Table 2 Treatment-emergent adverse events regardless of causality reported by ≥10% of patients on LY2787106 (safety population)
Event | Part A | Part B | Total (n = 33) | ||||
|---|---|---|---|---|---|---|---|
0.3 mg/kg (n = 4) | 1 mg/kg (n = 3) | 3 mg/kg (n = 7) | 10 mg/kg (n = 5) | 10 mg/kg without oral iron (cohort B1) (n = 7) | 10 mg/kg with oral iron (cohort B2) (n = 7) | ||
Fatigue | 0 | 1 (33.3) | 2 (28.6) | 0 | 5 (71.4) | 7 (100) | 15 (45.5) |
Nausea | 1 (25.0) | 1 (33.3) | 2 (28.6) | 1 (20.0) | 3 (42.9) | 4 (57.1) | 12 (36.4) |
Dyspnea | 1 (25.0) | 0 | 0 | 0 | 4 (57.1) | 5 (71.4) | 10 (30.3) |
Constipation | 1 (25.0) | 2 (66.7) | 0 | 1 (20.0) | 2 (28.6) | 1 (14.3) | 7 (21.2) |
Edema | 0 | 1 (33.3) | 0 | 0 | 3 (42.9) | 2 (28.6) | 7 (21.2) |
Abdominal pain | 1 (25.0) | 2 (66.7) | 2 (28.6) | 0 | 0 | 1 (14.3) | 6 (18.2) |
Headache | 0 | 0 | 2 (28.6) | 0 | 1 (14.3) | 3 (42.9) | 6 (18.2) |
Hyponatremia | 1 (25.) | 0 | 1 (14.3) | 0 | 2 (28.6) | 2 (28.6) | 6 (18.2) |
Arthralgia | 0 | 0 | 1 (14.3) | 0 | 2 (28.6) | 2 (28.6) | 5 (15.2) |
Bone pain | 0 | 0 | 0 | 0 | 2 (28.6) | 3 (42.9) | 5 (15.2) |
Diarrhea | 0 | 0 | 0 | 0 | 2 (28.6) | 3 (42.9) | 5 (15.2) |
Vomiting | 0 | 0 | 0 | 1 (20.0) | 2 (28.6) | 2 (28.6) | 5 (15.2) |
Chills | 0 | 0 | 0 | 0 | 1 (14.3) | 3 (42.9) | 4 (12.1) |
Cough | 0 | 0 | 1 (14.3) | 0 | 2 (28.6) | 1 (14.3) | 4 (12.1) |
Decreased appetite | 2 (50.0) | 0 | 0 | 0 | 2 (28.6) | 0 | 4 (12.1) |
Dizziness | 0 | 0 | 2 (28.6) | 0 | 1 (14.3) | 1 (14.3) | 4 (12.1) |
Muscle spasms | 1 (25.0) | 0 | 1 (14.3) | 0 | 0 | 2 (28.6) | 4 (12.1) |
Myalgia | 0 | 0 | 1 (14.3) | 0 | 1 (14.3) | 2 (28.6) | 4 (12.1) |
Nasal congestion | 0 | 1 (33.3) | 1 (14.3) | 0 | 1 (14.3) | 1 (14.3) | 4 (12.1) |
Pain in extremity | 1 (25.0) | 0 | 0 | 0 | 0 | 3 (42.9) | 4 (12.1) |