Table 5.
Arm | Duration of SAE (days) | Severity | Months after randomisation | Relationship to study treatment | Outcome | |
---|---|---|---|---|---|---|
Stab wound | IPE | 30 | Severe | 10 | Not related | Resolved |
Hospitalisation | IPE | 61 | Severe | 8 | Not related | Resolved |
Renal stone removal | Inulin | 1 | Moderate | 4 | Not related | Resolved |
Meningitis bacterial | Inulin | 17 | Severe | 6 | Not related | Resolved |
IPE, inulin-propionate ester; SAE, severe adverse event.