Table 5 Safety analyses results using the safety analysis set
Safety outcome measure | Values | Percentage standardized difference | Estimated differencea | 95% Confidence Intervala | P 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) | ||||||