Itraconazole

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Bar-Oz, 2000	prospective cohort	Details (timing and dose) of maternal drug therapy were reported by the treating physician.	Pregnancy outcome reports were sent to the manufacturer by the treating physician.	Subjects were matched for maternal age (within 2 years), last menstrual period (within 6 months), gravidity, parity, and alcohol and smoking status.
De Santis, 2009	prospective cohort	A structured questionnaire used to collect information about maternal medical features and details of itraconazole therapy (dosage and timing).	A structured questionnaire administered to women by telephone to collect information about major congenital anomalies (presence and type), delivery (gestational age and type), birth weight and neonatal complications using .	Groups were matched according to maternal age, gravidity and parity, cigarette smoking, alcohol and illicit drug consumption.
Jick, 1999	retrospective cohort (claims database)	General Practice Research Database of prescription.	Computer record was reviewed to identify indications of a congenital anomaly. For those with a suspected anomaly, we requested relevant clinical records from the general practitioner.	Age- and practice-matched women.
Molgaard-Nielsen, 2013	population based cohort retrospective	Prescriptions for oral fluconazole that were filled by the women during pregnancy was obtained from the National Prescription Registry.	Cases of major birth defects were identified through the National Patient Register.	The covariates included calendar year; demographic characteristics; socioeconomic variables; and status with respect to smoking, previous births with malformation, selected coexisting conditions, and treatment with oral antibiotic agents, immunosuppres- sive agents, oral corticosteroids, antiepileptic agents, oral contraceptives, or drugs for in vitro fertilization
Molgaard-Nielsen (Controls exposed to pivmecillinam), 2016	population based cohort retrospective	Information on prescriptions for oral fluconazole (a prescription-only drug) was obtained from the National Prescription Register.	The Medical Birth Register and the National Patient Register.	No match/adjustment for this group of comparison.
Molgaard-Nielsen (Controls unexposed, NOS), 2016	population based cohort retrospective	Information on prescriptions for oral fluconazole (a prescription-only drug) was obtained from the National Prescription Register.	The Medical Birth Register and the National Patient Register.	Each exposed pregnancy was matched to up to 4 unexposed control pregnancies based on propensity scores, maternal age (5-year categories), calendar year, and gestational age.

master protocol