Assessments and outcomes
haemorrhage, petechiae, ecchymosis, pain
HAEMORRHAGE, PETECHIAE, ECCHYMOSIS
Patients were followed up at weeks 1, 2 and 4, and every 4 weeks thereafter until week 36 (The primary endpoint was the proportion of patients meeting ACR20 criteria at week 12 in the combined TAS5315 2 and 4 mg group versus placebo. ACR20 was defined as a 20% improvement in the tender joint count and swollen joint count (SJC) scores and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, Health Assessment Questionnaire-Disability Index (HAQ-DI), pain Visual Analogue Scale (VAS), and erythrocyte sedimentation rate (ESR) or CRP level.Safety was assessed by recording AEs, serious AEs (SAEs) and laboratory parameters. Bleeding-related AEs, such as haemorrhage, petechiae and ecchymosis, were considered to be AEs of special interest.