Table 3:
Adverse events related to treatment
| Chemoradiotherapy plus trastuzumab group (n=95*) | Chemoradiotherapy group (n=96) | |||||||
|---|---|---|---|---|---|---|---|---|
|
|
|
|||||||
| Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
| Overall highest grade | 29 (31%) | 41 (43%) | 20 (21%) | 5 (5%) | 20 (21%) | 52 (54%) | 21 (22%) | 3 (3%) |
| Haematological† | 34 (36%) | 36 (38%) | 17 (18%) | 0 | 39 (41%) | 36 (38%) | 19 (20%) | 0 |
| Blood and lymphatic system disorders | 52 (55%) | 7 (7%) | 1 (1%) | 0 | 51 (53%) | 2 (2%) | 0 | 0 |
| Cardiac disorders | 9 (9%) | 4 (4%) | 1 (1%) | 0 | 9 (9%) | 1 (1%) | 2 (2%) | 0 |
| Ear and labyrinth disorders | 4 (4%) | 0 | 0 | 0 | 3 (3%) | 0 | 0 | 0 |
| Eye disorders | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gastrointestinal disorders | 62 (65%) | 25 (26%) | 3 (3%) | 0 | 68 (71%) | 19 (20%) | 1 (1%) | 0 |
| General disorders and administration site conditions | 71 (75%) | 2 (2%) | 1 (1%) | 2 (2%) | 65 (68%) | 11 (11%) | 0 | 2 (2%) |
| Hepatobiliary disorders | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 |
| Infections and infestations | 4 (4%) | 5 (5%) | 5 (5%) | 1 (1%) | 5 (5%) | 5 (5%) | 1 (1%) | 1 (1%) |
| Injury, poisoning, and procedural complications | 11 (12%) | 0 | 1 (1%) | 1 (1%) | 15 (16%) | 1 (1%) | 1 (1%) | 0 |
| Investigations | 36 (38%) | 35 (37%) | 16 (17%) | 0 | 39 (41%) | 37 (39%) | 19 (20%) | 0 |
| Metabolism and nutrition disorders | 51 (54%) | 12 (13%) | 0 | 0 | 39 (41%) | 19 (20%) | 0 | 0 |
| Musculoskeletal and connective tissue disorders | 15 (16%) | 1 (1%) | 0 | 0 | 14 (15%) | 4 (4%) | 0 | 0 |
| Nervous system disorders | 35 (37%) | 0 | 0 | 0 | 33 (34%) | 2 (2%) | 1 (1%) | 0 |
| Psychiatric disorders | 14 (15%) | 2 (2%) | 0 | 0 | 18 (19%) | 0 | 0 | 0 |
| Renal and urinary disorders | 1 (1%) | 0 | 1 (1%) | 0 | 2 (2%) | 0 | 0 | 0 |
| Respiratory, thoracic, and mediastinal disorders | 26 (27%) | 3 (3%) | 2 (2%) | 1 (1%) | 26 (27%) | 5 (5%) | 2 (2%) | 0 |
| Skin and subcutaneous tissue disorders | 32 (34%) | 0 | 0 | 0 | 24 (25%) | 2 (2%) | 0 | 0 |
| Surgical and medical procedures | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 1 (1%) | 0 |
| Vascular disorders | 13 (14%) | 3 (3%) | 1 (1%) | 0 | 9 (9%) | 4 (4%) | 0 | 0 |
Data are n (%).
*
Excludes patients who did not receive any protocol treatment. Adverse events were graded with National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.
†
Haematological includes the following CTCAE version 4 terms from the investigations system organ class: CD4 lymphocytes decreased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell decreased; and all terms from the system organ class of blood and lymphatic system disorders.