Efficacy and Safety of a New Formulation of Pancrelipase (Ultrase MT20) in the Treatment of Malabsorption in Exocrine Pancreatic Insufficiency in Cystic Fibrosis

Table 1

Baseline characteristics of study patients.

	Safety population	mITT population
	𝑁=31	𝑁=24
Age (years)	19.6±6.6	19.1±5.9
Gender, 𝑛 (%)
Male	20 (64.5)	15 (62.5)
Female	11 (35.5)	9 (37.5)
Race, 𝑛 (%)
Caucasian	29 (93.5)	23 (95.8)
Black	2 (6.5)	1 (4.2)
Weight (kg)	55.6±11.6	55.0±9.6
BMI (kg/m^2)	20.4±2.2	20.1±1.9
Fecal elastase-1, 𝑛 (%)
<15 (𝜇g/g of stool)	30 (96.8)	23 (95.8)
=34 (𝜇g/g of stool)	1 (3.2)	1 (4.2)

Values are mean ±1standard deviation, unless otherwise noted. BMI: body mass index; mITT: modified Intent-To-Treat (patients completing both treatment periods).