Table 4.
Long-Term Safety During Tadalafil Treatment
| Variable | n (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Entire Period | ≤3M | 4–6M | 7–12M | ≥12M | ||||||
| Number of patients analyzed | 1393 | 1393 | 1086 | 970 | 817 | |||||
| Number of patients experienced ADR | 115 | 90 | 12 | 4 | 3 | |||||
| Incidence (%) (b/a × 100) | 8.3 | 6.5 | 1.1 | 0.4 | 0.4 | |||||
| MedDRA PT*, n (%) | ||||||||||
| Headache | 21 | (1.5) | 19 | (1.4) | 1 | (0.1) | 0 | (0.0) | 0 | (0.0) |
| Dyspepsia | 7 | (0.5) | 5 | (0.4) | 1 | (0.1) | 0 | (0.0) | 0 | (0.0) |
| Spontaneous penile erection | 7 | (0.5) | 5 | (0.4) | 1 | (0.1) | 0 | (0.0) | 0 | (0.0) |
| Palpitations | 5 | (0.4) | 5 | (0.4) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) |
| Diarrhea | 5 | (0.4) | 4 | (0.3) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) |
| Pollakiuria | 5 | (0.4) | 4 | (0.3) | 1 | (0.1) | 0 | (0.0) | 0 | (0.0) |
| Blood pressure decreased | 5 | (0.4) | 5 | (0.4) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) |
| Dizziness | 4 | (0.3) | 2 | (0.1) | 1 | (0.1) | 1 | (0.1) | 0 | (0.0) |
| Vision blurred | 3 | (0.2) | 1 | (0.1) | 1 | (0.1) | 1 | (0.1) | 0 | (0.0) |
| Dysuria | 3 | (0.2) | 2 | (0.1) | 1 | (0.1) | 0 | (0.0) | 0 | (0.0) |
| Malaise | 3 | (0.2) | 3 | (0.2) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) |
| Abdominal discomfort | 2 | (0.1) | 1 | (0.1) | 0 | (0.0) | 0 | (0.0) | 1 | (0.1) |
| Constipation | 2 | (0.1) | 1 | (0.1) | 0 | (0.0) | 0 | (0.0) | 1 | (0.1) |
| Myocardial infarction | 1 | (0.1) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 1 | (0.1) |
Note: *Frequently reported ADRs (≥3 incidence) over an entire period and ADRs reported after 12 months were selected.
Abbreviations: ADRs, adverse drug reactions; M, months; MedDRA, Medical Dictionary for Regulatory Activities version 20.0; PT, preferred term.