Table 4 Serious adverse events during the phase III study and 5-year follow-up observational study
Patients who continue LC | Patients who did not continue LC | |||||
|---|---|---|---|---|---|---|
Patients with events 2/30 (6.7 %) | Patients with events 5/18 (27.8 %) | Patients with events 3/12 (25.0 %) | ||||
Number of patients | Number of events | Number of patients | Number of events | Number of patients | Number of events | |
Infections and infestations | ||||||
Gangrene | 1 | 1 | ||||
Pneumonia | 1a | 1 | ||||
Pyelonephritis acute | 1 | 1 | ||||
Neoplasms benign, malignant, and unspecified (including cysts and polyps) | ||||||
Colon cancer | 1 | 1 | ||||
Nervous system disorder | ||||||
Cerebral haemorrhage | 1 | 1 | ||||
Cardiac disorders | ||||||
Myocardial ischaemia | 1 | 1 | ||||
Tachycardia | 1 | 1 | ||||
Cardiac valve disease | 1 | 1 | ||||
Cardiac failure | 1 | 1 | ||||
Cardiac failure acute | 1a | 1 | ||||
Vascular disorders | ||||||
Peripheral arterial occlusive disease | 2 | 2 | 1 | 1 | ||
Gastrointestinal disorders | ||||||
Constipation | 1 | 1 | ||||
Upper gastrointestinal haemorrhage | 1 | 1 | ||||
Surgical and medical procedures | ||||||
Foot amputation | 1 | 1 | ||||
General disorders and administration site conditions | ||||||
Death | 1a | 1 | ||||