Table 3.
Summary of all AEs in at least 20% of subjects in any treatment arm (safety population)
| Arm 1 trastuzumab N = 32 a | Arm 2 lapatinib N = 34 | Arm 3 trastuzumab + Lapatinib N = 31 a | |
|---|---|---|---|
|
Any AE, n (%) |
31 (97) |
34 (100) |
31 (100) |
| Diarrhea |
17 (53) |
29 (85) |
31 (100) |
| Nausea |
26 (81) |
26 (76) |
27 (87) |
| Rash |
14 (44) |
28 (82) |
26 (84) |
| Fatigue |
22 (69) |
24 (71) |
24 (77) |
| Alopecia |
21 (66) |
23 (68) |
18 (58) |
| Neutropenia |
15 (47) |
12 (35) |
16 (52) |
| Neuropathy peripheral |
15 (47) |
19 (56) |
14 (45) |
| Anemia |
10 (31) |
12 (35) |
12 (39) |
| Hypokalaemia |
2 (6) |
10 (29) |
11 (35) |
| Epistaxis |
7 (22) |
10 (29) |
10 (32) |
| Dysgeusia |
4 (13) |
10 (29) |
9 (29) |
| Myalgia |
4 (13) |
10 (29) |
9 (29) |
| Pyrexia |
3 (9) |
8 (24) |
9 (29) |
| Vomiting |
7 (22) |
15 (44) |
9 (29) |
| Mucosal inflammation |
6 (19) |
7 (21) |
8 (26) |
| Nail disorder |
4 (13) |
10 (29) |
8 (26) |
| Cough |
8 (25) |
3 (9) |
7 (23) |
| Headache |
8 (25) |
6 (18) |
7 (23) |
| Decreased appetite |
5 (16) |
7 (21) |
7 (23) |
| Dyspepsia |
6 (19) |
5 (15) |
7 (23) |
| Dyspnea |
4 (13) |
6 (18) |
7 (23) |
| Edema peripheral |
5 (16) |
10 (29) |
7 (23) |
| Stomatitis |
5 (16) |
7 (21) |
7 (23) |
| Arthralgia |
5 (16) |
11 (32) |
6 (19) |
| Constipation |
12 (38) |
8 (24) |
6 (19) |
| Pruritus | 3 (9) | 7 (21) | 6 (19) |
Abbreviation:AE adverse event.
a1 patient in the trastuzumab arm and 2 patients in the trastuzumab + lapatinib arms did not receive therapy and therefore were not included in the safety population.