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

From: 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

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
  1. *The safety analysis set was defined as all randomized patients who received at least one dose of the study drug.
  2. 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 HbA1c.
  3. The per-protocol set defined as all randomized patients who completed the trial without a major protocol violation.
  4. §No post-baseline HbA1c measurement.
  5. This was the same patient.
  6. Abbreviations: SAS safety analysis set, FAS full analysis set, PPS per-protocol set.