Skip to main content

Advertisement

Table 7 Adverse events (ITT)

From: Brazilian multicenter study for the evaluation of patients’ satisfaction of blood glucose self-monitoring with BGStar® blood glucose meter in insulinized patients with diabetes mellitus type 1 and 2

  N. of patients (%) N. of events
N. (%) of patients with any AE 10 (3.4 %) 13
SAE 1 (0.3 %) 1
Criterion for SAE
Life-threatening 1 (0.3 %) 1
Intensity
Mild 8 (2.7 %) 11
Moderate 1 (0.3 %) 1
Severe 1 (0.3 %) 1
Treatment/corrective therapy
No 8 (2.7 %) 11
Yes 2 (0.7 %) 2
Related with investigation BGM technical complaint
Yes (serious) 1 (0.3 %) 1
N. of patients without any AE 282 (96.6 %)  
Total of available patients 292 (100 %)  
  1. AE adverse event; SAE serious adverse eventa