Table 4 Overall summary of AEs, safety analysis set^a

Any AEs, n (%)

4 (18.2)

6 (26.1)

 Allergy to arthropod sting

0

1 (4.3)

 Aphonia

1 (4.5)

0

 Bronchiolitis

0

1 (4.3)

 Colon cancer

1 (4.5)

0

 Cough

1 (4.5)

0

 Dyspnea

0

2 (8.7)

 Edema peripheral

0

1 (4.3)

 Hypertension

1 (4.5)

0

 Pruritus

0

1 (4.3)

Any AEs with an outcome of death, n (%)

0

0

Any serious TEAEs (including events with outcome of death), n (%)

1 (4.5)

0

 Colon cancer

1 (4.5)

0

Any AE leading to discontinuation of study treatment, n (%)

0

1 (4.3)

 Dyspnea

0

1 (4.3)

Any AEs related to study treatment^b, n (%)

1 (4.5)

3 (13.0)

 Aphonia

1 (4.5)

0

 Bronchiolitis

0

1 (4.3)

 Dyspnea

0

1 (4.3)

 Pruritus

0

1 (4.3)

Any serious AEs related to study treatment^b, n (%)

0

0