Table 2. AEs Among Patients Who Had or Had Not Undergone Gastrectomya.
| Variable | Patients, No. (%) | |||||||
|---|---|---|---|---|---|---|---|---|
| Gastrectomy Subgroup | No Gastrectomy Subgroup | |||||||
| Trifluridine/Tipiracil (n = 145) | Placebo (n = 73) | Trifluridine/Tipiracil (n = 190) | Placebo (n = 95) | |||||
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3b | Any Grade | Grade ≥3b | |
| Any AE | 143 (98.6) | 122 (84.1) | 69 (94.5) | 44 (60.3) | 183 (96.3) | 145 (76.3) | 88 (92.6) | 53 (55.8) |
| Treatment-related AE | 128 (88.3) | 93 (64.1) | 38 (52.1) | 7 (9.6) | 143 (75.3) | 83 (43.7) | 57 (60.0) | 15 (15.8) |
| Action taken because of AE of any cause | ||||||||
| Dose modification: delay or dose | 94 (64.8) | 75 (51.7) | 15 (20.5) | 13 (17.8) | 101 (53.2) | 73 (38.4) | 22 (23.2) | 16 (16.8) |
| Treatment discontinuation | 15 (10.3) | 12 (8.3) | 12 (16.4) | 8 (11.0) | 28 (14.7) | 24 (12.6) | 16 (16.8) | 13 (13.7) |
| AEs of any cause in ≥10% of patients | ||||||||
| Hematologic | ||||||||
| Neutropeniac | 87 (60.0) | 64 (44.1) | 1 (1.4) | 0 | 89 (46.8) | 50 (26.3) | 6 (6.3) | 0 |
| Anemiad | 77 (53.1) | 31 (21.4) | 8 (11.0) | 3 (4.1) | 73 (38.4) | 33 (17.4) | 24 (25.3) | 10 (10.5) |
| Leukopeniae | 40 (27.6) | 21 (14.5) | 1 (1.4) | 0 | 38 (20.0) | 10 (5.3) | 2 (2.1) | 0 |
| Thrombocytopeniaf | 30 (20.7) | 7 (4.8) | 1 (1.4) | 0 | 30 (15.8) | 4 (2.1) | 7 (7.4) | 0 |
| Gastrointestinal | ||||||||
| Nausea | 57 (39.3) | 4 (2.8) | 26 (35.6) | 3 (4.1) | 67 (35.3) | 6 (3.2) | 27 (28.4) | 2 (2.1) |
| Diarrhea | 43 (29.7) | 5 (3.4) | 13 (17.8) | 3 (4.1) | 33 (17.4) | 4 (2.1) | 11 (11.6) | 0 |
| Vomiting | 36 (24.8) | 5 (3.4) | 12 (16.4) | 1 (1.4) | 47 (24.7) | 7 (3.7) | 22 (23.2) | 2 (2.1) |
| Abdominal pain | 26 (17.9) | 5 (3.4) | 16 (21.9) | 7 (9.6) | 29 (15.3) | 9 (4.7) | 15 (15.8) | 8 (8.4) |
| Constipation | 17 (11.7) | 1 (0.7) | 12 (16.4) | 2 (2.7) | 28 (14.7) | 3 (1.6) | 13 (13.7) | 2 (2.1) |
| Ascites | 5 (3.4) | 3 (2.1) | 4 (5.5) | 3 (4.1) | 14 (7.4) | 9 (4.7) | 12 (12.6) | 8 (8.4) |
| Upper abdominal pain | 5 (3.4) | 0 | 5 (6.8) | 0 | 17 (8.9) | 1 (0.5) | 10 (10.5) | 2 (2.1) |
| Other | ||||||||
| Decreased appetite | 50 (34.5) | 11 (7.6) | 23 (31.5) | 5 (6.8) | 65 (34.2) | 18 (9.5) | 29 (30.5) | 6 (6.3) |
| Fatigue | 36 (24.8) | 3 (2.1) | 16 (21.9) | 4 (5.5) | 53 (27.9) | 20 (10.5) | 19 (20.0) | 6 (6.3) |
| Asthenia | 30 (20.7) | 3 (2.1) | 19 (26.0) | 5 (6.8) | 35 (18.4) | 13 (6.8) | 21 (22.1) | 6 (6.3) |
| Back pain | 15 (10.3) | 1 (0.7) | 4 (5.5) | 1 (1.4) | 10 (5.3) | 1 (0.5) | 7 (7.4) | 3 (3.2) |
| Dyspnea | 12 (8.3) | 2 (1.4) | 9 (12.3) | 3 (4.1) | 12 (6.3) | 4 (2.1) | 8 (8.4) | 3 (3.2) |
| General physical health deterioration | 10 (6.9) | 10 (6.9) | 7 (9.6) | 6 (8.2) | 13 (6.8) | 12 (6.3) | 10 (10.5) | 9 (9.5) |
| Malaise | 5 (3.4) | 0 | 8 (11.0) | 1 (1.4) | 4 (2.1) | 0 | 1 (1.1) | 0 |
Abbreviation: AE, adverse event.
a
As-treated population.
b
Grade 5 AEs were reported in 1 patient (0.5%) (cardiopulmonary arrest) in the trifluridine/tipiracil group and 1 patient (1.1%) (toxic hepatitis) in the placebo group.
c
Neutropenia and/or decreased neutrophil count.
d
Anemia and/or decreased hemoglobin level.
e
Leukopenia and/or decreased white blood cell count.
f
Thrombocytopenia and/or decreased platelet count.