Table 5.
Specific reasons for protocol deviation (n = 179)
| Reasons | Patients experiencing deviation, n (%) | Number of deviations | |
|---|---|---|---|
| Total frequency (%) | Median (IQR) deviation/patient | ||
| Toxicity | |||
| Gastrointestinal | 46 (23.2) | 80 | 1 (1 to 2) |
| Haematological | 25 (12.6) | 61 | 2 (1 to 3) |
| Central nervous system | 26 (13.1) | 35 | 1 (1 to 2) |
| Abnormal liver function | 18 (9.1) | 28 | 1 (1 to 2) |
| Skin and hair | 13 (6.6) | 16 | 1 (1 to 1) |
| Fatigue | 12 (6.1) | 14 | 1 (1 to 1) |
| Muco-cutaneous | 9 (4.5) | 13 | 1 (1 to 2) |
| Other 1 | 8 (4.0) | 9 | 1 (1 to 1) |
| Comorbidities | |||
| Infection | 28 (14.1) | 45 | 1 (1 to 2) |
| Other co-morbidities 2 | 51 (25.8) | 134 | 2 (1 to 4) |
| Patient-related | |||
| Poor concordance | 71 (35.9) | 106 | 1 (1 to 2) |
| Reluctance to modify therapy | 48 (24.2) | 94 | 1 (1 to 3) |
| Other 3 | 20 (10.1) | 21 | 1 (1 to 1) |
| Physician-related | |||
| Wait and see | 50 (25.3) | 95 | 1 (1 to 3) |
| Limited option | 11 (5.6) | 27 | 1 (1 to 5) |
| Persistent disease 4 | 14 (7.1) | 15 | 2 (1 to 2) |
| Other 5 | 65 (32.8) | 84 | 1 (1 to 2) |
| Other 6 | 35 (17.7) | 66 (7.3) | 1 (1 to 2) |
1Respiratory, cardiovascular disease, weight loss et cetera; 2other muscle-skeletal conditions such as osteoarthritis and fibromyalgia, respiratory disease, cancer and pregnancy; 3social issues such as relocation or other problems; 4deviation related to persistent disease activity was intensification when dose modification criteria were not fulfilled; 5patient in remission, risk of toxicity, risk of flare et cetera; 6awaiting laboratory results, awaiting approval of biological disease modifiying anti-rheumatic drugs (DMARDs), logistic reasons, prophylaxis for tuberculosis before initiating biological DMARDs.