Discontinuation due to adverse events Pivotal studies See Table 14. Table 14: Discontinuations due to adverse events reported in sponsor initiated trials. Trial Number Duration of of due to patients AE in treated treated patients HRT 29 1 year 9 (1985) 200mg daily on days of cycle Kleinstein Luteal 218 10 1 (2002) Support 600mg daily Lorain HRT 20 13 Unknown (1994) 200mg months on days 14-28 of cycle Menstrual 39 10 days 0 (1988) 200mg 19 and 200mg 300mg 20 daily 300mg Luteal Up to 22 60 days Unknown support 600mg (1988) daily Moyer HRT 200mg or 157 >5 79 for (1987) 300mg ‘personal 131 daily on reasons’ 200mg days 26 of cycle 300mg studies These were meta-analyses which were not evaluable for withdrawals due to adverse events.
Discontinuation due to adverse events Pivotal studies See Table 14. Table 14: Discontinuations due to adverse events reported in sponsor initiated trials. Trial Number of patients treated Duration of due to AE in treated patients (1985) HRT 200mg daily on days of cycle 29 1 year 9 Kleinstein (2002) Luteal Support 600mg daily 218 10 1 Lorain (1994) HRT 200mg on days 14-28 of cycle 20 13 months Unknown (1988) Menstrual 200mg and 300mg daily 39 19 200mg 20 300mg 10 days 0 (1988) Luteal support Up to 600mg daily 22 60 days Unknown Moyer (1987) HRT 200mg or 300mg daily on days of cycle 157 131 200mg 26 300mg >5 79 for ‘personal reasons’ studies These were meta-analyses which were not evaluable for withdrawals due to adverse events.
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