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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