Table 3.
Incidence and Severity of Adverse Events (n = 9)
| BODY SYSTEM | MILD | MODERATE | SEVERE | TOTAL | ||||
|---|---|---|---|---|---|---|---|---|
| Event | Rel | NR | Rel | NR | Rel | NR | Rel | NR |
|
CARDIAC DISORDERS | ||||||||
| Angina unstable | 1 | 1 | ||||||
| Cardiac failure | 1 | 1 | ||||||
| Cardiac failure congestive | 1 | 1 | ||||||
| Cardiogenic shock | 1 | 1 | ||||||
| Ventricular tachycardia | 1 | 1 | 1 | 1 | ||||
|
| ||||||||
|
GASTROINTESTINAL DISORDERS | ||||||||
| Abdominal distention | 1 | 1 | ||||||
|
| ||||||||
|
GENERAL | ||||||||
| Catheter site hemorrhage | 1 | 1 | ||||||
| Chest discomfort | 1 | 1 | ||||||
| Fatigue | 2 | 1 | 3 | |||||
| Pyrexia | 1 | 1 | ||||||
| Sudden death | 1 | 1 | ||||||
|
| ||||||||
|
INFECTIONS and INFESTATIONS | ||||||||
| Bronchitis | 1 | 1 | ||||||
| Herpes zoster | 1 | 1 | ||||||
| Influenza | 1 | 1 | ||||||
| Nasopharyngitis | 1 | 1 | ||||||
|
| ||||||||
|
INJURY, POISONING, and PROCEDURAL COMPLICATIONS | ||||||||
| Device lead damage | 1 | 1 | ||||||
|
| ||||||||
|
INVESTIGATIONS | ||||||||
| Blood CK increased | 1 | 1 | ||||||
| Weight increased | 1 | 1 | ||||||
|
| ||||||||
|
METABOLISM and NUTRITION DISORDERS | ||||||||
| Diabetes mellitus inadequate control | 1 | 1 | ||||||
| Gout | 1 | 1 | ||||||
| Hypokalemia | 2 | 2 | ||||||
| Hyponatremia | 1 | 1 | ||||||
|
| ||||||||
|
MUSCULOSKELETAL and CONNECTIVE TISSUE DISORDERS | ||||||||
| Muscle spasms | 1 | 1 | 1 | 1 | ||||
| Nervous system disorders | ||||||||
| Hypoesthesia | 1 | 1 | ||||||
|
| ||||||||
|
RENAL and URINARY DISORDERS | ||||||||
| Renal impairment | 2 | 2 | ||||||
|
| ||||||||
|
RESPIRATORY | ||||||||
| Asthma | 1 | 1 | ||||||
| Orthopnea | 1 | 1 | ||||||
| Throat tightness | 1 | 1 | ||||||
|
| ||||||||
|
SKIN | ||||||||
| Ecchymosis | 1 | 1 | ||||||
|
| ||||||||
|
VASCULAR DISORDERS | ||||||||
| Hematoma | 1 | 1 | ||||||
| Hypertension | 1 | 1 | ||||||
Related, definitely, probable, or possible as judged by the investigator; NR, unlikely or not related to investigational product as judged by the investigator; CK, creatine kinase.
Event tabulated once as worst severity or most related for the same event occurring multiple times within the same patient.