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表 2.7.6.25－143 鉄剤の投与を受けた被験者の割合（Fas） （続き）

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表 2.7.6.25－143 鉄剤の投与を受けた被験者の割合（Fas） （続き） 2.7.6 個々の試験のまとめ 表 2.7.6.25－143 鉄剤の投与を受けた被験者の割合（FAS）（続き） 5.3.5.1―8 表 11.4.1―8 より引用 1282 Page 460 of 1887 2.7.6 個々の試験のまとめ (8) 血清フェリチン値 100 ng/mL 以上又は TSAT 20%以上の被験者の割合 血清フェリチン値 100 ng/mL 以上又は TSAT 20%以上の被験者の割合を表 2.7.6.25－144 に示した．血清フェリチン値 100 ng/mL 以上又は TSAT 20%以上の被験者の割合は，全集 団を対象に記載した． 血清フェリチン値 100 ng/mL 以上又は TSAT 20%以上の被験者の割合は，MT-6548 群に おいてベースラインで 94.7%に対し，52 週後では 93.6%であり，darbepoetin 群においてベ ースラインで 90.8%に対し，52 週後では 96.7%であった． 1283 Page 461 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－144 血清フェリチン値 100 ng/mL 以上又は TSAT 20%以上の被験者の割合（FAS） 5.3.5.1―8 表 14.2.3.8.1 より引用 1284 Page 462 of 1887 2.7.6 個々の試験のまとめ (9) 血球関連評価項目 MMRM を用いた MCV，MCH，ヘマトクリット，RBC，網状赤血球数及び網状赤血球 率のベースラインからの変化量を表 2.7.6.25－145，表 2.7.6.25－146，表 2.7.6.25－147， 表 2.7.6.25－148，表 2.7.6.25－149 及び表 2.7.6.25－150 に示した．血球関連評価項目は， 全集団を対象に記載した． MMRM を用いた MCV の 52 週後のベースラインからの変化量の LSMean 及びその 95%CI は，MT-6548 群で 2.7 fL 及び 2.2～3.2 fL，darbepoetin 群で 0.1 fL 及び -0.3～0.6 fL であった．MMRM を用いた MCV の 52 週後のベースラインからの変化量の MT-6548 群 と darbepoetin 群の差の LSMean 及びその 95%CI は，2.6 fL 及び 1.9～3.3 fL であり，統計 学的に有意な差が認められた（p<0.001）. MMRM を用いた MCH の 52 週後のベースラインからの変化量の LSMean 及びその 95%CI は，MT-6548 群で 1.06 pg 及び 0.86～1.26 pg，darbepoetin 群で 0.01 pg 及び -0.19～ 0.20 pg であった．MMRM を用いた MCH の 52 週後のベースラインからの変化量の MT- 6548 群と darbepoetin 群の差の LSMean 及びその 95%CI は，1.05 pg 及び 0.77～1.34 pg で あり，統計学的に有意な差が認められた（p<0.001）. MMRM を用いたヘマトクリットの 52 週後のベースラインからの変化量の LSMean 及 びその 95%CI は，MT-6548 群で 2.87%及び 2.37%～3.37%，darbepoetin 群で 3.24%及び 2.76%～3.72%であった．MMRM を用いたヘマトクリットの 52 週後のベースラインから の変化量の MT-6548 群と darbepoetin 群の差の LSMean 及びその 95%CI は，-0.37 %及び - 1.06%～0.32%であり，統計学的に有意な差は認められなかった. MMRM を用いた RBC の 52 週後のベースラインからの変化量の LSMean 及びその 95%CI は，MT-6548 群で 20.7×104/μL 及び 14.9×104/μL～26.6×104/μL，darbepoetin 群で 34.1×104/μL 及び 28.5×104/μL～39.8×104/μL であった．MMRM を用いたヘマトクリットの 52 週後のベースラインからの変化量の MT-6548 群と darbepoetin 群の差の LSMean 及びそ の 95%CI は，-13.4×104/μL 及び -21.5×104/μL～ -5.3×104/μL であり，統計学的に有意な差 が認められた（p=0.001）. MMRM を用いた網状赤血球数の 52 週後のベースラインからの変化量の LSMean 及び その 95%CI は，MT-6548 群で 0.99×104/μL 及び 0.66×104/μL～1.31×104/μL，darbepoetin 群 で -0.54×104/μL 及び -0.85×104/μL～ -0.23×104/μL であった．MMRM を用いた網状赤血球 数の 52 週後のベースラインからの変化量の MT-6548 群と darbepoetin 群の差の LSMean 及 びその 95%CI は，1.53×104/μL 及び 1.08×104/μL～1.98×104/μL であり，統計学的に有意な 差が認められた（p<0.001）. MMRM を用いた網状赤血球率の 52 週後のベースラインからの変化量の LSMean 及び その 95%CI は，MT-6548 群で 2.0‰及び 1.1‰～2.9‰，darbepoetin 群で -2.6‰及び -3.5‰ ～ -1.8‰であった．MMRM を用いた網状赤血球率の 52 週後のベースラインからの変化 量の MT-6548 群と darbepoetin 群の差の LSMean 及びその 95%CI は，4.6‰及び 3.4‰～ 5.9‰であり，統計学的に有意な差が認められた（p<0.001）. 1285 Page 463 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－145 平均赤血球容積のベースラインからの変化量（MMRM，FAS） 1286 Page 464 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－145 平均赤血球容積のベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―9 より引用 1287 Page 465 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－146 平均赤血球ヘモグロビン量のベースラインからの変化量（MMRM，FAS） 1288 Page 466 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－146 平均赤血球ヘモグロビン量のベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―10 より引用 1289 Page 467 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－147 ヘマトクリットのベースラインからの変化量（MMRM，FAS） 1290 Page 468 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－147 ヘマトクリットのベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―11 より引用 1291 Page 469 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－148 RBC のベースラインからの変化量（MMRM，FAS） 1292 Page 470 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－148 RBC のベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―12 より引用 1293 Page 471 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－149 網状赤血球数のベースラインからの変化量（MMRM，FAS） 1294 Page 472 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－149 網状赤血球数のベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―13 より引用 1295 Page 473 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－150 網状赤血球率のベースラインからの変化量（MMRM，FAS） 1296 Page 474 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－150 網状赤血球率のベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―14 より引用 1297 Page 475 of 1887 2.7.6 個々の試験のまとめ (10) EPO MMRM を用いた MT-6548 群の EPO のベースラインからの変化量を表 2.7.6.25－151， MT-6548 群の EPO の記述統計量を表 2.7.6.25－152 に示した．EPO は，全集団を対象に記 載した． MMRMを用いた EPO の52 週後のベースラインからの変化量の LSMean 及びその 95%CI は，MT-6548 群で -3.42 mIU/mL 及び -5.95～ -0.90 mIU/mL であった．MT-6548 群の EPO の平均値±SD は，ベースラインで 15.37±16.02 mIU/mL であり，52 週後は 10.88±12.52 mIU/mL であった．また，2 週～52 週後の EPO の最大値は 216.0 mIU/mL であった． 1298 Page 476 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－151 エリスロポエチンのベースラインからの変化量（MMRM，FAS） 5.3.5.1―8 表 11.4.1―15 より引用 表 2.7.6.25－152 エリスロポエチンの記述統計量（FAS） 5.3.5.1―8 表 11.4.1―16 より引用 1299 Page 477 of 1887 2.7.6 個々の試験のまとめ (11) 脂質関連評価項目 MMRM を用いた総コレステロール，LDL-C，HDL-C，LDL-C／HDL-C 比及び中性脂肪 のベースラインからの変化量を表 2.7.6.25－153，表 2.7.6.25－154，表 2.7.6.25－155，表 2.7.6.25－156 及び表 2.7.6.25－157 に示した．脂質関連評価項目は，全集団を対象に記載 した． MMRM を用いた総コレステロールの 52 週後のベースラインからの変化量の LSMean 及びその 95%CI は，MT-6548 群で 5.8 mg/dL 及び 1.5～10.1 mg/dL，darbepoetin 群で 5.1 mg/dL 及び 0.9～9.3 mg/dL であった．MMRM を用いた総コレステロールの 52 週後のベー スラインからの変化量の MT-6548 群と darbepoetin 群の差の LSMean 及びその 95%CI は， 0.7 mg/dL 及び -5.3～6.7 mg/dL であり，統計学的に有意な差は認められなかった. MMRM を用いた LDL-C の 52 週後のベースラインからの変化量の LSMean 及びその 95%CI は，MT-6548 群で 3.6 mg/dL 及び 0.2～7.1 mg/dL，darbepoetin 群で 1.5 mg/dL 及び -1.8～4.8 mg/dL であった．MMRM を用いた LDL-C の 52 週後のベースラインからの変化 量の MT-6548 群と darbepoetin 群の差の LSMean 及びその 95%CI は，2.2 mg/dL 及び -2.6 ～7.0 mg/dL であり，統計学的に有意な差は認められなかった. MMRM を用いた HDL-C の 52 週後のベースラインからの変化量の LSMean 及びその 95%CI は，MT-6548 群で -2.6 mg/dL 及び -4.2～ -1.0 mg/dL，darbepoetin 群で 2.6 mg/dL 及 び 1.1～4.1 mg/dL であった．MMRM を用いた HDL-C の 52 週後のベースラインからの変 化量の MT-6548 群と darbepoetin 群の差の LSMean 及びその 95%CI は，-5.2 mg/dL 及び -7.4～ -3.0 mg/dL であり，統計学的に有意な差が認められた（p<0.001）. MMRM を用いた LDL-C／HDL-C 比の 52 週後のベースラインからの変化量の LSMean 及びその 95%CI は，MT-6548 群で 0.13 及び 0.05～0.22，darbepoetin 群で -0.07 及び -0.15 ～0.01 であった．MMRM を用いた LDL-C／HDL-C 比の 52 週後のベースラインからの変 化量の MT-6548 群と darbepoetin 群の差の LSMean 及びその 95%CI は，0.20 及び 0.08～ 0.32 であり，統計学的に有意な差が認められた（p<0.001）. MMRM を用いた中性脂肪の 52 週後ベースラインからの変化量の LSMean 及びその 95%CI は，MT-6548 群で 13.0 mg/dL 及び 1.3～24.8 mg/dL，darbepoetin 群で -3.7 mg/dL 及 び -15.0～7.5 mg/dL であった．MMRM を用いた中性脂肪の 52 週後のベースラインから の変化量の MT-6548 群と darbepoetin 群の差の LSMean 及びその 95%CI は，16.8 mg/dL 及 び 0.5～33.0 mg/dL であり，統計学的に有意な差が認められた（p=0.043）. 1300 Page 478 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－153 総コレステロールのベースラインからの変化量（MMRM，FAS） 1301 Page 479 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－153 総コレステロールのベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―17 より引用 1302 Page 480 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－154 LDL-C のベースラインからの変化量（MMRM，FAS） 1303 Page 481 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－154 LDL-C のベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―18 より引用 1304 Page 482 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－155 HDL-C のベースラインからの変化量（MMRM，FAS） 1305 Page 483 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－155 HDL-C のベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―19 より引用 1306 Page 484 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－156 LDL-C／HDL-C 比のベースラインからの変化量（MMRM，FAS） 1307 Page 485 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－156 LDL-C／HDL-C 比のベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―20 より引用 1308 Page 486 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－157 中性脂肪のベースラインからの変化量（MMRM，FAS） 1309 Page 487 of 1887 2.7.6 個々の試験のまとめ 表 2.7.6.25－157 中性脂肪のベースラインからの変化量（MMRM，FAS）（続き） 5.3.5.1―8 表 11.4.1―21 より引用 1310 Page 488 of 1887 2.7.6 個々の試験のまとめ (12) 随時血糖 MMRM を用いた随時血糖のベースラインからの変化量を表 2.7.6.25－158 に示した． 随時血糖は，全集団を対象に記載した． MMRM を用いた随時血糖の 52 週後のベースラインからの変化量の LSMean 及びその 95%CI は，MT-6548 群で -9.6 mg/dL 及び -15.5～ -3.7 mg/dL，darbepoetin 群で -2.7 mg/dL 及び -8.3～2.9 mg/dL であった．MMRM を用いた随時血糖の 52 週後のベースラインから の変化量の MT-6548 群と darbepoetin 群の差の LSMean 及びその 95%CI は，-6.9 mg/dL 及 び -15.0～1.2 mg/dL であり，統計学的に有意な差は認められなかった.
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