Adverse Events with a Frequency >/=5% Regardless of Causality by Body System
|
|
Placebo
(n=63) |
Levocarnitine
10 mg (n=34) |
Levocarnitine
20 mg (n=62) |
Levocarnitine
40 mg (n=34) |
Levocarnitine
10, 20 & 40 mg
(n=130) |
| Body as Whole |
|
Abdominal pain
|
17
|
21
|
5
|
6
|
9
|
|
Accidental injury
|
10
|
12
|
8
|
12
|
10
|
|
Allergic reaction
|
5
|
6
|
|
|
2
|
|
Asthenia
|
8
|
9
|
8
|
12
|
9
|
|
Back pain
|
10
|
9
|
8
|
6
|
8
|
|
Chest pain
|
14
|
6
|
15
|
12
|
12
|
|
Fever
|
5
|
6
|
5
|
12
|
7
|
|
Flu syndrome
|
40
|
15
|
27
|
29
|
25
|
|
Headache
|
16
|
12
|
37
|
3
|
22
|
|
Infection
|
17
|
15
|
10
|
24
|
15
|
|
Injection site reaction
|
59
|
38
|
27
|
38
|
33
|
|
Pain
|
49
|
21
|
32
|
35
|
30
|
| Cardiovascular |
|
Arrhythmia
|
5
|
3
|
|
3
|
2
|
|
Atrial fibrillation
|
|
|
2
|
6
|
2
|
|
Cardiovascular disorder
|
6
|
3
|
5
|
6
|
5
|
|
Electrocardiogram abnormal
|
|
3
|
|
6
|
2
|
|
Hemorrhage
|
6
|
9
|
2
|
3
|
4
|
|
Hypertension
|
14
|
18
|
21
|
21
|
20
|
|
Hypotension
|
19
|
15
|
19
|
3
|
14
|
|
Palpitations
|
|
3
|
8
|
|
5
|
|
Tachycardia
|
5
|
6
|
5
|
9
|
6
|
|
Vascular disorder
|
2
|
|
2
|
6
|
2
|
| Digestive |
|
Anorexia
|
3
|
3
|
5
|
6
|
5
|
|
Constipation
|
6
|
3
|
3
|
3
|
3
|
|
Diarrhea
|
19
|
9
|
10
|
35
|
16
|
|
Dyspepsia
|
10
|
9
|
6
|
|
5
|
|
Gastrointestinal disorder
|
2
|
3
|
|
6
|
2
|
|
Melena
|
3
|
6
|
|
|
2
|
|
Nausea
|
10
|
9
|
5
|
12
|
8
|
|
Stomach atony
|
5
|
|
|
|
|
|
Vomiting
|
16
|
9
|
16
|
21
|
15
|
| Endocrine System |
|
Parathyroid disorder
|
2
|
6
|
2
|
6
|
4
|
| Hemic/Lymphatic |
|
Anemia
|
3
|
3
|
5
|
12
|
6
|
| Metabolic/Nutritional |
|
Hypercalcemia
|
3
|
15
|
8
|
6
|
9
|
|
Hyperkalemia
|
6
|
6
|
6
|
6
|
6
|
|
Hypervolemia
|
17
|
3
|
3
|
12
|
5
|
|
Peripheral edema
|
3
|
6
|
5
|
3
|
5
|
|
Weight decrease
|
3
|
3
|
8
|
3
|
5
|
|
Weight increase
|
2
|
3
|
|
6
|
2
|
| Musculo-Skeletal |
|
Leg cramps
|
13
|
|
8
|
|
4
|
|
Myalgia
|
6
|
|
|
|
|
| Nervous |
|
Anxiety
|
5
|
|
2
|
|
1
|
|
Depression
|
3
|
6
|
5
|
6
|
5
|
|
Dizziness
|
11
|
18
|
10
|
15
|
13
|
|
Drug dependence
|
2
|
6
|
|
|
2
|
|
Hypertonia
|
5
|
3
|
|
|
1
|
|
Insomnia
|
6
|
3
|
6
|
|
4
|
|
Paresthesia
|
3
|
3
|
3
|
12
|
5
|
|
Vertigo
|
|
6
|
|
|
2
|
| Respiratory |
|
Brochitis
|
|
|
5
|
3
|
3
|
|
Cough increase
|
16
|
|
10
|
18
|
9
|
|
Dyspnea
|
19
|
3
|
11
|
3
|
7
|
|
Pharyngitis
|
33
|
24
|
27
|
15
|
23
|
|
Respiratory disorder
|
5
|
|
|
|
|
|
Rhinitis
|
10
|
6
|
11
|
6
|
9
|
|
Sinusitis
|
5
|
|
2
|
3
|
2
|
| Skin And Appendages |
|
Pruritus
|
13
|
|
8
|
3
|
5
|
|
Rash
|
3
|
|
5
|
3
|
3
|
| Special Senses |
|
Amblyopia
|
2
|
|
6
|
|
3
|
|
Eye disorder
|
3
|
6
|
3
|
|
3
|
|
Taste perversion
|
|
|
2
|
9
|
3
|
| Urogenital |
|
Urinary tract infect
|
6
|
3
|
3
|
|
2
|
|
Kidney failure
|
5
|
6
|
6
|
6
|
6
|
