Table 5.
Safety summary
| Number of Patients (% of N = 39) | |
|---|---|
| Any adverse event (AE) | 37 (95) |
| During Weeks 1‐4 | 28 (72) |
| Any GI eventa | 28 (72) |
| During Weeks 1‐4 | 22 (56) |
| Any non‐GI event | 37 (95) |
| During Weeks 1‐4 | 21 (54) |
| Any serious AE (SAE) | 8 (21) |
| During Weeks 1‐4 | 3 (8) |
| Any AE leading to a discontinuation | 5 (13) |
| During Weeks 1‐4 | 1 (3) |
| Death | 1 (3) |
| During Weeks 1‐4 | 0 |
| AEs Occurring in ≥ 10% Patients | |
| Procedural pain | 13 (33) |
| Stoma site infection | 11 (28) |
| Stoma site pain | 9 (23) |
| Anxiety | 8 (21) |
| Stoma site erythema | 8 (21) |
| Fall | 7 (18) |
| Weight decreased | 7 (18) |
| Urinary tract infection | 6 (15) |
| Orthostatic hypotension | 5 (13) |
| Excessive granulation tissue | 4 (10) |
| Flatulence | 4 (10) |
| Nausea | 4 (10) |
| Stoma site irritation | 4 (10) |
| Vitamin B6 deficiency | 4 (10) |
| SAEs Occurring in Any Patient | |
| Acute respiratory failure | 1 (3) |
| Anxiety | 1 (3)b |
| Atrial fibrillation | 1 (3)b |
| Aspiration pneumonia | 1 (3) |
| Basal cell carcinoma | 1 (3) |
| Congestive cardiac failure | 1 (3) |
| Internal hernia | 1 (3)b |
| Major depression | 1 (3)b |
| Osteoarthritis | 1 (3) |
| Peritonitis | 1 (3)b |
| Radiculopathy | 1 (3) |
| Respiratory distress | 1 (3)b |
| Sedation | 1 (3) |
| Suicidal ideation | 1 (3)b |
AE, adverse event; GI, gastrointestinal; SAE, serious adverse event.
a
GI events includes all MedDRA preferred terms in the GI and GI procedure related events query.
b
Investigator determined SAE had a reasonable possibility of being related to treatment