Table 3. Treatment-emergent adverse events reported by ⩾10% of patients, any causality.
| |
Total (N=110)a |
|
|---|---|---|
| Adverse event, n (%) | All grades | Grade ⩾3 |
| Diarrhoea |
101 (92) |
32 (29) |
| Peripheral sensory neuropathy |
56 (51) |
3 (3) |
| Neutropenia |
55 (50) |
22 (20) |
| Alopecia |
51 (46) |
0 |
| Leukopenia |
45 (41) |
20 (18) |
| Anaemia |
41 (37) |
9 (8) |
| Nausea |
37 (34) |
1 (1) |
| Rash |
32 (29) |
1 (1) |
| Vomiting |
29 (26) |
2 (2) |
| Decreased appetite |
28 (25) |
1 (1) |
| Fatigue |
23 (21) |
4 (4) |
| Peripheral oedema |
23 (21) |
1 (1) |
| Pyrexia |
23 (21) |
0 |
| Cough |
21 (19) |
0 |
| Asthenia |
20 (18) |
1 (1) |
| Stomatitis |
20 (18) |
0 |
| ALT increased |
17 (15) |
4 (4) |
| Urinary tract infection |
17 (15) |
0 |
| AST increased |
14 (13) |
3 (3) |
| Dyspnea |
14 (13) |
4 (4) |
| Decreased weight |
13 (12) |
1 (1) |
| Dyspepsia |
13 (12) |
0 |
| Headache |
13 (12) |
0 |
| Dizziness |
12 (11) |
1 (1) |
| Hypokalemia |
12 (11) |
3 (3) |
| Upper abdominal pain |
12 (11) |
0 |
| Abdominal pain |
11 (10) |
0 |
| Pain in extremity | 11 (10) | 0 |
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase.
a
Includes three patients from part 1 of the study who received neratinib 160 mg per day plus paclitaxel, who experienced grade 3/4 events of anaemia (n=1), abdominal discomfort (n=1), and diarrhoea (n=1).