Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study

Table 1 Numbers of patients included in each analysis set, reasons for study withdrawal, and numbers of patients who completed the study

Analysis set	Placebo	Tofogliflozin
		10 mg	20 mg	40 mg	Total
Target sample size	55	55	55	55	220
Patients enrolled	57	59	60	59	235
SAS*	56	58	58	58	230
Patients excluded from the SAS (did not take the study drug)	1	1	2	1	5
FAS^†	56	57	58	58	229
Patients excluded from the FAS	0	1^§	0	0	1
PPS^‡	54	54	58	56	222
Patients excluded from the PPS	2	3	0	2	7
Administered <75% of the scheduled doses	0	0	0	1	1
Administered the study drug for <8 weeks from the start of treatment	2	2	0	1^§‖	5
Used a prohibited drug during treatment	0	1	0	1^‖	2
Study withdrawals before starting the study drug	1	1	2	1	5
Violated eligibility criteria	0	0	1	0	1
Other protocol violation	0	0	0	1	1
Patient decided to withdraw	0	1	1	0	2
Administrative/other reason	1	0	0	0	1
Study withdrawals after starting the study drug	8	4	1	4	17
Adverse event	1	2	0	3	6
Inadequate efficacy	4	0	0	0	4
Protocol violation	0	1	0	1	2
Patient did not administer the study drug/did not cooperate	2	1	0	0	3
Patient decided to withdraw	0	0	1	0	1
Other reason	1	0	0	0	1
Completers	48	54	57	54	213

*The safety analysis set was defined as all randomized patients who received at least one dose of the study drug.
^†The full analysis set was defined as all randomized patients who received at least one dose of the study drug and had both a baseline value and at least one post baseline value of HbA_1c.
^‡The per-protocol set defined as all randomized patients who completed the trial without a major protocol violation.
^§No post-baseline HbA_1c measurement.
^‖This was the same patient.
Abbreviations: SAS safety analysis set, FAS full analysis set, PPS per-protocol set.

ISSN: 1475-2840