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Table 3 Treatment-emergent Adverse Events That Occurred in ≥10% of Patients

From: Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results

TEAEa

Patients Treated With Lenvatinib 24 mg Once Daily (N = 26)

Patients with any-grade TEAE, n (%)

26 (100)

Patients with any TEAE ≥ grade 3, n (%)

21 (80.8)

Preferred term, n (%)

Any grade

Grade 3 or 4

Hypertension

22 (84.6)

10 (38.5)

Dysphonia

16 (61.5)

0

Proteinuria

16 (61.5)

3 (11.5)

Palmar-plantar erythrodysesthesia syndrome

15 (57.7)

3 (11.5)

Decreased appetite

14 (53.8)

3 (11.5)

Thrombocytopenia

14 (53.8)

1 (3.8)

Fatigue

13 (50.0)

0

Hypothyroidism

12 (46.2)

0

Peripheral edema

9 (34.6)

0

Constipation

8 (30.8)

0

Decreased weight

8 (30.8)

0

Diarrhea

8 (30.8)

1 (3.8)

Pyrexia

8 (30.8)

0

Anemia

6 (23.1)

3 (11.5)

Cholangitis

6 (23.1)

4 (15.4)

Nausea

6 (23.1)

0

Rash

6 (23.1)

1 (3.8)

Upper abdominal pain

6 (23.1)

0

Malaise

5 (19.2)

0

Ascites

4 (15.4)

2 (7.7)

Cancer pain

4 (15.4)

0

Headache

4 (15.4)

0

Myalgia

4 (15.4)

0

Stomatitis

4 (15.4)

0

Tumor pain

4 (15.4)

0

Alopecia

3 (11.5)

0

Bile duct obstruction

3 (11.5)

2 (7.7)

Delirium

3 (11.5)

0

Epistaxis

3 (11.5)

0

Hypoalbuminemia

3 (11.5)

2 (7.7)

Hypophosphatemia

3 (11.5)

1 (3.8)

Lymphopenia

3 (11.5)

2 (7.7)

Pruritis

3 (11.5)

0

Vomiting

3 (11.5)

0

  1. TEAE treatment-emergent adverse event
  2. aTEAEs were any adverse events that occurred between initiation of treatment and 30 days from last dose