Table 4.
Serious adverse events by MedDRA System Organ Classification
| Co-careldopa (n=74) | Placebo (n=58) | |
|---|---|---|
| Blood and lymphatic system disorders | 1 (1%) | 0 (0%) |
| Cardiac disorders | 6 (8%) | 2 (3%) |
| Gastrointestinal disorders | 4 (5%) | 3 (5%) |
| General disorders and administration site conditions | 0 (0%) | 1 (2%) |
| Hepatobiliary disorders | 1 (1%) | 2 (3%) |
| Infections and infestations | 10 (14%) | 6 (10%) |
| Injury, poisoning, and procedural complications | 4 (5%) | 3 (5%) |
| Metabolism and nutrition disorders | 2 (3%) | 1 (2%) |
| Musculoskeletal and connective tissue disorders | 1 (1%) | 0 (0%) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 2 (3%) | 3 (5%) |
| Nervous system disorders | 10 (14%) | 11 (19%) |
| Psychiatric disorders | 2 (3%) | 0 (0%) |
| Renal and urinary disorders | 2 (3%) | 1 (2%) |
| Reproductive system and breast disorders | 1 (1%) | 3 (5%) |
| Respiratory, thoracic, and mediastinal disorders | 8 (11%) | 12 (21%) |
| Social circumstances | 4 (5%) | 0 (0%) |
| Vascular disorders | 16 (22%) | 10 (17%) |
Data are n (%).