. Author manuscript; available in PMC: 2021 Jul 6.

Published in final edited form as: Stat Med. 2020 Feb 12;39(10):1541–1557. doi: 10.1002/sim.8495

TABLE 3.

AEs of Grade 1 or higher for NIDA-CSP-999

SOC	AE	1 mg (185)	8 mg (188)	Raw p	MiST	new DFDR
BODY AS A WHOLE	FLU SYND (13)	6 (3.2)	23 (12.2)	0.00086	NS	NS
BODY AS A WHOLE	PAIN BACK (26)	18 (9.7)	32 (17.0)	0.0330	NS	NS
DIGESTIVE SYSTEM	CONSTIP (43)	12 (6.5)	26 (13.8)	0.0164	NS	NS
DIGESTIVE SYSTEM	DIARRHEA (44)	19 (10.3)	8 (4.3)	0.0441	NS	NS
DIGESTIVE SYSTEM	NAUSEA (57)	13 (7.0)	27 (14.4)	0.0190	NS	NS

Abbreviations: AE, adverse event; DFDR, double false discovery rate; SOC, system organ class.