[c09aa8]: / clusters / 3009knumclusters / clust_166.txt

Download this file

669 lines (668 with data), 128.8 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
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353
354
355
356
357
358
359
360
361
362
363
364
365
366
367
368
369
370
371
372
373
374
375
376
377
378
379
380
381
382
383
384
385
386
387
388
389
390
391
392
393
394
395
396
397
398
399
400
401
402
403
404
405
406
407
408
409
410
411
412
413
414
415
416
417
418
419
420
421
422
423
424
425
426
427
428
429
430
431
432
433
434
435
436
437
438
439
440
441
442
443
444
445
446
447
448
449
450
451
452
453
454
455
456
457
458
459
460
461
462
463
464
465
466
467
468
469
470
471
472
473
474
475
476
477
478
479
480
481
482
483
484
485
486
487
488
489
490
491
492
493
494
495
496
497
498
499
500
501
502
503
504
505
506
507
508
509
510
511
512
513
514
515
516
517
518
519
520
521
522
523
524
525
526
527
528
529
530
531
532
533
534
535
536
537
538
539
540
541
542
543
544
545
546
547
548
549
550
551
552
553
554
555
556
557
558
559
560
561
562
563
564
565
566
567
568
569
570
571
572
573
574
575
576
577
578
579
580
581
582
583
584
585
586
587
588
589
590
591
592
593
594
595
596
597
598
599
600
601
602
603
604
605
606
607
608
609
610
611
612
613
614
615
616
617
618
619
620
621
622
623
624
625
626
627
628
629
630
631
632
633
634
635
636
637
638
639
640
641
642
643
644
645
646
647
648
649
650
651
652
653
654
655
656
657
658
659
660
661
662
663
664
665
666
667
668
Within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Within 2 weeks prior to registration: Subject has prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) test =< 1.3 x the laboratory upper limit of normal (ULN)
International normalized ratio of prothrombin time (INR) and prothrombin time (PT) must be =< 1.5 x ULN for the lab within 28 days before randomization; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history
Prothrombin time (PT)/ international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN
Patients must have the following tests within 28 days prior to registration to obtain baseline measurements:\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR)/fibrinogen (all patients)\r\n* Neurologic assessment
Within 10 days of treatment initiation: Prothrombin time (PT) and partial thromboplastin time (aPTT) =< 1.5 X institutional upper limit of normal (IULN)
Within 21 days of treatment initiation:\r\nInternational normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x upper limit of normal (ULN); subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization
PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
Partial thromboplastin time (PTT) / prothrombin time (PT) =< 1.5 x ULN or international normalized ratio (INR) < 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose.
Prothrombin time, international normalized ratio (INR), and/or activated partial thromboplastin time within =< 1.5 x ULN (for treatment phase)
International Normalized Ratio (INR) or Prothrombin Time (PT) ?1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 14 days of treatment initiation)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT/INR/ partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants obtained within 14 days prior to registration
Within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (up to 14 days before treatment initiation)
International normalized ratio (INR)/ prothrombin time (PT) =< 1.5 x institutional ULN unless subject is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN
Within 14 days of treatment initiation:\r\nInternational normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Any of the following abnormal laboratory values (unless due to underlying lymphoma): International normalized ratio (INR) or prothrombin time (PT) >1.5*upper limit of normal (ULN) in the absence of therapeutic anticoagulation; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) >1.5*ULN in the absence of a lupus anticoagulant
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Patients must have adequate coagulation function as evidenced by prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR) within normal institutional limits
International normalized ratio (INR)/prothrombin time (PT) =< 1.5 times ULN unless participant is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
FOR SECOND-LINE THERAPY ONLY: Prothrombin time and partial thromboplastin time (PTT) must be =< 2 X the upper limit of the institution's normal range and INR (international normalized ratio) < 2; subjects on anticoagulation (such as coumadin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 14 days of treatment initiation
COHORT 1: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation
COHORT 2: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 2 times normal; timeline: within 3 weeks prior to enrollment or
SAFETY RUN-IN: Within 10 days of registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
RANDOMIZED PHASE II CLINICAL TRIAL: Within 10 days of registration: International normalized ratio (INR) or PT =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Patients must have adequate coagulation (international normalized ratio (INR) or prothrombin time (PT), partial thromboplastin time (PTT) ?1.5 times ULN)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR)* =< 1.3 x upper limit of normal (ULN)\r\n* Subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization; PT and partial thromboplastin time (PTT) > 1.5 x ULN are permitted in these subjects
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of cabozantinib
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN)
Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control
Prothrombin time (PT) / partial thromboplastin time (PTT); PT such that international normalized ratio (INR) =< 1.5 x ULN (unless a patient is on therapeutic warfarin) or a PTT =< 1.5 x ULN
Abnormal coagulation profile (PT or INR, PTT) > 1.3x ULN
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulant.
Within 10 (except as noted) days of planned treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN, unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULN unless subject is receiving anticoagulation therapy as long as PT or INR is within therapeutic range of intended use of anticoagulant within 28 days of treatment initiation and must be independent of hematopoietic growth factor support
International normalized ratio or prothrombin time =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.
Prothrombin time (PT)/partial thromboplastin time (PTT) ? 1.2 × ULN (unless receiving anticoagulation therapy, if receiving anticoagulation therapy, eligibility will be based upon international normalized ratio [INR]).
Partial thromboplastin (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit
Obtained within 28 days prior to registration: International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5
International normalized ratio (INR) or prothrombin rime (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
Within 14 days of treatment registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) < 1.5 times the upper limit of normal unless subject is receiving anticoagulant therapy, as long as PT or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants
INCLUSION - PROCUREMENT: If pheresis required to collect blood\r\n* Prothrombin time (PT) and activated partial thromboplastin time (APTT) <1.5 × upper limit normal
For patients with planned deep tumor injections: prothrombin time (PT), activated partial thromboplastin time (aPPT), and international normalized ratio (INR) within normal limits; Platelet count ?100,000/?L; hemoglobin ? 9 gm/dL.
International normalized ratio (INR) or prothrombin time (PT) < 1.5 times the upper limit of normal unless subject is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin and a partial thromboplastin time (PTT) =< upper limit of normal
Adequate Coagulation defined as prothrombin time (PT) and partial thromboplastin time (PTT) <= 1.2 x upper limit of normal and an international normalized ratio (INR) <= 1.2.
The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
Adequate coagulation function, defined by prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT), or thrombin time (TT) of ?1.5 × ULN
International normalized ratio (INR) or prothrombin time (PT) < 1.5 times the upper limit of normal unless subject is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN
International normalized ratio (INR) ? 1.5 and partial thromboplastin time (PTT) ? 1.5 x ULN. Prothrombin time (PT) may be used instead of INR if ? 1.5 x ULN.
PT and PTT <1.5 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 14 days of treatment initiation
Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (for patients on warfarin, INR should be maintained within therapeutic limits (either 2-3 or 2.5-3.5 for heart valve patients)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation
Prothrombin time/International Normalized Ratio (PT/INR) < 1.5 x ULN and partial thromboplastin time (PTT) activated partial thromboplastin time (aPTT) < 1.5 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants or patient has disseminated intravascular coagulation deemed by investigator to be due to leukemia, performed within 14 days of D1 of treatment under LCCC1522
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (performed within 28 days of treatment initiation)
International normalized ratio (INR) ?1.5 or prothrombin time (PT) ?1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ?1.5 × ULN.
The patient has adequate coagulation: prothrombin time (PT) and an International Normalized Ratio (INR), and partial thromboplastin time (PTT) ? 1.5 times the upper limit of normal (ULN),
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 28 days of study registration
Prothrombin time (PT)/international normalized ratio and (PTT) in normal range ± 25%
International normalized ratio (INR) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
PT and PTT w/in ?1.5× ULN
PHASE I: Prothrombin time (PT) (or international normalized ratio [INR]) and partial thromboplastin time (PTT) =< 1.5 x ULN
Prothrombin time (PT) or international normalize rate (INR) within 1.5x upper limit of normal;
Partial thromboplastin time (PTT) within 1.5x upper limit of normal;
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapy
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time (PTT) > 1.5 times the upper limit of normal
Prothrombin time (PT/international normalized ratio [INR]) and activated partial thromboplastin time (aPTT) must be within 80 to 120% of the normal range at baseline
PART I: Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x the upper limits of normal
Prothrombin Time (PT) and activated partial thromboplastin time (aPTT) <= 1.5x the upper limit of normal.
Normal prothrombin time (PT)
Partial thromboplastin time (PTT) at enrollment per institutional range
Prothrombin time (PT)/partial thromboplastin time (PTT) > 1.5 upper limit of normal (ULN)
Performed within 10 business days of treatment initiation with the exception of beta- HCG (72 hours), if applicable: International normalized ratio (INR) or prothrombin time (PT) =<1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants.
Subject has prothrombin time/International Normalized Ratio or partial thromboplastin time test results at screening ?1.5 x ULN.
Partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
Prothrombin time (PT)/partial thromboplastin time (PTT) less than 1.5 times normal
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation
Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, should be performed within 10 days of treatment initiation
Within 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Prothrombin time (PT) & activated partial thromboplastin time (aPTT) =< 1.5 X ULN (correction with vitamin K allowed) unless subject is\r\nreceiving anticoagulant therapy (which should be managed according to institutional norms prior to and after excisional biopsy).
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x ULN
If not receiving anticoagulants: international normalized ratio (INR) OR prothrombin (PT) =< 1.5 x ULN, performed within 14 days prior to day 1 of protocol therapy\r\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment
International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 21 days of treatment initiation
Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.5 times upper limit of normal
Prothrombin time (PT) ?1.5 × ULN (Grade ?1).
International normalized ratio or prothrombin time =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 21 days of treatment initiation
Performed within 10 days of treatment initiation: international normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) or international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 x ULN
Should be performed within 30 days of treatment initiation: international normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Within 28 days of cycle 1 day 1: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving\r\nanticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (performed within 10 days of treatment initiation)
Within 5 days prior to the start of study treatment: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.
Adequate coagulation function as defined by International Normalized Ratio ?1.5 or prothrombin time ?1.5 x ULN, and partial thromboplastin time ?1.5 x ULN
Activated partial thromboplastin time (aPTT), prothrombin time (PT) =< 1.2 x upper limit of normal (ULN)
Coagulation parameters: international normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN
Prothrombin time (PT)/ international normalized ratio (INR), partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN)
Prothrombin time (PT)/ international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 28 days before the first dose of study treatment.
Prothrombin time (PT) > 16.5 seconds or
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) and/or prothrombin time international normalized ratio (PT-INR) and/or activated partial thromboplastin time (APTT) =< 1.3 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 14 days of treatment initiation
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation
International normalized ratio (INR) or prothrombin rime (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Coagulation international normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
To be performed within 14 days of treatment initiation: international normalized ratio (INR) or prothrombin time (PT) ? 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation
Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test =< 1.5 x ULN
Prothrombin time (PT)/partial thromboplastin time (PTT) ? 1.5 times the ULN
Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =<1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range on intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.
Within 7 days of registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants
Obtained =< 14 days prior to registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN).
Within 10 days prior to on-study date: International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) no more than 2 seconds above the upper limits of normal (ULN)
Prothrombin time (PT)/institutional normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use on anticoagulant
Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants
Within 7 days (+ 3 day window) of enrollment: Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x the institutional upper limit of normal (ULN), (this will not apply to subjects with confirmed Factor XII deficiency)
Within 7 days before the first dose of study treatment: Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test < 1.3 x the ULN within 7 days before the first dose of study treatment
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
Prothrombin time (PT) and partial thromboplastin time (PTT) must be =< 2 x the upper limit of the institution's normal range, at the time of enrollment
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder).
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory upper limit of normal (ULN) within 7 days before the first dose of study treatment
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and activated partial thromboplastin time (aPTT) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)
Obtained =< 28 days prior to registration: Prothrombin time (PT) =< 1.5 x upper limit of normal (ULN) unless patient is receiving anticoagulant therapy and PT or partial prothrombin time (PTT) is within therapeutic range of intended use of coagulants
Performed within 7 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Performed within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT)\r\nactivated partial thromboplastin time (aPTT) =< 1.5 X ULN; if on active anticoagulants prior to study treatment, levels must be within standard therapeutic ranges per investigator
International Normalized Ratio (INR) or Prothrombin Time (PT) ?1.5 times the ULN and Activated Partial Thromboplastin Time (aPTT) ?1.5 times the ULN. Note: If patient is receiving anticoagulant therapy, then PT or PTT must be within therapeutic range of intended use of anticoagulants;
International normalized ratio (INR) or prothrombin time (PT) =<1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 14 days of treatment initiation
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
Within 14 days prior to cycle 1 day 1 of treatment: International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin Time (aPTT) =< 1.5 x ULN (Note: This applies only to subjects who are not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose)
Prothrombin time (PT) within 2 seconds of the upper limit of normal (institutional normal ratio [INR] =< 1.8)
International normalized ratio (INR)/prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.4 x ULN unless on therapeutic warfarin then INR/PT =< 3.5 obtained =< 14 days prior to registration
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 14 days of protocol registration
Prothrombin time (PT) < 1.5
Hepatic: Total bilirubin 1.5 x ULN; transaminases ? 2.5 x ULN (may be up to 5 x ULN if clearly due to liver metastases); prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x (ULN).
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional upper limit of normal; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to alternate assignment
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)
Within 28 days prior to registration for protocol therapy: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy; in the case of anticoagulants, PT/INR/partial thromboplastin time (PTT) must be within therapeutic range of intended use of anticoagulants
Normal PT/INR and PTT;
A Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) within normal range
Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Determined within 3 weeks of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time/international normalized ratio (PT/INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN
Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN)
FULL STUDY INCLUSION CRITERIA: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN (Common Terminology Criteria for Adverse Events [CTCAE] grade =< 1)\r\n* Note: patients on stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and partial thromboplastin time (PTT) / activated (a)PTT test results are compatible with the acceptable benefit-risk ratio at the investigator’s discretion
FULL STUDY INCLUSION CRITERIA: Partial thromboplastin time (PTT) or activated PTT (aPTT) =< 1.5 x ULN (CTCAE grade =< 1)\r\n* Note: patients on stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and PTT / aPTT test results are compatible with the acceptable benefit-risk ratio at the investigator’s discretion
Prothrombin time (PT) =< 1.5 x ULN
Partial thromboplastin time (PTT) =< 1.5 x ULN
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x ULN
Within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) test =< 1.3 ULN
Prothrombin time (PT) or international normalized ratio (INR) or partial thromboplastin time ?1.5 x ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to study drug administration may have PT/INR measurements >1.5 x ULN if, in the opinion of the Investigator, the patient is suitable for the study. An adequate rationale must be provided to the Sponsor prior to randomization.
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 14 days of registration
A prothrombin time (PT) or activated partial thromboplastin time (aPTT) above the ULN or a history of a coagulopathy or bleeding disorder.
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) levels ?1.5 x ULN. If institution does not report PT value, the international normalization ratio (INR) must be ? ULN.
Abnormal coagulation parameters (prothrombin time [PT] > 15 seconds, partial thromboplastin time [PTT] > 40 seconds, and/or international normalized ratio [INR] > 1.5)
International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (APTT) as follows: \r\n* In the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x ULN or aPTT < 1.5 x ULN\r\n* In the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registration
Obtained =< 14 days prior to registration: International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN
Prothrombin time (PT)/international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN
To be performed within 10 business days prior to day 1: If not receiving anticoagulants: international normalization ratio (INR) OR prothrombin (PT) =< 1.5 x ULN; if on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
Within 14 days prior to planned start of treatment: If not receiving anticoagulants: international normalized ratio (INR) AND prothrombin (PT) =< 1.5 x ULN\r\n* If on anticoagulant therapy: PT must be within therapeutic range of intended used of anticoagulants
Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants
Acceptable coagulation status: international normalised ratio (INR) of blood clotting, prothrombin time and activated partial thromboplastin time within ?1.5 x upper limit of normal (ULN).
Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) =< 1.5 x ULN (unless B-ALL related)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin and partial thromboplastin times =< 1.2 x normal prior to biopsy
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulant (performed within 28 days of registration)
International Normalized Ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy, in which case, the PT/INR should be within therapeutic range for intended use, performed within 10 days of treatment initiation
International normalized ratio (INR) and/or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Normal prothrombin time (PT) or international normalized ratio (INR) and normal activated partial thromboplastin time (aPTT)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 10-15 days of treatment initiation)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 16 days of treatment initiation
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, during screening and on cycle 1, day 1
Contraindication to biopsy or prostatectomy (for neoadjuvant cohort only):\r\n* Bleeding disorders\r\n* Artificial heart valve\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT) >= 1.5 x ULN in patients not taking anticoagulation; patients on anticoagulation (e.g. enoxaparin, oral anticoagulants) are eligible regardless of PT/PTT; prior to biopsy, anticoagulation will be held per standard practice
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation
Adequate hemostatic function as determined by prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 x ULN (unless on therapeutic coagulation, in which case the adequate level of anticoagulation will be determined by the investigator)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (performed within 10 days of treatment initiation)
Obtained within 14 days prior to registration; prothrombin time and partial thromboplastin time (PT / PTT) ? 50% increase from institutional ULN
Prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN
Prothrombin time (PT)/activated partial thromboplastin time (aPTT) within normal limits at time of surgery
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International Normalized Ratio (INR) or Prothrombin Time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Total bilirubin =< 1.5 X institutional limits; subjects with Gilbert's syndrome may have a bilirubin > 1.5 x upper limit of normal (ULN); activated partial thromboplastin time (aPTT), prothrombin time (PT) not to exceed 1.2 x ULN
International normalized ratio (INR) or prothrombin time (PT): =< 1.5 unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Completed within 10 days of SBRT treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =<1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) =< 2.3 or PT =< 6 seconds above control (within 14 days prior to registration)\r\n* NOTE: Abnormal PT/INR may be considered, with documented principal investigator (PI) approval, if it is due to the use of anticoagulants; for such patients, a normal PT/INR must be available from before the start of anticoagulation treatment\r\n* NOTE: Performed at time of screening angiogram; can be outside 14 days if applicable
If not receiving anticoagulants: international normalized ratio (INR) OR prothrombin (PT) =< 1.5 x ULN; if on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 14 days prior to registration
Within 14 days prior to registration: International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) as follows:\r\n* In the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x upper normal limit (ULN) or aPTT < 1.5 x ULN\r\n* In the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registration
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
UROTHELIAL CARCINOMA EXPANSION COHORT: Prothrombin (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) within 1.25 X ULN institutional limits, except where a lupus anti-coagulant has been confirmed
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
Prothrombin time (PT) < 1.5
Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTT
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Partial thromboplastin time (PTT) < IULN
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT) (activated PTT [aPTT]) < 1.5 x ULN
International normalized ratio (INR) =< 1.5 or prothrombin time (PT) =< 1.5 ULN, and a partial thromboplastin time (PTT/activated partial thromboplastin time [aPTT]) =< 1.5 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 X ULN; patients on anticoagulation are expected to hold anticoagulation for at least 5 days prior to surgery
Performed 28 days prior to study registration up to the first dose of study drug: international normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy; if subject receiving anticoagulants, PT or partial thromboplastin time (PTT) should be within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
Partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 28 days of treatment initiation)
International normalized ratio (INR) =< 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution
Performed within 14 days (+3 working days) of treatment initiation: Coagulation international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.5 X ULN
Normal coagulation parameters (elevated international normalized ratio (INR), prothrombin time or activated partial thromboplastin time (APTT) ?1.3 ULN range acceptable).
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
No baseline prothrombin time (PT)/partial thromboplastin time (PTT) abnormalities, coagulopathies, or who are on any blood thinners
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 X IULN, AND international normalized ratio (INR) =< 1.5 X IULN (unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalization ratio (INR) < 1.5 x ULN
Partial thromboplastin time (PTT) < 1.5 x ULN
Partial thromboplastin time =< 1.5 x institutional ULN obtained within 14 days of first treatment
Prothrombin time (PT) =< 1.5 x ULN
Partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
PT and PTT <1.5 ULN
Prothrombin time (PT) =< 1.5 x institutional upper limit of normal (ULN)
Partial thromboplastin time (PTT) =< 1.5 x institutional ULN
Prothrombin time (PT) with an international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) of =< 1.5 times the ULN; for patients on full-dose oral anti-coagulation (such as warfarin or rivaroxaban), in-range INR (usually between 2 and 3) and a PTT < 1.2 times the ULN
Normal coagulation parameters (prothrombin time [PT], activated partial thromboplastin time [aPTT])
Prothrombin time (PT) (or international normalized ratio [INR]) and partial thromboplastin time (PTT) (or activated partial thromboplastin time [aPTT]) > 1.5 x ULN
Performed within 28 days prior to study registration up to the first dose of study drug: International normalized ratio (INR) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) < 14 sec; partial thromboplastin time (PTT) < 35 sec
International normalized ratio (INR) of prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 X ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.5 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
Prothrombin time (PT) and partial thromboplastin time (PTT) < 50% of deviation from institutional upper limit of normal (IULN)
Blood coagulation parameters: prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin or anticoagulants for management of venous thrombosis including pulmonary thrombo-embolus) and a partial thromboplastin time (PTT) =< 1.5 times the upper limit of normal
Failure to meet the following laboratory levels on preoperative screening:\r\n* Platelet count >= 100,000 mm^3\r\n* Hemoglobin >= 10 g/dl\r\n* Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)\r\n* Activated partial thromboplastin time =< 1.5 times ULN\r\n* Serum creatinine < 2.5 times ULN
Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)
Normal prothrombin time (PT) for age
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN
The subject has prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
Prothrombin time (PT) no greater than 6 seconds longer than control.
Prothrombin time (PT)/international normalized ratio (INR)/ activated partial thromboplastin time (aPTT) =< 1.5 x ULN (to be performed within 7 days prior to start of study treatment)
Prothrombin time (PT) < 1.3 x upper limit of normal (ULN)
Partial thromboplastin time (PTT) < 1.3 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 x institutional ULN
The subject has prothrombin time (PT)/International Normalized Ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
Prothrombin time (PT) with normal limits (WNL); if patient is on warfarin for prophylactic clot presentation for indwelling catheter, PT/partial thromboplastin time (PTT) may be +/- 15 %
Evidence of bleeding diathesis or coagulopathy as documented by an elevated prothrombin time (PT), partial thromboplastin time (PTT) or bleeding time
Partial thromboplastin time (PTT) < 70 seconds (sec)
Partial thromboplastin time (PTT) =< 1.2 x ULN
Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (secpatient may be eligible for trial if abnormality is deemed clinically insignificant and cleared for protocol therapy by Hematology Consult service)
Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control
Abnormal prothrombin time (PT) (international normalized ratio [Inr]) > 1.5 INR or partial thromboplastin time (PTT) > 42 seconds (sec) (may be corrected with flash frozen plasma [FFP], cryoprecipitate, vitamin K, etc)
Abnormal level of platelets (< 100000), PT (>14) or PTT (>36), and INR > 1.3.
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x institutional ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x institutional ULN
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.4 times upper limit of normal range
Prothrombin time (PT)/international normalized ratio (INR); partial thromboplastin time (PTT) =< 1.3; =< 1.3 x ULN
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN for age
Abnormal coagulation parameter (prothrombin time [PT] or activated partial thromboplastin time [aPTT] > 1.3x longer than standard reference)
Prothrombin time (PT) and partial thromboplastin time (PTT) =< 2 x normal outside the setting of stable chronic anticoagulation therapy
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ? 1.5 x ULN (except for subjects receiving anticoagulation therapy)
International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, should be performed within 10 days of treatment initiation
Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
PT and PTT ? 1.5 X ULN
Prothrombin time less than 1.5 × ULN for the institution
Laboratory values: Screening serum creatinine > upper limits of normal (ULN); total bilirubin > ULN: alanine aminotransferase (ALT) and AST >/= 2.5 ULN or >/= 5.0 x ULN if liver metastases are present; absolute neutrophil count < 1,500/mm3, platelet concentration < 100,00/mm3, hematocrit level < 27% for females or < 30% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) > 1.5 x ULN unless on therapeutic doses of warfarin.
Or partial thromboplastin time [PTT] > 100 sec
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapy
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4 x ULN
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4 x ULN
Prothrombin time (PT) and/or partial thromboplastin time (PTT) =< 1.5 X ULN.
Prothrombin time/partial thromboplastin time (PT/PTT) ? 1.5 x upper limit of normal (ULN) (unless receiving anticoagulation)
International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International Normalized Ratio (INR) or prothrombin time (PT) ?1.5 × ULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)
Prothrombin time (PT) =< 1.5 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
For high risk and very high risk CLL-IPI (Arms A and B) only; obtained ? 30 days prior to randomization: prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (PTT) ? 1.5 X ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants
Prothrombin time (PT) and partial thromboplastin time (PTT) ? 1.5 x of institutional upper limit of normal (ULN) (Note: If coagulopathy is related to disease, this criteria do not apply) within 14 days prior to registration
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless on anticoagulation therapy, in which case PT or partial thromboplastin time (PTT) should be in the therapeutic range
PTT =< 1.5 x ULN unless on anticoagulation therapy, in which case PT or PTT should be in the therapeutic range
International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants within 7 days of treatment initiation
The subject has prothrombin time (PT)/institutional normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
All screening labs should be performed within 14 days (+3 working days) of treatment initiation: international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.5 x ULN.
INR (prothrombin time ratio) or partial thromboplastin time (PTT) > 1.5 x ULN (Please note: patients with hematopoietic cell transplantation (Hct) < 30%, WBC < 2500/mm/^3 and platelets < 50,000/mm^3 immediately prior to leukapheresis. The procedure may be deferred.)
International normalized ratio (INR) or prothrombin time (PT) ? 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT of partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation
Prothrombin time (PT)/international normalized ratio (INR) less than or equal to 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) less than or equal to 1.5 x ULN
Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) performed within 3 weeks prior to starting study therapy must be =< 1.5 x ULN
International normalized ratio (INR) within 1.5 times ULN (or if receiving anticoagulant therapy an INR of =< 3.0 is allowed with concomitant increase in prothrombin time (PT) or an activated partial thromboplastin time (aPTT) =< 2.5 x control)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anti-coagulant therapy as long as partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.2 times upper limit of normal
Prothrombin time (PT)/partial thromboplastin time (PTT) < 1.5 x normal institutional standard
Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ? 1.6x unless therapeutically warranted
Partial thromboplastin time (PTT) within normal limits (+/- 15%)
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN =< 7 days before the first dose of study treatment
Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), OR international normalized ratio (INR) < 1.5
International normalized ratio (INR) or partial thromboplastin time (PTT)/prothrombin time (PT) =< 1.5 ULN, unless the patient is on stable therapeutic dose of warfarin
International normalized ratio (INR) or prothrombin time (PT): =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio INR/ prothrombin time (PT)/ partial thromboplastin time (PTT) each < 1.5 x ULN
Patients with prothrombin time (PT) and/or international normalized ratio (INR) higher than or equal to 1.5 time upper limit of normal, unless patients have lupus anticoagulant in which case they are eligible if cleared by hematology
Partial thromboplastin time (PTT) =< 48 seconds (1.25 x ULN)
Activated partial thromboplastin time (aPTT), prothrombin time (PT) =< 1.2 x upper limit of normal (ULN)
International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, obtained =< 14 days prior to registration
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< upper limit of normal (ULN) for age
Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN
Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (11.6 - 15.2 / 25.3 - 37.3 sec)
Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x ULN (or an in range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.5 times the upper limit of normal
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy not requiring laboratory monitoring as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants; therapeutic Coumadin is not acceptable
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization
Prothrombin time (PT) > 12 seconds or partial thromboplastin time (PTT) > 31 seconds
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULN
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.3 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) must be < 1.5 x the upper limit of the normal range (ULN); except if, in the opinion of the investigator, the aPTT is elevated because of a positive lupus anticoagulant
International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants, specimens must be collected within 10 days prior to the start of study treatment
Prothrombin time (PT) within 2 seconds of the upper limit of normal (ULN)
Partial thromboplastin time (PTT) must be =< 1.5 × upper normal limit of institution's normal range
International Normalized Ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Partial thromboplastin time (PTT) =< 1.5 x ULN
Prothrombin time (PT) and partial thromboplastin time (PTT) =< 2 x ULN
Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)
Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, international normalized ratio (INR) or platelet count (as determined by institutional lab parameters) at the time of screening
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.2 x upper limit of normal (ULN)
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulation
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN
Prothrombin time (PT), international normalized ratio (INR) =< 1.5 x institutional ULN unless patient is therapeutically anticoagulated; if on anticoagulants, PT/INR need to be within appropriate anticoagulation limits for the clinical indication; patients who are receiving anticoagulants may participate in the trial if their anticoagulation can be stopped safely for several days at the time of each biopsy
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with PT/INR/PTT established within the therapeutic range prior to randomization; subjects will be eligible if it is determined by a hematologist that the cause is not associated with clinical bleeding (e.g., deficiency of factor XII), within 2 weeks of the first dose of study treatment
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization
For patients on Coumadin, INR/prothrombin time (PT)/PTT must be > 1.5 ULN
Prothrombin time (PT) =< 1.2 x ULN
Prothrombin time (PT) and partial thromboplastin time (PTT) within 1.5 times the institutional upper limit of normal
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional upper limit of normal (IULN) (subjects on Coumadin are included if their coagulation is within a normal therapeutic range)
Partial thromboplastin time (PTT) < 1.5 x the upper limit of institution’s normal range
Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normal within 10 days prior to registration unless the patient is receiving coumadin and has a stable INR that is in range for the desired level of anticoagulation
Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.5 x ULN
Prothrombin time (PT)/international normalized ratio (INR) =< 2.3 or PT =< 6 seconds above control; if subjects are being anticoagulated they can participate if proof of no coagulation abnormality existed prior to use of anticoagulants
PT ?1.5 ULN
Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.2 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.2 x ULN; Note: Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation
Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN
Normal coagulation [prothrombin time and partial thromboplastin time within normal limits (±15%)].
Partial thromboplastin time (PTT) =< 1.2 x IULN (if not receiving anticoagulation therapy)
Prothrombin time (PT) or partial thromboplastin time (PTT) test >= 1.3 x laboratory upper limit of normal (ULN) within 7 days before the first dose of study treatment
Prothrombin time (PT) and partial thromboplastin time (PTT) ? 1.5 X ULN after correction of nutritional deficiencies that may have contributed to prolonged PT/PTT.
Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 upper limit of normal (ULN)
Prothrombin time (PT) and activated partial thromboplastin time (APTT) =< 1.5 times upper limit of normal
INR ? 2.3 or Prothrombin time (PT) ? 6 seconds above control;
International normalized ratio (INR), activated partial thromboplastin (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)
Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN.
Prothrombin time (PT), partial thromboplastin time (PTT) and international normalized ratio (INR) =< 1.5 upper limit of normal (ULN)
PT <1.5 ULN
Baseline laboratory data as defined as: Hemoglobin (Hb): >=8g/dL Absolute Neutrophil Count (ANC): >=1000/µL Platelet (PLT): >=25000/µL Glomerular Filtration Rate (GFR) or Creatinine Clearance: >=30ml/min Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): <3 x Upper Limit of Normal (ULN) Bilirubin - total: <1.5 x ULN Activated Partial Thromboplastin Time (aPTT), Prothrombin Time (PT) or International Normalized Ratio (INR): <=1.5 x ULN PT <=1.5 x ULN, INR <=1.5
AMKL PATIENTS: Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN
MF PATIENTS: PT and PTT =< 1.5 x ULN
Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN
Coagulation parameters: international normalized ratio (INR) =< 2, prothrombin time (PT) and partial thromboplastin time (PTT) < 1.5 X institutional ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Coagulation: Prothrombin time (PT) <1.5 × ULN and partial thromboplastin time (PTT) <1.5 × ULN
Normal prothrombin time (PT)/international normalized ratio (INR) and partial prothrombin time (PTT)
Prothrombin Time or INR ?1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation.
Partial Thromboplastin Time (PTT) ?1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation.
Evidence of bleeding diathesis, coagulopathy as documented by an elevated (? 1.5 x ULN) prothrombin time (PT), partial thromboplastin time (PTT), or bleeding time. The use of full-dose oral or parenteral anticoagulants is permitted as long as the PT or aPTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the subject has been on a stable dose of anticoagulants for at least 2 weeks prior to the first study treatment.
INR and PTT within 1.5 X institutional ULN
Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (+/-15%).
Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN
International normalized ratio (INR)/prothrombin time (PT) =< 1.5 X ULN (unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time [PTT] is within therapeutic range of intended use of anticoagulants)
International normalization ratio (INR) or prothrombin time (PT) 1.5 x upper limit of normal (ULN), unless the subject is receiving anticoagulant therapy, in which case PT and partial thromboplastin time (PTT)/ activated PTT (aPTT) must be within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) or prolongation of the activated thromboplastin time (aPTT) >1.5 ULN or active uncontrolled coagulopathy or bleeding disorder.
Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4x the ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN
PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional upper limit of normal (ULN)
Prothrombin time (PT) =< 1.5 times the upper limit of normal
Partial thromboplastin time (PTT) =< 1.5 times the upper limit of normal
Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 and a partial thromboplastin time (PTT) =< 1.2 time the upper limit of normal unless the patient is therapeutically anti-coagulated for history of cancer-related thrombosis and has stable coagulation parameters
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal
Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 x ULN
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN for the lab
Partial thromboplastin time > 50 seconds (secs)
Prothrombin time (PT) within normal limits (UIHC)
Adequate coagulation defined as:\r\n* Prothrombin time (PT) =< 1.2 x upper limit of normal
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 × the laboratory ULN within 7 days before the first dose of study treatment
Partial thromboplastin time (PTT) =< 1.2 x institutional ULN
Prothrombin time (PT) < 1.2 x ULN
Patients must NOT have a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) (greater than 1.2 times the institutional upper limit of normal)
Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), OR international normalized ratio (INR) < 1.5
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (performed within 10 days of treatment initiation)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/ international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x institutional upper limit of normal
The following laboratory values obtained =< 14 days prior to randomization\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 X ULN if not anticoagulated; within local institutional guidelines per local physician if anticoagulated
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 14 days of treatment initiation)
Prothrombin time/international normalized ratio (INR) and partial thromboplastin time within normal limits
Prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN
Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x institutional upper limit of normal, within 14 days of study registration
Within 72 h of initiating study treatment: International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 x ULN unless on anticoagulation medication with stable dosing for at least one month; in addition, patient must be able to stop taking medication for up to a week in order to have percutaneous biopsies of tumor tissue performed
No patients will have coagulation parameters: international normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% deviation of the institutional ULN
Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on warfarin therapy, levels should be within therapeutic range
International normalized ratio (INR) or prothrombin time (PT) ? 1.5 x ULN unless participant is receiving anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Other: Prothrombin time (PT) and partial thromboplastin time (PTT) < ULN.
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN
International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (APTT) as follows: in the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x ULN or aPTT < 1.5 x ULN; in the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registration (within 7 days prior to registration)
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN)
Within 4 weeks of administration of study therapy: International normalized ration (INR) or prothrombin time (PT) =< 1.5 x ULN (only if not using anticoagulants); if patient is receiving anticoagulants, then value must be within therapeutic range for the condition that patient is being treated for
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) and partial thromboplastin time (PTT) =< 2 x ULN
Partial thromboplastin time 5 seconds above ULN.
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 14 days prior to registration
Within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Partial thromboplastin time (PTT) less than or equal to 1.3 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (only if submitting to a biopsy), performed within 28 days of treatment initiation
Normal prothrombin time (PT)/partial thromboplastin time (PTT)
International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 X ULN; if on active anticoagulants prior to study treatment, levels must be within standard therapeutic ranges per investigator
International normalized ratio (INR) < 2, prothrombin time (PT) < 20 sec, and partial thromboplastin time (PTT) < 55 sec
Partial thromboplastin time (PTT) < 1.5 times upper limit of normal within 14 days before enrollment
Adequate coagulation parameters, defined as International Normalisation Ratio <1.5 x ULN or activated partial thromboplastin time <1.5 x ULN.
Partial thromboplastin time (PTT) =< 1.5 times the upper limit of normal
prothrombin time (PT) and activated partial thromboplastin time (PTT) ? 1.6 x control unless therapeutically warranted
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 ULN and partial thromboplastin time (PTT) activated partial thromboplastin time (aPTT) < 1.5 X ULN; if value is higher due to hepatic involvement by CLL, patient is eligible
At least 4 weeks (28 days) prior to registration: Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (unless on medication known to alter INR and aPTT)
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the institutional ULN =< 7 days before the first dose of study treatment, unless PT/PTT prolongation known to be secondary to conditions not associated with increased bleeding risk (as on antiphospholipid antibody syndrome)
pT3, G any, N1; or, pT4, G any, N1; or, pT any, G any, N1 or M1)
Prothrombin time (PT) and partial thromboplastin time (PTT) must not be more than 1.5 x upper limit of normal (ULN) within 72 hours prior to enrollment; PT and PTT should be drawn by venipuncture, rather than from a central venous catheter when feasible
International normalized ratio (INR), activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) > 1.5 × ULN (unless on anticoagulation medication)
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal (ULN)
Partial thromboplastin time (PTT) =< 60
Prothrombin time (PT) or international normalized ratio (INR), and activated partial thromboplastin time (aPTT) =< 1.2 x ULN; subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization\r\n* NOTE: this applies to patient in the normal and renal dysfunction cohorts (N, R3 and R4); elevated PT/INR is allowed for patients in the liver dysfunction cohorts
Prothrombin time (PT)-international normalized ratio (INR) =< 2.3 or PT =< 6 seconds above control
Coagulopathy (as evidence by prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times upper limit of normal in patients not undergoing anticoagulation)
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) < 1.5 x ULN
Prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x normal outside the setting of stable chronic anticoagulation therapy
Partial thromboplastin time (PTT) =< 1.5 X institutional upper limit of normal
Partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
Partial thromboplastin time (PTT) >= 45 seconds
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limits of normal
Prothrombin time (PT) and partial thromboplastin time =< 1.5 upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulation
Absence of active treatment with systemic anticoagulation and a baseline prothrombin time (PT) and activated partial thromboplastin time (aPTT) that does not exceed 1.5 x ULN
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (Note: subjects receiving anticoagulation treatment may enroll with INR established within the therapeutic range prior to day 1 [D1] of treatment)
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 × the laboratory ULN within 7 days before the first dose of study treatment
Prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.2 x institution’s ULN
Subjects must have normal coagulation parameters as measured by prothrombin time (PT)/partial thromboplastin time (PTT)
Prothrombin time (PT) or international normalized ratio (INR), and activated partial thromboplastin time (APTT) =< 1.5 x upper limit of normal (ULN), unless the abnormality can be explained by the presence of lupus anticoagulant or if these values are in the therapeutic range for a patient on low molecular weight heparin
Prothrombin time (PT)/INR and partial thromboplastin time (PTT) =< grade 1 within two weeks before initial biopsy of visceral organs
Prothrombin time (PT) =< 1.2 X ULN; subjects receiving anticoagulant therapy are eligible if their PT is stable and within the recommended range for the desired level of anticoagulation
Partial thromboplastin time (PTT) =< 1.2 ULN; subjects receiving anticoagulant therapy are eligible if their PTT is stable and within the recommended range for the desired level of anticoagulation
The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 X the laboratory ULN
Partial thromboplastin time (PTT) must be =< 1.5 × upper normal limit of institution's normal range
The patient has a PT (or INR) and PTT up to 1.25×ULN
Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis) and a partial thromboplastin time (PTT) < 1.2 x ULN
Partial thromboplastin time (PTT) < 1.2 times institutional upper limit of normal
Prothrombin and partial thromboplastin times =< 1.2 x normal prior to biopsy
Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 X the ULN unless a subject is receiving Coumadin and has stable INR which is in range for the desired level of anticoagulation
For patients undergoing biopsy procedures: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be within the normal range
Prothrombin time (PT) =< 2 x normal outside the setting of stable chronic anticoagulation therapy
Partial thromboplastin time (PTT) =< 2 x normal outside the setting of stable chronic anticoagulation therapy
Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.2 X upper limit normal (ULN)
Abnormal laboratory values as defined by protocol for creatinine, creatinine clearance, aspartate transaminase (AST) or alanine transaminase (ALT), total bilirubin, international normalized ration (INR), partial thromboplastin time (PTT) or activated partial thromboplastin time (aPPT), unless these abnormalities are due to underlying lymphoma
International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) less than or equal to 1.5 x ULN, unless patient is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
The patient has an adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) or prothrombin time (PT) =< 1.5 x ULN, and partial thromboplastin time (PTT or aPTT) =< 1.5 x ULN (those receiving anticoagulation therapy except low molecular weight heparin are excluded) within 30 days prior to registration
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalize ratio (INR) and the partial thromboplastin time (PTT) < 1.5 x ULN. (Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists)
Prothrombin time (PT)/international normalized ratio (INR) > 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) > 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)
Partial thromboplastin time (PTT) =< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation
Prothrombin time or INR =< 1.5 x ULN unless receiving therapeutic anticoagulation
Partial thromboplastin time (PTT) =< 1.2 x upper limit of normal (ULN) unless the patient is receiving therapeutic anticoagulation
Prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x normal outside the setting of stable chronic anticoagulation therapy
Prothrombin time (PT) and partial thromboplastin time (PTT) =< 120% of control, unless patient has the presence of a lupus anticoagulant
active, uncorrected bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, or INR at the time of HIFU (use international lab normal ranges for parameters);
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR), activated partial thromboplastin time (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT), partial thromboplastin time (PTT) less than or equal to 1 to 1.5 x upper limit of normal, CTCAE v 4.0 grade 1 except for patients on therapeutic anticoagulation
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x upper limit of normal (ULN) unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Patients must have baseline prothrombin time (PT)/international normalized ratio (INR) < 3 x institutional upper limit of normal and partial thromboplastin time (PTT) < 3 x ULN within 7 days of initiating the induction cycle; (for patients with coagulation abnormalities that are correctable, coagulation factor support per institutional standard of care for AML is allowed)
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) <1.5 times the upper limit of normal (ULN)
Prothrombin time and activated partial thromboplastin time (aPTT) < 1.5 times the upper limit of normal (ULN)
Subjects must have adequate coagulation as assessed by: international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN (CTCAE Grade <=1), partial thromboplastin time (PTT) <=1.5 x ULN (CTCAE Grade <=1)
Coagulopathy (as evidenced by prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times in control patients not undergoing anticoagulation)
International normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN
Prothrombin time (PT-INR)/ partial thromboplastin time (PTT) ? 1.5 x ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement that is pre dose as defined by the local standard of care
Subject has acceptable coagulation studies (obtained ? 14 days prior to starting Cycle 1 Day 1) partial thromboplastin time (PTT) < 1.2 x ULN and INR ? 1.5 x ULN.
Normal partial thromboplastin time (PTT) and either international normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULN
Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 upper limit of normal (ULN)
The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 the laboratory ULN within 7 days before the first dose of study treatment
Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 X ULN
Partial thromboplastin time (PTT) < 1.2 x institutional upper limits of normal
International normalized ratio of prothrombin time and activated partial thromboplastic time </=1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.
Prothrombin time (PT) =< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on anticoagulation therapy, levels should be within therapeutic range, or
Prothrombin time < 1.5 x ULN
Prothrombin time (PT) or International Normalized Ratio (INR) ? 1.25 x ULN; for patients with hepatocellular carcinoma only, INR <1.7 or prothrombin time (PT) or < 4 seconds above ULN (i.e. Child-Pugh Score is no greater than 1 for the coagulation parameter); for patients with hepatocellular carcinoma only, serum albumin > 2.8 g/dL (i.e. Child-Pugh Score for albumin is no greater than 2). For the hematologic malignancy patients, the coagulation and albumin status cited above do not apply
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULN
Normal prothrombin time
International normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate
Prothrombin time (PT) ? 1.5 x ULN
TREATMENT: Prothrombin time (PT) within 2 seconds of the upper limit of normal (ULN)
TPI 287 may interfere with Coumadin dosing and patients who are taking this combination will require monitoring of their prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR)
Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 times the institutional upper limit of normal; patients receiving low molecular weight heparin for the prevention or treatment of venous thromboembolic disease are eligible if considered clinically stable on their regimen
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 7 days of treatment initiation
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 upper limit of normal (ULN)
Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal unless subject is receiving anticoagulants; if the subject is on anticoagulation therapy, levels should be within therapeutic range
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.5 x the laboratory ULN within 7 days before the first dose of study treatment
The subject has prothrombin time/international normalized ratio (PT/INR) or partial thromboplastin time (PTT) test results at screening >= 1.5 x the laboratory upper limit of normal
Serum creatinine >ULN, or Prothrombin time (PT) or international normalized ratio (INR) >1.5 × ULN or activated partial thromboplastin time (aPTT) > 1.5 × ULN
International normalized ratio or prothrombin time (PT) ? 1.5 x ULN unless subject is receiving anticoagulant therapy and the PT or partial thromboplastin time (PTT) must be within the therapeutic range of the intended use of anticoagulants.
Prothrombin time (PT)-international normalized ratio (INR)/partial thromboplastin time (PTT) < 1.5 x ULN except in patients receiving active anticoagulation
Coagulation status: prothrombin time (PT) ? 1.5 ULN or INR within normal limits; and partial thromboplastin time (PTT) ? 1.2 × ULN
No evidence of coagulopathy as indicated by prothrombin time (PT) =< 1.5 X upper limit of normal
Normal PT or INR and aPTT
PT/INR <1.5 x ULN and PTT/ aPTT <1.5 x ULN
Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy in which case the INR or PT must be within the therapeutic range of intended use for the anticoagulant
Coagulation parameters: International normalised ratio (INR) < 2 and partial prothrombin Time (PTT) = 2xULN
Patients with known bleeding diathesis, or PT (Prothrombin time) or aPTT (activated partial thromboplastin time) > 1.5x ULN or <0.5x LLN.
Prothrombin time (PT) and activated partial thromboplastin time (aPTT) <=1.5*ULN
Patients must have prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normal
PT/aPIT ? 1.5 x ULN
Prothrombin time (PT)/International normalized ratio (INR) and partial thromboplastin time (PTT) <=1.3xULN
Coagulation parameters: International normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening that are >= 1.3 x ULN
PART I: Absolute neutrophil count (ANC), hemoglobin, platelet, total bilirubin, creatinine, transaminase (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]), prothrombin time (PT), partial thromboplastin time (PTT), urine uric acid, urine pH, urine oxalate must be within standard normal ranges
PT/INR and aPTT ? 1.5 ULN.
Adequate baseline organ function as defined by: absolute neutrophil count (ANC) >= 1.2 × 109/L; Hemoglobin >= 9 g/dL; Platelet count >= 100 x 109/L; prothrombin time (PT) / international normalized ratio (INR) and partial thromboplastin time (PTT) <= 1.5 x upper limit of normal (ULN); Albumin >= 2.5 g/dL; Total bilirubin <= 1.5 x ULN; aspartate aminotransferase (AST) and alanine transaminase (ALT) <= 2.0 x ULN; Creatinine <=1.5 mg/mL; Left Ventricular Ejection fraction (LVEF) >= lower limit of normal (LLN) by ECHO
Partial thromboplastin time (PTT) > 80
Prothrombin time (PT)/partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
Prothrombin time (PT) and partial thromboplastin time (PTT) ? 1.2 x the upper limit of normal (ULN) unless receiving anticoagulation therapy. If receiving anticoagulation therapy, eligibility will be based upon International Normalization Ratio (INR)
Coagulation Prothrombin time ? 1.5 X upper limit
Partial thromboplastin time ? 1.5 X upper limit
International normalized ratio (INR) or prothrombin time (PT) ? 1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Partial thromboplastin time (PTT) or activated (a)PTT =< 1.5 x upper limit of normal (ULN) per institutional laboratory range
Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (IULN)
International normalized ratio (INR) < 1.5 and a partial thromboplastin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly (INR must be therapeutic in the range of 2-3)
Prothrombin time (PT) =< 4 seconds above upper limit of normal (ULN) and partial thromboplastin time (PTT) =< 10 seconds above ULN
Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution
Partial thromboplastin time (PTT) < 1.2 times the upper limit of normal
Prothrombin time (PT) or partial thromboplastin time (PTT) > 1.5 x the upper limit of normal, except if the patient is on therapeutic anticoagulation, in which case they should demonstrate stability of PT/PTT for at least two weeks
Partial thromboplastin time (PTT) =< 1.2 X ULN
Prothrombin time (PT) < 1.5 ULN
Prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 x ULN
Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Prothrombin time (PT) no more than 2 seconds above the upper limit of normal (ULN)
Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)
Prothrombin time (PT) such that the international normalized ratio (INR) is less than or equal to 1.2 x ULN (institutional upper limit of normal) (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.2 x ULN; subjects receiving anticoagulant therapy are eligible if their INR is stable and PT/PTT therapeutic and within the recommended range for the desired level of anticoagulation
Prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.2 X upper limit of normal (ULN)
International normalized ratio (INR) of prothrombin time (PT; PT-INR) and activated partial thromboplastin time (aPTT) =< 1.5: subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists per medical history; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care
Partial thromboplastin time (PTT) within normal limits (WNL)
Prothrombin time > 1.5 x control
Have a bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and platelet count < 140,000 platelets per microliter of circulating blood1
Prothrombin time (PT) and partial thromboplastin time (PTT) > 1.5 x ULN
Prothrombin time (PT) and partial thromboplastin (PTT) =< 1.5 x IULN
International normalized ratio (INR)/prothrombin time (PT) =< 1.5 times ULN unless participant is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Patients must have prothrombin time (PT) / international normalized ratio (INR) and partial thromboplastin time (PTT) =< 2.0 x institutional upper limit of normal (IULN) unless the patient is on anticoagulant therapy within 28 days prior to registration (if the patient is receiving anticoagulant therapy, PT, and a PTT must be within therapeutic range of intended use of anticoagulants)
Partial thromboplastin time (PTT) =< 60
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (performed within 10 days of treatment initiation)
Partial thromboplastin time (PTT) < 1.5 times the upper limit of normal (heparin, lovenox or alternative anticoagulants are acceptable)
Evidence of bleeding diathesis or coagulopathy (partial thromboplastin time [PTT] and/or either prothrombin time [PT] or international normalized ratio [INR] > 1.5 x upper limit of normal) (except for subjects receiving anti-coagulation therapy); concurrent use of Coumadin or warfarin will be acceptable and monitoring patients on warfarin or Coumadin will follow the standard of care as dictated by the prescribing physician (PT/PTT); if the prescribing physician is not a Moffitt medical doctor (MD), then the prescribing MD will be notified by the research staff of the subject participating in the study, and monitors for PT, PTT will be obtained from patient during the 3 month study visit for review
Prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.5 x institutional upper limit of normal (ULN) for age
Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN
International normalized ratio (INR)/prothrombin time (PT) =< 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time [PTT] is within therapeutic range of intended use of anticoagulants)
Subjects unable to undergo routine endoscopy with biopsy:\r\n* Women who are pregnant or breastfeeding\r\n* Prothrombin time < 50% of control; partial thromboplastin time (PTT) > 50 sec, or international normalized ratio (INR) > 2.0\r\n* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues
Prothrombin time greater than 50% of control
Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal
Screening laboratory values (serum chemistry, hematology, prothrombin time [PT](international normalized ratio [INR])/activated partial thromboplastin time [APTT], and creatine phosphokinase [CPK]) obtained up to 28 days prior to administration of first vaccine injection on day 0 within institutional normal range or judged to be not clinically significant by principal investigator (PI) and medical monitor
Prothrombin time (PT)/partial thromboplastin time (PTT) within normal institutional limits
Presence of coagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] > 1.2 x upper limit of normal)
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) =< 1.5 x upper limit of normal
Thrombin time (TT), prothrombin time (PT), or partial thromboplastin time (PTT) > 2 x upper limit of normal
Prior anticoagulant therapy use is allowed provided therapy is discontinued at least 7 days prior to the breast biopsy in order to reduce the risk of bleeding. For participants who have taken an anticoagulation within the past 7 days, international normalized ratio must be ? 1.5 x institutional upper limit of normal and prothrombin time and partial thromboplastin time ? ULN prior to the breast biopsy.
Patients not taking warfarin must have prothrombin time (PT)/partial thromboplastin time (PTT) levels =< 1.5 times the upper limit of normal provided by the reference laboratory performing the test
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 times institutional upper limit of normal
Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 1.5 × ULN; unless the patient is on a therapeutic anticoagulant
Prothrombin time (PT)/partial thromboplastin time (PTT) within normal institutional limits
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
Partial thromboplastin time (PTT) =< 2 x upper limit of normal (ULN)
PTT (partial thromboplastin time) =< 1 x ULN
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN, unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, obtained within 14 days prior to C11-AMT PET scan
PT/PTT/INR (prothrombin time/partial thromboplastin time) without clinically significant abnormalities after review by the study physicians
Contraindication to biopsy:\r\n* Bleeding disorders\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT) >= 1.5 times the upper limit of normal\r\n* Artificial heart valve
Patients with coagulopathies who are at increased risk for bleeding or on active anti-coagulation therapy (platelets less than 100,000 per mm^3 or prothrombin time [PT]/partial thromboplastin time [PTT] greater than 1.5 times the upper normal limit [UNL]); patients are eligible if the underlying cause is correctable
Partial thromboplastin time less than 4.0 times below or above the upper or lower limit range
Partial thromboplastin time (PTT) =< 1.2 X ULN (evaluated within 28 days of randomization)
Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x institutional upper limit of normal (within 14 days of study registration)
Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 x upper limit of normal (ULN), completed within 2 weeks prior to start of protocol therapy
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, obtained =< 30 days prior to registration
International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation
Pre-treatment laboratory tests for patients receiving fluorine F 18 fluorothymidine ([18F]FLT) must be performed within 21 days prior to baseline imaging; these laboratory tests must be less than 4.0 times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless not clinically relevant); 2.5 x for prothrombin time and partial thromboplastin time; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed 6 times the upper limit of the normal range; the initial 4.0 x value will be critical for liver function test results which can be extremely variable, and a 4.0 x above the upper normal range is still acceptable for inclusion in this study; urinalysis abnormalities will not preclude the patient from being enrolled and studied; the baseline and subsequent laboratory testing will include liver enzymes (serum glutamic oxaloacetic transaminase [SGOT], serum glutamate pyruvate transaminase [SGPT], anaplastic lymphoma kinase [ALK]), bilirubin (total), serum electrolytes, complete blood count (CBC) with platelets prothrombin time, partial thromboplastin time, blood urea nitrogen (BUN), and creatinine
Prothrombin time (PT)/partial thromboplastin time (PTT) =< the institution ULN
PT/PTT > the institution ULN
Prothrombin time > 1.5 x control
Patients with abnormal prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) or bleeding diathesis
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 X upper limit of normal (ULN)
Coagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] > 1.5 x upper limit of normal)
internal normalized ratio and partial thromboplastin time <1.5x upper limit of normal
The patient has adequate coagulation: prothrombin time (PT), partial thromboplastin time (PTT), and an International Normalized Ratio within normal limits.
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International Normalized Ratio (INR) or Prothrombin Time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of protocol enrollment
Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.5 times upper limit of normal
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants