Table 5

 Summary of the adverse events reported for all 52 patients who participated in the second year of the study

AssessmentYear 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 event47 (90)
Patients who discontinued the study owing to an adverse event3 (6)
Patients reporting at least 1 clinically relevant serious adverse event6 (12)
Patients reporting at least 1 treatment related* serious adverse event2 (4)
Most frequently reported adverse events (⩾5% of patients)
Upper respiratory tract infections9 (17)
Rhinitis7 (13)
Herpes simplex6 (12)
Influenza-like symptoms5 (10)
Pulmonary infection5 (10)
Antinuclear factor test positive4 (8)
Symptoms associated with infusion4 (8)
Hepatic enzymes increased4 (8)
Bronchitis4 (8)
Headache3 (6)
Fatigue3 (6)
Dry eyes3 (6)
Allergy3 (6)
Accidental injury3 (6)
Alanine aminotransferase increased3 (6)
Menorrhagia†1 (5)
Fungal vaginitis†1 (5)