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Table 2 Incidence rates of adverse events (AEs) and premature discontinuation.

From: Evaluation of vardenafil for the treatment of subjective tinnitus: a controlled pilot study

 

Vardenafil

(N = 21)

Placebo

(N = 21)

Treatment-emergent AEs

8 (38.1%)

3 (14.3%)

Drug-related AEs

6 (28.5%)

2 (9.5%)

   - Headache

1 (4.75%)

2 (9.5%)

   - Diarrhea

2 (9.5%)

0 (0%)

   - Nasal congestion

2 (9.5%)

0 (0%)

   - Prolonged penile erection

1 (4.75%)

0 (0%)

Serious or fatal AEs

0 (0%)

0 (0%)

Premature discontinuation

5 (23.8%)

2 (9.5%)

   - due to drug-related AEs

4 (19.05%)

1 (4.75%)

   - due to poor compliance

1 (4.75%)

1 (4.75%)

  1. Data are expressed as number and percentage of subjects in both treatment groups.