Table 4.
Summary of adverse events occurring in each group during treatment
| AE | LOX-T group (n = 91) | LOX-O group (n = 91) | p value |
|---|---|---|---|
| n (%) | n (%) | ||
| Any AEs | 13 (14.3%) | 20 (22.0%) | 0.178 |
| Drug-related AEsa | 7 (7.7%) | 14 (15.4%) | 0.178 |
| Gastrointestinal disorders | 5 (5.5%) | 7 (7.7%) | |
| Abdominal discomfort | 4 (4.4%) | 3 (3.3%) | |
| Abdominal pain | 1 (1.1%) | 1 (1.1%) | |
| Diarrhea | 0 (0.0%) | 3 (3.3%) | |
| Oral pain | 0 (0.0%) | 1 (1.1%) | |
| Infections | 3 (3.3%) | 3 (3.3%) | |
| Rhinopharyngitis | 2 (2.2%) | 1 (1.1%) | |
| Upper respiratory tract infection | 1 (1.1%) | 2 (2.2%) | |
| General disorders and administration site conditions | 2 (2.2%) | 0 (0.0%) | |
| Discomfort | 1 (1.1%) | 0 (0.0%) | |
| Inflammation | 1 (1.1%) | 0 (0.0%) | |
| Skin or subcutaneous disorders | 2 (2.2%) | 3 (3.3%) | |
| Erythema | 2 (2.2%) | 1 (1.1%) | |
| Pruritus | 1 (1.1%) | 1 (1.1%) | |
| Hidrosis | 0 (0.0%) | 1 (1.1%) | |
| Cardiac system disorders | 1 (1.1%) | 1 (1.1%) | |
| Tachycardia | 1 (1.1%) | 0 (0.0%) | |
| Palpitation | 0 (0.0%) | 1 (1.1%) | |
| Musculoskeletal/connective tissue diseases | 1 (1.1%) | 1 (1.1%) | |
| Muscle fatigue | 1 (1.1%) | 0 (0.0%) | |
| Ostealgia | 0 (0.0%) | 1 (1.1%) | |
| Mental disorders | 1 (1.1%) | 0 (0.0%) | |
| Insomnia | 1 (1.1%) | 0 (0.0%) | |
| Respiratory system disorders | 1 (1.1%) | 1 (1.1%) | |
| Cough | 1 (1.1%) | 1 (1.1%) | |
| Laboratory tests | 0 (0.0%) | 4 (4.4%) | |
| Decreased Hb | 0 (0.0%) | 1 (1.1%) | |
| Hepatic dysfunction | 0 (0.0%) | 1 (1.1%) | |
| Decreased platelet count | 0 (0.0%) | 1 (1.1%) | |
| Decreased WBC count | 0 (0.0%) | 2 (2.2%) | |
| Elevated WBC count | 0 (0.0%) | 1 (1.1%) | |
| Metabolic or nutrition-related disorder | 0 (0.0%) | 1 (1.1%) | |
| Reduced appetite | 0 (0.0%) | 1 (1.1%) | |
| Nervous system disorders | 0 (0.0%) | 1 (1.1%) | |
| Dizziness | 0 (0.0%) | 1 (1.1%) | |
| Genital system disorder | 0 (0.0%) | 1 (1.1%) | |
| Menstrual disorder | 0 (0.0%) | 1 (1.1%) |
AEs were reported according to the Medical Dictionary for Regulatory Activities (MedDRA) Version 14.1
aDrug-related AEs were determined by the investigator to be definitely, probably, or possibly medication related, and unknown relationship with medication. Patients were counted once for each unique AE and may have had more than one unique AE. p value was evaluated using the Fisher’s exact model. a: local AEs under and around patch. b: diffuse symptom at whole body