Table 4.
Adverse events and haematological laboratory abnormalities of grade ≥3 occurring in >5%, any group (as-treated population).
| n (%) | USA |
EU |
Japan |
|||
|---|---|---|---|---|---|---|
| FTD/TPI (n = 64) | Placebo (n = 35) | FTD/TPI (n = 270) | Placebo (n = 131) | FTD/TPI (n = 178) | Placebo (n = 88) | |
| Abdominal pain | 3 (4.7) | 4 (11.4) | 5 (1.9) | 4 (3.1) | 1 (0.6) | 1 (1.1) |
| Anaemia | 9 (14.1) | 2 (5.7) | 35 (13.0) | 2 (1.5) | 41 (23.0) | 3 (3.4) |
| Aspartate aminotransferase increased | 2 (3.1) | 2 (5.7) | 3 (1.1) | 1 (0.8) | 2 (1.1) | 4 (4.5) |
| Asthenia | 0 | 0 | 18 (6.7) | 8(6.1) | 0 | 0 |
| Blood alkaline phosphatase increased | 2(3.1) | 4 (11.4) | 9 (3.3) | 5 (3.8) | 7 (3.9) | 4 (4.5) |
| Blood bilirubin increased | 2(3.1) | 0 | 13 (4.8) | 7 (5.3) | 6 (3.4) | 2 (2.3) |
| Decreased appetite | 0 | 1 (2.9) | 9 (3.3) | 5 (3.8) | 10 (5.6) | 7 (8.0) |
| Dyspnoea | 1 (1.6) | 0 | 13 (4.8) | 7 (5.3) | 0 | 3 (3.4) |
| Fatigue | 3 (4.7) | 3 (8.6) | 12 (4.4) | 6 (4.6) | 5 (2.8) | 6 (6.8) |
| Febrile neutropenia | 4 (6.3) | 0 | 6 (2.2) | 0 | 10 (5.6) | 0 |
| Gamma-glutamyltransferase increased | 1 (1.6) | 0 | 9 (3.3) | 7 (5.3) | 7 (3.9) | 3 (3.4) |
| General physical health deterioration | 0 | 0 | 15 (5.6) | 9 (6.9) | 3 (1.7) | 3 (3.4) |
| Hepatic failure | 1 (1.6) | 2 (5.7) | 2 (0.7) | 2(1.5) | 0 | 4 (4.5) |
| Hyperbilirubinaemia | 2(3.1) | 2 (5.7) | 8 (3.0) | 2(1.5) | 1 (0.6) | 0 |
| Hypoalbuminaemia | 1 (1.6) | 2 (5.7) | 2 (0.7) | 0 | 1 (0.6) | 0 |
| Hypokalaemia | 6 (9.4) | 0 | 5(1.9) | 2 (1.5) | 1 (0.6) | 0 |
| Leukopenia | 4 (6.3) | 0 | 9 (3.3) | 0 | 0 | 0 |
| Neutropenia | 20 (31.3) | 0 | 79 (29.3) | 0 | 3 (1.7) | 0 |
| Peripheral oedema | 0 | 2 (5.7) | 0 | 0 | 1 (0.6) | 0 |
| Tumour pain | 0 | 0 | 1 (0.4) | 0 | 2(1.1) | 5 (5.7) |
| Vomiting | 3 (4.7) | 0 | 5(1.9) | 1 (0.8) | 3 (1.7) | 0 |
| Haematological laboratory abnormalities | ||||||
| Haemoglobin | 15 (23.8) | 2 (5.7) | 39 (14.6) | 3 (2.3) | 41 (23.0) | 3 (3.4) |
| Lymphocytes | 17 (27.0) | 3 (8.6) | 41 (15.6) | 11 (8.6) | 47 (26.4) | 11 (12.5) |
| Neutrophils | 28 (44.4) | 0 | 100 (37.3) | 0 | 67 (37.6) | 0 |
| Platelets | 5 (7.9) | 0 | 11 (4.1) | 0 | 11 (6.2) | 1(1.1) |
| Leukocytes | 18 (28.6) | 0 | 50 (18.7) | 0 | 43 (24.2) | 0 |
| Hospitalisations | ||||||
| Total hospitalisations | 17 (26.6) | 12 (34.3) | 84 (31.1) | 45 (34.4) | 52 (29.2) | 36 (40.9) |
| Median total days hospitalised | 7.0 | 10.5 | 7.5 | 9.0 | 13.0 | 19.5 |
| Median hospitalisation ratioa | 0.09 | 0.19 | 0.11 | 0.20 | 0.19 | 0.30 |
| Reason for hospitalisation | ||||||
| Serious adverse event | 16 (25.0) | 10 (28.6) | 79 (29.3) | 41 (31.3) | 45 (25.3) | 34 (38.6) |
| Febrile neutropenia | 4 (6.3) | 0 | 4(1.5) | 0 | 6 (3.4) | 0 |
| Elective preplanned surgery alone | 0 | 0 | 3(1.1) | 0 | 1 (0.6) | 0 |
| Hospice/palliative care alone | 0 | 1 (2.9) | 1 (0.4) | 3 (2.3) | 2(1.1) | 2 (2.3) |
| Palliative radiation alone | 0 | 1 (2.9) | 0 | 0 | 0 | 0 |
| Other | 1 (1.6) | 2 (5.7) | 8 (3.0) | 4 (3.1) | 5 (2.8) | 2 (2.3) |
Abbreviation: FTD/TPI, trifluridine/tipiracil.
a
Total days hospitalised divided by total days followed.