Table 3.
Adverse Events Occurring in More Than 15% of Patients at Any Grade in Either the Phase 1 or Phase 2 Cohort by Preferred Term.*
| Phase 1, No. (%) |
Phase 2, No. (%) |
|||
|---|---|---|---|---|
| Adverse Events by Preferred Term | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 |
| All | 47 (100.0) | 33 (70.2) | 45 (100) | 36 (80.0) |
| Adrenal insufficiency | 17 (36.2) | 15 (31.9) | 6 (13.3) | 3 (6.7) |
| Anemia | 16 (34.0) | 7 (14.9) | 17 (37.8) | 6 (13.3) |
| Asthenia | 14 (29.8) | 2 (4.3) | 13 (28.9) | 2 (4.4) |
| Fatigue | 14 (29.8) | 0 | 17 (37.8) | 3 (6.7) |
| Dyspnea | 6 (12.8) | 0 | 12 (26.7) | 2 (4.4) |
| Muscle spasms | 14 (29.8) | 0 | 8 (17.8) | 1 (2.2) |
| Hyponatremia | 15 (31.9) | 6 (12.8) | 10 (22.2) | 2 (4.4) |
| Hyperkalemia | 13 (27.7) | 1 (2.1) | 9 (20.0) | 1 (2.2) |
| Edema peripheral | 10 (21.3) | 0 | 12 (26.7) | 0 |
| Tumor pain | 10 (21.3) | 4 (8.5) | 11 (24.4) | 3 (6.7) |
| ALT increased | 10 (21.3) | 1 (2.1) | 7 (15.6) | 0 |
| Arthralgia | 5 (10.6) | 0 | 8 (17.8) | 1 (2.2) |
| Decreased appetite | 0 | 0 | 8 (17.8) | 1 (2.2) |
| Amylase increased | 9 (19.1) | 4 (8.5) | 0 | 1 (2.2) |
| AST increased | 8 (17.0) | 1 (2.1) | 9 (20.0) | 0 |
| Hypertension | 8 (17.0) | 5 (10.6) | 5 (11.1) | 3 (6.7) |
| Insomnia | 8 (17.0) | 0 | 9 (20.0) | 0 |
| Bone pain | 7 (14.9) | 1 (2.1) | 9 (20.0) | 2 (4.4) |
| Abdominal pain | 0 | 1 (2.1) | 7 (15.6) | 0 |
| Hypocalcemia | 0 | 0 | 7 (15.6) | 0 |
| Hypotension | 0 | 0 | 7 (15.6) | 2 (4.4) |
| Myalgia | 6 (12.8) | 0 | 7 (15.6) | 0 |
| Platelet count decreased | 0 | 0 | 7 (15.6) | 1 (2.2) |
| ALP increased | 6 (12.8) | 3 (6.4) | 7 (15.6) | 3 (6.7) |
| Nausea | 7 (14.9) | 0 | 10 (22.2) | 0 |
| Diarrhea | 1 (2.1) | 1 (2.1) | 9 (20.0) | 2 (4.4) |
*
ALP denotes alkaline phosphatase; ALT, alanine aminotransferase; and AST, aspartate aminotransferase.