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Table 6 TEAEs occurring in 2 or more patients during the main study, n (%) (Safety Population)

From: Randomized, active-controlled, comparative phase 3 efficacy and safety equivalence trial of Ovaleap® (recombinant human follicle-stimulating hormone) in infertile women using assisted reproduction technology (ART)

Symptom Ovaleap® (n = 153) Gonal-f® (n = 146) Total (N = 299)
OHSS 7 (4.6) 4 (2.7) 11 (3.7)*
Abdominal pain 5 (3.3) 1 (0.7) 6 (2.0)
Abortion missed 0 3 (2.1) 3 (1.0)
Ectopic pregnancy 2 (1.3) 1 (0.7) 3 (1.0)**
Nasopharyngitis 1 (0.7) 2 (1.4) 3 (1.0)
Nausea 2 (1.3) 1 (0.7) 3 (1.0)
Antepartum hemorrhage 1 (0.7) 1 (0.7) 2 (0.7)
Headache 2 (1.3) 0 2 (0.7)
  1. OHSS, ovarian hyperstimulation syndrome; TEAEs, treatment-emergent adverse events
  2. *P = 0.54
  3. **P = 1.0