Sample 45

NCT: NCT01887600 Model: local-longctx-7b RAG: rag
Raw (original text) Processed (cleaned & structured)
Ground Truth
Prediction

Raw Ground Truth

Inclusion criteria:Subject has a diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not receiving dialysis; with an Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m^2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation.The mean of the subject's three most recent Hb values during the Screening period, obtained at least 4 days apart, must be less than or equal to 10.0 g/dL, with a difference of less than or equal to 1.0 g/dL between the highest and the lowest values. The last Hb value must be within 10 days prior to randomization.Subject has a ferritin level greater than or equal to 30 ng/mL (greater than or equal to 67.4 pmol/L) at screening.Subject has a transferrin saturation (TSAT) level greater than or equal to 5% at screening.Subject has a serum folate level greater than or equal to lower limit of normal at screening.Subject has a serum vitamin B12 level greater than or equal to lower limit of normal at screening.Subject's alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels are less than or equal to 3 x upper limit of normal (ULN), and total bilirubin (TBL) is less than or equal to 1.5 x ULN.Subject's body weight is 45.0 kg up to a maximum of 160.0 kg.Exclusion criteria:Subject has received any ESA treatment within 12 weeks prior to randomization.Subject has had more than one dose of IV iron within 12 weeks prior to randomization.Subject has received a RBC transfusion within 8 weeks prior to randomization.Subject has a known history of myelodysplastic syndrome or multiple myeloma.Subject has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD.Subject has a known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition.Subject has chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.Subject is anticipated to have elective surgery that is expected to lead to significant blood loss or anticipated elective coronary revascularization.Subject has active or chronic gastrointestinal bleeding.Subject has received any prior treatment with roxadustat or a hypoxia-inducible factor Prolyl Hydroxylase Inhibitor (HIF-PHI).Subject has been treated with iron-chelating agents within 4 weeks prior to randomization.Subject has a history of chronic liver disease (e.g., cirrhosis or fibrosis of the liver)Subject has a known New York Heart Association Class III or Intravenous (IV) congestive heart failure.Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12 weeks prior to randomization.Uncontrolled hypertension or two or more blood pressure (BP) values of systolic BP (SBP) greater than or equal to 160 mmHg or diastolic BP (DBP) greater than or equal to 95 mmHg confirmed by repeat measurement within 2 weeks prior to randomization.Subject has a diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category 2F or higher) of renal cell carcinoma on renal ultrasound within 12 weeks prior to randomization.Subject has a history of malignancy, except the following: cancers determined to be cured or in remission for greater than or equal to 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.Subject is positive for any of the following: Human Immunodeficiency Virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab).Subject has an active clinically significant infection manifested by White Blood Count (WBC) > ULN, and/or fever, in conjunction with clinical signs or symptoms of infection within one week prior to randomization.Subject has a known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration and retinal vein occlusion.Subject has had any prior organ transplant (that has not been explanted) or a scheduled organ transplantation.Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives or limit set by national law, whichever is longer, prior to the initiation of Screening.Subject has an anticipated use of dapsone in any dose amount or chronic use of acetaminophen (paracetamol) > 2.0 g/day during the treatment or follow-up period of the study.Subject has a history of alcohol or drug abuse within 2 years prior to randomization.

Raw Prediction

, and safety data. Safety Data: The primary safety endpoints are: 1. Incidence of Dose-Related Adverse Events (DRAEs) 2. Incidence of Death or serious AEs (SAEs) 3. Incidence of Non-Disproportionate AEs (NDAEs) 4. Incidence of Hb rebound (Hb >16.0 g/dL) 5. Incidence of Hb decrease (Hb <8.0 g/dL) 6. Incidence of Other Non-Serious Adverse Events (ONSAEs) 7. Incidence of Transferring to another study site 8. Incidence of Treatment-Related Death (TRD) 9. Incidence of TRD due to Hb-related causes 10. Incidence of TRD due to other causes 11. Incidence of Hb-related adverse events (HbAEs) 12. Incidence of Other Adverse Events (OAEs) 13. Incidence of Hb rebound (Hb >16.0 g/dL) 14. Incidence of Hb decrease (Hb <8.0 g/dL) 15. Incidence of Other Non-Serious Adverse Events (ONSAEs) 16. Incidence of TRD 17. Incidence of TRD due to Hb-related causes 18. Incidence of TRD due to other causes 19. Incidence of Hb-related adverse events (HbAEs) 20. Incidence of Other Adverse Events (OAEs) 21. Incidence of Hb rebound (Hb >16.0 g/dL) 22. Incidence of Hb decrease (Hb <8.0 g/dL) 23. Incidence of Other Non-Serious Adverse Events (ONSAEs) 24. Incidence of TRD 25. Incidence of TRD due to Hb-related causes 26. Incidence of TRD due to other causes 27. Incidence of Hb-related adverse events (HbAEs) 28. Incidence of Other Adverse Events (OAEs) 29. Incidence of Hb rebound (Hb >16.0 g/dL) 30. Incidence of Hb decrease (Hb <8.0 g/dL) 31. Incidence of Other Non-Serious Adverse Events (ONSAEs) 32. Incidence of TRD 33. Incidence of TRD due to Hb-related causes 34. Incidence of TRD due to other causes 35. Incidence of Hb-related adverse events (HbAEs) 36. Incidence of Other Adverse Events (OAEs) 37. Incidence of Hb rebound (Hb >16.0 g/dL) 38. Incidence of Hb decrease (Hb <8.0 g/dL) 39. Incidence of Other Non-Serious Adverse Events (ONSAEs) 40. Incidence of TRD 41. Incidence of TRD due to Hb-related causes 42. Incidence of TRD due to other causes 43. Incidence of Hb-related adverse events (HbAEs) 44. Incidence of Other Adverse Events (OAEs) 45. Incidence of Hb rebound (Hb >16.0 g/dL) 46. Incidence of Hb decrease (Hb <8.0 g/dL) 47. Incidence of Other Non-Serious Adverse Events (ONSAEs) 48. Incidence of TRD 49. Incidence of TRD due to Hb-related causes 50. Incidence of TRD due to other causes 51. Incidence of Hb-related adverse events (HbAEs) 52. Incidence of Other Adverse Events (OAEs) 53. Incidence of Hb rebound (Hb >16.0 g/dL) 54. Incidence of Hb decrease (Hb <8.0 g/dL) 55. Incidence of Other Non-Serious Adverse Events (ONSAEs) 56. Incidence of TRD 57. Incidence of TRD due to Hb-related causes 58. Incidence of TRD due to other causes 59. Incidence of Hb-related adverse events (HbAEs) 60. Incidence of Other Adverse Events (OAEs) 61. Incidence of Hb rebound (Hb >16.0 g/dL) 62. Incidence of Hb decrease (Hb <8.0 g/dL) 63. Incidence of Other Non-Serious Adverse Events (ONSAEs) 64. Incidence of TRD 65. Incidence of TRD due to Hb-related causes 66. Incidence of TRD due to other causes 67. Incidence of Hb-related adverse events (HbAEs) 68. Incidence of Other Adverse Events (OAEs) 69. Incidence of Hb rebound (Hb >16.0 g/dL) 70. Incidence of Hb decrease (Hb <8.0 g/dL) 71. Incidence of Other Non-Serious Adverse Events (ONSAEs) 72. Incidence of TRD 73. Incidence of TRD due to Hb-related causes 74. Incidence of TRD due to other causes 75. Incidence of Hb-related adverse events (HbAEs) 76. Incidence of Other Adverse Events (OAEs) 77. Incidence of Hb rebound (Hb >16.0 g/dL) 78. Incidence of Hb decrease (Hb <8.0 g/dL) 79. Incidence of Other Non-Serious Adverse Events (ONSAEs) 80. Incidence of TRD 81. Incidence of TRD due to Hb-related causes 82. Incidence of TRD due to other causes 83. Incidence of Hb-related adverse events (HbAEs) 84. Incidence of Other Adverse Events (OAEs) 85. Incidence of Hb rebound (Hb >16.0 g/dL) 86. Incidence of Hb decrease (Hb <8.0 g/dL) 87. Incidence of Other Non-Serious Adverse Events (ONSAEs) 88. Incidence of TRD 89. Incidence of TRD due to Hb-related causes 90. Incidence of TRD due to other causes 91. Incidence of Hb-related adverse events (HbAEs) 92. Incidence of Other Adverse Events (OAEs) 93. Incidence of Hb rebound (Hb >16.0 g/dL) 94. Incidence of Hb decrease (Hb <8.0 g/dL) 95. Incidence of Other Non-Serious Adverse Events (ONSAEs) 96. Incidence of TRD 97. Incidence of TRD due to Hb-related causes 98. Incidence of TRD due to other causes 99. Incidence of Hb-related adverse events (HbAEs) 100. Incidence of Other Adverse Events (OAEs) 101. Incidence of Hb rebound (Hb >16.0 g/dL) 102. Incidence of Hb decrease (Hb <8.0 g/dL) 103. Incidence of Other Non-Serious Adverse Events (ONSAEs) 104. Incidence of TRD 105. Incidence of TRD due to Hb-related causes 106. Incidence of TRD due to other causes 107. Incidence of Hb-related adverse events (HbAEs) 108. Incidence of Other Adverse Events (OAEs) 109. Incidence of Hb rebound (Hb >16.0 g/dL) 110. Incidence of Hb decrease (Hb <8.0 g/dL) 111. Incidence of Other Non-Serious Adverse Events (ONSAEs) 112. Incidence of TRD 113. Incidence of TRD due to Hb-related causes 114. Incidence of TRD due to other causes 115. Incidence of Hb-related adverse events (HbAEs) 116. Incidence of Other Adverse Events (OAEs) 117. Incidence of Hb rebound (Hb >16.0 g/dL) 118. Incidence of Hb decrease (Hb <8.0 g/dL) 119. Incidence of Other Non-Serious Adverse Events (ONSAEs) 120. Incidence of TR

Processed Ground Truth

INCLUSION CRITERIA:
1. Subject has a diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not receiving dialysis; with an Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m^2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation.The mean of the subject's three most recent Hb values during the Screening period, obtained at least 4 days apart, must be less than or equal to 10.0 g/dL, with a difference of less than or equal to 1.0 g/dL between the highest and the lowest values. The last Hb value must be within 10 days prior to randomization.Subject has a ferritin level greater than or equal to 30 ng/mL (greater than or equal to 67.4 pmol/L) at screening.Subject has a transferrin saturation (TSAT) level greater than or equal to 5% at screening.Subject has a serum folate level greater than or equal to lower limit of normal at screening.Subject has a serum vitamin B12 level greater than or equal to lower limit of normal at screening.Subject's alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels are less than or equal to 3 x upper limit of normal (ULN), and total bilirubin (TBL) is less than or equal to 1.5 x ULN.Subject's body weight is 45.0 kg up to a maximum of 160.0 kg.Exclusion criteria:Subject has received any ESA treatment within 12 weeks prior to randomization.Subject has had more than one dose of IV iron within 12 weeks prior to randomization.Subject has received a RBC transfusion within 8 weeks prior to randomization.Subject has a known history of myelodysplastic syndrome or multiple myeloma.Subject has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD.Subject has a known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition.Subject has chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.Subject is anticipated to have elective surgery that is expected to lead to significant blood loss or anticipated elective coronary revascularization.Subject has active or chronic gastrointestinal bleeding.Subject has received any prior treatment with roxadustat or a hypoxia-inducible factor Prolyl Hydroxylase Inhibitor (HIF-PHI).Subject has been treated with iron-chelating agents within 4 weeks prior to randomization.Subject has a history of chronic liver disease (e.g., cirrhosis or fibrosis of the liver)Subject has a known New York Heart Association Class III or Intravenous (IV) congestive heart failure.Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12 weeks prior to randomization.Uncontrolled hypertension or two or more blood pressure (BP) values of systolic BP (SBP) greater than or equal to 160 mmHg or diastolic BP (DBP) greater than or equal to 95 mmHg confirmed by repeat measurement within 2 weeks prior to randomization.Subject has a diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category 2F or higher) of renal cell carcinoma on renal ultrasound within 12 weeks prior to randomization.Subject has a history of malignancy, except the following: cancers determined to be cured or in remission for greater than or equal to 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.Subject is positive for any of the following: Human Immunodeficiency Virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab).Subject has an active clinically significant infection manifested by White Blood Count (WBC) > ULN, and/or fever, in conjunction with clinical signs or symptoms of infection within one week prior to randomization.Subject has a known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration and retinal vein occlusion.Subject has had any prior organ transplant (that has not been explanted) or a scheduled organ transplantation.Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives or limit set by national law, whichever is longer, prior to the initiation of Screening.Subject has an anticipated use of dapsone in any dose amount or chronic use of acetaminophen (paracetamol) > 2.0 g/day during the treatment or follow-up period of the study.Subject has a history of alcohol or drug abuse within 2 years prior to randomization.

Processed Prediction

INCLUSION CRITERIA:
1. , and safety data.
2. Safety Data: The primary safety endpoints are: 1.
3. Incidence of Dose-Related Adverse Events (DRAEs) 2.
4. Incidence of Death or serious AEs (SAEs) 3.
5. Incidence of Non-Disproportionate AEs (NDAEs) 4.
6. Incidence of Hb rebound (Hb >16.0 g/dL) 5.
7. Incidence of Hb decrease (Hb <8.0 g/dL) 6.
8. Incidence of Other Non-Serious Adverse Events (ONSAEs) 7.
9. Incidence of Transferring to another study site 8.
10. Incidence of Treatment-Related Death (TRD) 9.
11. Incidence of TRD due to Hb-related causes 10.
12. Incidence of TRD due to other causes 11.
13. Incidence of Hb-related adverse events (HbAEs) 12.
14. Incidence of Other Adverse Events (OAEs) 13.
15. Incidence of Hb rebound (Hb >16.0 g/dL) 14.
16. Incidence of Hb decrease (Hb <8.0 g/dL) 15.
17. Incidence of Other Non-Serious Adverse Events (ONSAEs) 16.
18. Incidence of TRD 17.
19. Incidence of TRD due to Hb-related causes 18.
20. Incidence of TRD due to other causes 19.
21. Incidence of Hb-related adverse events (HbAEs) 20.
22. Incidence of Other Adverse Events (OAEs) 21.
23. Incidence of Hb rebound (Hb >16.0 g/dL) 22.
24. Incidence of Hb decrease (Hb <8.0 g/dL) 23.
25. Incidence of Other Non-Serious Adverse Events (ONSAEs) 24.
26. Incidence of TRD 25.
27. Incidence of TRD due to Hb-related causes 26.
28. Incidence of TRD due to other causes 27.
29. Incidence of Hb-related adverse events (HbAEs) 28.
30. Incidence of Other Adverse Events (OAEs) 29.
31. Incidence of Hb rebound (Hb >16.0 g/dL) 30.
32. Incidence of Hb decrease (Hb <8.0 g/dL) 31.
33. Incidence of Other Non-Serious Adverse Events (ONSAEs) 32.
34. Incidence of TRD 33.
35. Incidence of TRD due to Hb-related causes 34.
36. Incidence of TRD due to other causes 35.
37. Incidence of Hb-related adverse events (HbAEs) 36.
38. Incidence of Other Adverse Events (OAEs) 37.
39. Incidence of Hb rebound (Hb >16.0 g/dL) 38.
40. Incidence of Hb decrease (Hb <8.0 g/dL) 39.
41. Incidence of Other Non-Serious Adverse Events (ONSAEs) 40.
42. Incidence of TRD 41.
43. Incidence of TRD due to Hb-related causes 42.
44. Incidence of TRD due to other causes 43.
45. Incidence of Hb-related adverse events (HbAEs) 44.
46. Incidence of Other Adverse Events (OAEs) 45.
47. Incidence of Hb rebound (Hb >16.0 g/dL) 46.
48. Incidence of Hb decrease (Hb <8.0 g/dL) 47.
49. Incidence of Other Non-Serious Adverse Events (ONSAEs) 48.
50. Incidence of TRD 49.
51. Incidence of TRD due to Hb-related causes 50.
52. Incidence of TRD due to other causes 51.
53. Incidence of Hb-related adverse events (HbAEs) 52.
54. Incidence of Other Adverse Events (OAEs) 53.
55. Incidence of Hb rebound (Hb >16.0 g/dL) 54.
56. Incidence of Hb decrease (Hb <8.0 g/dL) 55.
57. Incidence of Other Non-Serious Adverse Events (ONSAEs) 56.
58. Incidence of TRD 57.
59. Incidence of TRD due to Hb-related causes 58.
60. Incidence of TRD due to other causes 59.
61. Incidence of Hb-related adverse events (HbAEs) 60.
62. Incidence of Other Adverse Events (OAEs) 61.
63. Incidence of Hb rebound (Hb >16.0 g/dL) 62.
64. Incidence of Hb decrease (Hb <8.0 g/dL) 63.
65. Incidence of Other Non-Serious Adverse Events (ONSAEs) 64.
66. Incidence of TRD 65.
67. Incidence of TRD due to Hb-related causes 66.
68. Incidence of TRD due to other causes 67.
69. Incidence of Hb-related adverse events (HbAEs) 68.
70. Incidence of Other Adverse Events (OAEs) 69.
71. Incidence of Hb rebound (Hb >16.0 g/dL) 70.
72. Incidence of Hb decrease (Hb <8.0 g/dL) 71.
73. Incidence of Other Non-Serious Adverse Events (ONSAEs) 72.
74. Incidence of TRD 73.
75. Incidence of TRD due to Hb-related causes 74.
76. Incidence of TRD due to other causes 75.
77. Incidence of Hb-related adverse events (HbAEs) 76.
78. Incidence of Other Adverse Events (OAEs) 77.
79. Incidence of Hb rebound (Hb >16.0 g/dL) 78.
80. Incidence of Hb decrease (Hb <8.0 g/dL) 79.
81. Incidence of Other Non-Serious Adverse Events (ONSAEs) 80.
82. Incidence of TRD 81.
83. Incidence of TRD due to Hb-related causes 82.
84. Incidence of TRD due to other causes 83.
85. Incidence of Hb-related adverse events (HbAEs) 84.
86. Incidence of Other Adverse Events (OAEs) 85.
87. Incidence of Hb rebound (Hb >16.0 g/dL) 86.
88. Incidence of Hb decrease (Hb <8.0 g/dL) 87.
89. Incidence of Other Non-Serious Adverse Events (ONSAEs) 88.
90. Incidence of TRD 89.
91. Incidence of TRD due to Hb-related causes 90.
92. Incidence of TRD due to other causes 91.
93. Incidence of Hb-related adverse events (HbAEs) 92.
94. Incidence of Other Adverse Events (OAEs) 93.
95. Incidence of Hb rebound (Hb >16.0 g/dL) 94.
96. Incidence of Hb decrease (Hb <8.0 g/dL) 95.
97. Incidence of Other Non-Serious Adverse Events (ONSAEs) 96.
98. Incidence of TRD 97.
99. Incidence of TRD due to Hb-related causes 98.
100. Incidence of TRD due to other causes 99.
101. Incidence of Hb-related adverse events (HbAEs) 100.
102. Incidence of Other Adverse Events (OAEs) 101.
103. Incidence of Hb rebound (Hb >16.0 g/dL) 102.
104. Incidence of Hb decrease (Hb <8.0 g/dL) 103.
105. Incidence of Other Non-Serious Adverse Events (ONSAEs) 104.
106. Incidence of TRD 105.
107. Incidence of TRD due to Hb-related causes 106.
108. Incidence of TRD due to other causes 107.
109. Incidence of Hb-related adverse events (HbAEs) 108.
110. Incidence of Other Adverse Events (OAEs) 109.
111. Incidence of Hb rebound (Hb >16.0 g/dL) 110.
112. Incidence of Hb decrease (Hb <8.0 g/dL) 111.
113. Incidence of Other Non-Serious Adverse Events (ONSAEs) 112.
114. Incidence of TRD 113.
115. Incidence of TRD due to Hb-related causes 114.
116. Incidence of TRD due to other causes 115.
117. Incidence of Hb-related adverse events (HbAEs) 116.
118. Incidence of Other Adverse Events (OAEs) 117.
119. Incidence of Hb rebound (Hb >16.0 g/dL) 118.
120. Incidence of Hb decrease (Hb <8.0 g/dL) 119.
121. Incidence of Other Non-Serious Adverse Events (ONSAEs) 120.
122. Incidence of TR
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