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Table 3 Adverse events: overall summary (safety-analysis set)

From: Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN study

 

Eliapixant 25 mg BID

n = 39 (100%)

Eliapixant 75 mg BID

n = 38 (100%)

Eliapixant 150 mg BID

n = 38 (100%)

Placebo

n = 37 (100%)

Elagolix 150 mg QD

n = 38

(100%)

Any AE

33 (84.6%)

28 (73.7%)

32 (84.2%)

30 (81.1%)

32 (84.2%)

Any SAE

1 (2.6%)

2 (5.3%)

3 (7.9%)

1 (2.7%)

2 (5.3%)

Any AE resulting in death

0

0

0

0

0

Any AE resulting in permanent discontinuation of the study drug

0

1 (2.6%)

1 (2.6%)

2 (5.4%)

1 (2.6%)

Any TEAE

23 (59.0%)

21 (55.3%)

29 (76.3%)

27 (73.0%)

28 (73.7%)

Any drug-related TEAE

4 (10.3%)

6 (15.8%)

10 (26.3%)

10 (27.0%)

13 (34.2%)

Any serious TEAE

0

2 (5.3%)

2 (5.3%)

1 (2.7%)

1 (2.6%)

Any drug-related serious TEAE

0

0

1 (2.6%)

0

1 (2.6%)

Any TEAE resulting in death

0

0

0

0

0

Any TEAE resulting in permanent discontinuation of the study drug

0

1 (2.6%)

1 (2.6%)

2 (5.4%)

1 (2.6%)

  1. Abbreviations: AE adverse event, BID twice daily, QD once daily, SAE serious adverse event, TEAE treatment-emergent adverse event
  2. TEAEs were reported from the start of study intervention to 14 days after the last study medication intake