
Adverse Events According to System Organ Classes
System-organ classes | Symptom | 2-6 weeks | 10 weeks≤ |
---|---|---|---|
Gastro-intestinal system disorders | Nausea | 5 (14.7) | 3 (12.5) |
Dyspepsia | 2 (5.9) | 2 (8.3) | |
Constipation | 4 (11.8) | 5 (20.8) | |
Diarrhea | 1 (2.9) | 0 (0.0) | |
Subtotal | 12 (35.3) | 10 (41.7) | |
Central & peripheral nervous system disorders | Dizziness | 6 (17.6) | 3 (12.5) |
Headache | 3 (8.8) | 1 (4.2) | |
Hand tremor | 1 (2.9) | 0 (0.0) | |
Subtotal | 10 (29.4) | 4 (16.7) | |
Psychiatric disorders | Insomnia | 3 (8.8) | 2 (8.3) |
Subtotal | 3 (8.8) | 2 (8.3) | |
Autonomic nervous system disorders | Dry mouth | 1 (2.9) | 1 (4.2) |
Palpitation | 1 (2.9) | 1 (4.2) | |
Sweating increased | 3 (8.8) | 0 (0.0) | |
Subtotal | 5 (14.7) | 2 (8.3) | |
Body as a whole-general disorders | Fatigue | 2 (5.9) | 1 (4.2) |
Temperature changed sensation | 1 (2.9) | 0 (4.0) | |
Subtotal | 3 (8.8) | 1 (4.2) | |
Skin and appendages disorders | Rash | 1 (2.9) | 1 (4.2) |
Acne | 0 (0.0) | 1 (4.2) | |
Subtotal | 1 (2.9) | 2 (8.3) | |
Reproductive disorders, female | Menstrual disorder | 0 (0.0) | 2 (8.3) |
Subtotal | 0 (0.0) | 2 (8.3) | |
Musculo-skeletal system disorders | Dystonia cervical | 0 (0.0) | 1 (4.2) |
Subtotal | 0 (0.0) | 1 (4.2) | |
Total | 34 (100.0) | 24 (100.0) |
Data are expressed number (%).