Table 3 Summary of all AEs in at least 20% of subjects in any treatment arm (safety population)
Arm 1 trastuzumab N = 32a | Arm 2 lapatinib N = 34 | Arm 3 trastuzumab + Lapatinib N = 31a | |
|---|---|---|---|
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) |