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for the COC group. Table 2 Summary of absolute changes in secondary coagulation parameters (full analysis set) Parameters Novel Bayer patcha COCb n c Mean SD n c Mean SD Primary hemostasis parameters Prothrombin fragments 1 + 2 (nmol/L) [reference range 0.07–0.23 nmol/L] d Period 1: baseline 15 0.1 0.0 14 0.1 0.0 Period 1: treatment cycle 3 15 0.1 0.1 14 0.1 0.1 Period 1: absolute change (baseline to cycle 3) 15 0.0 0.0 14 0.0 0.1 Period 2: baseline 13 0.1 0.0 14 0.1 0.0 Period 2: treatment cycle 3 13 0.1 0.1 13 0.1 0.0 Period 2: absolute change (baseline to cycle 3) 13 0.0 0.0 13 0.0 0.0 click here Both periods together: absolute change (baseline to cycle 3) 28 0.0 0.0 27 0.0 0.0 d -dimer (nmol/L) [reference range 0.0–500 nmol/L] e Period 1: baseline 15
174.1 55.4 14 164.2 66.2 Period 1: treatment cycle 3 15 269.5 185.4 14 268.0 179.6 Period 1: absolute change (baseline to cycle 3) 15 95.3 172.8 14 103.8 150.2 Period 2: Amylase baseline 13 145.5 85.7 14 164.9 47.7 Period 2: treatment cycle 3 13 265.9 146.4 13 289.5 180.5 Period 2: absolute change (baseline to cycle 3) 13 120.5 116.6 13 124.4 173.5 Both periods together: absolute change (baseline to cycle 3) 28 107.0 147.2 27 113.7 159.0 Thrombin and fibrin turnover (activation marker) Prothrombin (Factor II) (%) [reference range 70–120 %] Period 1: baseline 15 99.9 10.0 14 113.4 13.2 Period 1: treatment cycle 3 15 117.2 8.4 14 114.9 11.3 Period 1: absolute change (baseline to cycle
3) 15 17.3 11.7 14 1.5 13.5 Period 2: baseline 13 101.2 15.6 14 101.4 10.1 Period 2: treatment cycle 3 13 118.1 11.6 13 110.5 13.2 Period 2: absolute change (baseline to cycle 3) 13 16.9 15.0 13 9.0 7.2 Baseline (both periods together) 28 100.5 12.7 28 107.4 13.1 Absolute change (both periods together) 28 17.1 13.1 27 5.1 11.4 (Pro)coagulatory parameters Fibrinogen (g/L) [reference range 1.8–3.5 g/L] Period 1: baseline 15 2.7 0.5 14 2.7 0.5 Period 1: treatment cycle 3 15 2.7 0.6 14 3.0 1.0 Period 1: absolute change (baseline to cycle 3) 15 0.0 0.7 14 0.2 0.9 Period 2: baseline 13 2.4 0.6 14 2.3 0.5 Period 2: treatment cycle 3 13 2.7 0.8 13 2.5 0.4 Period 2: absolute change (baseline to cycle 3) 13 0.3 0.7 13 0.2 0.4 Baseline (both periods together) 28 2.6 0.5 28 2.5 0.5 Absolute change (both periods together) 28 0.2 0.7 27 0.2 0.