Table 3 Numbers of patients (%) receiving sildenafil and placebo who experienced adverse events during the 8-week study period (all-cause and treatment-related events)a

From: A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea

  Sildenafil group (n=66) Placebo group (n=67)
Adverse event All-cause b Treatment related c All-cause b Treatment related c
All adverse events 46 (69.7%) 37 (56.1%) 25 (27.3%) 14 (20.9%)
Cardiovascular events (total) 21 (31.8%) 21 (31.8%) 3 (4.5%) 3 (4.5%)
 Flushing 21 (31.8%) 21 (31.8%) 3 (4.5%) 3 (4.5%)
Body as a whole events (total) 21 (31.8%) 18 (27.3%) 9 (13.4%) 8 (11.9%)
 Headache 17 (25.8%) 15 (22.7%) 6 (9.0%) 6 (9.0%)
Respiratory system events (total) 5 (7.6%) 3 (4.5%) 3 (4.5%) 0
 Upper respiratory tract infection 3 (4.5%) 0 3 (4.5%) 0
 Nasal congestion 3 (4.5%) 3 (4.5%) 1 (1.5%) 1 (1.5%)
Digestive system events (total) 8 (12.1%) 2 (3.0%) 9 (13.4%) 3 (4.5%)
 Dyspepsia 3 (4.5%) 1 (1.5%) 5 (7.5%) 2 (3.0%)
Special senses events (total) 10 (15.2%) 9 (13.6%) 3 (4.5%) 1 (1.5%)
 Abnormalities in colour vision 4 (6.1%) 4 (6.1%) 0 0
 Abnormal vision 3 (4.5%) 3 (4.5%) 1 (1.5%) 1 (1.5%)
  1. aAdverse events occurring in at least three patients (all-causality) are shown. The classification of adverse events is in accordance with the Coding Symbol Thesaurus of Adverse Reaction Terms (COSTART) system.
  2. bAdverse events recorded regardless of a suspected relationship to the study medication.
  3. cAdverse events judged by the investigator to be treatment-related.