Table 2 Summary of treatment-emergent adverse events

TEAEs, n

105

143

145

99

Patients with any TEAEs

41 (85.4)

53 (96.4)

48 (88.9)

40 (70.2)

Patients with drug-related TEAEs

33 (68.8)

50 (90.9)

44 (81.5)

23 (40.4)

Intensity of TEAEs

  Mild

36 (75.0)

46 (83.6)

45 (83.3)

34 (59.6)

  Moderate

5 (10.4)

7 (12.7)

2 (3.7)

6 (10.5)

  Severe

0 (0.0)

0 (0.0)

1 (1.9)

0 (0.0)

TEAEs leading to study drug discontinuation

0 (0.0)

1 (1.8)

0 (0.0)

1 (1.8)

Serious TEAEs (%)

0 (0.0)

1 (1.8)

1 (1.9)

1 (1.8)

TEAEs occurring in ≥ 10% of patients in any group

  Nasopharyngitis

9 (18.8)

4 (7.3)

7 (13.0)

16 (28.1)

  Hot flushes

2 (4.2)

16 (29.1)

21 (38.9)

2 (3.5)

  Irregular uterine bleeding

13 (27.1)

17 (30.9)

15 (27.8)

10 (17.5)

  Heavy menstrual bleeding

6 (12.5)

13 (23.6)

12 (22.2)

4 (7.0)

  Headache

1 (2.1)

8 (14.5)

7 (13.0)

1 (1.8)

  Genital hemorrhage

2 (4.2)

6 (10.9)

6 (11.1)

2 (3.5)

  Menstruation irregular

12 (25.0)

8 (14.5)

3 (5.6)

0 (0.0)