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) |