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Table 2 Definition of protocol deviation

From: Characterising deviation from treat-to-target strategies for early rheumatoid arthritis: the first three years

Dose escalation criteria fulfilled Significant toxicity occurred 1 Protocol deviation
No Yes
Yes No Intensified Continued/tapered/discontinued
Yes Yes Intensified2 Continued/tapered/discontinued3
No No Continued Intensified/tapered/discontinued
No Yes Continued/tapered/discontinued Intensified
Yes/no Yes/no   Discontinuation of all DMARDs4
  1. 1Severe toxicities, according to physician’s assessment, deemed to be unfavourable to the health of the patient. Minor complaints were not considered as significant toxicity; 2when the existing drug was withdrawn or dose reduced due to toxicity but the dose of another drug was increased or a new agent was added, treatment was considered as intensified; 3if significant toxicity occurred; therapy escalation was not expected. However, it was considered a deviation as the disease was still active (that is, dose escalation criteria fulfilled); 4stopping all disease-modifying anti-rheumatic drugs (DMARDs) regardless of patient’s disease activity or toxicity status were considered deviation.