Table 4.
Adverse events related to treatment with lenvatinib combined with capecitabine based chemoradiation in locally advanced rectal cancer (N = 20)
| Adverse events | Cohort 1 dose level (N = 5) | Cohort 2 dose level (N = 3) | Cohort 3 dose level (N = 12) | Total | Total grade 3 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCI-CTC grade | NCI-CTC grade | NCI-CTC grade | |||||||||
| 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |||
| Blood and lymphatic system disorder | |||||||||||
| Neutrophil count decreased | 1 | 1 | 0 | ||||||||
| Lymphocyte count decreased | 1 | 1 | 2 | 2 | 1 | 7 | 3 | ||||
| Platelet count decreased | 2 | 2 | 0 | ||||||||
| White blood cell count decreased | 2 | 2 | 0 | ||||||||
| Gastrointestinal disorders | |||||||||||
| Anorexia | 2 | 1 | 3 | 6 | 0 | ||||||
| Buttock pain | 1 | 1 | 0 | ||||||||
| Constipation | 1 | 1 | 2 | 0 | |||||||
| Diarrhea | 1 | 3 | 5 | 9 | 0 | ||||||
| Fecal incontinence | 1 | 1 | 0 | ||||||||
| Nausea | 2 | 3 | 7 | 1 | 13 | 0 | |||||
| Oral pain | 1 | 1 | 0 | ||||||||
| Proctitis | 2 | 2 | 2 | 1 | 7 | 0 | |||||
| Rectal pain | 1 | 1 | 2 | 0 | |||||||
| Vomiting | 2 | 2 | 0 | ||||||||
| Oral dysesthesia | 1 | 1 | 0 | ||||||||
| Other gastrointestinal disorders | 1 | 2 | 2 | 5 | 0 | ||||||
| General disorders and administration site conditions | |||||||||||
| Dry mouth | 1 | 1 | 0 | ||||||||
| Fatigue | 3 | 1 | 2 | 9 | 15 | 0 | |||||
| Injury, poisoning and procedural complications | |||||||||||
| Aspartate aminotransferase increased | 1 | 1 | 0 | ||||||||
| Skin and subcutaneous tissue disorders | |||||||||||
| Palmar plantar erythrodysesthesia syndrome | 1 | 1 | 0 | ||||||||
| Papulopustular rash | 1 | 1 | 0 | ||||||||
| Dermatitis radiation | 2 | 1 | 2 | 1 | 3 | 1 | 10 | 0 | |||
| Pruritis | 3 | 1 | 1 | 5 | 0 | ||||||
| Rash maculo-papular | 1 | 1 | 0 | ||||||||
| Cardiovascular disorders | |||||||||||
| Sinus bradycardia | 1 | 1 | 0 | ||||||||
| Hypertension | 1 | 3 | 3 | 2 | 3 | 12 | 3 | ||||
| Infections and cutaneous | |||||||||||
| Urinary tract infection | 1 | 1 | 0 | ||||||||
| Other infections and infestations | 1 | 1 | 0 | ||||||||
| Miscellaneous | |||||||||||
| Arthralgia | 1 | 1 | 0 | ||||||||
| Creatinine increased | 1 | 1 | 0 | ||||||||
| Headache | 2 | 1 | 3 | ||||||||
| Myalgia | 1 | 1 | 0 | ||||||||
| Urinary frequency | 1 | 1 | 0 | ||||||||
| Urinary incontinence | 1 | 1 | 0 | ||||||||
| Urinary urgency | 1 | 1 | 0 | ||||||||
| Urinary tract pain | 1 | 1 | 2 | 0 | |||||||
| Erectile dysfunction | 1 | 1 | 0 | ||||||||
| Hiccups | 1 | 1 | 0 | ||||||||
| Hoarseness | 3 | 3 | 0 | ||||||||
| Other renal and urinary disorders | 1 | 1 | 0 | ||||||||