Table 2.
Adverse events (by system organ class/preferred term)
| MedDRA/J term | Open-label period | Double-blind perioda | |
|---|---|---|---|
| Tramadol | Placebo | ||
| N = 248 | N = 78 | N = 81 | |
| Any | 200 (80.6) | 30 (38.5) | 11 (13.6) |
| Infections and infestations | 5 (2.0) | 4 (5.1) | 4 (4.9) |
| Cellulitis | 0 | 1 (1.3) | 0 |
| Cystitis | 1 (0.4) | 1 (1.3) | 0 |
| Gastroenteritis | 0 | 1 (1.3) | 0 |
| Nasopharyngitis | 3 (1.2) | 2 (2.6) | 3 (3.7) |
| Otitis media | 1 (0.4) | 0 | 0 |
| Paronychia | 0 | 0 | 1 (1.2) |
| Metabolism and nutrition disorders | 13 (5.2) | 2 (2.6) | 0 |
| Dehydration | 2 (0.8) | 0 | 0 |
| Decreased appetite | 12 (4.8) | 2 (2.6) | 0 |
| Psychiatric disorders | 2 (0.8) | 0 | 0 |
| Insomnia | 2 (0.8) | 0 | 0 |
| Nervous system disorders | 77 (31.0) | 2 (2.6) | 1 (1.2) |
| Dizziness | 21 (8.5) | 0 | 0 |
| Dysgeusia | 2 (0.8) | 0 | 0 |
| Headache | 11 (4.4) | 1 (1.3) | 1 (1.2) |
| Hypoesthesia | 3 (1.2) | 0 | 0 |
| Migraine | 1 (0.4) | 0 | 0 |
| Somnolence | 53 (21.4) | 1 (1.3) | 0 |
| Tremor | 2 (0.8) | 0 | 0 |
| Ear and labyrinth disorders | 4 (1.6) | 0 | 0 |
| Vertigo | 4 (1.6) | 0 | 0 |
| Cardiac disorders | 2 (0.8) | 1 (1.3) | 0 |
| Palpitations | 2 (0.8) | 1 (1.3) | 0 |
| Supraventricular extrasystoles | 1 (0.4) | 0 | 0 |
| Vascular disorders | 3 (1.2) | 1 (1.3) | 0 |
| Hypertension | 3 (1.2) | 1 (1.3) | 0 |
| Respiratory, thoracic and mediastinal disorders | 1 (0.4) | 0 | 1 (1.2) |
| Cough | 0 | 0 | 1 (1.2) |
| Hyperventilation | 1 (0.4) | 0 | 0 |
| Gastrointestinal disorders | 175 (70.6) | 19 (24.4) | 2 (2.5) |
| Abdominal discomfort | 9 (3.6) | 4 (5.1) | 0 |
| Abdominal distension | 1 (0.4) | 0 | 0 |
| Abdominal pain upper | 1 (0.4) | 0 | 0 |
| Cheilitis | 0 | 1 (1.3) | 0 |
| Constipation | 101 (40.7) | 2 (2.6) | 0 |
| Diarrhea | 1 (0.4) | 0 | 0 |
| Dyspepsia | 6 (2.4) | 0 | 1 (1.2) |
| Feces hard | 1 (0.4) | 0 | 0 |
| Feces soft | 1 (0.4) | 0 | 0 |
| Nausea | 110 (44.4) | 8 (10.3) | 1 (1.2) |
| Stomatitis | 0 | 1 (1.3) | 0 |
| Vomiting | 44 (17.7) | 5 (6.4) | 0 |
| Esophageal discomfort | 0 | 0 | 1 (1.2) |
| Hepatobiliary disorders | 1 (0.4) | 0 | 0 |
| Liver disorder | 1 (0.4) | 0 | 0 |
| Skin and subcutaneous tissue disorders | 18 (7.3) | 2 (2.6) | 1 (1.2) |
| Cold sweat | 2 (0.8) | 0 | 0 |
| Dermatitis contact | 0 | 1 (1.3) | 0 |
| Hemorrhage subcutaneous | 1 (0.4) | 0 | 0 |
| Hyperhidrosis | 2 (0.8) | 0 | 0 |
| Palmoplantar keratoderma | 1 (0.4) | 0 | 0 |
| Pruritus | 11 (4.4) | 1 (1.3) | 0 |
| Pruritus generalized | 1 (0.4) | 0 | 1 (1.2) |
| Rash | 2 (0.8) | 0 | 0 |
| Musculoskeletal and connective tissue disorders | 2 (0.8) | 4 (5.1) | 1 (1.2) |
| Arthralgia | 0 | 1 (1.3) | 0 |
| Back pain | 0 | 1 (1.3) | 0 |
| Neck pain | 1 (0.4) | 0 | 0 |
| Muscle rigidity | 0 | 1 (1.3) | 0 |
| Musculoskeletal pain | 1 (0.4) | 0 | 0 |
| Musculoskeletal chest pain | 1 (0.4) | 0 | 0 |
| Musculoskeletal stiffness | 1 (0.4) | 0 | 0 |
| Rotator cuff syndrome | 0 | 0 | 1 (1.2) |
| Spinal osteoarthritis | 0 | 1 (1.3) | 0 |
| Renal and urinary disorders | 4 (1.6) | 0 | 0 |
| Dysuria | 1 (0.4) | 0 | 0 |
| Pollakiuria | 1 (0.4) | 0 | 0 |
| Proteinuria | 1 (0.4) | 0 | 0 |
| Urinary retention | 1 (0.4) | 0 | 0 |
| Renal impairment | 1 (0.4) | 0 | 0 |
| General disorders and administration site conditions | 13 (5.2) | 1 (1.3) | 0 |
| Feeling abnormal | 1 (0.4) | 0 | 0 |
| Malaise | 0 | 1 (1.3) | 0 |
| Thirst | 12 (4.8) | 0 | 0 |
| Laboratory tests | 7 (2.8) | 3 (3.8) | 3 (3.7) |
| Alanine aminotransferase increased | 0 | 0 | 1 (1.2) |
| Blood creatine phosphokinase increased | 3 (1.2) | 1 (1.3) | 0 |
| Blood creatinine increased | 0 | 1 (1.3) | 0 |
| Blood pressure increased | 0 | 0 | 1 (1.2) |
| Blood urine present | 1 (0.4) | 0 | 0 |
| Gamma-glutamyltransferase increased | 1 (0.4) | 0 | 0 |
| Glucose urine present | 1 (0.4) | 0 | 1 (1.2) |
| Occult blood positive | 0 | 1 (1.3) | 0 |
| Urine output decreased | 1 (0.4) | 0 | 0 |
| Injury, poisoning and procedural complications | 2 (0.8) | 2 (2.6) | 0 |
| Animal bite | 1 (0.4) | 0 | 0 |
| Contusion | 1 (0.4) | 0 | 0 |
| Foot fracture | 0 | 1 (1.3) | 0 |
| Nail avulsion | 0 | 1 (1.3) | 0 |
Safety analysis set (open-label and double-blind periods)
MedDRA/J Version 17.1
Values are number (percent) of patients
aAdverse events that newly occurred in the double-blind period; adverse events that occurred in both periods are shown only in the open-label period