Imiquimod 3.75% Cream Applied Daily to Treat Anogenital Warts: Combined Results from Women in Two Randomized, Placebo-Controlled Studies
Table 3
Summary of safety by treatment group, evaluation period, all women.
Women
Placebo
Imiquimod 2.5%
Imiquimod 3.75%
106
211a
217a
Adverse events (AEs)b, (%)
Any AEc
39 (36.8)
88 (41.7)
85 (39.2)
Any serious
1 (0.9)
2 (0.9)
5 (2.3)
Any resulting in study discontinuation
1 (0.9)
3 (1.4)
5 (2.3)
Any severe grade
4 (3.8)
15 (7.1)
11 (5.1)
Any treatment-related AEd
4 (3.8)
41 (19.4)
42 (19.4)
Any resulting in study discontinuation
0 (0)
3 (1.4)
3 (1.4)
Application site reactions (ASRs), (%)
Any ASRc
4 (3.8)
39 (18.5)
38 (17.5)
Any severe
1 (0.9)
9 (4.3)
6 (2.8)
Treatment-related AEs in >1% women for imiquimod 3.75% that were more frequent than in placebo, (%)b,d
Application site pain
0 (0)
11 (5.2)
17 (7.8)
Application site irritation
1 (0.9)
11 (5.2)
12 (5.5)
Application site pruritus
2 (1.9)
14 (6.6)
7 (3.2)
Application site bleeding
1 (0.9)
1 (0.5)
3 (1.4)
Application site discharge
0 (0)
1 (0.5)
3 (1.4)
Application site erythema
0 (0)
3 (1.4)
3 (1.4)
Rest periods
At least 1 rest period, (%)
3 (2.8)
70 (33.2)
77 (35.5)
Dosing days missed due to rest, mean days (standard deviation)e
6.7 (4.7)
9.1 (7.2)
8.9 (7.2)
aOne woman assigned to imiquimod 2.5% received 3.75%. Displayed here based on treatment received.
bAdverse events reported from start of treatment to 30 days after study.
cBy preferred terms, regardless of causality assessment.
dInvestigator assessed causality of related or probably related.
eFor those women who took a rest.
