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Table 4 Summary of adverse events and adverse drug reactions (Safety population)

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

  Placebo Tofogliflozin
   10 mg 20 mg 40 mg
n 56 58 58 58
Number of patients with AEs 25 (44.6%) 35 (60.3%) 31 (53.4%) 31 (53.4%)
Number of AEs 40 80 62 69
Number of patients with ADRs 4 (7.1%) 16 (27.6%) 15 (25.9%) 16 (27.6%)
Number of ADRs 6 24 26 24
Deaths 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Serious AEs 2 (3.6%)* 2 (3.4%)† 0 (0.0%) 3 (5.2%)‡
Serious ADRs 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (1.7%)§
AEs leading to discontinuation 1 (1.8%) 1 (1.7%) 0 (0.0%) 2 (3.4%)
ADRs leading to discontinuation 0 (0.0%) 1 (1.7%) 0 (0.0%) 1 (1.7%)
AEs occurring in more than ≥5% of patients in any treatment groups  
Infections and infestations     
  Nasopharyngitis 12 (21.4%) 9 (15.5%) 6 (10.3%) 6 (10.3%)
  Upper respiratory tract infection 1 (1.8%) 0 (0.0%) 3 (5.2%) 2 (3.4%)
Investigations     
  Hyperketonemia 1 (1.8%) 2 (3.4%) 7 (12.1%) 8 (13.8%)
  Ketonuria 0 (0.0%) 1 (1.7%) 3 (5.2%) 0 (0.0%)
  Increased urinary β-2 microglobulin 1 (1.8%) 3 (5.2%) 0 (0.0%) 0 (0.0%)
Renal and urinary disorders     
  Pollakiuria 1 (1.8%) 3 (5.2%) 4 (6.9%) 6 (10.3%)
Musculoskeletal and connective tissue disorders     
  Back pain 3 (5.4%) 3 (5.2%) 2 (3.4%) 1 (1.7%)
Nervous system disorders     
  Headache 0 (0.0%) 3 (5.2%) 0 (0.0%) 1 (1.7%)
Other events of special interest in <5% of patients  
  Genitourinary infections     
   Cystitis 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (1.7)
   Vulvitis 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (1.7)
  Hypoglycemia 0 (0.0%) 1 (1.7) 0 (0.0%) 1 (1.7)
  Increased urine volume 0 (0.0%) 0 (0.0%) 1 (1.7) 1 (1.7)
  Volume-related events     
   Orthostatic hypotension 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (1.7)
   Dizziness 1 (1.8%) 2 (3.4%) 0 (0.0%) 0 (0.0%)
   Postural dizziness 0 (0.0%) 1 (1.7) 1 (1.7) 0 (0.0%)
  1. *Fibular fracture in one patient; colon and esophageal cancer in one patient.
  2. Meniscus disorder in one patient; unconsciousness in one patient.
  3. Myocardial ischemia in one patient; gastrointestinal interstitial cancer in one patient; whiplash and contusion in one patient.
  4. §Myocardial ischemia in one patient.
  5. Abbreviations: AE Adverse event, ADR Adverse drug reaction.