. 2017 Dec 21;9:1–10. doi: 10.2147/PROM.S122401

Table 3.

FU and treatment-discontinuation rates in Phase III clinical trials and the LONGTERMS extension

Patient disposition		FREEDOMS17	FREEDOMS219	TRANSFORMS18	LONGTERMS 10-year FU31
ITT (n)		425	358	429	3,168
Patients having completed FU (n, %)		369 (87)	272 (76)	398 (93)	2,767 (87)
Patients having discontinued drug (n, %)	Total	80 (19)	116 (32)	44 (10)	401 (13)
Reason for drug discontinuation (n, %)	Adverse events	15 (19)^a	35 (30)^a	16 (36)^a	109 (27)^a
	Abnormal laboratory values	20 (25)^a	25 (21.5)^a	7 (16)^a	40 (10)^a
	Efficacy	8 (10)^a	14 (12)^a	5 (11)^a	73 (18)^a
	Withdrawal of consent	17 (4)	19 (5)	9 (2)	88 (3)
	Lost to FU	6 (1.5)	11 (3)	0	26 (1)

Note:

Of total number of patients having discontinued the study drug.

Abbreviations: FU, follow-up; ITT, intent to treat.