Table 3 –
Number of patients with an adverse event by category and grade any relationship to protocol treatment
| Category | RT + paclitaxel + trastuzumab (n = 20) Grade |
 RT + paclitaxel (n = 45) Grade |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | |
| Allergy/immunology, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Auditory/ear, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 8 (17.8) | 8 (17.8) | 1 (2.2) | 0 (0.0) |
| Blood/bone marrow, n (%) | 5 (25.0) | 4 (20.0) | 9 (45.0) | 1 (5.0) | 0 (0.0) | 9 (20.0) | 3 (6.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Cardiac arrhythmia, n (%) | 2 (10.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 14 (31.1) | 9 (20.0) | 6 (13.3) | 0 (0.0) | 0 (0.0) |
| Cardiac general, n (%) | 2 (10.0) | 4 (20.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 3 (6.7) | 1 (2.2) | 1 (2.2) | 0 (0.0) | 0 (0.0) |
| Coagulation, n (%) | 3 (15.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 8 (17.8) | 8 (17.8) | 3 (6.7) | 1 (2.2) | 0 (0.0) |
| Constitutional symptoms, n (%) | 4 (20.0) | 1 (5.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 3 (6.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Death, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 8 (17.8) | 15 (33.3) | 5 (11.1) | 0 (0.0) | 0 (0.0) |
| Dermatology/skin, n (%) | 1 (5.0) | 2 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 12 (26.7) | 1 (2.2) | 5 (11.1) | 1 (2.2) | 1 (2.2) |
| Gastrointestinal, n (%) | 4 (20.0) | 7 (35.0) | 6 (30.0) | 0 (0.0) | 1 (5.0) | 11 (24.4) | 11 (24.4) | 11 (24.4) | 1 (2.2) | 0 (0.0) |
| Hemorrhage/bleeding, n (%) | 1 (5.0) | 4 (20.0) | 4 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hepatobiliary/pancreas, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Infection, n (%) | 0 (0.0) | 6 (30.0) | 2 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (4.4) | 2 (4.4) | 1 (2.2) | 0 (0.0) |
| Lymphatics, n (%) | 1 (5.0) | 2 (10.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Metabolic/laboratory, n (%) | 4 (20.0) | 9 (45.0) | 4 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 8 (17.8) | 8 (17.8) | 1 (2.2) | 0 (0.0) |
| Musculoskeletal/soft tissue, n (%) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 9 (20.0) | 3 (6.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Neurology, n (%) | 4 (20.0) | 3 (15.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 14 (31.1) | 9 (20.0) | 6 (13.3) | 0 (0.0) | 0 (0.0) |
| Ocular/visual, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (6.7) | 1 (2.2) | 1 (2.2) | 0 (0.0) | 0 (0.0) |
| Pain, n (%) | 5 (25.0) | 3 (15.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 8 (17.8) | 8 (17.8) | 3 (6.7) | 1 (2.2) | 0 (0.0) |
| Pulmonary/upper respiratory, n (%) | 2 (10.0) | 3 (15.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 3 (6.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Renal/genitourinary, n (%) | 1 (5.0) | 1 (5.0) | 5 (25.0) | 0 (0.0) | 0 (0.0) | 8 (17.8) | 15 (33.3) | 5 (11.1) | 0 (0.0) | 0 (0.0) |
| Sexual/reproductive function, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 12 (26.7) | 1 (2.2) | 5 (11.1) | 1 (2.2) | 1 (2.2) |
| Syndromes, n (%) | 1 (5.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 11 (24.4) | 11 (24.4) | 11 (24.4) | 1 (2.2) | 0 (0.0) |
| Vascular, n (%) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
CTCAE = Common Terminology Criteria for Adverse Events; RT = radiotherapy.
Includes adverse events where relationship to protocol treatment is missing. Adverse events were graded with CTCAE version 3.0.