Table 2 Most common TRAEs (≥10%) of conteltinib (CT-707) in SS
TRAEs n (%) | Total (n=64) | 50 mg QD (n=2) | 100 mg QD (n=8) | 200 mg QD (n=3) | 300 mg QD (n=3) | 450 mg QD (n=14) | 600 mg QD (n=18) | 800 mg QD (n=4) | 300 mg BID (n=12) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
All grade | Grade 1–2 | Grade ≥ 3 | Grade 1–2 | Grade ≥ 3 | Grade 1–2 | Grade ≥ 3 | Grade 1–2 | Grade ≥ 3 | Grade 1–2 | Grade ≥ 3 | Grade 1–2 | Grade ≥ 3 | Grade 1–2 | Grade ≥ 3 | Grade 1–2 | Grade ≥ 3 | Grade 1–2 | Grade ≥ 3 | |
Patients with any TRAE | 58 (90.6) | 58 (90.6) | 9 (14.1) | 1 (50.0) | 0 (0.0) | 6 (75.0) | 0 (0.0) | 3 (100) | 0 (0.0) | 3 (100) | 0 (0.0) | 14 (100) | 3 (21.4) | 18 (100) | 5 (27.8) | 3 (75.0) | 0 (0.0) | 10 (83.3) | 1 (8.3) |
Diarrhea | 46 (71.9) | 44 (68.8) | 2 (3.1) | 1 (50.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (100) | 0 (0.0) | 13 (92.9) | 0 (0.0) | 16 (88.9) | 2 (11.1) | 3 (75.0) | 0 (0.0) | 8 (66.7) | 0 (0.0) |
Serum creatinine elevated | 29 (45.3) | 28 (43.8) | 1 (1.6) | 0 (0.0) | 0 (0.0) | 2 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 10 (71.4) | 0 (0.0) | 8 (44.4) | 1 (5.6) | 2 (50.0) | 0 (0.0) | 5 (41.7) | 0 (0.0) |
AST elevated | 25 (39.1) | 25 (39.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (25.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 9 (64.3) | 0 (0.0) | 8 (44.4) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 3 (25.0) | 0 (0.0) |
Nausea | 24 (37.5) | 24 (37.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (37.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 6 (42.9) | 0 (0.0) | 9 (50.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 4 (33.3) | 0 (0.0) |
Vomiting | 23 (35.9) | 23 (35.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 6 (42.9) | 0 (0.0) | 11 (61.1) | 0 (0.0) | 2 (50.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) |
ALT elevated | 22 (34.4) | 22 (34.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (100) | 0 (0.0) | 10 (71.4) | 0 (0.0) | 7 (38.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (25.0) | 0 (0.0) |
γ-GGT elevated | 21 (32.8) | 16 (25.0) | 5 (7.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (21.4) | 3 (21.4) | 8 (44.4) | 1 (5.6) | 2 (50.0) | 0 (0.0) | 3 (25.0) | 1 (8.3) |
Hyperuricemia | 20 (31.3) | 20 (31.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (21.4) | 0 (0.0) | 10 (55.6) | 0 (0.0) | 3 (75.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) |
Weight loss | 18 (28.1) | 18 (28.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (100) | 0 (0.0) | 3 (21.4) | 0 (0.0) | 8 (44.4) | 0 (0.0) | 2 (50.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) |
Abdominal pain | 17 (26.6) | 17 (26.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (35.7) | 0 (0.0) | 7 (38.9) | 0 (0.0) | 3 (75.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) |
Hypertriglyceridemia | 15 (23.4) | 15 (23.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 2 (14.3) | 0 (0.0) | 8 (44.4) | 0 (0.0) | 2 (50.0) | 0 (0.0) | 1 (8.3) | 0 (0.0) |
Proteinuria | 14 (21.9) | 14 (21.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (7.1) | 0 (0.0) | 8 (44.4) | 0 (0.0) | 2 (50.0) | 0 (0.0) | 3 (25.0) | 0 (0.0) |
Appetite decreased | 12 (18.8) | 12 (18.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (14.3) | 0 (0.0) | 7 (38.9) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 2 (16.7) | 0 (0.0) |
Hypoalbuminemia | 11 (17.2) | 11 (17.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 2 (14.3) | 0 (0.0) | 3 (16.7) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 4 (33.3) | 0 (0.0) |
Abdominal pain upper | 11 (17.2) | 11 (17.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (35.7) | 0 (0.0) | 2 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (25.0) | 0 (0.0) |
Hyperglycemia | 10 (15.6) | 10 (15.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (7.1) | 0 (0.0) | 6 (33.3) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hypercholesterolemia | 8 (12.5) | 8 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (7.1) | 0 (0.0) | 4 (22.2) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Conjugated bilirubin elevated | 7 (10.9) | 6 (9.4) | 1 (1.6) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (14.3) | 0 (0.0) | 2 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (8.3) | 1 (8.3) |