TABLE 3.

Incidence of LSRs and adverse events during study period

Reaction or eventNo. (%) of subjects
0.25Resi2x (n = 6)0.05Resi3x (n = 6)0.05Resi2x (n = 12)a0.01Resi3x (n = 7)Vehicle (n = 10)b
LSRs
    Erythema6 (100)6 (100)9 (75)4 (57)6 (60)
    Edema02 (33)1 (8)00
    Induration6 (100)4 (67)4 (33)1 (14)0
    Vesiclesc5 (83)6 (100)7 (58)3 (43)7 (70)
    Erosions2 (33)2 (33)000
    Ulcerations01 (17)000
    Excoriation5 (83)3 (50)001 (10)
    Scabbing6 (100)4 (67)1 (8)1 (14)1 (10)
Adverse eventsd
    Pruritis at biopsy site01 (17)1 (8)02 (20)
    Burning sensation at dose site2 (33)0000
    Erythema due to tape irritation02 (33)3 (25)04 (40)
    Pruritis at dose site5 (83)3 (50)4 (33)00
    Diaphoresis1 (17)001 (14)0
    Vasovagal episode01 (17)1 (8)00
    Chills1 (17)0001 (10)
    Fever6 (100)5 (83)9 (75)5 (71)8 (80)
    Tiredness02 (33)2 (17)01 (10)
    Headache2 (33)2 (33)2 (17)2 (29)0
    Arthralgia2 (33)1 (17)000
    Myalgia1 (17)2 (33)01 (14)0
    Pain at biopsy site002 (17)01 (10)
    Drowsiness0001 (14)1 (10)
    Neutropenia3 (50)001 (14)0
  • a Includes resiquimod-treated subjects from both cohorts assigned to 0.05Resi2x.

  • b Data for vehicle-treated subjects from each cohort are pooled.

  • c Papules were included in this category by the assessing investigative staff.

  • d Only adverse events present in more than one subject are listed.