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Table 3 Most common (≥2%) treatment-emergent adverse events by treatment group (safety population), severity, and study discontinuation

From: Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting from chronic anal fissure: a randomized, double-blind, placebo-controlled study

TEAEs

NTG 0.4%

Placebo

n (%)

(n = 123)

(n = 124)

Number of patients with ≥1 AE

96 (78.0)

67 (54.0)

  Mild

31 (25.2)

15 (12.1)

  Moderate

41 (33.3)

38 (30.6)

  Severe

24 (19.5)

14 (11.3)

Headaches

86 (69.9)

59 (47.6)

Dizziness

6 (4.9)

2 (1.6)

Diarrhea

4 (3.3)

4 (3.2)

Nausea

2 (1.6)

5 (4.0)

Sinusitis

3 (2.4)

1 (0.8)

AEs leading to study discontinuation

9 (7.3)

4 (3.2)

  Headache

7 (5.7)

1 (0.8)

  Palpitations

1 (0.8)

0

  Celiac disease

0

1 (0.8)

  Diarrhea

0

1 (0.8)

  Skin fissures

1 (0.8)

0

  Pain of skin

0

1 (0.8)

  1. Abbreviation: AE Adverse event, TEAE Treatment-emergent adverse event.