Table 2.
Adverse Events Occurring in ≥2% of Patients (Full Analysis Set, n = 1631) During Treatment.a
| MedDRA Preferred Term | n (%) |
|---|---|
| At least 1 adverse event | 1007 (61.7) |
| Headache | 155 (9.5) |
| Application-site reaction | 139 (8.5) |
| Nasopharyngitis | 114 (7.0) |
| Cervical dysplasiab | 101 (6.2) |
| Application-site erythema | 80 (4.9) |
| Metrorrhagia | 73 (4.5) |
| Application-site pruritus | 64 (3.9) |
| Application-site hypersensitivity | 59 (3.6) |
| Application-site rash | 56 (3.4) |
| Vulvovaginal mycotic infection | 46 (2.8) |
| Cystitis | 43 (2.6) |
| Breast pain | 43 (2.6) |
| Dysmenorrhea | 41 (2.5) |
| Application-site irritation | 39 (2.4) |
| Bronchitis | 38 (2.3) |
| Tonsillitis | 37 (2.3) |
| Nausea | 36 (2.2) |
| Influenza | 34 (2.1) |
| Urinary tract infection | 33 (2.0) |
Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities.
a Participants may have experienced more than one adverse event.
b Abnormal cervical smears had to be reported by the investigators as adverse events. These events included the category “atypical squamous cells of undetermined significance,” for which there is no immediate risk of cancer.