Table 3 Reported adverse events in mITTb population during follow-up.

From: Standardized Brazilian green propolis extract (EPP-AF®) in COVID-19 outcomes: a randomized double-blind placebo-controlled trial

Adverse events (AE)

EPP-AF (n = 98)

Placebo (n = 90)

p valuea

Patients with at least one reported AE

9/98 (9.2%)

2/90 (2.2%)

0.085

Headache

1/98 (1.0%)

0/90 (0%)

1

Nausea

2/98 (2.0%)

0/90 (0%)

0.515

Rash

1/98 (1.0%)

0/90 (0%)

1

Itching

2/98 (2.0%)

0/90 (0%)

0.515

Epigastralgia

2/98 (2.0%)

1/90 (1.1%)

1

Pollakiuria

0/98 (0%)

1/90 (1.1%)

1

Gastroesophageal reflux

1/98 (1.0%)

0/90 (0%)

1

  1. aFisher’s exact test.
  2. bmITT: Modified intention-to-treat population (all randomized patients < 80 years who received propolis or placebo at least one time).