Summary of the adverse events reported for all 52 patients who participated in the second year of the study
| Assessment | Year 2 study group (n = 52) No (%) |
|---|---|
| *The determination of an event’s relationship to treatment was made by the investigator; †percentage is based on the population of women only. | |
| Patients reporting at least 1 adverse event | 47 (90) |
| Patients who discontinued the study owing to an adverse event | 3 (6) |
| Patients reporting at least 1 clinically relevant serious adverse event | 6 (12) |
| Patients reporting at least 1 treatment related* serious adverse event | 2 (4) |
| Most frequently reported adverse events (⩾5% of patients) | |
| Upper respiratory tract infections | 9 (17) |
| Rhinitis | 7 (13) |
| Herpes simplex | 6 (12) |
| Influenza-like symptoms | 5 (10) |
| Pulmonary infection | 5 (10) |
| Antinuclear factor test positive | 4 (8) |
| Symptoms associated with infusion | 4 (8) |
| Hepatic enzymes increased | 4 (8) |
| Bronchitis | 4 (8) |
| Headache | 3 (6) |
| Fatigue | 3 (6) |
| Dry eyes | 3 (6) |
| Allergy | 3 (6) |
| Accidental injury | 3 (6) |
| Alanine aminotransferase increased | 3 (6) |
| Menorrhagia† | 1 (5) |
| Fungal vaginitis† | 1 (5) |