Table 2

Summary of adverse events

Category, n (%)E7046 dose (mg)
125
(n=8)
250
(n=8)
500
(n=7)
750
(n=7)
Combined
(N=30)
Patients with any TEAEs8 (100.0)7 (87.5)6 (85.7)7 (100.0)28 (93.3)
 Grade ≥3 TEAEs5 (62.5)6 (75.0)3 (42.9)3 (42.9)17 (56.7)
 Treatment-related TEAEs4 (50.0)5 (62.5)3 (42.9)4 (57.1)16 (53.3)
Patients with SAE*5 (62.5)6 (75.0)3 (42.9)3 (42.9)17 (56.7)
 Fatal SAEs2 (25.0)2 (25.0)004 (13.3)
Patient with any TEAEs leading to study drug
 Discontinuation1 (12.5)3 (37.5)01 (14.3)5 (16.7)
 Dose reduction01 (12.5)1 (14.3)02 (6.7)
 Dose interruption05 (62.5)3 (42.9)2 (28.6)10 (33.3)
TEAEs, preferred term, n (%)
 Fatigue1 (12.5)3 (37.5)4 (57.1)3 (42.9)11 (36.7)
 Diarrhea2 (25.0)2 (25.0)3 (42.9)3 (42.9)10 (33.3)
 Nausea03 (37.5)3 (42.9)3 (42.9)9 (30.0)
 Decreased appetite2 (25.0)2 (25.0)2 (28.6)1 (14.3)7 (23.3)
 Anemia2 (25.0)1 (12.5)3 (42.9)1 (14.3)7 (23.3)
 Vomiting1 (12.5)2 (25.0)1 (14.3)2 (28.6)6 (20.0)
 Abdominal pain03 (37.5)1 (14.3)1 (14.3)5 (16.7)
 Dyspnea04 (50.0)1 (14.3)05 (16.7)
 Dehydration01 (12.5)1 (14.3)2 (28.6)4 (13.3)
 Headache03 (37.5)1 (14.3)04 (13.3)
 Fever2 (25.0)1 (12.5)1 (14.3)04 (13.3)
 Decreased weight02 (25.0)01 (14.3)3 (10.0)
 Hypokalemia2 (25.0)001 (14.3)3 (10.0)
 Hyponatremia1 (12.5)1 (12.5)1 (14.3)03 (10.0)
 Tumor pain001 (14.3)2 (28.6)3 (10.0)
 Dizziness1 (12.5)1 (12.5)01 (14.3)3 (10.0)
  • *Includes SAEs up to 30 days post-treatment.

  • TEAE, treatment-emergent adverse event; SAE, serious adverse event.