% 0.3%
Diarrhea 1.1% 0.5%
Fatigue 1.4% 0.3%
Decreased appetite 0.1% 0%
Arthralgia 0% 0%
Hot flush 0% 0%
Nausea 0% 0%
Peripheral edema 0% 0%

In the combined data of 2 randomized, placebo-controlled clinical studies, rash associated with ERLEADA® was most commonly described as macular or maculopapular. The onset of rash occurred at a median of 83 days of ERLEADA® treatment. Rash resolved in 78% of patients within a median of 78 days from onset of rash.1

Additional safety information in the SPARTAN study2,3

Treatment-Emergent Adverse Events ERLEADA® + ADT
Placebo + ADT
Any mental impairment disorder* 3.9% 3.4%
Amnesia 1.9% 1.0%
Memory impairment 1.6% 1.5%
Disturbance in attention 1.2% 0.3%
Cognitive disorder 0.7% 0.8%

To evaluate the potential effect of ERLEADA® on cognitive deficits, events of amnesia, cognitive disorder, memory impairment, and disturbance in attention were assessed.2

*All mental impairment disorders were Grades 1 or 2.

Exposure-adjusted rate. An exposure-adjusted rate is 100 times the number of distinct mental impairment disorder treatment-emergent adverse events divided by total years of exposure.

Consistent safety profile after long-term follow-up

After more than 4 years of median follow-up, the safety profile of ERLEADA® was consistent with the initial analysis of the SPARTAN study.4

ERLEADA® is the AR inhibitor with the longest follow-up reported in registration trials of nmCRPC4-6

  • 52.0 months of median follow-up in SPARTAN4

ADT = androgen deprivation therapy; nmCRPC = non-metastatic castration-resistant prostate cancer; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509.


1. ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

2. U.S. Food and Drug Administration. Drug Approval Package: ERLEADA® (apalutamide). SPARTAN Clinical Study Report. Accessed October 5, 2021.

3. Smith MR, Saad F, Chowdhury S, et al; for the SPARTAN Investigators. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418.

4. Smith MR, Saad F, Chowdhury S, et al. Apalutamide and overall survival in prostate cancer. Eur Urol. 2021;79(1):150-158.

5. Sternberg CN, Fizazi K, Saad F, et al; PROSPER Investigators. Enzalutamide and survival in nonmetastatic castration-resistant prostate cancer. N Engl J Med. 2020;382(23):2197-2206.

6. Fizazi K, Shore N, Tammela TL, et al; ARAMIS Investigators. Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide. N Engl J Med. 2020;383(11):1040-1049.