Table 3.
Percentage of patients reporting adverse drug reactions (> 2% of patients in present study) and associated withdrawal rates, in comparison with [4, 5]
| Present study | [4] | [5] | |||||
|---|---|---|---|---|---|---|---|
| ADR | Withdrawal | ADR | ADR | ||||
| n | % | % | % | Withdrawal | % | Withdrawal | |
| Withdrawal (per patient-yearfollow-up) | |||||||
| Overall | 56.2 | 30 | 47 | ||||
| ADR | 29.6 | 19 | 22 | ||||
| Inefficacy | 12.6 | 7 | 4 | ||||
| ADR/Inefficacy | 7.4 | ||||||
| Other | 6.7 | 4 | 8 | ||||
| ADR | |||||||
| Diarrhoea | 40 | 29.4 | 18.4 | 33.5 | 5.5* | 18 | 2 |
| Nausea | 15 | 11.0 | 5.9 | 20.9† | 11.2 | 1.2 | |
| Pruritus | 10 | 7.4 | 4.4 | ||||
| Hypertension | 9 | 6.6 | 4.4 | 11 | 1.1 | ||
| Skin problems‡ | 8 | 5.9 | 3.7 | 2.2 (rash) | 7.4 (rash) | 1.2 (rash) | |
| Alopecia | 7 | 5.1 | 2.9 | 9.9 | 0.5 | 16.6 | 1.4 |
| Gastrointestinal pain | 7 | 5.1 | 2.2 | 13.7 | 5.6 | 0.8 | |
| Abnormal enzyme elevations§ | 6 | 4.4 | 3.7 | 11 | 7.1 | 5.4 | 1.6 |
| Loss of appetite | 6 | 4.4 | 2.2 | ||||
| Headache | 4 | 2.9 | 1.5 | 6.2 | 0.6 | ||
| Vomiting | 3 | 2.2 | 2.2 | ||||
| Hoarseness | 3 | 2.2 | 2.2 | ||||
| Weight loss | 3 | 2.2 | 1.5 | ||||
| Mouth ulceration | 3 | 2.2 | 0.7 | 6.0 | 3.0 | 0.2 | |
*
Withdrawal for all gastrointestinal ADR.
†
Nausea and vomiting.
‡
ADR skin events reported (n): eczema (2), rash (2), psoriasis (1), urticaria (1), dry skin (1), not specified (1).
§
Abnormal plasma liver enzyme levels are defined as ALAT or ASAT values >2 x upper limit of normal values, reference [5] >3 x upper limit of normal values. ADR, Adverse drug reaction.