[96a5a0]: / output / allTrials / identified / NCT01987362_identified.json

Download this file

929 lines (929 with data), 40.2 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
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
669
670
671
672
673
674
675
676
677
678
679
680
681
682
683
684
685
686
687
688
689
690
691
692
693
694
695
696
697
698
699
700
701
702
703
704
705
706
707
708
709
710
711
712
713
714
715
716
717
718
719
720
721
722
723
724
725
726
727
728
729
730
731
732
733
734
735
736
737
738
739
740
741
742
743
744
745
746
747
748
749
750
751
752
753
754
755
756
757
758
759
760
761
762
763
764
765
766
767
768
769
770
771
772
773
774
775
776
777
778
779
780
781
782
783
784
785
786
787
788
789
790
791
792
793
794
795
796
797
798
799
800
801
802
803
804
805
806
807
808
809
810
811
812
813
814
815
816
817
818
819
820
821
822
823
824
825
826
827
828
829
830
831
832
833
834
835
836
837
838
839
840
841
842
843
844
845
846
847
848
849
850
851
852
853
854
855
856
857
858
859
860
861
862
863
864
865
866
867
868
869
870
871
872
873
874
875
876
877
878
879
880
881
882
883
884
885
886
887
888
889
890
891
892
893
894
895
896
897
898
899
900
901
902
903
904
905
906
907
908
909
910
911
912
913
914
915
916
917
918
919
920
921
922
923
924
925
926
927
928
929
{
"info": {
"nct_id": "NCT01987362",
"official_title": "A Two-Part, Phase I, Multicenter, Open-Label Study of RO6870810/TEN-010 Given Subcutaneously: Part A: A Dose-Escalation Study in Patients With Advanced Solid Tumors. Part B: An Expansion Cohort in Patients With Selected Malignancies",
"inclusion_criteria": "General:\n\n* Participants with solid tumors must have one or more metastatic tumors evaluable or measurable on radiographic imaging\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (or 2 upon approval by the medical monitor)\n* Life expectancy of greater than or equal to (>/=) 3 months\n* Disease-free of active second/secondary or prior malignancies >/= 2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"in-situ\" of the cervix or breast\n* Adequate hematological, renal, hepatic and coagulation laboratory test results\n* Women of child bearing potential and men must agree to use adequate contraception during the study and for 4 months after the last dose of study drug\n\nAdvanced Solid Malignancies:\n\n* Participants with previously treated, histologically confirmed advanced solid malignancy with progressive disease requiring therapy\n* Participants must be refractory or intolerant to standard therapy\n\nNUT-midline carcinoma:\n\n* Participants with histologically confirmed newly diagnosed or relapsed/refractory NMC with PD requiring therapy\n* Diagnosis of one of the following is required:\n\n 1. NUT Midline Carcinoma based on ectopic expression of NUT protein as determined by Immunohistochemistry (IHC) and/or;\n 2. Detection of NUT gene translocation as determined by Fluorescence In-Situ Hybridization (FISH) Advanced Aggressive DLBCL\n* Histologically confirmed advanced aggressive B-cell lymphoma with abnormal MYC expression with persistent disease requiring treatment\n* Participants must have relapsed or progressed after at least 2 lines of prior therapy and not eligible for any curative treatment\n* Participants must have measurable disease\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Participants with hematologic malignancies\n* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia\n* Have Fridericia-corrected QT interval (QTcF) greater than (>) 470 milliseconds (msec) (female) or > 450 (male), or history of congenital long QT syndrome\n* Active, uncontrolled bacterial, viral, or fungal infections\n* Known clinically important respiratory impairment\n* Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies\n* History of major organ transplant\n* History of an autologous or allogeneic bone marrow transplant. For DLBCL participants only: DLBCL participants may have had a previous autologous transplant but not within 90 days of study entry\n* Symptomatic central nervous system malignancy or metastasis\n* Pregnant or nursing\n* Treatment with surgery or chemotherapy within 28 days prior to study entry\n* Prior treatment with small molecule (BET) family inhibitor\n* Radiation for symptomatic lesions within 14 days of study enrollment",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Participants with solid tumors must have one or more metastatic tumors evaluable or measurable on radiographic imaging",
"criterions": [
{
"exact_snippets": "solid tumors",
"criterion": "solid tumors",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "metastatic tumors evaluable or measurable on radiographic imaging",
"criterion": "metastatic tumors",
"requirements": [
{
"requirement_type": "evaluable or measurable",
"expected_value": true
}
]
}
]
},
{
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (or 2 upon approval by the medical monitor)",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (or 2 upon approval by the medical monitor)",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"0",
"1",
"2 upon approval by the medical monitor"
]
}
]
}
]
},
{
"line": "* Life expectancy of greater than or equal to (>/=) 3 months",
"criterions": [
{
"exact_snippets": "Life expectancy of greater than or equal to (>/=) 3 months",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Disease-free of active second/secondary or prior malignancies >/= 2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"in-situ\" of the cervix or breast",
"criterions": [
{
"exact_snippets": "Disease-free of active second/secondary or prior malignancies >/= 2 years",
"criterion": "active second/secondary or prior malignancies",
"requirements": [
{
"requirement_type": "disease-free duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"in-situ\" of the cervix or breast",
"criterion": "currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"in-situ\" of the cervix or breast",
"requirements": [
{
"requirement_type": "exception",
"expected_value": true
}
]
}
]
},
{
"line": "* Adequate hematological, renal, hepatic and coagulation laboratory test results",
"criterions": [
{
"exact_snippets": "Adequate hematological ... laboratory test results",
"criterion": "hematological laboratory test results",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... renal ... laboratory test results",
"criterion": "renal laboratory test results",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... hepatic ... laboratory test results",
"criterion": "hepatic laboratory test results",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... coagulation laboratory test results",
"criterion": "coagulation laboratory test results",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "* Women of child bearing potential and men must agree to use adequate contraception during the study and for 4 months after the last dose of study drug",
"criterions": [
{
"exact_snippets": "Women of child bearing potential",
"criterion": "women of child bearing potential",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "men must agree to use adequate contraception",
"criterion": "men contraception agreement",
"requirements": [
{
"requirement_type": "agreement",
"expected_value": true
}
]
},
{
"exact_snippets": "Women of child bearing potential and men must agree to use adequate contraception during the study and for 4 months after the last dose of study drug",
"criterion": "contraception duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "during the study and for 4 months after the last dose of study drug"
}
]
}
]
},
{
"line": "Advanced Solid Malignancies:",
"criterions": [
{
"exact_snippets": "Advanced Solid Malignancies",
"criterion": "solid malignancies",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "advanced"
}
]
}
]
},
{
"line": "* Participants with previously treated, histologically confirmed advanced solid malignancy with progressive disease requiring therapy",
"criterions": [
{
"exact_snippets": "previously treated",
"criterion": "treatment history",
"requirements": [
{
"requirement_type": "status",
"expected_value": "previously treated"
}
]
},
{
"exact_snippets": "histologically confirmed",
"criterion": "diagnosis confirmation",
"requirements": [
{
"requirement_type": "method",
"expected_value": "histologically confirmed"
}
]
},
{
"exact_snippets": "advanced solid malignancy",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "advanced"
},
{
"requirement_type": "type",
"expected_value": "solid malignancy"
}
]
},
{
"exact_snippets": "progressive disease",
"criterion": "disease progression",
"requirements": [
{
"requirement_type": "status",
"expected_value": "progressive"
}
]
},
{
"exact_snippets": "requiring therapy",
"criterion": "treatment necessity",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* Participants must be refractory or intolerant to standard therapy",
"criterions": [
{
"exact_snippets": "refractory ... to standard therapy",
"criterion": "refractory to standard therapy",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
},
{
"exact_snippets": "intolerant to standard therapy",
"criterion": "intolerant to standard therapy",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
}
]
},
{
"line": "NUT-midline carcinoma:",
"criterions": [
{
"exact_snippets": "NUT-midline carcinoma",
"criterion": "NUT-midline carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Participants with histologically confirmed newly diagnosed or relapsed/refractory NMC with PD requiring therapy",
"criterions": [
{
"exact_snippets": "histologically confirmed newly diagnosed or relapsed/refractory NMC",
"criterion": "NMC diagnosis",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": true
},
{
"requirement_type": "status",
"expected_value": [
"newly diagnosed",
"relapsed/refractory"
]
}
]
},
{
"exact_snippets": "PD requiring therapy",
"criterion": "PD",
"requirements": [
{
"requirement_type": "treatment necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* Diagnosis of one of the following is required:",
"criterions": [
{
"exact_snippets": "Diagnosis of one of the following is required",
"criterion": "diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "1. NUT Midline Carcinoma based on ectopic expression of NUT protein as determined by Immunohistochemistry (IHC) and/or;",
"criterions": [
{
"exact_snippets": "NUT Midline Carcinoma based on ectopic expression of NUT protein",
"criterion": "NUT Midline Carcinoma",
"requirements": [
{
"requirement_type": "expression",
"expected_value": "ectopic"
}
]
},
{
"exact_snippets": "NUT protein as determined by Immunohistochemistry (IHC)",
"criterion": "NUT protein",
"requirements": [
{
"requirement_type": "determination method",
"expected_value": "Immunohistochemistry (IHC)"
}
]
}
]
},
{
"line": "2. Detection of NUT gene translocation as determined by Fluorescence In-Situ Hybridization (FISH) Advanced Aggressive DLBCL",
"criterions": [
{
"exact_snippets": "Detection of NUT gene translocation",
"criterion": "NUT gene translocation",
"requirements": [
{
"requirement_type": "detection",
"expected_value": true
}
]
},
{
"exact_snippets": "Advanced Aggressive DLBCL",
"criterion": "Advanced Aggressive DLBCL",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Histologically confirmed advanced aggressive B-cell lymphoma with abnormal MYC expression with persistent disease requiring treatment",
"criterions": [
{
"exact_snippets": "Histologically confirmed advanced aggressive B-cell lymphoma",
"criterion": "B-cell lymphoma",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
},
{
"requirement_type": "stage",
"expected_value": "advanced"
},
{
"requirement_type": "aggressiveness",
"expected_value": "aggressive"
}
]
},
{
"exact_snippets": "abnormal MYC expression",
"criterion": "MYC expression",
"requirements": [
{
"requirement_type": "expression status",
"expected_value": "abnormal"
}
]
},
{
"exact_snippets": "persistent disease requiring treatment",
"criterion": "disease persistence",
"requirements": [
{
"requirement_type": "persistence",
"expected_value": true
},
{
"requirement_type": "treatment requirement",
"expected_value": true
}
]
}
]
},
{
"line": "* Participants must have relapsed or progressed after at least 2 lines of prior therapy and not eligible for any curative treatment",
"criterions": [
{
"exact_snippets": "relapsed or progressed",
"criterion": "disease status",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"relapsed",
"progressed"
]
}
]
},
{
"exact_snippets": "after at least 2 lines of prior therapy",
"criterion": "prior therapy",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "lines"
}
}
]
},
{
"exact_snippets": "not eligible for any curative treatment",
"criterion": "curative treatment eligibility",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": false
}
]
}
]
},
{
"line": "* Participants must have measurable disease",
"criterions": [
{
"exact_snippets": "Participants must have measurable disease",
"criterion": "disease",
"requirements": [
{
"requirement_type": "measurability",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Participants with hematologic malignancies",
"criterions": [
{
"exact_snippets": "hematologic malignancies",
"criterion": "hematologic malignancies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia",
"criterions": [
{
"exact_snippets": "New York Heart Association Class III or IV",
"criterion": "New York Heart Association class",
"requirements": [
{
"requirement_type": "severity",
"expected_value": [
"III",
"IV"
]
}
]
},
{
"exact_snippets": "cardiac disease",
"criterion": "cardiac disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "myocardial infarction within the past 6 months",
"criterion": "myocardial infarction",
"requirements": [
{
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
]
},
{
"exact_snippets": "unstable arrhythmia",
"criterion": "unstable arrhythmia",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "unstable"
}
]
}
]
},
{
"line": "* Have Fridericia-corrected QT interval (QTcF) greater than (>) 470 milliseconds (msec) (female) or > 450 (male), or history of congenital long QT syndrome",
"criterions": [
{
"exact_snippets": "Fridericia-corrected QT interval (QTcF) greater than (>) 470 milliseconds (msec) (female)",
"criterion": "Fridericia-corrected QT interval (QTcF)",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 470,
"unit": "milliseconds"
}
}
]
},
{
"exact_snippets": "Fridericia-corrected QT interval (QTcF) ... > 450 (male)",
"criterion": "Fridericia-corrected QT interval (QTcF)",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 450,
"unit": "milliseconds"
}
}
]
},
{
"exact_snippets": "history of congenital long QT syndrome",
"criterion": "congenital long QT syndrome",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Active, uncontrolled bacterial, viral, or fungal infections",
"criterions": [
{
"exact_snippets": "Active, uncontrolled bacterial ... infections",
"criterion": "bacterial infections",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
},
{
"requirement_type": "activity status",
"expected_value": "active"
}
]
},
{
"exact_snippets": "Active, uncontrolled ... viral ... infections",
"criterion": "viral infections",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
},
{
"requirement_type": "activity status",
"expected_value": "active"
}
]
},
{
"exact_snippets": "Active, uncontrolled ... fungal infections",
"criterion": "fungal infections",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
},
{
"requirement_type": "activity status",
"expected_value": "active"
}
]
}
]
},
{
"line": "* Known clinically important respiratory impairment",
"criterions": [
{
"exact_snippets": "Known clinically important respiratory impairment",
"criterion": "respiratory impairment",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "clinically important"
},
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies",
"criterions": [
{
"exact_snippets": "Positive for human immunodeficiency virus (HIV)",
"criterion": "HIV status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Positive for ... hepatitis B surface antigen",
"criterion": "hepatitis B surface antigen",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Positive for ... hepatitis C antibodies",
"criterion": "hepatitis C antibodies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* History of major organ transplant",
"criterions": [
{
"exact_snippets": "History of major organ transplant",
"criterion": "major organ transplant",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* History of an autologous or allogeneic bone marrow transplant. For DLBCL participants only: DLBCL participants may have had a previous autologous transplant but not within 90 days of study entry",
"criterions": [
{
"exact_snippets": "History of an autologous or allogeneic bone marrow transplant",
"criterion": "bone marrow transplant",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "DLBCL participants may have had a previous autologous transplant",
"criterion": "autologous transplant for DLBCL participants",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "not within 90 days of study entry",
"criterion": "autologous transplant timing for DLBCL participants",
"requirements": [
{
"requirement_type": "timing",
"expected_value": {
"operator": ">",
"value": 90,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Symptomatic central nervous system malignancy or metastasis",
"criterions": [
{
"exact_snippets": "Symptomatic central nervous system malignancy",
"criterion": "central nervous system malignancy",
"requirements": [
{
"requirement_type": "symptomatic",
"expected_value": true
}
]
},
{
"exact_snippets": "Symptomatic ... metastasis",
"criterion": "metastasis",
"requirements": [
{
"requirement_type": "symptomatic",
"expected_value": true
}
]
}
]
},
{
"line": "* Pregnant or nursing",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "nursing",
"criterion": "nursing status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Treatment with surgery or chemotherapy within 28 days prior to study entry",
"criterions": [
{
"exact_snippets": "Treatment with surgery ... within 28 days prior to study entry",
"criterion": "surgery treatment",
"requirements": [
{
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
]
},
{
"exact_snippets": "Treatment with ... chemotherapy within 28 days prior to study entry",
"criterion": "chemotherapy treatment",
"requirements": [
{
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Prior treatment with small molecule (BET) family inhibitor",
"criterions": [
{
"exact_snippets": "Prior treatment with small molecule (BET) family inhibitor",
"criterion": "prior treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": "small molecule (BET) family inhibitor"
}
]
}
]
},
{
"line": "* Radiation for symptomatic lesions within 14 days of study enrollment",
"criterions": [
{
"exact_snippets": "Radiation for symptomatic lesions within 14 days of study enrollment",
"criterion": "radiation for symptomatic lesions",
"requirements": [
{
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 14,
"unit": "days"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "General:",
"criterions": []
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}