Table 3 Adverse events (AEs) occurring for ≥ 5% subjects in any treatment group, regardless of relation to study drug (all-subjects-treated group)

Subjects with any AE (n, %)

84 (70)

91 (82)

20 (69)

26 (84)

Abdominal pain

1 (1)

6 (5)

1 (3)

1 (3)

Upper abdominal pain

6 (5)

2 (2)

–

2 (6)

Nausea

10 (8)

13 (12)

4 (14)

7 (23)

Odynophagia

6 (5)

3 (3)

–

–

Vomiting

11 (9)

11 (10)

–

–

Fatigue

–

–

2 (7)

–

Pyrexia

16 (13)

16 (14)

2 (7)

1 (3)

Sensation of foreign body

7 (6)

4 (4)

–

–

Cardiac anesthetic complication

1 (1)

6 (5)

–

4 (13)

Incision site pain

28 (23)

26 (23)

–

–

Procedural hypotension

–

–

–

5 (16)

Procedural nausea

4 (3)

7 (6)

–

–

Procedural pain

10 (8)

10 (9)

13 (45)

12 (39)

Procedural vomiting

4 (3)

7 (6)

–

–

Wound complication

3 (3)

2 (2)

3 (10)

3 (10)

Dizziness

11 (9)

21 (19)

2 (7)

–

Headache

5 (4)

6 (5)

1 (3)

1 (3)

Insomnia

2 (2)

1 (1)

2 (7)

2 (6)

Vaginal hemorrhage

5 (4)

9 (8)

–

–

Increased upper airway secretion

5 (4)

10 (9)

–

–