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Table 5 Adverse events

From: Improved home BP profile with dapagliflozin is associated with amelioration of albuminuria in Japanese patients with diabetic nephropathy: the Yokohama add-on inhibitory efficacy of dapagliflozin on albuminuria in Japanese patients with type 2 diabetes study (Y-AIDA study)

Event

Grade 1

Grade 2

Grade 3

Special interest categories

 Hypoglycemia

6 (7.1%)

2 (2.4%)

0 (0.0%)

 Volume depletion

2 (2.4%)

0 (0.0%)

0 (0.0%)

 Urinary tract/genital infection

0 (0.0%)

1 (1.2%)

0 (0.0%)

 Cutaneous symptom

0 (0.0%)

0 (0.0%)

0 (0.0%)

Others

 Cold

2 (2.4%)

4 (4.7%)

0 (0.0%)

 Influenza

0 (0.0%)

3 (3.5%)

0 (0.0%)

 Pollenosis

1 (1.2%)

2 (2.4%)

0 (0.0%)

 Hypertension

0 (0.0%)

2 (2.4%)

0 (0.0%)

 Angina pectoris

0 (0.0%)

0 (0.0%)

1 (1.2%)

 Cataract

0 (0.0%)

0 (0.0%)

1 (1.2%)

 Retinal detachment

0 (0.0%)

0 (0.0%)

1 (1.2%)

 Vitreous surgery due to retinopathy

0 (0.0%)

0 (0.0%)

1 (1.2%)

 Cough variant asthma

0 (0.0%)

1 (1.2%)

0 (0.0%)

 Elevated LDL

0 (0.0%)

1 (1.2%)

0 (0.0%)

 Fever

0 (0.0%)

1 (1.2%)

0 (0.0%)

 Fracture

0 (0.0%)

1 (1.2%)

0 (0.0%)

 Hemorrhagic stool

0 (0.0%)

1 (1.2%)

0 (0.0%)

 Hordeolum

0 (0.0%)

1 (1.2%)

0 (0.0%)

 Prostatitis

0 (0.0%)

1 (1.2%)

0 (0.0%)

 Elevated CK

1 (1.2%)

0 (0.0%)

0 (0.0%)

 Nausea

1 (1.2%)

0 (0.0%)

0 (0.0%)

 Odontectomy

1 (1.2%)

0 (0.0%)

0 (0.0%)

 Pruritus

1 (1.2%)

0 (0.0%)

0 (0.0%)

 Thamuria

1 (1.2%)

0 (0.0%)

0 (0.0%)

 Wobbliness

1 (1.2%)

0 (0.0%)

0 (0.0%)

  1. Values are n (%)
  2. Evaluation of adverse events (AEs) was performed based on Common Terminology Criteria for Adverse Event version 4.0. Grade 1: mild (no need for therapeutic intervention); Grade 2: moderate (needs therapeutic intervention in outpatient clinic); Grade 3: severe (needs therapeutic intervention by admission); Grade 4: life threatening, or places the participant, in the view of the investigator, at immediate risk of death from the experience as it occurred; Grade 5: death. AEs of Grade 4 or 5 were not reported
  3. LDL low-density lipoprotein cholesterol, CK creatine kinase