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Table 5 Safety analyses results using the safety analysis set

From: Evaluating the efficacy and safety of GKT137831 in adults with type 1 diabetes and persistently elevated urinary albumin excretion: a statistical analysis plan

Safety outcome measureValuesPercentage standardized differenceEstimated differencea95% Confidence IntervalaP valuea
Intervention (GKT137831) group (n = xxx)Placebo group (n = xxx)
Treatment-emergent adverse events, n (%)      
Abnormal laboratory analytes, n (%)      
Abnormal physical examination and vital signs, n (%)      
QT corrected electrocardiogram (ECG), mean (SD)      
Treatment-emergent qualitative ECG, n (%)      
Concomitant medications, n (%)      
Systolic blood pressure (mmHg), mean (SD)      
Diastolic blood pressure (mmHg), mean (SD)      
Heart rate (beats per minute), mean (SD)      
Weight (Kg), mean (SD)      
  1. SD standard deviation
  2. a If feasible to carry out testing; in the intervention group compared to the placebo group