Table 4.
Physician-reported new and worsened side effects during follow-up according to CTCAE classification. PRO data is reported as PROCTCAE and listed separately, hence, not included in the physician reported results
| CTCAE grade | Pre RT (n = 219) | < 6 months (n = 208) | 6–12 months (n = 130) | > 12 months (n = 120) | PRO (n = 38) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |
| Pain | 6 (3%) | 4 (2%) | – | – | 14 (7%) | 4 (2%) | 1 (< 1%) | – | 6 (5%) | 2 (2%) | – | – | 3 (3%) | 6 (5%) | 1 (1%) | – | 9 (24%) | 7 (18%) | – | – |
| Fatigue | 2 (1%) | – | – | – | 21 (10%) | 5 (2%) | – | – | 4 (3%) | 2 (2%) | – | – | 5 (4%) | 3 (3%) | – | – | 9 (24%) | 16 (42%) | – | – |
| Nausea/vomiting | – | – | – | – | 1 (< 1%) | – | – | – | – | – | – | – | 1 (1%) | – | – | – | 1 (3%) | 3 (8%) | – | – |
| Dermatitis | – | – | – | – | 3 (1%) | – | – | – | 1 (1%) | – | – | – | – | 1 (1%) | – | – | 3 (8%) | 1 (3%) | 1 (3%) | – |
| Hyperpigmentation | – | – | – | – | 3 (1%) | – | – | – | 2 (2%) | – | – | – | – | – | – | – | 2 (5%) | – | – | – |
| Edema | 1 (< 1%) | – | – | – | 6 (3%) | – | – | – | 5 (4%) | 2 (2%) | – | – | 3 (3%) | 1 (1%) | – | – | 7 (18%) | 7 (18%) | – | – |
| Osteonecrosis, rib fracture | – | – | – | – | – | – | – | – | – | – | – | – | – | – | 1 (1%) | – | – | – | – | – |
| Sensory deficits | – | 1 (< 1%) | – | – | – | – | – | – | – | – | – | – | 2 (2%) | – | – | – | 10 (26%) | 5 (13%) | 1 (3%) | 1 (3%) |
| Motor deficits | – | – | – | – | 2 (1%) | – | – | – | – | – | – | – | 2 (2%) | – | – | – | 7 (18%) | 6 (16%) | 2 (5%) | – |
| Weight loss | – | – | 1 (< 1%) | – | 3 (1%) | – | – | – | 3 (2%) | – | – | – | 5 (4%) | – | – | – | 4 (11%) | 5 (13%) | 1 (3%) | – |
| Fibrosis | 1 (< 1%) | – | – | – | 25 (12%) | 3 (1%) | – | – | 22 (17%) | 6 (5%) | – | – | 13 (11%) | 2 (2%) | 1 (1%) | – | – | – | – | – |
| Pneumonitis | – | – | – | – | 24 (12%) | 20 (10%) | 1 (< 1%) | – | 5 (4%) | 3 (1%) | – | – | 1 (1%) | 1 (1%) | – | – | – | – | – | – |
| Dysphagia | 2 (1%) | 2 (1%) | 1 (< 1%) | – | 3 (1%) | – | 1 (< 1%) | – | 1 (1%) | 2 (2%) | – | – | 4 (3%) | – | – | – | 10 (26%) | 4 (11%) | 1 (3%) | – |
| Dyspnea | 17 (8%) | 9 (4%) | 1 (< 1%) | – | 27 (13%) | 23 (11%) | 3 (1%) | – | 5 (4%) | 3 (2%) | – | – | 7 (6%) | 6 (5%) | – | – | 10 (26%) | 8 (21%) | 4 (11%) | 2 (5%) |
| Cough | 15 (7%) | 1 (< 1%) | – | – | 35 (17%) | 5 (2%) | – | – | 10 (8%) | 2 (2%) | – | – | 15 (13%) | 2 (2%) | – | – | 10 (26%) | 14 (37%) | 1 (3%) | – |
| Xerostomia | 2 (1%) | – | – | – | 3 (1%) | 1 (< 1%) | – | – | – | – | – | – | 1 (1%) | 1 (1%) | – | – | 11 (29%) | 11 (29%) | – | – |
| Dysphonia | 1 (< 1%) | – | – | – | 1 (< 1%) | – | 1 (< 1%) | – | 2 (2%) | – | – | – | 1 (1%) | – | – | – | 8 (21%) | 4 (11%) | 1 (3%) | – |
RT Radiotherapy, PRO Patient-reported outcome, CTCAE Common Terminology Criteria for Adverse Events