TABLE 4.
Safety summary
| Patients with | n (% of N = 195) | |
|---|---|---|
| Any severe AE | 46 (23.6) | |
| Any SAE | 79 (40.5) | |
| Any SAE with reasonable possibility of causal relationship with LCIG | 23 (11.8) | |
| Any AE leading to drug being withdrawn | 29 (14.9) | |
| Deaths | 13 (6.7) | |
| Deaths considered to be related to LCIG treatment by the study investigatora | 1 (0.5) | |
| SAEs | Treatment‐emergent SAEs (reasonable possibility) | |
|---|---|---|
| n (% of N = 195) | n (% of N = 195) | |
| Patient with any SAE | 79 (40.5) | 23 (11.8) |
| Treatment‐emergent SAE occurring in >1% of patients by MedDRA preferred term | ||
| Fall | 6 (3.1) | 2 (1.0) |
| Urinary tract infection | 6 (3.1) | 1 (0.5) |
| Hip fracture | 5 (2.6) | 0 |
| Pneumonia | 5 (2.6) | 0 |
| Abdominal pain | 4 (2.1) | 3 (1.5) |
| Device dislocation | 3 (1.5) | 2 (1.0) |
| Device occlusion | 3 (1.5) | 2 (1.0) |
| Femoral neck fracture | 3 (1.5) | 0 |
| Hallucination | 3 (1.5) | 2 (1.0) |
| Neuropathyb , c | 3 (1.5) | 0 |
| Pneumoperitoneum | 3 (1.5) | 2 (1.0) |
| Urosepsis | 3 (1.5) | 1 (0.5) |
a
Intestinal obstruction.
b
Chronic inflammatory demyelinating polyradiculoneuropathy (n = 1), polyneuropathy (n = 1), and sensory loss (n = 1).
c
All 3 neuropathies were reported by the investigator as not treatment related.
AE, adverse event; LCIG, levodopa‐carbidopa intestinal gel; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event.