Created at	Source	Raw Value	Validated value
June 25, 2024, noon	usa	* participant had fulminant hepatic failure at screening * participant had end stage renal disease at screening * participant had a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection * participant was concurrently participating in another clinical trial for an investigational product or device at screening	* participant had fulminant hepatic failure at screening * participant had end stage renal disease at screening * participant had a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection * participant was concurrently participating in another clinical trial for an investigational product or device at screening
July 28, 2022, 3 p.m.	usa	participant had fulminant hepatic failure at screening participant had end stage renal disease at screening participant had a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection participant was concurrently participating in another clinical trial for an investigational product or device at screening	participant had fulminant hepatic failure at screening participant had end stage renal disease at screening participant had a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection participant was concurrently participating in another clinical trial for an investigational product or device at screening
Oct. 26, 2020, 11:31 p.m.	usa	- participant has fulminant hepatic failure at screening - participant has end stage renal disease at screening - participant has a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection - be concurrently participating in another clinical trial for an investigational product or device at screening	- participant has fulminant hepatic failure at screening - participant has end stage renal disease at screening - participant has a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection - be concurrently participating in another clinical trial for an investigational product or device at screening