Safety results—treatment emergent adverse events (TEAEs)
| Paracetamol | Placebo (n = 405) | All (n = 374) | p Values* (n = 779) | |
|---|---|---|---|---|
| *p Values for χ2 test; †percentages based on total number of patients; ‡percentages based on total number of reported AEs. | ||||
| Patients with at least 1 TEAE, No (%) | 85 (21) | 86 (23) | 171 (22) | 0.499 |
| Patients with at least 1 serious AE, No (%) | 5 (1) | 3 (1) | 8 (1) | |
| Patients withdrawn for safety reasons, No (%) | 36 (9) | 29 (8) | 65 (8) | |
| Body system involved† | ||||
| Gastrointestinal system disorders, No (%) | 46 (11) | 42 (11) | 88 (11) | 0.739 |
| Musculoskeletal system disorders, No (%) | 10 (2) | 16 (4) | 26 (3) | 0.104 |
| Respiratory system disorders, No (%) | 12 (3) | 13 (3) | 25 (3) | 0.955 |
| Body as a whole—general disorders, No (%) | 8 (2) | 12 (3) | 20 (3) | 0.161 |
| Central and peripheral nervous system disorders, No (%) | 7 (2) | 6 (2) | 13 (2) | |
| Skin and appendages disorders, No (%) | 6 (1) | 4 (1) | 10 (1) | |
| Total number of reported AEs | 142 | 132 | 274 | |
| Intensity‡ | ||||
| Mild | 42 (30) | 30 (23) | 72 (26) | |
| Moderate | 77 (54) | 69 (52) | 146 (53) | |
| Severe | 18 (13) | 31 (23) | 49 (18) | |
| Missing data | 5 (4) | 2 (2) | 7 (3) | |
| Relationship with study drug‡ | ||||
| Definite | 13 (9) | 8 (6) | 21 (8) | |
| Probable | 38 (27) | 36 (27) | 74 (27) | |
| Possible | 28 (20) | 23 (17) | 51 (19) | |
| Improbable | 63 (44) | 65 (49) | 128 (47) | |