Table 4. Summary of non-serious adverse events reported by ≥ 20% of patients (full analysis set).
| Preferred Term | PIS (N = 51) n (%) | RPT (N = 77) n (%) | Total (N = 128) n (%) |
|---|---|---|---|
| Nausea | 37 (72.5) | 50 (64.9) | 87 (68.0) |
| Fatigue | 33 (64.7) | 47 (61.0) | 80 (62.5) |
| Neuropathy peripheral | 28 (54.9) | 52 (67.5) | 80 (62.5) |
| Diarrhea | 28 (54.9) | 44 (57.1) | 72 (56.3) |
| Constipation | 26 (51.0) | 26 (33.8) | 52 (40.6) |
| Abdominal pain | 14 (27.5) | 30 (39.0) | 44 (34.4) |
| Palmar-plantar erythrodysaesthesia syndrome | 14 (27.5) | 24 (31.2) | 38 (29.7) |
| Vomiting | 14 (27.5) | 26 (33.8) | 40 (31.3) |
| Neutropenia | 15 (29.4) | 18 (23.4) | 33 (25.8) |
| Mucosal inflammation | 14 (27.5) | 17 (22.1) | 31 (24.2) |
| Epistaxis | 9 (17.6) | 21 (27.3) | 30 (23.4) |
| Decreased appetite | 16 (31.4) | 12 (15.6) | 28 (21.9) |
| Gastroesophageal reflux disease | 15 (29.4) | 12 (15.6) | 27 (21.1) |
| Paraesthesia | 10 (19.6) | 16 (20.8) | 26 (20.3) |
| Alopecia | 7 (13.7) | 19 (24.7) | 26 (20.3) |
Abbreviations: NLR = neutrophil/lymphocyte ratio; PIS = primary in situ tumor; RPT = resected primary tumor. The denominator for percentages is the number of patients in the FAS for each Primary Intact or Resected group. Sorted in descending order of frequency based on the total column. Note: This table contains counts of subjects. If a subject experienced more than one episode of an adverse event, the subject is counted only once within a preferred term.