Table 4.
Summary of treatment-emergent adverse events (safety population)
| MedDRA preferred term | ABP 980 (n = 50) | Trastuzumab (US) (n = 52) | Trastuzumab (EU) (n = 55) | |||
|---|---|---|---|---|---|---|
| n (%) | No. of events | n (%) | No. of events | n (%) | No. of events | |
| Headache | 16 (32.0) | 21 | 19 (36.5) | 26 | 24 (43.6) | 30 |
| Upper respiratory tract infection | 21 (42.0) | 25 | 18 (34.6) | 20 | 20 (36.4) | 22 |
| Chills | 3 (6.0) | 3 | 6 (11.5) | 7 | 7 (12.7) | 8 |
| Pyrexia | 3 (6.0) | 3 | 5 (9.6) | 5 | 8 (14.5) | 8 |
| Myalgia | 8 (16.0) | 8 | 3 (5.8) | 3 | 1 (1.8) | 1 |
| Nausea | 2 (4.0) | 2 | 5 (9.6) | 5 | 4 (7.3) | 4 |
| Epistaxis | 3 (6.0) | 4 | 3 (5.8) | 3 | 3 (5.5) | 3 |
| Arthralgia | 5 (10.0) | 5 | 1 (1.9) | 1 | 1 (1.8) | 1 |
| Lethargy | 3 (6.0) | 3 | 2 (3.8) | 2 | 0 | 0 |
Adverse events were coded using MedDRA Version 17.0
A TEAE is defined as an AE that was not present prior to treatment with investigational product, but appeared following treatment or was present at treatment initiation but worsened during treatment. Subjects with multiple events in the same category were counted only once in that category; subjects with events in more than 1 category were counted once in each of those categories