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Table 4 Most common TEAEs according to duration of exposure to vismodegib

From: Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study

TEAE Occurring in >20% of Patients, n (%)a

Exposure <12 Months (n = 48)

Exposure ≥12 Months (n = 56)

 

Any Grade

Grade

≥ 3b

Any Grade

Grade

≥ 3b

Any AE

48 (100.0)

27 (56.3)

56 (100.0)

31 (55.4)

Muscle spasms

25 (52.1)

2 (4.2)

49 (87.5)

4 (7.1)

Alopecia

24 (50.0)

NA

45 (80.4)

NA

Dysgeusia

20 (41.7)

NA

38 (67.9)

NA

Weight decreased

18 (37.5)

0

36 (64.3)

9 (16.1)

Fatigue

17 (35.4)

4 (8.3)

28 (50.0)

1 (1.8)

Nausea

11 (22.9)

0

23 (41.1)

0

Decreased appetite

15 (31.3)

2 (4.2)

14 (25.0)

1 (1.8)

Diarrhea

10 (20.8)

0

18 (32.1)

3 (5.4)

Constipation

10 (20.8)

0

10 (17.9)

0

Cough

8 (16.7)

0

12 (21.4)

0

Arthralgia

5 (10.4)

0

12 (21.4)

1 (1.8)

  1. AE adverse event, NA not applicable, TEAE treatment-emergent adverse event
  2. aMedical Dictionary for Regulatory Activities–preferred term
  3. bNCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0