Table 2.

Summary of Treatment-Emergent Adverse Events and a List of Adverse Events (Regardless of Causality) Occurring in Greater Than or Equal to 15% of Patients in Either the Phase 1 or Phase 2 Cohort by Preferred Term and Maximum National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) Grade.^*

Adverse Events by Preferred Term	Phase 1 (All Dose Cohorts Combined; N=47), n (%)	Phase 2 (5 mg Twice a Day; N=45), n (%)
All adverse events	47 (100.0)	45 (100)
Grade ≥3	33 (70.2)	36 (80.0)
Related to ODM-208	44 (93.6)	38 (84.4)
Grade ≥3	21 (44.7)	10 (22.2)
Serious adverse events	29 (61.7)	29 (64.4)
Related to ODM-208	19 (40.4)	6 (13.3)
Serious adrenal insufficiency-like events †	16 (34.0)	3 (6.7)
Adverse events leading to permanent discontinuation	20 (42.6)	10 (22.2)
Adverse events leading to ODM-208 interruption	26 (55.3)	20 (44.4)
No. of patients who died	2 (4.3)	10 (22.2)
Deaths related to ODM-208	0	0

^*The treatment relatedness of adverse events was determined by site investigators; it is possible that adverse events not considered treatment related were, in fact, so related.

^†Adrenal insufficiency–like events (i.e., adrenal insufficiency and glucocorticoid deficiency) were determined by the investigators on the basis of clinical symptoms and signs (such as fever, asthenia/fatigue, nausea, vomiting, anorexia, abdominal pain, weight loss, muscle cramps/pain, and orthostatic hypotension) and laboratory tests (such as C-reactive protein, lowered serum sodium, and elevated serum potassium).