Table 3 Adverse events in FGF401 single-agent arm regardless of study treatment relationship by preferred term*
Preferred term | Phase 1 part | Phase II part | All patients | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
50 mg | 80 mg | 120 mg | 150 mg | Group 1 | Group 2 | Group 3 | ||||||||||||||
Fasted | Fasted | Fed | Fasted | Fed | Fasted | Â | ||||||||||||||
N = 11 | N = 6 | N = 5 | N = 26 | N = 19 | N = 7 | N = 30 | N = 36 | N = 20 | N = 160 | |||||||||||
All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | |
n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
Diarrhea | 8 (72.7) | 2 (18.2) | 4 (66.7) | 0 | 4 (80.0) | 0 | 18 (69.2) | 0 | 14 (73.7) | 0 | 7 (100) | 0 | 23 (76.7) | 2 (6.7) | 23 (63.9) | 3 (8.3) | 17 (85.0) | 1 (5.0) | 118 (73.8) | 8 (5.0) |
Nausea | 1 (9.1) | 0 | 1 (16.7) | 0 | 0 | 0 | 5 (19.2) | 0 | 6 (31.6) | 0 | 1 (14.3) | 0 | 7 (23.3) | 0 | 6 (16.7) | 0 | 11 (55.0) | 0 | 38 (23.8) | 0 |
Abdominal pain | 0 | 0 | 1 (16.7) | 0 | 3 (60.0) | 1 (20.0) | 3 (11.5) | 0 | 6 (31.6) | 1 (5.3) | 0 | 0 | 5 (16.7) | 0 | 8 (22.2) | 1 (2.8) | 9 (45.0) | 3 (15.0) | 35 (21.9) | 6 (3.8) |
Vomiting | 1 (9.1) | 0 | 1 (16.7) | 0 | 1 (20.0) | 0 | 4 (15.4) | 0 | 6 (31.6) | 0 | 1 (14.3) | 0 | 5 (16.7) | 0 | 4 (11.1) | 0 | 9 (45.0) | 1 (5.0) | 32 (20.0) | 1 (0.6) |
Constipation | 1 (9.1) | 0 | 0 | 0 | 1 (20.0) | 0 | 4 (15.4) | 0 | 1 (5.3) | 0 | 0 | 0 | 5 (16.7) | 0 | 5 (13.9) | 0 | 6 (30.0) | 0 | 23 (14.4) | 0 |
Ascites | 1 (9.1) | 1 (9.1) | 1 (16.7) | 1 (16.7) | 2 (40.0) | 1 (20.0) | 6 (23.1) | 4 (15.4) | 1 (5.3) | 1 (5.3) | 2 (28.6) | 0 | 4 (13.3) | 1 (3.3) | 3 (8.3) | 1 (2.8) | 2 (10.0) | 1 (5.0) | 22 (13.8) | 11 (6.9) |
Abdominal distension | 1 (9.1) | 0 | 0 | 0 | 1 (20.0) | 1 (20.0) | 3 (11.5) | 0 | 0 | 0 | 3 (42.9) | 0 | 4 (13.3) | 0 | 1 (2.8) | 0 | 1 (5.0) | 0 | 14 (8.8) | 1 (0.6) |
Pyrexia | 3 (27.3) | 0 | 0 | 0 | 2 (40.0) | 0 | 6 (23.1) | 0 | 1 (5.3) | 0 | 1 (14.3) | 0 | 9 (30.0) | 0 | 4 (11.1) | 0 | 6 (30.0) | 0 | 32 (20.0) | 0 |
Fatigue | 2 (18.2) | 0 | 1 (16.7) | 0 | 0 | 0 | 6 (23.1) | 1 (3.8) | 5 (26.3) | 1 (5.3) | 0 | 0 | 2 (6.7) | 0 | 8 (22.2) | 0 | 7 (35.0) | 0 | 31 (19.4) | 2 (1.3) |
Edema peripheral | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 10 (38.5) | 0 | 0 | 0 | 0 | 0 | 8 (26.7) | 0 | 9 (25.0) | 0 | 3 (15.0) | 0 | 31 (19.4) | 0 |
Asthenia | 2 (18.2) | 0 | 2 (33.3) | 1 (16.7) | 0 | 0 | 4 (15.4) | 0 | 3 (15.8) | 1 (5.3) | 2 (28.6) | 0 | 4 (13.3) | 1 (3.3) | 6 (16.7) | 2 (5.6) | 4 (20.0) | 2 (10.0) | 27 (16.9) | 7 (4.4) |
Aspartate aminotransferase increased | 4 (36.4) | 2 (18.2) | 3 (50.0) | 0 | 2 (40.0) | 1 (20.0) | 16 (61.5) | 9 (34.6) | 14 (73.7) | 3 (15.8) | 7 (100) | 5 (71.4) | 14 (46.7) | 8 (26.7) | 11 (30.6) | 5 (13.9) | 5 (25.0) | 4 (20.0) | 76 (47.5) | 37 (23.1) |
Alanine aminotransferase increased | 3 (27.3) | 2 (18.2) | 3 (50.0) | 0 | 2 (40.0) | 2 (40.0) | 14 (53.8) | 4 (15.4) | 11 (57.9) | 3 (15.8) | 7 (100) | 3 (42.9) | 13 (43.3) | 5 (16.7) | 11 (30.6) | 6 (16.7) | 6 (30.0) | 4 (20.0) | 70 (43.8) | 29 (18.1) |
Blood bilirubin increased | 4 (36.4) | 1 (9.1) | 3 (50.0) | 0 | 1 (20.0) | 0 | 11 (42.3) | 3 (11.5) | 2 (10.5) | 2 (10.5) | 0 | 0 | 6 (20.0) | 3 (10.0) | 3 (8.3) | 2 (5.6) | 1 (5.0) | 1 (5.0) | 31 (19.4) | 12 (7.5) |
Decreased appetite | 3 (27.3) | 0 | 1 (16.7) | 0 | 0 | 0 | 10 (38.5) | 0 | 2 (10.5) | 0 | 4 (57.1) | 0 | 6 (20.0) | 0 | 9 (25.0) | 0 | 12 (60.0) | 0 | 47 (29.4) | 0 |
Pruritus | 2 (18.2) | 0 | 2 (33.3) | 0 | 1 (20.0) | 0 | 4 (15.4) | 0 | 5 (26.3) | 0 | 1 (14.3) | 0 | 5 (16.7) | 0 | 8 (22.2) | 1 (2.8) | 0 | 0 | 28 (17.5) | 1 (0.6) |