Table 5.
Summary of treatment-emergent adverse events (safety sample)
| Double-blind phase, n (%) | Any time*, n (%) | ||
|---|---|---|---|
| Pancreatin (n = 32) | Placebo (n = 26) | (n = 58) | |
| At least one TEAE | 12 (37.5) | 7 (26.9) | 44 (75.9) |
| At least one TESAE | 0 | 0 | 15 (25.9) |
| At least one severe TEAE | 2 (6.3) | 1 (3.8) | 11 (19.0) |
| TEAEs possibly/probably related to treatment | 4 (12.5) | 3 (11.5) | 8 (13.8) |
| TEAEs leading to discontinuation | 0 | 0 | 2 (3.4) |
| TEAEs occurring in ≥5% patients in any group by preferred term | |||
| Abdominal pain | 1 (3.1) | 0 | 9 (15.5) |
| Diarrhoea | 1 (3.1) | 1 (3.8) | 4 (6.9) |
| Flatulence | 4 (12.5) | 2 (7.7) | 7 (12.1) |
| Gamma-glutamyltransferase increased | 0 | 0 | 4 (6.9) |
| Headache | 2 (6.3) | 0 | 3 (5.2) |
| Hypertension | 1 (3.1) | 0 | 3 (5.2) |
| Nasopharyngitis | 0 | 1 (3.8) | 5 (8.6) |
| Pyrexia | 2 (6.3) | 0 | 7 (12.1) |
| Vomiting | 1 (3.1) | 0 | 3 (5.2) |
TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event.
*
During pancreatin treatment.