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Table 3 Treatment-emergent adverse events occurring in ≥5 % after goserelin, XM17 or Gonal-f®

From: Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f® in healthy women after follicle-stimulating hormone downregulation

Event term Goserelin XM17 Gonal-f®
(n = 39) (n = 36) (n = 36)
x (y, z %) x (y, z %) x (y, z %)
Overall 26 (17, 43.6 %) 43 (25, 69.4 %) 42 (20, 55.6 %)
Headache 11 (10, 25.6 %) 15 (14, 38.9 %) 14 (11, 30.6 %)
Hot flushes 5 (5, 13.9 %) 5 (5, 13.9 %)
Abdominal pain, lower 1 (1, 2.8 %) 3 (3, 8.3 %)
Nausea 2 (2, 5.6 %) 2 (2, 5.6 %)
Dizziness 2 (2, 5.1 %) 2 (2, 5.6 %) 2 (2, 5.6 %)
Metrorrhagia 2 (2, 5.6 %) 1 (1, 2.8 %)
Dysgeusia 1 (1, 2.8 %) 2 (2, 5.6 %)
Rash 1 (1, 2.8 %) 2 (2, 5.6 %)
Injection site pain 2 (2, 5.6 %)a
Abdominal pain 2 (2, 5.1 %) 1 (1, 2.8 %) 1 (1, 2.8 %)
Breast pain 2 (2, 5.1 %)
Oropharyngeal pain 2 (2, 5.1 %) 1 (1, 2.8 %)
  1. aThese AEs occurred immediately upon injection/drug administration and lasted only one minute each and thus were included in the AE assessment but not the first local tolerability assessment (1 h post-dose). Abbreviation: x (y, z %) = number of events (number of participants, percent by treatment)