Table 1.
Subject characteristics at baseline (safety sample)
| Double-blind phase | OLE | ||
|---|---|---|---|
| Pancreatin (n = 32) | Placebo (n = 26) | Pancreatin (n = 58) | |
| Age (years), mean ± s.d. | 57.6 ± 10.2 | 59.3 ± 8.7 | 58.4 ± 9.6 |
| Men, n (%) | 18 (56.3) | 17 (65.4) | 35 (60.3) |
| Weight (kg), mean ± s.d. | 68.5 ± 18.1 | 67.9 ± 12.7 | 68.0 ± 15.5 |
| BMI (kg/m2), mean ± s.d. | 23.8 ± 5.5 | 23.4 ± 4.9 | 23.5 ± 5.1 |
| Type of pancreatic resection, n (%) | |||
| Total | 4 (12.5) | 0 | 4 (6.9) |
| Partial | 28 (87.5) | 26 (100.0) | 54 (93.1) |
| Whipple/PPPD/equivalent | 16 (50.0) | 13 (50.0) | 29 (50.0) |
| Duodenal-preserving PHR | 7 (21.9) | 6 (23.1) | 13 (22.4) |
| Other | 5 (15.6) | 7 (26.9) | 12 (20.7) |
| Time since surgery (months), mean ±s.d. | 57.3 ± 37.9 | 48.9 ± 41.4 | 53.4 ± 39.4 |
| Reason for surgery, n (%) | |||
| Malignancy | 9 (28.1) | 5 (19.2) | 14 (24.1) |
| Chronic pancreatitis | 23 (71.9) | 21 (80.8) | 44 (75.9) |
PHR, pancreatic head resection; PPPD, pylorus-preserving pancreaticoduodenectomy; OLE, open-label extension; s.d., standard deviation.