Table 2.
Overview of adverse events and discontinuations stratified by dose, in 67 double-blind placebo-controlled trials
| Fixed-dose trials |
Flexible-dose trials |
|||||
|---|---|---|---|---|---|---|
| Sildenafil dose |
Modal sildenafil dose* |
|||||
| Adverse events† | 50 mg (N = 804) | 100 mg (N = 1373) | Placebo (N = 1623) | 50 mg (N = 2060) | 100 mg (N = 3479) | Placebo (N = 4979) |
| AE, number of events | ||||||
| All causality | 1101 | 1419 | 769 | 1807 | 2768 | 2491 |
| Treatment-related | 501 | 781 | 181 | 1077 | 1421 | 668 |
| AE, number (%) of patients | ||||||
| All causality | 498 (61.9) | 655 (47.7) | 489 (30.1) | 951 (46.2) | 1549 (44.5) | 1572 (31.6) |
| Severe | 51 (6.3) | 56 (4.1) | 41 (2.5) | 87 (4.2) | 102 (2.9) | 127 (2.6) |
| Serious | 17 (2.1) | 19 (1.4) | 23 (1.4) | 37 (1.8) | 55 (2.6) | 67 (1.3) |
| DC | 14 (1.7) | 20 (1.5) | 19 (1.2) | 50 (2.4) | 27 (0.8) | 49 (1.0) |
| Dose reduction or temporary DC | 20 (2.5) | 18 (1.3) | 17 (1.0) | 118 (5.7) | 59 (1.7) | 68 (1.4) |
| Treatment-related | 295 (36.7) | 436 (31.8) | 136 (8.4) | 655 (32.3) | 885 (25.4) | 480 (9.6) |
| Severe | 21 (2.6) | 19 (1.4) | 6 (0.4) | 35 (1.7) | 29 (0.8) | 19 (0.4) |
| Serious | 1 (0.1) | 1 (0.1) | 1 (0.1) | 3 (0.1) | 5 (0.1) | 3 (0.1) |
| DC | 8 (1.0) | 10 (0.7) | 7 (0.4) | 28 (1.4) | 10 (0.3) | 18 (0.4) |
| Dose reductions or temporary DC | 1 (0.1) | 8 (0.6) | 1 (0.1) | 102 (5.0) | 29 (0.8) | 32 (0.6) |
AE, adverse event; DC, discontinuation.
Modal dose: dose the patient was exposed to the longest during the study period. If the duration was the same for two different doses, the higher dose was selected as the modal dose of the patient.
An event was categorised according to investigator judgment as severe if it interrupted daily activity and required systemic drug therapy or other medical treatment. A serious adverse event was defined as any untoward medical occurrence that resulted in death, was life threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, or resulted in a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Listed are DCs, dose reductions and temporary DCs that were caused by an AE.