Table 4.
Reported serious adverse events, selected genital adverse events, and primary safety events
|
End of study |
Censored at 2% PRO2000 gel discontinuation Feb 14, 2008 |
|||||
|---|---|---|---|---|---|---|
| 0·5% PRO2000 (n=3326) | Placebo (n=3325) | 2% PRO2000 (n=2734) | 0·5% PRO2000 (n=2732) | Placebo (n=2722) | ||
| Attended at least one visit after enrolment | 3258 | 3223 | 2571 | 2524 | 2511 | |
| Primary safety events* | 163 | 137 | 92 | 99 | 85 | |
| Woman-years of follow-up | 3349 | 3317 | 1956 | 1929 | 1911 | |
| Primary safety event (first) | 154 | 128 | 88 | 96 | 80 | |
| Incidence† | 4·6 (3·9–5·4) | 3·9 (3·2–4·6) | 4·5 (3·7–5·5) | 5·0 (4·1–6·1) | 4·2 (3·4–5·2) | |
| Hazard ratio | 1·18 (0·93–1·49) | 1 | 1·05 (0·78–1·43) | 1·19 (0·88–1·60) | 1 | |
| p value | 0·17 | .. | 0·74 | 0·26 | .. | |
| Adverse events | ||||||
| Non-menstrual bleeding | 551 (17%) | 527 (16%) | 320 (13%) | 339 (13%) | 318 (13%) | |
| Ulcers (internal) | 32 (1%) | 38 (1%) | 20 (1%) | 22 (1%) | 25 (1%) | |
| Ulcers (external) | 161 (5%) | 157 (5%) | 121 (5%) | 111 (4%) | 116 (5%) | |
| Oedema (internal) | 11 (<1%) | 15 (<1%) | 5 (<1%) | 5 (<1%) | 9 (<1%) | |
| Oedema (external) | 8 (<1%) | 5 (<1%) | 6 (<1%) | 3 (<1%) | 5 (<1%) | |
| Erythema (internal) | 201 (6%) | 201 (6%) | 134 (5%) | 117 (5%) | 122 (5%) | |
| Erythema (external) | 54 (2%) | 35 (1%) | 39 (2%) | 32 (1%) | 29 (1%) | |
| Itching | 349 (11%) | 310 (10%) | 214 (9%) | 247 (10%) | 232 (9%) | |
| Burning | 72 (2%) | 56 (2%) | 52 (2%) | 53 (2%) | 46 (2%) | |
| Other genital events | 379 (12%) | 356 (11%) | 232 (9%) | 241 (10%) | 239 (10%) | |
| Other non-genital events | 685 (21%) | 631 (20%) | 442 (18%) | 435 (17%) | 424 (17%) | |
| Serious adverse events‡ | ||||||
| Deaths | 9 (<1%) | 5 (<1%) | 7 (<1%)§ | 4 (<1%) | 0 | |
| Other serious adverse events | 142 (4%) | 119 (4%) | 86 (3%) | 95 (3%) | 75 (3%) | |
Data are n (%) or n (95% CI). ..=not applicable.
*
Defined as adverse events of grade 3 or more reported any time after enrolment. For women with more than one event, the time-to-event analysis uses the first event only.
†
Per 100 woman-years.
‡
Serious adverse events were death, an immediate threat to life, admission to hospital, disability, congenital abnormality, vaginal oedema with sloughing, profuse non-menstrual bleeding, and cervical or gynaecological cancer.
§
Two additional deaths were reported after Feb 14, 2008.