Table 6.
Adverse events in ≥10% of Japanese patients in ToGA
| Trastuzumab plus XP (n = 51) | XP (n = 50) | |||
|---|---|---|---|---|
| All grade n (%) | Grade ≥3 n (%) | All grade n (%) | Grade ≥3 n (%) | |
| Total | 51 (100) | 43 (84) | 50 (100) | 36 (72) |
| Gastrointestinal disorders | ||||
| Nausea | 44 (86) | 7 (14) | 44 (88) | 7 (14) |
| Vomiting | 33 (65) | 1 (2) | 28 (56) | 2 (4) |
| Constipation | 24 (47) | 1 (2) | 24 (48) | – |
| Diarrhoea | 23 (45) | 4 (8) | 24 (48) | 2 (4) |
| Stomatitis | 29 (57) | – | 16 (32) | 1 (2) |
| Blood and lymphatic system disorders | ||||
| Neutropenia | 30 (59) | 18 (35) | 34 (68) | 20 (40) |
| Thrombocytopenia | 11 (22) | 1 (2) | 8 (16) | 3 (6) |
| Anemia | 15 (29) | 13 (25) | 11 (22) | 8 (16) |
| Febrile neutropenia | 5 (10) | 5 (10) | 3 (6) | 3 (6) |
| Skin and subcutaneous tissue disorders | ||||
| Palmar–plantar erythrodysaesthesia syndrome | 21 (41) | – | 23 (46) | 1 (2) |
| Alopecia | 12 (24) | – | 9 (18) | – |
| Skin hyperpigmentation | 6 (12) | – | 5 (10) | – |
| Rash | 10 (20) | – | 5 (10) | – |
| Pigmentation disorder | 10 (20) | – | 7 (14) | – |
| Nail disorder | 5 (10) | – | 5 (10) | – |
| Metabolism and nutrition disorders | ||||
| Anorexia | 43 (84) | 12 (24) | 46 (92) | 10 (20) |
| Dehydration | 3 (6) | 1 (2) | 6 (12) | 1 (2) |
| General disorders and administration site conditions | ||||
| Fatigue | 31 (61) | 4 (8) | 26 (52) | 4 (8) |
| Pyrexia | 19 (37) | 1 (2) | 12 (24) | – |
| Chill | 7 (14) | – | 0 (0) | – |
| Edema | 19 (37) | – | 23 (46) | – |
| Nervous system disorders | ||||
| Peripheral neuropathy | 16 (31) | 1 (2) | 10 (20) | – |
| Dysgeusia | 13 (25) | – | 8 (16) | – |
| Peripheral sensory neuropathy | 2 (4) | – | 11 (22) | – |
| Dizziness | 5 (10) | 1 (2) | 5 (10) | – |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Hiccups | 21 (41) | – | 16 (32) | – |
| Epistaxis | 5 (10) | – | 3 (6) | – |
| Renal and urinary disorders | ||||
| Renal impairment | 32 (63) | 2 (4) | 27 (54) | – |
| Vascular disorders | ||||
| Hypertension | 4 (8) | 1 (2) | 3 (6) | – |
| Investigations | ||||
| Weight decreased | 27 (53) | 2 (4) | 13 (26) | 1 (2) |
| Weight increased | 10 (20) | 1 (2) | 9 (18) | – |
| Psychiatric disorders | ||||
| Insomnia | 11 (22) | – | 8 (16) | – |
| Infections and infestations | ||||
| Nasopharyngitis | 18 (35) | – | 6 (12) | – |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 5 (10) | – | 1 (2) | – |
XP capecitabine plus cisplatin