[c09aa8]: / clusters / 9knumclustersv2 / clust_1517.txt

Download this file

80 lines (79 with data), 7.2 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
Laboratory values adequate for patient to undergo surgery, including:
Screening laboratory values must meet the following criteria and should be obtained within days (or days if a biopsy is repeated) prior to study treatment:
Laboratory values at the Screening Visit:
Must have the following laboratory values, obtained less than or equal to days prior to registration:
Patients must have normal laboratory values as defined below:
Screening laboratory values must meet the following criteria:
Adequate safety laboratory values:
The following required Initial Laboratory Values should be obtained within weeks of the start of treatment:
Subject has the following laboratory values at Screening:
Most recent laboratory values within weeks prior to Week Day (WD) meet the following standards:
Laboratory values must be no older than seven () days prior to the start of therapy; if a test that is repeated after registration and prior to therapy is outside the limits for eligibility, it must be rechecked within hours prior to the start of therapy; if laboratory values still fail to meet eligibility criteria, the patient may not receive protocol therapy
Impaired hepatic or renal function as demonstrated by any of the following laboratory values:
Screening chemistry values of the following:
Adequate baseline laboratory values collected within days of starting the study treatment
Patients with abnormal laboratory values, defined as any of the following:
Have laboratory values (obtained ? days prior to first infusion day) in accordance with the study protocol
Serum biochemical values with the following limits unless considered due to leukemia:
Adequate baseline laboratory values collected no more than days before starting study treatment
Serum biochemical values with the following limits unless considered due to leukemia:
The following laboratory values must be documented within days prior to the first dose of study drug:
Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma)
Baseline hematology laboratories will be performed prior to registration, the patient can be enrolled in the trial if laboratory values are deemed clinically acceptable by treating physician
Supranormal values judged to be of benign or inconsequential etiology will be acceptable
Screening hematology values of the following:
Screening chemistry values of the following:
Adequate hematology laboratory values at Cycle Day pre-dosing defined as follows:
Patient must meet required laboratory values at the screening
Adequate liver and renal function and hematology laboratory values
- Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.
Screening laboratory values:
RENAL COHORT: Laboratory values as follows within days before the first dose of daratumumab: platelets ? ,/mm^
RENAL COHORT: Laboratory values as follows within days before the first dose of daratumumab: hemoglobin ? g/dL
RENAL COHORT: Laboratory values as follows within days before the first dose of daratumumab: serum albumin ? . g/dl
RENAL COHORT: Laboratory values as follows within days before the first dose of daratumumab: calcium ? LLN
RENAL COHORT: Laboratory values as follows within days before the first dose of daratumumab: magnesium ? LLN
RENAL COHORT: Laboratory values as follows within days before the first dose of daratumumab: potassium ? LLN
Adequate laboratory values;
Subject has the following laboratory values at screening:
Abnormal laboratory values (unless due to underlying lymphoma)
Standard -lead ECG values defined as the mean of the triplicate ECGs and assessed by the central laboratory.
Clinical laboratory values within the following parameters (repeat within days before the first dose of study drug if laboratory values used for randomization were obtained more than days before the first dose of study drug):
Baseline laboratory values as follows:
Patients with the following laboratory values during screening and on Day predose:
Screening laboratory values must meet the following criteria and should be obtained within days ( if biopsy is repeated) prior to study treatment:
Laboratory values as follows at screening and within days of planned first dose of therapy:
The following laboratory values:
Patients with abnormal laboratory values during screening and on day of pre-dose
Screening laboratory values should be used to confirm subject eligibility. Laboratory results may be retested if necessary to confirm eligibility.
Hematology and biochemical values within protocol-defined limits
The patient has adequate serum chemistry levels, evidenced by the following laboratory values
Laboratory values fulfilling the following:
Hematology and biochemical values within protocol-defined limits
Patients with abnormal laboratory values as defined by the protocol
Adequate organ functions as indicated by the following laboratory values (based on screening visit values from the central laboratory).
Laboratory values obtained ? days prior to randomization:
Meeting the following laboratory values:
Systemic disease must be such that laboratory values are within . x normal
Any of the following baseline laboratory values:
Patients must have the following baseline laboratory values:
All baseline laboratory requirements will be assessed and should be obtained within days of first dose of study drug. Screening laboratory values must meet the following criteria:
Laboratory values and anticoagulation management per consensus guidelines, including:
Required screening laboratory values as described in the protocol
Patients with any of the following laboratory values at Screening/baseline
Laboratory values fulfilling the following:
Adequate hematology, hepatic and renal function laboratory values within days prior to first dose of study drug.
Adequate hematology, liver and renal function laboratory values within days prior to first dose of study treatment.
No platelet or blood transfusions within two weeks of obtaining baseline laboratory values
Screening laboratory values:
Abnormal serum chemistry or hematology laboratory values
Laboratory values fulfilling the following:
Patients must have clinical laboratory values meeting the following criteria within days prior to registration:
Patients whose laboratory values do not meet protocol criteria
Laboratory values obtained =< * days prior to registration:\r\n* Note: Without medical situations that should change these parameters since they were done
sustained clinically-significant worsening (investigator's assessment) from baseline granulocyte, platelet, or hemoglobin values (? values, separated by ? weeks)
Subjects must have the following laboratory values:
Subjects must have the following laboratory values at screening within weeks of the first dose of investigational agents:
Most recent laboratory values (within weeks prior to Week Day (WD)) before study entry meet the following standards:
The patient has hepatic dysfunction confirmed by bilirubin > x normal (based on reference values from the laboratory used by the patient)
Subjects must have the following screening laboratory values: