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Table 1 Patient Demographic and Clinical Characteristics: Phase I, Qualitative

From: Development and validation of the Crohn’s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary

Demographic and Clinical Characteristics Total (n = 49)
Age
 Mean (SD) 43.3 (15.43)
 Range (19–72)
Gender, n (%)
 Male 15 (30.6%)
 Female 34 (69.4%)
Ethnicity, n (%)
 Hispanic or Latino 2 (4.1%)
 Not Hispanic or Latino 46 (93.9%)
 Missing 1 (2.0%)
Race,a n (%)
 American Indian or Alaska Native 0 (0.0%)
 Asian 1 (2.0%)
 Black or African American 5 (10.2%)
 Native Hawaiian or other Pacific Islander 0 (0.0%)
 White 40 (81.6%)
 Other 3 (6.1%)
SeCDAI score
 Mean (SD) 470.8 (262.82)
 Range (42–1078)
 Remission (< 150) 5 (10.2%)
 Mild (150–220) 3 (6.1%)
 Moderate (≥ 220) 41 (83.7%)
Extent of disease, n (%)
 Affecting only the colon (large intestine) 14 (28.6%)
 Affecting only the lower small intestine (ileum and jejunum) 6 (12.2%)
 Affecting only the upper GI tract (stomach, esophagus, and duodenum) 0 (0.0%)
 Affecting the colon (large intestine) and lower small intestine 22 (44.9%)
 Affecting the lower small intestine and upper GI tract 3 (6.1%)
 Affecting the colon (large intestine), and the lower small intestine, and the upper GI tract (stomach, esophagus, and duodenum) 4 (8.2%)
Disease location,b n (%)
 L1, ileal only 4 (13%)
 L2, colonic only 13 (43%)
 L3, ileocolonic 12 (40%)
 L4, isolated upper disease
 Missing 1 (3%)
Disease behavior,b,c n (%)
 B1, non-stricturing non-penetrating 14 (47%)
 B2, stricturine 11 (37%)
 B3, penetrating (not including abscess) 6 (20%)
  1. Note: Percents may not add to 100 due to rounding
  2. aNot mutually exclusive
  3. bData were only collected for additional concept elicitation and cognitive interview (n = 30)
  4. cResponses are not mutually exclusive
  5. Abbreviations: n Number, SD Standard deviation, SeCDAI Sandler estimated Crohn’s disease Activity Index