Adverse Events According to System-Organ Classes
| System-organ classes | Symptom | Wk 2-4 | Wk 6-8 | Wk 10-12 | Wk 14-16 | Wk 18-20 | Wk 22-26 | Total |
|---|---|---|---|---|---|---|---|---|
| Gastro-intestinal system disorders | Constipation | 7(14) | 4(21) | 5(22.7) | 4 (25) | 0 (0) | 2(12.5) | 22(16.7) |
| Dyspepsia | 5(10) | 0(0) | 1(4.5) | 1 (6.3) | 0 (0) | 1(6.3) | 8(6.1) | |
| Nausea | 2(4) | 2(10.5) | 2(9) | 1 (6.3) | 1 (11.1) | 5(31.3) | 13(9.8) | |
| Vomiting | 1(2) | 0(0) | 0(0) | 0 (0) | 0 (0) | 0(0) | 1(0.8) | |
| Diarrhea | 0(0) | 1(5.3) | 0(0) | 0 (0) | 0 (0) | 0(0) | 1(0.8) | |
| Stools loose | 0(0) | 0(0) | 1(4.5) | 0 (0) | 0 (0) | 0(0) | 1(0.8) | |
| Abdominal pain | 1(2) | 0(0) | 0(0) | 1 (6.3) | 0 (0) | 0(0) | 2(1.5) | |
| Flatulence | 1(2) | 0(0) | 0(0) | 0 (0) | 0 (0) | 0(0) | 1(0.8) | |
| Belching | 1(2) | 0(0) | 0(0) | 0 (0) | 0 (0) | 0(0) | 1(0.8) | |
| Subtotal | 18(36) | 7(36.8) | 9(40.9) | 6 (43.9) | 1 (11.1) | 9(56.3) | 50(37.9) | |
| Central & peripheral nervous system disorders | Dizziness | 5(10) | 1(5.3) | 2(9) | 0 (0) | 0 (0) | 0(0) | 8(6.1) |
| Headache | 3(6) | 1(5.3) | 2(9) | 1 (6.3) | 0 (0) | 1(6.3) | 7(5.3) | |
| Hyperhidrosis | 1(2) | 0(0) | 1(4.5) | 0 (0) | 0 (0) | 0(0) | 2(1.5) | |
| Limpness body | 0(0) | 0(0) | 0(0) | 0 (0) | 0 (0) | 1(6.3) | 1(0.8) | |
| Sweating increased | 2(4) | 0(0) | 1(4.5) | 0 (0) | 2 (22.2) | 0(0) | 5(3.8) | |
| Tremor | 2(4) | 1(5.3) | 0(0) | 1 (6.3) | 0 (0) | 0(0) | 4(3.0) | |
| Subtotal | 13(26) | 3(15.8) | 6(27.3) | 2 (12.5) | 2 (22.2) | 2(12.5) | 27(20.5) | |
| Psychiatric disorders | Insomnia | 6(12) | 5(26.3) | 4(18.2) | 1 (6.3) | 2 (22.2) | 1(6.3) | 19(14.4) |
| Autonomic nervous system disorders | Mouth dry | 0(0) | 1(5.3) | 1(4.5) | 0 (0) | 1 (11.1) | 2(12.5) | 5(3.8) |
| Palpitation | 4(8) | 0(0) | 0(0) | 2 (12.5) | 1 (11.1) | 0(0) | 7(5.3) | |
| Subtotal | 4(8) | 1(5.3) | 1(4.5) | 2 (12.5) | 2 (22.2) | 2(12.5) | 12(9.1) | |
| Body as a whole-general disorders | Leg pain | 0(0) | 0(0) | 0(0) | 1 (6.3) | 0 (0) | 0(0) | 1(0.8) |
| Chest pressure | 1(2) | 0(0) | 0(0) | 0 (0) | 0 (0) | 0 | 1(0.8) | |
| Chest discomfort | 3(6) | 0(0) | 0(0) | 0 (0) | 0 (0) | 0(0) | 3(2.3) | |
| Subtotal | 4(8) | 0(0) | 0(0) | 1 (6.3) | 0 (0) | 0(0) | 5(3.8) | |
| Musculo-skeletal system disorders | Muscle pain | 0(0) | 1(5.3) | 0(0) | 1 (6.3) | 1 (11.1) | 1(6.3) | 4(3.0) |
| Respiratory system disorders | Dyspnea | 2(4) | 0(0) | 0(0) | 0 (0) | 0 (0) | 0(0) | 2(1.5) |
| Breath shortness | 0(0) | 0(0) | 1(4.5) | 0 (0) | 1 (11.1) | 0(0) | 2(1.5) | |
| Subtotal | 2(4) | 0(0) | 1(4.5) | 0 (0) | 1 (11.1) | 0(0) | 4(3.0) | |
| Skin and appendages disorders | Pruritus | 0(0) | 0(0) | 1(4.5) | 1 (6.3) | 0 (0) | 1(6.3) | 3(2.3) |
| Reproductive disorders, female | Menstrual disorder | 1(2) | 1(5.3) | 0(0) | 0 (0) | 0 (0) | 1(6.3) | 3(2.3) |
| Platelet, bleeding & clotting disorders | Anal hemorrhage | 1(2) | 0(0) | 0(0) | 0 (0) | 0 (0) | 0(0) | 1(0.8) |
| Vascular (extracardiac) disorders | Peripheral coldness | 0(0) | 0(0) | 0(0) | 1 (6.3) | 0 (0) | 0(0) | 1(0.8) |
| Liver and biliary system disorders | ALT increased | 1(2) | 0(0) | 0(0) | 0 (0) | 0 (0) | 0(0) | 1(0.8) |
| Vision disorders | Muscae volitantes | 0(0) | 1(5.3) | 0(0) | 0 (0) | 0 (0) | 0(0) | 1(0.8) |
The data was expressed as a number (%).
Wk: week, ALT: alanine aminotransferase.
