Table 2.
Treatment-emergent adverse events occurring in >5% of the total patients (N=87) treated with INCAGN01949 (all grades and grade ≥3)
| Preferred term, n (%) | Treatment group (dose level) | Total (N=87) |
||||||
| 7 mg (n=4) |
20 mg (n=4) |
70 mg (n=22) |
200 mg (n=18) |
350 mg (n=23) |
700 mg (n=12) |
1400 mg (n=4) |
||
| Fatigue | 2 (50.0) | 2 (50.0) | 6 (27.3) | 7 (38.9) | 8 (34.8) | 4 (33.3) | 2 (50.0) | 31 (35.6) |
| Grade ≥3 | 0 | 1 (25.0) | 2 (9.1) | 0 | 0 | 0 | 0 | 3 (3.4) |
| Decreased appetite | 1 (25.0) | 3 (75.0) | 6 (27.3) | 4 (22.2) | 7 (30.4) | 3 (25.0) | 0 | 24 (27.6) |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | – | 0 |
| Constipation | 1 (25.0) | 1 (25.0) | 4 (18.2) | 6 (33.3) | 4 (17.4) | 1 (8.3) | 1 (25.0) | 18 (20.7) |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vomiting | 1 (25.0) | 0 | 6 (27.3) | 4 (22.2) | 5 (21.7) | 0 | 0 | 16 (18.4) |
| Grade ≥3 | 0 | – | 1 (4.5) | 1 (5.6) | 1 (4.3) | – | – | 3 (3.4) |
| Dyspnea | 1 (25.0) | 2 (50.0) | 2 (9.1) | 3 (16.7) | 3 (13.0) | 2 (16.7) | 2 (50.0) | 15 (17.2) |
| Grade ≥3 | 0 | 0 | 0 | 0 | 1 (4.3) | 0 | 0 | 1 (1.1) |
| Nausea | 0 | 1 (25.0) | 3 (13.6) | 4 (22.2) | 6 (26.1) | 0 | 1 (25.0) | 15 (17.2) |
| Grade ≥3 | – | 0 | 1 (4.5) | 1 (5.6) | 1 (4.3) | – | 0 | 3 (3.4) |
| Abdominal pain | 0 | 1 (25.0) | 2 (9.1) | 3 (16.7) | 5 (21.7) | 2 (16.7) | 1 (25.0) | 14 (16.1) |
| Grade ≥3 | – | 0 | 1 (4.5) | 0 | 2 (8.7) | 2 (16.7) | 0 | 5 (5.7) |
| Back pain | 1 (25.0) | 0 | 4 (18.2) | 2 (11.1) | 5 (21.7) | 1 (8.3) | 0 | 13 (14.9) |
| Grade ≥3 | 0 | – | 1 (4.5) | 0 | 1 (4.3) | 0 | – | 2 (2.3) |
| Cough | 0 | 1 (25.0) | 4 (18.2) | 5 (27.8) | 1 (4.3) | 1 (8.3) | 1 (25.0) | 13 (14.9) |
| Grade ≥3 | – | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Diarrhea | 1 (25.0) | 0 | 3 (13.6) | 4 (22.2) | 4 (17.4) | 1 (8.3) | 0 | 13 (14.9) |
| Grade ≥3 | 0 | – | 0 | 0 | 2 (8.7) | 0 | – | 2 (2.3) |
| Anemia | 0 | 0 | 4 (18.2) | 2 (11.1) | 1 (4.3) | 2 (16.7) | 2 (50.0) | 11 (12.6) |
| Grade ≥3 | – | 1 (4.5) | 0 | 1 (8.3) | 1 (25.0) | 3 (3.4) | ||
| Arthralgia | 0 | 3 (75.0) | 3 (13.6) | 1 (5.6) | 2 (8.7) | 1 (8.3) | 0 | 10 (11.5) |
| Grade ≥3 | – | 0 | 0 | 0 | 1 (4.3) | 0 | – | 1 (1.1) |
| Fever | 0 | 2 (50.0) | 1 (4.5) | 0 | 3 (13.0) | 1 (8.3) | 1 (25.0) | 8 (9.2) |
| Grade ≥3 | – | 0 | 0 | – | 1 (4.3) | 0 | 0 | 1 (1.1) |
| Edema peripheral | 0 | 0 | 1 (4.5) | 3 (16.7) | 0 | 2 (16.7) | 1 (25.0) | 7 (8.0) |
| Grade ≥3 | – | – | 0 | 0 | – | 0 | 0 | 0 |
| Weight decreased | 2 (50.0) | 1 (25.0) | 0 | 2 (11.1) | 2 (8.7) | 0 | 0 | 7 (8.0) |
| Grade ≥3 | 0 | 0 | – | 0 | 0 | – | – | 0 |
| Dyspnea exertional | 0 | 0 | 1 (4.5) | 1 (5.6) | 0 | 2 (16.7) | 2 (50.0) | 6 (6.9) |
| Grade ≥3 | – | – | 0 | 0 | – | 0 | 0 | 0 |
| Pruritus | 0 | 0 | 2 (9.1) | 2 (11.1) | 2 (8.7) | 0 | 0 | 6 (6.9) |
| Grade ≥3 | – | – | 0 | 0 | 0 | – | – | 0 |
| Rash | 0 | 0 | 2 (9.1) | 2 (11.1) | 1 (4.3) | 0 | 1 (25.0) | 6 (6.9) |
| Grade ≥3 | – | – | 0 | 0 | 0 | – | 0 | 0 |
| Blood creatinine increased | 1 (25.0) | 0 | 0 | 1 (5.6) | 2 (8.7) | 1 (8.3) | 0 | 5 (5.7) |
| Grade ≥3 | 0 | – | – | 0 | 1 (4.3) | 0 | – | 1 (1.1) |
| Myalgia | 1 (25.0) | 2 (50.0) | 0 | 1 (5.6) | 0 | 1 (8.3) | 0 | 5 (5.7) |
| Grade ≥3 | 1 (25.0) | 0 | – | 0 | – | 0 | – | 1 (1.1) |
Patients were counted once under each MedDRA preferred term.
MedDRA, Medical Dictionary for Regulatory Activities.