[c09aa8]: / clusters / ordered9kclusters / clust_681.txt

Download this file

139 lines (138 with data), 8.2 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
Child-Pugh score A within 14 days prior to study entry
Patient with a Child-Pugh score B or C
Child-Pugh Score 5 or 6
Child-Pugh score A
Patient with a Child-Pugh score B or C
Child-Pugh score A or B7
Patients with chronic liver disease with a Child-Pugh score B or C
Severe liver dysfunction (Child-Pugh Class B or C) is not present; and
Child Pugh score A5, A6, B7 or B8
Child Pugh score B9 or C10
Child-Pugh Score class A
Child-Pugh class A
Patient with a Child-Pugh score B or C
Child-Pugh score of A
Patient with a Child-Pugh score B or C
Child Pugh B or C stage liver disease
Child Pugh B or C disease
Patients with liver disease classified as Child Pugh class A or B, with score =< 9
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Child-Pugh score > 7
Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known underlying liver dysfunction
Chronic liver disease, Child-Pugh class B or C
Child-Pugh score A
Child-Pugh score of A. A score of B7 is allowed without severe ascites or without hepatic encephalopathy.
Child Pugh A score 5 or 6 liver function
Impaired liver function Child-Pugh class B or C (score 7-15).
Subjects must have a Child-Turcotte-Pugh (CTP) score =< 7 to be eligible
Child-Pugh class B and C liver failure
Child-Pugh score of A
Subjects with severe hepatic insufficiency Child-Pugh score > 6
Child-Pugh scores 5-7
Obtained with 21 days of registration: Child Pugh class A (5-6 points) or B (7 points)
Child Pugh class B (8,9) and class C are excluded.
Child-Pugh class-A liver function
Patients with Child Pugh B or C liver failure will be excluded
Subject with a Child-Pugh score B or C.
Patient with a Child-Pugh score B or C
Child-Pugh class A or B7 liver function
Obtained =< 14 days prior to registration: If baseline liver disease, Child Pugh score not exceeding class A
Child-Pugh A or B7
Have a Child-Pugh A liver score within 7 days of first dose of study drug
Child-Pugh cirrhotic status A or B with a score of 7
Child Pugh class B & C
Patients with severe chronic liver disease (Child-Pugh score > 10)
Child-Pugh score 8 or greater
Patient with a Child-Pugh score B or C
Several hepatic impairments, define as Child-Pugh Class C or worse
Child-Pugh class A or B7 without ascites
Child-Pugh score of A
Child-Pugh score must be A to B7.
Must have Child-Pugh A or B liver disease
Child-Pugh C liver function
Subject has hepatic decompensation (Child-Pugh score > 6 [class B and C])
The Child Pugh score must be 5 or 6 (Child Pugh class A)
Patients with Child-Pugh A and Child-Pugh B7 (if due to low albumin but not elevated international normalized ratio [INR] or bilirubin) cirrhosis are allowed; Child-Pugh Turcot (CPT) Classification System score will be based upon INR, total bilirubin and serum albumin, as well as the presence/absence of ascites and hepatic encephalopathy
Child-Pugh B (except Child-Pugh B7 due to low albumin) or Child-Pugh C cirrhosis
Child Pugh score A or B
Child-Pugh status C
Child-Pugh Class A without either current encephalopathy or ascites.
Child-Turcotte-Pugh Classification A or B
Child-Pugh Class A
Cirrhotic status of Child-Pugh class A or B
Child-Pugh score A
Adequate hepatic function for squamous cell NSCLC patients, as defined per protocol. For HCC patients: Child-Pugh score ?6 and Model for End-Stage Liver Disease (MELD) score?15
Adequate hepatic function for squamous cell NSCLC patients, as defined per protocol. For HCC patients: Child-Pugh score ?6 and Model for End-Stage Liver Disease (MELD) score?15
Liver disease with Child-Pugh class B or C liver dysfunction
Has hepatic decompensation (Child-Pugh score > 6; = class B and C)
HCC patients only: Child Pugh class A or B7 liver disease
Must have Child-Turcotte-Pugh (CTP) A or B7
Patient with severe liver impairment (Child Pugh score B/C)
ARM B: Child Pugh Score A
Subjects with known hepatic insufficiency (i.e. Child-Pugh score A [mild], Child-Pugh score B [moderate] or Child-Pugh score C [severe]) according to Child-Pugh criteria
Patient with a Child-Pugh score B or C
Subject is classified into Child-Pugh class C
Child-Pugh score of A or B with =< 7 points and meeting laboratory eligibility for all parameters
Has a Child-Pugh Class A liver score within 7 days of first dose of study drug.
Child-Pugh Score of A.
Patients with Child pugh score B or C
Patients with Child-Pugh A-C liver disease
Subject is classified into Child-Pugh class C
Subject has Child-Pugh score of ?6, i.e., Child-Pugh A (Appendix 2);
Patient with a Child-Pugh score B or C
Child-Pugh Class A
Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less
Patients with hepatocellular carcinoma may be eligible provided they have total bilirubin ? 3.0 x ULN and are considered Child-Pugh Class A or Child-Pugh Class B7 (Child-Pugh Class B with a total Child-Pugh score not to exceed 7).
Child Pugh score ? 7 points
Has a Child-Pugh Class A liver score within 7 days of first dose of study drug
Child-Pugh score A
Patients with liver disease Child Pugh classification B and C.
Child-Pugh score of 10-15 (Class C)
Patient with Child-Pugh score B or C
Preserved liver function (Child-Pugh class A or B)
Child Pugh score =< 10
Subject has hepatic function status of Child Pugh Class A at Screening.
Subject has status of Child-Pugh Class B or C at Screening.
Child Pugh B and C
Child-Pugh class A
Child-Pugh score =< 7 (Child A-B)
Child-Pugh liver function class A
Child Pugh score =< 10
Child-Pugh Stage: A or B7 for Parts A & B, A for Part C, and D
Child-Pugh Class A or B.
Subject has Child-Pugh score of less than 7 (ie, class A or better) with neither encephalopathy nor clinically significant ascites (ascites requiring paracentesis within 3 months of signing the ICF is excluded). Child-Pugh status is calculated based on clinical findings and laboratory results during the screening period.
Serum albumin of at least 2.8 g/dL Note: Laboratories in combination must still be Child Pugh score less than 7 Other laboratory parameters:
Decompensated liver disease (Child-Pugh score > 6) or active or past auto-immune hepatitis
Child Pugh Class A disease
Child Pugh A
For patients with hepatocellular carcinoma only, Child-Pugh Class A (score 5-6) disease. Score for hepatic encephalopathy must be 1; the score for ascites must be no greater than 2 and clinically irrelevant; for the determination of the Child-Pugh Class.
Child-Pugh class A with no clinically apparent ascites
Child-Pugh class of A
Child-Pugh Class B and C.
Hepatic function with a score of < 7 points according to the Child-Pugh System
Subjects with impaired hepatic function will be grouped according to Child-Pugh classification score
Child Pugh Class A liver function score
Cirrhotic status of Child-Pugh grade A. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix B). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a <1.7 baseline PT/INR.
Child-Pugh Classification A (see Appendix D)
Child-Pugh Score A (5-6)
Child-Pugh B-C cirrhotic status based on clinical findings and laboratory results
Must be Child-Pugh class A a. Patients with uncontrolled massive ascites or presence of hepatic encephalopathy are excluded
Significant liver dysfunction determined as Child-Pugh score B or C
Child Pugh class A or B7 liver disease
ECOG PS 0 or 1; Child-Pugh Cirrhotic Status A or B with a score of 7;
Child-Pugh Class A.
Child-Pugh Class A in the absence of hepatoencephalopathy or clinically evident ascites
Hepatic function with a score of 7-9 points according to the Child-Pugh System
Child Pugh class A liver function or class B7
Patients with Child Pugh liver function worse than B7
Subjects with severe hepatic insufficiency (Child Pugh score > 9)
Severe liver impairment (Child-Pugh score > 9)
Child-Pugh Score of up to B7
Child-Pugh score of up to B7
Child-Pugh score A
Child-Pugh category A
Child-Pugh score <7 (Child-Pugh Class A).
Child-Pugh class B and C liver failure
Child Pugh A or B
Child-Pugh A/B
Child-Pugh liver function Class B or C.
Child-Pugh score ? 6