Research Article

Effects of Levodopa-Carbidopa Intestinal Gel Compared with Optimized Medical Treatment on Nonmotor Symptoms in Advanced Parkinson’s Disease: INSIGHTS Study

Table 3

Summary of serious AEs in the safety population.

LCIG n = 43OMT n = 44

Any AE36 (83.7)21 (47.7)
Any serious AE8 (18.6)4 (9.1)
Treatment-emergent serious AEs
 Pneumoperitoneum2 (4.7)0
 Stoma site infection2 (4.7)0
 Bacteremia01 (2.3)
 Urinary tract infection01 (2.3)
 Femur fracture1 (2.3)1 (2.3)
 Parkinson’s disease01 (2.3)
 Fall1 (2.3)0
 Lower limb fracture1 (2.3)0
 Patella fracture1 (2.3)0
 Subdural hematoma1 (2.3)0
 Neuralgia1 (2.3)0
 Depression1 (2.3)0

Data are reported as n (%). Patients are counted once in each row, regardless of the number of events they may have had. Abbreviations: AE: adverse event, LCIG: levodopa-carbidopa intestinal gel, and OMT: optimized medical treatment.