Table 2 Summary of adverse events (AEs) and serious AEs
Number of patients (%) | Number of patients (%) | ||
|---|---|---|---|
Any AE | 31 (100) | Any serious AE | 4 (12.9) |
Any AE with reasonable possibility of being related to LCIG (drug/device) | 30 (96.8) | Any serious AE with reasonable possibility of being related to LCIG (drug/device) | 2 (6.5) |
AEs occurring in ⩾5% patients by preferred term | Serious AEs occurring in any patient by preferred term | ||
Incision site pain | 13 (41.9) | Abdominal pain | 1 (3.2) |
Excessive granulation tissue | 10 (32.3) | Constipation | 1 (3.2) |
Constipation | 7 (22.6) | Device dislocation | 1 (3.2) |
Diarrhea | 6 (19.4) | Device kink | 1 (3.2) |
Fall | 6 (19.4) | Disseminated intravascular coagulation | 1 (3.2) |
Nasopharyngitis | 6 (19.4) | Femur fracture | 1 (3.2) |
Blood homocysteine increased | 5 (16.1) | Gastrointestinal perforation | 1 (3.2) |
Dyskinesia | 5 (16.1) | Melena | 1 (3.2) |
Procedural pain | 5 (16.1) | Pneumonia aspiration | 1 (3.2) |
Incision site erythema | 4 (12.9) | Sepsis | 1 (3.2) |
Anemia | 3 (9.7) | ||
Anxiety | 3 (9.7) | ||
Tinea pedis | 3 (9.7) | ||
Abdominal distension | 2 (6.5) | ||
Abdominal pain | 2 (6.5) | ||
Abdominal pain upper | 2 (6.5) | ||
Blood pressure decreased | 2 (6.5) | ||
Complication of device insertion | 2 (6.5) | ||
Eczema | 2 (6.5) | ||
Epistaxis | 2 (6.5) | ||
Headache | 2 (6.5) | ||
Incision site rash | 2 (6.5) | ||
Insomnia | 2 (6.5) | ||
Musculoskeletal pain | 2 (6.5) | ||
Oropharyngeal pain | 2 (6.5) | ||
Pneumonia aspiration | 2 (6.5) | ||
Pruritis | 2 (6.5) | ||
Pyrexia | 2 (6.5) | ||
Stoma site infection | 2 (6.5) | ||
Suture related complication | 2 (6.5) | ||
Toothache | 2 (6.5) | ||
Weight decreased | 2 (6.5) | ||
