Table 2.
Demographics, indications and baseline characteristics in the ITT population
| Category | SCC (N = 65) | HCP (N = 68) | Total (N = 133) | |
|---|---|---|---|---|
| A. Demographics | ||||
| Age (years) | ||||
| Mean ± SD | 43.6 ± 10.5 | 44.8 ± 10 | 44.2 ± 10.2 | |
| 20 to <40 | 20 (31 %) | 21 (31 %) | 41 (31 %) | |
| 40 to <60 | 43 (66 %) | 46 (68 %) | 89 (67 %) | |
| ≥60 | 2 (3 %) | 1 (1 %) | 3 (2 %) | |
| Sex | ||||
| Female | 43 (66 %) | 39 (57 %) | 82 (62 %) | |
| Male | 22 (34 %) | 29 (43 %) | 51 (38 %) | |
| Race | ||||
| Caucasian | 55 (84.6 %) | 62 (91.2 %) | 117 (88 %) | |
| African American | 5 (7.7 %) | 5 (7.4 %) | 10 (7.5 %) | |
| Other | 5 (7.7 %) | 1 (1.4 %) | 6 (4.5 %) | |
| B. Indication a | ||||
| Screening | 24 (36.9 %) | 32 (47.1 %) | 56 (42.1 %) | |
| Mild constipation | 13 (20 %) | 12 (17.6 %) | 25 (18.8 %) | |
| Hematochezia | 14 (21.5 %) | 12 (17.6 %) | 26 (19.5 %) | |
| Abdominal pain | 7 (10.8 %) | 7 (10.3 %) | 14 (10.5 %) | |
| Anemia | 2 (3.1 %) | 2 (2.9 %) | 4 (3 %) | |
| Mild diarrhea | 2 (3.1 %) | 2 (2.9 %) | 4 (3 %) | |
| Otherb | 3 (4.6 %) | 1 (1.5 %) | 4 (3 %) | |
| C. Baseline data | ||||
| Weight (lbs) | Mean ± SD | 155 ± 29 | 163 ± 36 | 160 ± 33 |
| Systolic blood pressure (mmHg) | Mean ± SD | 121 ± 13 | 125 ± 17 | 123 ± 15 |
| Diastolic blood Pressure (mmHg) | Mean ± SD | 76 ± 10 | 80 ± 10 | 78 ± 10 |
| Sodium (mEq/L) | Mean ± SD | 140 ± 2 | 140 ± 3 | 140 ± 2 |
| Potassium (mEq/L) | Mean ± SD | 4.2 ± 0.4 | 4.3 ± 0.3 | 4.3 ± 0.3 |
| Chloride (mEq/L) | Mean ± SD | 104 ± 2 | 104 ± 3 | 104 ± 3 |
| CO2 (mEq/L) | Mean ± SD | 23.4 ± 2.7 | 23.2 ± 2.8 | 23.3 ± 2.7 |
| BUN (mEq/L) | Mean ± SD | 14.3 ± 3.1 | 14.6 ± 4.3 | 14.4 ± 3.8 |
| Creatinine (mEq/L) | Mean ± SD | 0.81 ± 0.16 | 0.85 ± 0.18 | 0.83 ± 0.17 |
| Serum glucose (mg/dL) | Mean ± SD | 89 ± 15 | 92 ± 15 | 90 ± 15 |
aMultiple indications possible
bUlcerative colitis (n = 2, Yoga), elevated liver function tests (n = 3, two patients in HalfLytely, one patient in Yoga)