Wednesday, April 11, 2018 10:50:39 PM 1

Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1037 End Stage Renal Disease 0 345

1040 End Stage Renal Disease 0 252

1041 End Stage Renal Disease 0 281

1042 End Stage Renal Disease 0 279

1043 End Stage Renal Disease 0 265

1044 End Stage Renal Disease 0 267

1045 End Stage Renal Disease 0 261

1046 End Stage Renal Disease 0 256

1047 End Stage Renal Disease 0 250

1037 End Stage Renal Disease 0.5 765

1040 End Stage Renal Disease 0.5 581

1041 End Stage Renal Disease 0.5 681

1042 End Stage Renal Disease 0.5 573

1043 End Stage Renal Disease 0.5 674

1044 End Stage Renal Disease 0.5 676

1045 End Stage Renal Disease 0.5 670

1046 End Stage Renal Disease 0.5 665

1047 End Stage Renal Disease 0.5 659

1037 End Stage Renal Disease 1 909

1040 End Stage Renal Disease 1 981

1041 End Stage Renal Disease 1 982

1042 End Stage Renal Disease 1 973

1043 End Stage Renal Disease 1 974

1044 End Stage Renal Disease 1 976

1045 End Stage Renal Disease 1 970

1046 End Stage Renal Disease 1 965

1047 End Stage Renal Disease 1 959

1037 End Stage Renal Disease 1.5 1079

1040 End Stage Renal Disease 1.5 1081

1041 End Stage Renal Disease 1.5 1082

1042 End Stage Renal Disease 1.5 1083

1043 End Stage Renal Disease 1.5 1084

1044 End Stage Renal Disease 1.5 1088

1045 End Stage Renal Disease 1.5 1085

1046 End Stage Renal Disease 1.5 1040

1047 End Stage Renal Disease 1.5 1045

1037 End Stage Renal Disease 2 978

 Wednesday, April 11, 2018 10:50:39 PM 2
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1040 End Stage Renal Disease 2 978

1041 End Stage Renal Disease 2 1001

1042 End Stage Renal Disease 2 996

1043 End Stage Renal Disease 2 1019

1044 End Stage Renal Disease 2 1042

1045 End Stage Renal Disease 2 950

1046 End Stage Renal Disease 2 952

1047 End Stage Renal Disease 2 957

1037 End Stage Renal Disease 3 878

1040 End Stage Renal Disease 3 878

1041 End Stage Renal Disease 3 901

1042 End Stage Renal Disease 3 896

1043 End Stage Renal Disease 3 919

1044 End Stage Renal Disease 3 942

1045 End Stage Renal Disease 3 755

1046 End Stage Renal Disease 3 757

1047 End Stage Renal Disease 3 762

1037 End Stage Renal Disease 4 750

1040 End Stage Renal Disease 4 750

1041 End Stage Renal Disease 4 773

1042 End Stage Renal Disease 4 768

1043 End Stage Renal Disease 4 791

1044 End Stage Renal Disease 4 814

1045 End Stage Renal Disease 4 722

1046 End Stage Renal Disease 4 724

1047 End Stage Renal Disease 4 729

1037 End Stage Renal Disease 6 677

1040 End Stage Renal Disease 6 677

1041 End Stage Renal Disease 6 700

1042 End Stage Renal Disease 6 695

1043 End Stage Renal Disease 6 718

1044 End Stage Renal Disease 6 741

1045 End Stage Renal Disease 6 699

1046 End Stage Renal Disease 6 701

1047 End Stage Renal Disease 6 706

1037 End Stage Renal Disease 8 623

1040 End Stage Renal Disease 8 623

 Wednesday, April 11, 2018 10:50:39 PM 3
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1041 End Stage Renal Disease 8 646

1042 End Stage Renal Disease 8 641

1043 End Stage Renal Disease 8 664

1044 End Stage Renal Disease 8 687

1045 End Stage Renal Disease 8 656

1046 End Stage Renal Disease 8 658

1047 End Stage Renal Disease 8 663

1037 End Stage Renal Disease 12 510

1040 End Stage Renal Disease 12 510

1041 End Stage Renal Disease 12 533

1042 End Stage Renal Disease 12 528

1043 End Stage Renal Disease 12 551

1044 End Stage Renal Disease 12 574

1045 End Stage Renal Disease 12 523

1046 End Stage Renal Disease 12 525

1047 End Stage Renal Disease 12 530

1037 End Stage Renal Disease 24 456

1040 End Stage Renal Disease 24 456

1041 End Stage Renal Disease 24 479

1042 End Stage Renal Disease 24 474

1043 End Stage Renal Disease 24 497

1044 End Stage Renal Disease 24 520

1045 End Stage Renal Disease 24 481

1046 End Stage Renal Disease 24 483

1047 End Stage Renal Disease 24 488

1037 End Stage Renal Disease 36 324

1040 End Stage Renal Disease 36 324

1041 End Stage Renal Disease 36 347

1042 End Stage Renal Disease 36 342

1043 End Stage Renal Disease 36 365

1044 End Stage Renal Disease 36 388

1045 End Stage Renal Disease 36 325

1046 End Stage Renal Disease 36 327

1047 End Stage Renal Disease 36 332

1037 End Stage Renal Disease 48 100

1040 End Stage Renal Disease 48 100

1041 End Stage Renal Disease 48 123

 Wednesday, April 11, 2018 10:50:39 PM 4
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1042 End Stage Renal Disease 48 118

1043 End Stage Renal Disease 48 141

1044 End Stage Renal Disease 48 164

1045 End Stage Renal Disease 48 101

1046 End Stage Renal Disease 48 103

1047 End Stage Renal Disease 48 108

1037 End Stage Renal Disease 72 72

1040 End Stage Renal Disease 72 72

1041 End Stage Renal Disease 72 95

1042 End Stage Renal Disease 72 90

1043 End Stage Renal Disease 72 113

1044 End Stage Renal Disease 72 136

1045 End Stage Renal Disease 72 56

1046 End Stage Renal Disease 72 58

1047 End Stage Renal Disease 72 63

1037 End Stage Renal Disease 96 3

1040 End Stage Renal Disease 96 8

1041 End Stage Renal Disease 96 31

1042 End Stage Renal Disease 96 26

1043 End Stage Renal Disease 96 49

1044 End Stage Renal Disease 96 72

1045 End Stage Renal Disease 96 0

1046 End Stage Renal Disease 96 2

1047 End Stage Renal Disease 96 7

1012 Mild Renal Impairment 0 400

1017 Mild Renal Impairment 0 400

1020 Mild Renal Impairment 0 420

1026 Mild Renal Impairment 0 425

1027 Mild Renal Impairment 0 427

1031 Mild Renal Impairment 0 427

1012 Mild Renal Impairment 0.5 500

1017 Mild Renal Impairment 0.5 530

1020 Mild Renal Impairment 0.5 505

1026 Mild Renal Impairment 0.5 555

1027 Mild Renal Impairment 0.5 557

1031 Mild Renal Impairment 0.5 499

1012 Mild Renal Impairment 1 1000

 Wednesday, April 11, 2018 10:50:39 PM 5
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1017 Mild Renal Impairment 1 1030

1020 Mild Renal Impairment 1 1025

1026 Mild Renal Impairment 1 625

1027 Mild Renal Impairment 1 627

1031 Mild Renal Impairment 1 621

1012 Mild Renal Impairment 1.5 1620

1017 Mild Renal Impairment 1.5 1622

1020 Mild Renal Impairment 1.5 1599

1026 Mild Renal Impairment 1.5 1605

1027 Mild Renal Impairment 1.5 1606

1031 Mild Renal Impairment 1.5 1585

1012 Mild Renal Impairment 2 1550

1017 Mild Renal Impairment 2 1555

1020 Mild Renal Impairment 2 1545

1026 Mild Renal Impairment 2 1553

1027 Mild Renal Impairment 2 1546

1031 Mild Renal Impairment 2 1571

1012 Mild Renal Impairment 3 1525

1017 Mild Renal Impairment 3 1530

1020 Mild Renal Impairment 3 1520

1026 Mild Renal Impairment 3 1528

1027 Mild Renal Impairment 3 1521

1031 Mild Renal Impairment 3 1546

1012 Mild Renal Impairment 4 1450

1017 Mild Renal Impairment 4 1455

1020 Mild Renal Impairment 4 1445

1026 Mild Renal Impairment 4 1453

1027 Mild Renal Impairment 4 1446

1031 Mild Renal Impairment 4 1471

1012 Mild Renal Impairment 6 1400

1017 Mild Renal Impairment 6 1405

1020 Mild Renal Impairment 6 1395

1026 Mild Renal Impairment 6 1403

1027 Mild Renal Impairment 6 1396

1031 Mild Renal Impairment 6 1421

1012 Mild Renal Impairment 8 1000

1017 Mild Renal Impairment 8 1005

 Wednesday, April 11, 2018 10:50:39 PM 6
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1020 Mild Renal Impairment 8 995

1026 Mild Renal Impairment 8 1003

1027 Mild Renal Impairment 8 996

1031 Mild Renal Impairment 8 1021

1012 Mild Renal Impairment 12 850

1017 Mild Renal Impairment 12 855

1020 Mild Renal Impairment 12 845

1026 Mild Renal Impairment 12 853

1027 Mild Renal Impairment 12 846

1031 Mild Renal Impairment 12 871

1012 Mild Renal Impairment 24 410

1017 Mild Renal Impairment 24 415

1020 Mild Renal Impairment 24 405

1026 Mild Renal Impairment 24 413

1027 Mild Renal Impairment 24 406

1031 Mild Renal Impairment 24 431

1012 Mild Renal Impairment 36 205

1017 Mild Renal Impairment 36 210

1020 Mild Renal Impairment 36 200

1026 Mild Renal Impairment 36 208

1027 Mild Renal Impairment 36 201

1031 Mild Renal Impairment 36 226

1012 Mild Renal Impairment 48 102

1017 Mild Renal Impairment 48 107

1020 Mild Renal Impairment 48 97

1026 Mild Renal Impairment 48 105

1027 Mild Renal Impairment 48 98

1031 Mild Renal Impairment 48 123

1012 Mild Renal Impairment 72 25

1017 Mild Renal Impairment 72 30

1020 Mild Renal Impairment 72 20

1026 Mild Renal Impairment 72 28

1027 Mild Renal Impairment 72 21

1031 Mild Renal Impairment 72 46

1012 Mild Renal Impairment 96 0

1017 Mild Renal Impairment 96 5

1020 Mild Renal Impairment 96 6

 Wednesday, April 11, 2018 10:50:39 PM 7
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1026 Mild Renal Impairment 96 3

1027 Mild Renal Impairment 96 7

1031 Mild Renal Impairment 96 32

1028 Moderate Renal Impairment 0 399

1029 Moderate Renal Impairment 0 404

1028 Moderate Renal Impairment 0.5 852

1029 Moderate Renal Impairment 0.5 896

1028 Moderate Renal Impairment 1 1745

1029 Moderate Renal Impairment 1 1747

1028 Moderate Renal Impairment 1.5 1500

1029 Moderate Renal Impairment 1.5 1625

1028 Moderate Renal Impairment 2 1450

1029 Moderate Renal Impairment 2 1525

1028 Moderate Renal Impairment 3 1350

1029 Moderate Renal Impairment 3 1475

1028 Moderate Renal Impairment 4 1300

1029 Moderate Renal Impairment 4 1400

1028 Moderate Renal Impairment 6 1250

1029 Moderate Renal Impairment 6 1201

1028 Moderate Renal Impairment 8 1000

1029 Moderate Renal Impairment 8 1010

1028 Moderate Renal Impairment 12 961.5

1029 Moderate Renal Impairment 12 966.5

1028 Moderate Renal Impairment 24 756

1029 Moderate Renal Impairment 24 750

1028 Moderate Renal Impairment 36 456

1029 Moderate Renal Impairment 36 457

1028 Moderate Renal Impairment 48 210

1029 Moderate Renal Impairment 48 200

1028 Moderate Renal Impairment 72 89

1029 Moderate Renal Impairment 72 15

1028 Moderate Renal Impairment 96 2

1029 Moderate Renal Impairment 96 9

1013 Normal Renal Function 0 325

1014 Normal Renal Function 0 333

1015 Normal Renal Function 0 324

1016 Normal Renal Function 0 233

 Wednesday, April 11, 2018 10:50:39 PM 8
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1018 Normal Renal Function 0 324

1019 Normal Renal Function 0 324

1021 Normal Renal Function 0 325

1022 Normal Renal Function 0 326

1023 Normal Renal Function 0 327

1024 Normal Renal Function 0 328

1025 Normal Renal Function 0 329

1030 Normal Renal Function 0 329

1032 Normal Renal Function 0 329

1038 Normal Renal Function 0 329

1013 Normal Renal Function 0.5 789

1014 Normal Renal Function 0.5 8.5

1015 Normal Renal Function 0.5 789

1016 Normal Renal Function 0.5 800

1018 Normal Renal Function 0.5 801

1019 Normal Renal Function 0.5 802

1021 Normal Renal Function 0.5 750

1022 Normal Renal Function 0.5 900

1023 Normal Renal Function 0.5 850

1024 Normal Renal Function 0.5 950

1025 Normal Renal Function 0.5 750

1030 Normal Renal Function 0.5 750

1032 Normal Renal Function 0.5 750

1038 Normal Renal Function 0.5 750

1013 Normal Renal Function 1 1111

1014 Normal Renal Function 1 1112

1015 Normal Renal Function 1 1111

1016 Normal Renal Function 1 1113

1018 Normal Renal Function 1 1110

1019 Normal Renal Function 1 1111

1021 Normal Renal Function 1 1111

1022 Normal Renal Function 1 1112

1023 Normal Renal Function 1 1114

1024 Normal Renal Function 1 1110

1025 Normal Renal Function 1 1113

1030 Normal Renal Function 1 1111

1032 Normal Renal Function 1 1112

 Wednesday, April 11, 2018 10:50:39 PM 9
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1038 Normal Renal Function 1 1110

1013 Normal Renal Function 1.5 1081

1014 Normal Renal Function 1.5 1082

1015 Normal Renal Function 1.5 1085

1016 Normal Renal Function 1.5 1073

1018 Normal Renal Function 1.5 1080

1019 Normal Renal Function 1.5 1081

1021 Normal Renal Function 1.5 1081

1022 Normal Renal Function 1.5 1622

1023 Normal Renal Function 1.5 1084

1024 Normal Renal Function 1.5 1622

1025 Normal Renal Function 1.5 1083

1030 Normal Renal Function 1.5 1081

1032 Normal Renal Function 1.5 1082

1038 Normal Renal Function 1.5 1080

1013 Normal Renal Function 2 1041

1014 Normal Renal Function 2 1042

1015 Normal Renal Function 2 1045

1016 Normal Renal Function 2 1033

1018 Normal Renal Function 2 1040

1019 Normal Renal Function 2 1041

1021 Normal Renal Function 2 1041

1022 Normal Renal Function 2 1560

1023 Normal Renal Function 2 1044

1024 Normal Renal Function 2 1046

1025 Normal Renal Function 2 1043

1030 Normal Renal Function 2 1041

1032 Normal Renal Function 2 1042

1038 Normal Renal Function 2 1040

1013 Normal Renal Function 3 991

1014 Normal Renal Function 3 992

1015 Normal Renal Function 3 995

1016 Normal Renal Function 3 983

1018 Normal Renal Function 3 990

1019 Normal Renal Function 3 991

1021 Normal Renal Function 3 991

1022 Normal Renal Function 3 1535

 Wednesday, April 11, 2018 10:50:39 PM 10
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1023 Normal Renal Function 3 994

1024 Normal Renal Function 3 996

1025 Normal Renal Function 3 993

1030 Normal Renal Function 3 991

1032 Normal Renal Function 3 992

1038 Normal Renal Function 3 990

1013 Normal Renal Function 4 931

1014 Normal Renal Function 4 932

1015 Normal Renal Function 4 935

1016 Normal Renal Function 4 923

1018 Normal Renal Function 4 930

1019 Normal Renal Function 4 931

1021 Normal Renal Function 4 931

1022 Normal Renal Function 4 1460

1023 Normal Renal Function 4 934

1024 Normal Renal Function 4 936

1025 Normal Renal Function 4 933

1030 Normal Renal Function 4 931

1032 Normal Renal Function 4 932

1038 Normal Renal Function 4 930

1013 Normal Renal Function 6 831

1014 Normal Renal Function 6 832

1015 Normal Renal Function 6 835

1016 Normal Renal Function 6 823

1018 Normal Renal Function 6 830

1019 Normal Renal Function 6 831

1021 Normal Renal Function 6 831

1022 Normal Renal Function 6 1410

1023 Normal Renal Function 6 834

1024 Normal Renal Function 6 836

1025 Normal Renal Function 6 833

1030 Normal Renal Function 6 831

1032 Normal Renal Function 6 832

1038 Normal Renal Function 6 830

1013 Normal Renal Function 8 721

1014 Normal Renal Function 8 721

1015 Normal Renal Function 8 724

 Wednesday, April 11, 2018 10:50:39 PM 11
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1016 Normal Renal Function 8 712

1018 Normal Renal Function 8 721

1019 Normal Renal Function 8 721

1021 Normal Renal Function 8 721

1022 Normal Renal Function 8 1010

1023 Normal Renal Function 8 721

1024 Normal Renal Function 8 726

1025 Normal Renal Function 8 721

1030 Normal Renal Function 8 721

1032 Normal Renal Function 8 721

1038 Normal Renal Function 8 721

1013 Normal Renal Function 12 605.5

1014 Normal Renal Function 12 606

1015 Normal Renal Function 12 609

1016 Normal Renal Function 12 597

1018 Normal Renal Function 12 605

1019 Normal Renal Function 12 605.5

1021 Normal Renal Function 12 605.5

1022 Normal Renal Function 12 860

1023 Normal Renal Function 12 607

1024 Normal Renal Function 12 610.5

1025 Normal Renal Function 12 606.5

1030 Normal Renal Function 12 605.5

1032 Normal Renal Function 12 606

1038 Normal Renal Function 12 605

1013 Normal Renal Function 24 302.75

1014 Normal Renal Function 24 303

1015 Normal Renal Function 24 306

1016 Normal Renal Function 24 294

1018 Normal Renal Function 24 302.5

1019 Normal Renal Function 24 302.75

1021 Normal Renal Function 24 302.75

1022 Normal Renal Function 24 420

1023 Normal Renal Function 24 303.5

1024 Normal Renal Function 24 307.75

1025 Normal Renal Function 24 303.25

1030 Normal Renal Function 24 302.75

 Wednesday, April 11, 2018 10:50:39 PM 12
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1032 Normal Renal Function 24 303

1038 Normal Renal Function 24 302.5

1013 Normal Renal Function 36 151.375

1014 Normal Renal Function 36 151.5

1015 Normal Renal Function 36 154.5

1016 Normal Renal Function 36 142.5

1018 Normal Renal Function 36 151.25

1019 Normal Renal Function 36 151.375

1021 Normal Renal Function 36 151.375

1022 Normal Renal Function 36 215

1023 Normal Renal Function 36 151.75

1024 Normal Renal Function 36 156.375

1025 Normal Renal Function 36 151.625

1030 Normal Renal Function 36 151.375

1032 Normal Renal Function 36 151.5

1038 Normal Renal Function 36 151.25

1013 Normal Renal Function 48 75.6875

1014 Normal Renal Function 48 75.75

1015 Normal Renal Function 48 78.75

1016 Normal Renal Function 48 66.75

1018 Normal Renal Function 48 75.625

1019 Normal Renal Function 48 75.6875

1021 Normal Renal Function 48 75.6875

1022 Normal Renal Function 48 112

1023 Normal Renal Function 48 75.875

1024 Normal Renal Function 48 80.6875

1025 Normal Renal Function 48 75.8125

1030 Normal Renal Function 48 75.6875

1032 Normal Renal Function 48 75.75

1038 Normal Renal Function 48 75.625

1013 Normal Renal Function 72 18.921875

1014 Normal Renal Function 72 18.9375

1015 Normal Renal Function 72 21.9375

1016 Normal Renal Function 72 9.9375

1018 Normal Renal Function 72 18.90625

1019 Normal Renal Function 72 18.921875

1021 Normal Renal Function 72 18.921875

 Wednesday, April 11, 2018 10:50:39 PM 13
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1022 Normal Renal Function 72 35

1023 Normal Renal Function 72 18.96875

1024 Normal Renal Function 72 23.921875

1025 Normal Renal Function 72 18.953125

1030 Normal Renal Function 72 18.921875

1032 Normal Renal Function 72 18.9375

1038 Normal Renal Function 72 18.90625

1013 Normal Renal Function 96 5

1014 Normal Renal Function 96 7

1015 Normal Renal Function 96 8

1016 Normal Renal Function 96 11

1018 Normal Renal Function 96 5

1019 Normal Renal Function 96 5

1021 Normal Renal Function 96 5

1022 Normal Renal Function 96 10

1023 Normal Renal Function 96 5

1024 Normal Renal Function 96 10

1025 Normal Renal Function 96 5

1030 Normal Renal Function 96 5

1032 Normal Renal Function 96 5

1038 Normal Renal Function 96 5

1033 Severe Renal Impairment 0 234

1034 Severe Renal Impairment 0 256

1035 Severe Renal Impairment 0 290

1036 Severe Renal Impairment 0 345

1039 Severe Renal Impairment 0 254

1033 Severe Renal Impairment 0.5 745

1034 Severe Renal Impairment 0.5 765

1035 Severe Renal Impairment 0.5 756

1036 Severe Renal Impairment 0.5 789

1039 Severe Renal Impairment 0.5 583

1033 Severe Renal Impairment 1 1234

1034 Severe Renal Impairment 1 1123

1035 Severe Renal Impairment 1 1156

1036 Severe Renal Impairment 1 907

1039 Severe Renal Impairment 1 983

1033 Severe Renal Impairment 1.5 1204

 Wednesday, April 11, 2018 10:50:39 PM 14
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1034 Severe Renal Impairment 1.5 1208

1035 Severe Renal Impairment 1.5 1209

1036 Severe Renal Impairment 1.5 1207

1039 Severe Renal Impairment 1.5 1207

1033 Severe Renal Impairment 2 987

1034 Severe Renal Impairment 2 982

1035 Severe Renal Impairment 2 986

1036 Severe Renal Impairment 2 977

1039 Severe Renal Impairment 2 985

1033 Severe Renal Impairment 3 912

1034 Severe Renal Impairment 3 907

1035 Severe Renal Impairment 3 911

1036 Severe Renal Impairment 3 902

1039 Severe Renal Impairment 3 885

1033 Severe Renal Impairment 4 876

1034 Severe Renal Impairment 4 871

1035 Severe Renal Impairment 4 875

1036 Severe Renal Impairment 4 866

1039 Severe Renal Impairment 4 757

1033 Severe Renal Impairment 6 811

1034 Severe Renal Impairment 6 806

1035 Severe Renal Impairment 6 810

1036 Severe Renal Impairment 6 801

1039 Severe Renal Impairment 6 684

1033 Severe Renal Impairment 8 712

1034 Severe Renal Impairment 8 707

1035 Severe Renal Impairment 8 711

1036 Severe Renal Impairment 8 702

1039 Severe Renal Impairment 8 630

1033 Severe Renal Impairment 12 678

1034 Severe Renal Impairment 12 673

1035 Severe Renal Impairment 12 677

1036 Severe Renal Impairment 12 668

1039 Severe Renal Impairment 12 517

1033 Severe Renal Impairment 24 602

1034 Severe Renal Impairment 24 604

1035 Severe Renal Impairment 24 605

 Wednesday, April 11, 2018 10:50:39 PM 15
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir

PatientID ReportingGroupArm Time PlasmaConcentration

1036 Severe Renal Impairment 24 603

1039 Severe Renal Impairment 24 463

1033 Severe Renal Impairment 36 144

1034 Severe Renal Impairment 36 143

1035 Severe Renal Impairment 36 135

1036 Severe Renal Impairment 36 139

1039 Severe Renal Impairment 36 331

1033 Severe Renal Impairment 48 77

1034 Severe Renal Impairment 48 76

1035 Severe Renal Impairment 48 68

1036 Severe Renal Impairment 48 72

1039 Severe Renal Impairment 48 107

1033 Severe Renal Impairment 72 23

1034 Severe Renal Impairment 72 21

1035 Severe Renal Impairment 72 13

1036 Severe Renal Impairment 72 17

1039 Severe Renal Impairment 72 79

1033 Severe Renal Impairment 96 4

1034 Severe Renal Impairment 96 2

1035 Severe Renal Impairment 96 3

1036 Severe Renal Impairment 96 2

1039 Severe Renal Impairment 96 15

 Wednesday, April 11, 2018 10:50:39 PM 16
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=End Stage Renal Disease Time=0

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 272.8889 29.1266 250.0000 345.0000

ReportingGroupArm=End Stage Renal Disease Time=0.5

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 660.4444 56.8465 573.0000 765.0000

ReportingGroupArm=End Stage Renal Disease Time=1

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 965.4444 22.3781 909.0000 982.0000

ReportingGroupArm=End Stage Renal Disease Time=1.5

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 1074.1111 18.1414 1040.0000 1088.0000

ReportingGroupArm=End Stage Renal Disease Time=2

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 985.8889 31.5652 950.0000 1042.0000

ReportingGroupArm=End Stage Renal Disease Time=3

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 854.2222 74.8060 755.0000 942.0000

ReportingGroupArm=End Stage Renal Disease Time=4

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 757.8889 31.5652 722.0000 814.0000

 Wednesday, April 11, 2018 10:50:39 PM 17
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=End Stage Renal Disease Time=6

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 701.5556 19.6984 677.0000 741.0000

ReportingGroupArm=End Stage Renal Disease Time=8

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 651.2222 20.5413 623.0000 687.0000

ReportingGroupArm=End Stage Renal Disease Time=12

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 531.5556 20.1315 510.0000 574.0000

ReportingGroupArm=End Stage Renal Disease Time=24

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 481.5556 19.7807 456.0000 520.0000

ReportingGroupArm=End Stage Renal Disease Time=36

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 341.5556 22.1648 324.0000 388.0000

ReportingGroupArm=End Stage Renal Disease Time=48

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 117.5556 22.1648 100.0000 164.0000

ReportingGroupArm=End Stage Renal Disease Time=72

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 83.8889 27.1360 56.0000 136.0000

 Wednesday, April 11, 2018 10:50:39 PM 18
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=End Stage Renal Disease Time=96

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

9 22.0000 24.9800 0.0000 72.0000

ReportingGroupArm=Mild Renal Impairment Time=0

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 416.5000 13.0346 400.0000 427.0000

ReportingGroupArm=Mild Renal Impairment Time=0.5

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 524.3333 27.0086 499.0000 557.0000

ReportingGroupArm=Mild Renal Impairment Time=1

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 821.3333 216.0506 621.0000 1030.0000

ReportingGroupArm=Mild Renal Impairment Time=1.5

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 1606.1667 13.7320 1585.0000 1622.0000

ReportingGroupArm=Mild Renal Impairment Time=2

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 1553.3333 9.4798 1545.0000 1571.0000

ReportingGroupArm=Mild Renal Impairment Time=3

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 1528.3333 9.4798 1520.0000 1546.0000

 Wednesday, April 11, 2018 10:50:39 PM 19
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=Mild Renal Impairment Time=4

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 1453.3333 9.4798 1445.0000 1471.0000

ReportingGroupArm=Mild Renal Impairment Time=6

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 1403.3333 9.4798 1395.0000 1421.0000

ReportingGroupArm=Mild Renal Impairment Time=8

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 1003.3333 9.4798 995.0000 1021.0000

ReportingGroupArm=Mild Renal Impairment Time=12

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 853.3333 9.4798 845.0000 871.0000

ReportingGroupArm=Mild Renal Impairment Time=24

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 413.3333 9.4798 405.0000 431.0000

ReportingGroupArm=Mild Renal Impairment Time=36

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 208.3333 9.4798 200.0000 226.0000

ReportingGroupArm=Mild Renal Impairment Time=48

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 105.3333 9.4798 97.0000 123.0000

 Wednesday, April 11, 2018 10:50:39 PM 20
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=Mild Renal Impairment Time=72

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 28.3333 9.4798 20.0000 46.0000

ReportingGroupArm=Mild Renal Impairment Time=96

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

6 8.8333 11.6175 0.0000 32.0000

ReportingGroupArm=Moderate Renal Impairment Time=0

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 401.5000 3.5355 399.0000 404.0000

ReportingGroupArm=Moderate Renal Impairment Time=0.5

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 874.0000 31.1127 852.0000 896.0000

ReportingGroupArm=Moderate Renal Impairment Time=1

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 1746.0000 1.4142 1745.0000 1747.0000

ReportingGroupArm=Moderate Renal Impairment Time=1.5

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 1562.5000 88.3883 1500.0000 1625.0000

ReportingGroupArm=Moderate Renal Impairment Time=2

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 1487.5000 53.0330 1450.0000 1525.0000

 Wednesday, April 11, 2018 10:50:39 PM 21
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=Moderate Renal Impairment Time=3

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 1412.5000 88.3883 1350.0000 1475.0000

ReportingGroupArm=Moderate Renal Impairment Time=4

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 1350.0000 70.7107 1300.0000 1400.0000

ReportingGroupArm=Moderate Renal Impairment Time=6

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 1225.5000 34.6482 1201.0000 1250.0000

ReportingGroupArm=Moderate Renal Impairment Time=8

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 1005.0000 7.0711 1000.0000 1010.0000

ReportingGroupArm=Moderate Renal Impairment Time=12

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 964.0000 3.5355 961.5000 966.5000

ReportingGroupArm=Moderate Renal Impairment Time=24

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 753.0000 4.2426 750.0000 756.0000

ReportingGroupArm=Moderate Renal Impairment Time=36

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 456.5000 0.7071 456.0000 457.0000

 Wednesday, April 11, 2018 10:50:39 PM 22
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=Moderate Renal Impairment Time=48

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 205.0000 7.0711 200.0000 210.0000

ReportingGroupArm=Moderate Renal Impairment Time=72

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 52.0000 52.3259 15.0000 89.0000

ReportingGroupArm=Moderate Renal Impairment Time=96

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

2 5.5000 4.9497 2.0000 9.0000

ReportingGroupArm=Normal Renal Function Time=0

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 320.3571 25.2788 233.0000 333.0000

ReportingGroupArm=Normal Renal Function Time=0.5

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 745.6786 220.6473 8.5000 950.0000

ReportingGroupArm=Normal Renal Function Time=1

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 1111.5000 1.2247 1110.0000 1114.0000

ReportingGroupArm=Normal Renal Function Time=1.5

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 1158.3571 196.4456 1073.0000 1622.0000

 Wednesday, April 11, 2018 10:50:39 PM 23
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=Normal Renal Function Time=2

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 1078.5000 138.6183 1033.0000 1560.0000

ReportingGroupArm=Normal Renal Function Time=3

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 1030.2857 145.2983 983.0000 1535.0000

ReportingGroupArm=Normal Renal Function Time=4

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 969.2143 141.2903 923.0000 1460.0000

ReportingGroupArm=Normal Renal Function Time=6

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 872.7857 154.6506 823.0000 1410.0000

ReportingGroupArm=Normal Renal Function Time=8

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 741.5714 77.3162 712.0000 1010.0000

ReportingGroupArm=Normal Renal Function Time=12

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 623.8571 68.0307 597.0000 860.0000

ReportingGroupArm=Normal Renal Function Time=24

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 311.1786 31.4596 294.0000 420.0000

 Wednesday, April 11, 2018 10:50:39 PM 24
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=Normal Renal Function Time=36

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 155.9107 17.2625 142.5000 215.0000

ReportingGroupArm=Normal Renal Function Time=48

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 78.2411 10.1589 66.7500 112.0000

ReportingGroupArm=Normal Renal Function Time=72

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 20.0067 5.2393 9.9375 35.0000

ReportingGroupArm=Normal Renal Function Time=96

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

14 6.5000 2.2787 5.0000 11.0000

ReportingGroupArm=Severe Renal Impairment Time=0

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 275.8000 43.6028 234.0000 345.0000

ReportingGroupArm=Severe Renal Impairment Time=0.5

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 727.6000 82.4427 583.0000 789.0000

ReportingGroupArm=Severe Renal Impairment Time=1

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 1080.6000 132.9259 907.0000 1234.0000

 Wednesday, April 11, 2018 10:50:39 PM 25
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=Severe Renal Impairment Time=1.5

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 1207.0000 1.8708 1204.0000 1209.0000

ReportingGroupArm=Severe Renal Impairment Time=2

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 983.4000 4.0373 977.0000 987.0000

ReportingGroupArm=Severe Renal Impairment Time=3

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 903.4000 11.0136 885.0000 912.0000

ReportingGroupArm=Severe Renal Impairment Time=4

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 849.0000 51.5800 757.0000 876.0000

ReportingGroupArm=Severe Renal Impairment Time=6

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 782.4000 55.1480 684.0000 811.0000

ReportingGroupArm=Severe Renal Impairment Time=8

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 692.4000 35.1041 630.0000 712.0000

ReportingGroupArm=Severe Renal Impairment Time=12

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 642.6000 70.3228 517.0000 678.0000

 Wednesday, April 11, 2018 10:50:39 PM 26
Clinical Trial NCT01830205: Observed Plasma Concentrations of Daclatasvir
ReportingGroupArm=Severe Renal Impairment Time=24

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 575.4000 62.8435 463.0000 605.0000

ReportingGroupArm=Severe Renal Impairment Time=36

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 178.4000 85.3803 135.0000 331.0000

ReportingGroupArm=Severe Renal Impairment Time=48

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 80.0000 15.5081 68.0000 107.0000

ReportingGroupArm=Severe Renal Impairment Time=72

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 30.6000 27.3276 13.0000 79.0000

ReportingGroupArm=Severe Renal Impairment Time=96

Analysis Variable : PlasmaConcentration

PlasmaConcentration

N Mean Std Dev Minimum Maximum

5 5.2000 5.5408 2.0000 15.0000

 Wednesday, April 11, 2018 10:50:39 PM 27

Clinical Trial NCT01830205: Mean Observed Plasma Concentrations of Daclatasvir

Vs. Time
1800
1700
1600
1500
Mean Observed Plasma Conc. of

1400
1300
Daclatasvir (ng/mL)

1200
1100
1000
900
800
700
600
500
400
300
200
100
0

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
Time (hours post-dose)

ReportingGroupArm
End Stage Renal Disease Mild Renal Impairment Moderate Renal Impairment
Normal Renal Function Severe Renal Impairment
 Wednesday, April 11, 2018 10:50:39 PM 28

Clinical Trial NCT01830205: Mean Observed Plasma Concentrations of Daclatasvir

Vs. Time
1800
Reporting Arm
1700
Mean Observed Plasma Conc. of Daclatasvir (ng/mL)
End Stage Renal Disease Mild Renal Impairment
1600 Moderate Renal Impairment Normal Renal Function
1500 Severe Renal Impairment
1400
1300
1200
1100
1000
900
800
700
600
500
400
300
200
100
0

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
Time (hours post-dose)
 Wednesday, April 11, 2018 10:50:39 PM 29

Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs.

Time
10
Reporting Arm
End Stage Renal Disease
Mild Renal Impairment
Moderate Renal Impairment
Normal Renal Function
Severe Renal Impairment
Natural Log of Mean (ng/mL)

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96
Time (hrs.)
 Wednesday, April 11, 2018 10:50:39 PM 30
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

Model Summary

Model Variables 2

Endogenous 1

Exogenous 1

Parameters 3

OutVars Variables 5

ID Variables 1

Equations 1

Number of Statements 23

Program Lag Length 1

Model Variables log_MeanPlasConc Time

Parameters intercept k tmax

Equations log_MeanPlasConc

The Equation to Estimate is

log_MeanPlasConc = F(intercept(1), k)

The estimation lag length (Lagexec) 1

 Wednesday, April 11, 2018 10:50:39 PM 31
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

OLS Estimation
ReportingGroupArm=End Stage Renal Disease

NOTE: At OLS Iteration 1 CONVERGE=0.001 Criteria Met.

Warning: At OLS Iteration 1 a total of 1 execution errors occurred for 1 observations.

 Wednesday, April 11, 2018 10:50:39 PM 32
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

OLS Estimation Summary

ReportingGroupArm=End Stage Renal Disease

Data Set Options

DATA= DACPHARMRDG686MEANSTABLOG

OUT= BIOSTATDATA

Minimization Summary

Parameters Estimated 2

Method Gauss

Iterations 1

Final Convergence Criteria

R 0

PPC 0

RPC(intercept) 66556.39

Object 0.996539

Trace(S) 0.147835

Objective Value 0.128124

Observations
Processed

Read 15

Solved 15

First 1

Last 15

Lagged 0
 Wednesday, April 11, 2018 10:50:39 PM 33
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=End Stage Renal Disease

Nonlinear OLS Summary of Residual Errors

DF DF Adj
Equation Model Error SSE MSE Root MSE R-Square R-Sq

log_MeanPlasConc 2 13 1.9219 0.1478 0.3845 0.8869 0.8782

Nonlinear OLS Parameter Estimates

Approx Approx
Parameter Estimate Std Err t Value Pr > |t|

intercept 6.722296 0.1230 54.65 <.0001

k 0.035033 0.00347 10.10 <.0001

Number of
Observations Statistics for System

Used 15 Objective 0.1281

Missing 0 Objective*N 1.9219

 Wednesday, April 11, 2018 10:50:39 PM 34
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=End Stage Renal Disease
 Wednesday, April 11, 2018 10:50:39 PM 35
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=End Stage Renal Disease
 Wednesday, April 11, 2018 10:50:39 PM 36
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

OLS Estimation
ReportingGroupArm=Mild Renal Impairment

NOTE: At OLS Iteration 1 CONVERGE=0.001 Criteria Met.

Warning: At OLS Iteration 1 a total of 1 execution errors occurred for 1 observations.

 Wednesday, April 11, 2018 10:50:39 PM 37
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

OLS Estimation Summary

ReportingGroupArm=Mild Renal Impairment

Data Set Options

DATA= DACPHARMRDG686MEANSTABLOG

OUT= BIOSTATDATA

Minimization Summary

Parameters Estimated 2

Method Gauss

Iterations 1

Final Convergence Criteria

R 0

PPC 0

RPC(intercept) 70463.68

Object 0.995187

Trace(S) 0.216331

Objective Value 0.187487

Observations
Processed

Read 15

Solved 15

First 16

Last 30

Lagged 0
 Wednesday, April 11, 2018 10:50:39 PM 38
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Mild Renal Impairment

Nonlinear OLS Summary of Residual Errors

DF DF Adj
Equation Model Error SSE MSE Root MSE R-Square R-Sq

log_MeanPlasConc 2 13 2.8123 0.2163 0.4651 0.9185 0.9123

Nonlinear OLS Parameter Estimates

Approx Approx
Parameter Estimate Std Err t Value Pr > |t|

intercept 7.116931 0.1488 47.83 <.0001

k 0.050815 0.00420 12.11 <.0001

Number of
Observations Statistics for System

Used 15 Objective 0.1875

Missing 0 Objective*N 2.8123

 Wednesday, April 11, 2018 10:50:39 PM 39
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Mild Renal Impairment
 Wednesday, April 11, 2018 10:50:39 PM 40
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Mild Renal Impairment
 Wednesday, April 11, 2018 10:50:39 PM 41
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

OLS Estimation
ReportingGroupArm=Moderate Renal Impairment

NOTE: At OLS Iteration 1 CONVERGE=0.001 Criteria Met.

Warning: At OLS Iteration 1 a total of 1 execution errors occurred for 1 observations.

 Wednesday, April 11, 2018 10:50:39 PM 42
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

OLS Estimation Summary

ReportingGroupArm=Moderate Renal Impairment

Data Set Options

DATA= DACPHARMRDG686MEANSTABLOG

OUT= BIOSTATDATA

Minimization Summary

Parameters Estimated 2

Method Gauss

Iterations 1

Final Convergence Criteria

R 0

PPC 0

RPC(intercept) 72436.43

Object 0.994183

Trace(S) 0.279057

Objective Value 0.241849

Observations
Processed

Read 15

Solved 15

First 31

Last 45

Lagged 0
 Wednesday, April 11, 2018 10:50:39 PM 43
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Moderate Renal Impairment

Nonlinear OLS Summary of Residual Errors

DF DF Adj
Equation Model Error SSE MSE Root MSE R-Square R-Sq

log_MeanPlasConc 2 13 3.6277 0.2791 0.5283 0.8951 0.8871

Nonlinear OLS Parameter Estimates

Approx Approx
Parameter Estimate Std Err t Value Pr > |t|

intercept 7.316179 0.1690 43.29 <.0001

k 0.050216 0.00477 10.53 <.0001

Number of
Observations Statistics for System

Used 15 Objective 0.2418

Missing 0 Objective*N 3.6277

 Wednesday, April 11, 2018 10:50:39 PM 44
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Moderate Renal Impairment
 Wednesday, April 11, 2018 10:50:39 PM 45
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Moderate Renal Impairment
 Wednesday, April 11, 2018 10:50:39 PM 46
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

OLS Estimation
ReportingGroupArm=Normal Renal Function

NOTE: At OLS Iteration 1 CONVERGE=0.001 Criteria Met.

Warning: At OLS Iteration 1 a total of 1 execution errors occurred for 1 observations.

 Wednesday, April 11, 2018 10:50:39 PM 47
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

OLS Estimation Summary

ReportingGroupArm=Normal Renal Function

Data Set Options

DATA= DACPHARMRDG686MEANSTABLOG

OUT= BIOSTATDATA

Minimization Summary

Parameters Estimated 2

Method Gauss

Iterations 1

Final Convergence Criteria

R 0

PPC 0

RPC(intercept) 68362.89

Object 0.996966

Trace(S) 0.126311

Objective Value 0.10947

Observations
Processed

Read 15

Solved 15

First 46

Last 60

Lagged 0
 Wednesday, April 11, 2018 10:50:39 PM 48
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Normal Renal Function

Nonlinear OLS Summary of Residual Errors

DF DF Adj
Equation Model Error SSE MSE Root MSE R-Square R-Sq

log_MeanPlasConc 2 13 1.6420 0.1263 0.3554 0.9537 0.9502

Nonlinear OLS Parameter Estimates

Approx Approx
Parameter Estimate Std Err t Value Pr > |t|

intercept 6.904752 0.1137 60.73 <.0001

k 0.05251 0.00321 16.37 <.0001

Number of
Observations Statistics for System

Used 15 Objective 0.1095

Missing 0 Objective*N 1.6420

 Wednesday, April 11, 2018 10:50:39 PM 49
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Normal Renal Function
 Wednesday, April 11, 2018 10:50:39 PM 50
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Normal Renal Function
 Wednesday, April 11, 2018 10:50:39 PM 51
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

OLS Estimation
ReportingGroupArm=Severe Renal Impairment

NOTE: At OLS Iteration 1 CONVERGE=0.001 Criteria Met.

Warning: At OLS Iteration 1 a total of 1 execution errors occurred for 1 observations.

 Wednesday, April 11, 2018 10:50:39 PM 52
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time

OLS Estimation Summary

ReportingGroupArm=Severe Renal Impairment

Data Set Options

DATA= DACPHARMRDG686MEANSTABLOG

OUT= BIOSTATDATA

Minimization Summary

Parameters Estimated 2

Method Gauss

Iterations 1

Final Convergence Criteria

R 0

PPC 0

RPC(intercept) 68203.58

Object 0.995384

Trace(S) 0.192977

Objective Value 0.167246

Observations
Processed

Read 15

Solved 15

First 61

Last 75

Lagged 0
 Wednesday, April 11, 2018 10:50:39 PM 53
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Severe Renal Impairment

Nonlinear OLS Summary of Residual Errors

DF DF Adj
Equation Model Error SSE MSE Root MSE R-Square R-Sq

log_MeanPlasConc 2 13 2.5087 0.1930 0.4393 0.9265 0.9209

Nonlinear OLS Parameter Estimates

Approx Approx
Parameter Estimate Std Err t Value Pr > |t|

intercept 6.888662 0.1405 49.02 <.0001

k 0.050762 0.00396 12.80 <.0001

Number of
Observations Statistics for System

Used 15 Objective 0.1672

Missing 0 Objective*N 2.5087

 Wednesday, April 11, 2018 10:50:39 PM 54
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Severe Renal Impairment
 Wednesday, April 11, 2018 10:50:39 PM 55
Natural Log of Mean Observed Plasma Concentrations of Daclatasvir (ng/mL) Vs. Time
ReportingGroupArm=Severe Renal Impairment
 Wednesday, April 11, 2018 10:50:39 PM 56
Clinical Trial NCT01830205: Pharmokinetic Data

Plasma
half-life
Elimination Area under Plasma (T-half)
Pharmacokinetic Rate Concentration-time of
ReportingGroupArm Statistics Constant k Curve (ng*hrs/mL) Daclatasvir

End Stage Renal Disease N 15.0000 13.00 15.0000

End Stage Renal Disease MIN 0.0350 296.05 19.7855

End Stage Renal Disease MAX 0.0350 626508.88 19.7855

End Stage Renal Disease MEAN 0.0350 161780.89 19.7855

End Stage Renal Disease STD 0.0000 225475.73 0.0000

Mild Renal Impairment N 15.0000 13.00 15.0000

Mild Renal Impairment MIN 0.0508 244.83 13.6407

Mild Renal Impairment MAX 0.0508 489706.54 13.6407

Mild Renal Impairment MEAN 0.0508 153294.55 13.6407

Mild Renal Impairment STD 0.0000 188376.91 0.0000

Moderate Renal Impairment N 15.0000 13.00 15.0000

Moderate Renal Impairment MIN 0.0502 472.51 13.8033

Moderate Renal Impairment MAX 0.0502 804914.75 13.8033

Moderate Renal Impairment MEAN 0.0502 235436.41 13.8033

Moderate Renal Impairment STD 0.0000 312812.04 0.0000

Normal Renal Function N 15.0000 13.00 15.0000

Normal Renal Function MIN 0.0525 338.12 13.2002

Normal Renal Function MAX 0.0525 359547.33 13.2002

Normal Renal Function MEAN 0.0525 112127.38 13.2002

Normal Renal Function STD 0.0000 138717.20 0.0000

Severe Renal Impairment N 15.0000 13.00 15.0000

Severe Renal Impairment MIN 0.0508 329.21 13.6549

Severe Renal Impairment MAX 0.0508 451720.60 13.6549

Severe Renal Impairment MEAN 0.0508 139057.11 13.6549

Severe Renal Impairment STD 0.0000 177632.91 0.0000

 Wednesday, April 11, 2018 10:50:39 PM 57
Clinical Trial NCT01830205: Maximum Observed Plasma Concentration (Cmax) of Daclatasvir

Time at
Maximum Maximum
Observed Observed
Plasma Plasma
Concentration Concentration
Obs Reporting Group Arm (Cmax) (Tmax)

1 End Stage Renal Disease 1074.11 1.5

2 Mild Renal Impairment 1606.17 1.5

3 Moderate Renal Impairment 1746.00 1

4 Normal Renal Function 1158.36 1.5

5 Severe Renal Impairment 1207.00 1.5