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

Table 4 TEAEs: Two most frequent PTs in each treatment group–number (%) of participants (safety-analysis set)

PT MedDRA version 25.0	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%)
Headache	7 (17.9%)	7 (18.4%)	6 (15.8%)	9 (24.3%)	8 (21.1%)
Activated partial thromboplastin time prolonged	3 (7.7%)	2 (5.3%)	2 (5.3%)	4 (10.8%)	5 (13.2%)
Blood fibrinogen decreased	3 (7.7%)	0	0	1 (2.7%)	3 (7.9%)
COVID-19	3 (7.7%)	2 (5.3%)	0	0	1 (2.6%)
Pyrexia	3 (7.7%)	1 (2.6%)	2 (5.3%)	3 (8.1%)	0
Nasopharyngitis	1 (2.6%)	4 (10.5%)	1 (2.6%)	2 (5.4%)	2 (5.3%)
Hot flush	0	0	0	2 (5.4%)	7 (18.4%)
Nausea	0	1 (2.6%)	5 (13.2%)	1 (2.7%)	2 (5.3%)
Vaccination-site pain	0	4 (10.5%)	0	4 (10.8%)	0

Abbreviations: AE adverse event, BID twice daily, MedDRA Medical Dictionary for Regulatory Activities, PT preferred term, QD once daily, SOC System Organ Class, TEAE treatment-emergent adverse event
AEs were sorted by descending frequency of PTs of the MedDRA classification in the eliapixant 25 mg BID arm. A participant was counted only once within each primary SOC and preferred term

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