[96a5a0]: / output / allTrials / logical / NCT00017082_logical.json

Download this file

779 lines (779 with data), 50.0 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
{
"info": {
"nct_id": "NCT00017082",
"official_title": "A Multicenter, Phase II Study Of Oxaliplatin Single Agent As Third-Line Treatment Of Metastatic Colorectal Carcinoma",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum Not amenable to potentially curative treatment (e.g., inoperable metastatic disease) Must have received 2, and only 2, prior chemotherapy regimens for metastatic or recurrent disease, including the following: First-line therapy with bolus or continuous infusion fluorouracil (5-FU) (with or without leucovorin calcium) or capecitabine OR Adjuvant therapy with 5-FU and leucovorin calcium after relapse during or within 6 months of completion of first-line therapy Second-line therapy with irinotecan or after adjuvant 5-FU and leucovorin calcium treatment failure Progressive disease by CT scan or MRI during or after first-line treatment as above OR during or within 6 months of completion of adjuvant chemotherapy as above AND during second-line irinotecan or after adjuvant treatment failure as above At least 1 unidimensionally measurable lesion At least 20 mm by CT scan or MRI At least 10 mm by spiral CT scan\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (6 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No myocardial infarction within the past 6 months No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: No history of intolerance to antiemetics (e.g., 5-HT3 antagonists) or antidiarrheal medication (e.g., loperamide) to be administered concurrently with study chemotherapy No history of allergies to drugs containing platinum No known concurrent peripheral neuropathy No diabetes No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No other active cancer from another primary site except surgically treated non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer with an undetectable PSA level\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy, including irinotecan, for metastatic or recurrent disease and recovered No other prior first-line chemotherapy agents for metastatic or recurrent disease No prior adjuvant irinotecan No prior oxaliplatin Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to target lesions unless documented disease progression within the radiation portal Surgery: See Disease Characteristics More than 4 weeks since prior surgery for primary or metastatic disease and recovered Other: No prior investigational anticancer drug administered with irinotecan No other concurrent investigational drugs"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy, including irinotecan, for metastatic or recurrent disease and recovered No other prior first-line chemotherapy agents for metastatic or recurrent disease No prior adjuvant irinotecan No prior oxaliplatin Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to target lesions unless documented disease progression within the radiation portal Surgery: See Disease Characteristics More than 4 weeks since prior surgery for primary or metastatic disease and recovered Other: No prior investigational anticancer drug administered with irinotecan No other concurrent investigational drugs",
"criterions": [
{
"exact_snippets": "No prior biologic therapy",
"criterion": "prior biologic therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "At least 3 weeks since prior chemotherapy",
"criterion": "time since prior chemotherapy",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "No other prior first-line chemotherapy agents for metastatic or recurrent disease",
"criterion": "prior first-line chemotherapy agents for metastatic or recurrent disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No prior adjuvant irinotecan",
"criterion": "prior adjuvant irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No prior oxaliplatin",
"criterion": "prior oxaliplatin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "At least 3 weeks since prior radiotherapy",
"criterion": "time since prior radiotherapy",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "No prior radiotherapy to target lesions unless documented disease progression within the radiation portal",
"criterion": "prior radiotherapy to target lesions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "More than 4 weeks since prior surgery for primary or metastatic disease",
"criterion": "time since prior surgery for primary or metastatic disease",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "No prior investigational anticancer drug administered with irinotecan",
"criterion": "prior investigational anticancer drug administered with irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No other concurrent investigational drugs",
"criterion": "concurrent investigational drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No prior biologic therapy",
"criterion": "prior biologic therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "At least 3 weeks since prior chemotherapy",
"criterion": "time since prior chemotherapy",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "No other prior first-line chemotherapy agents for metastatic or recurrent disease",
"criterion": "prior first-line chemotherapy agents for metastatic or recurrent disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "No prior adjuvant irinotecan",
"criterion": "prior adjuvant irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "No prior oxaliplatin",
"criterion": "prior oxaliplatin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "At least 3 weeks since prior radiotherapy",
"criterion": "time since prior radiotherapy",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
}
]
}
}
}
]
},
{
"condition": {
"exact_snippets": "No prior radiotherapy to target lesions unless documented disease progression within the radiation portal",
"criterion": "prior radiotherapy to target lesions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "documented disease progression within the radiation portal",
"criterion": "documented disease progression within the radiation portal",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
]
},
{
"exact_snippets": "More than 4 weeks since prior surgery for primary or metastatic disease",
"criterion": "time since prior surgery for primary or metastatic disease",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 4,
"unit": "weeks"
}
]
}
}
}
]
},
{
"exact_snippets": "No prior investigational anticancer drug administered with irinotecan",
"criterion": "prior investigational anticancer drug administered with irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "No other concurrent investigational drugs",
"criterion": "concurrent investigational drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "See Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "See Disease Characteristics"
}
}
]
},
{
"exact_snippets": "See Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "See Disease Characteristics"
}
}
]
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum Not amenable to potentially curative treatment (e.g., inoperable metastatic disease) Must have received 2, and only 2, prior chemotherapy regimens for metastatic or recurrent disease, including the following: First-line therapy with bolus or continuous infusion fluorouracil (5-FU) (with or without leucovorin calcium) or capecitabine OR Adjuvant therapy with 5-FU and leucovorin calcium after relapse during or within 6 months of completion of first-line therapy Second-line therapy with irinotecan or after adjuvant 5-FU and leucovorin calcium treatment failure Progressive disease by CT scan or MRI during or after first-line treatment as above OR during or within 6 months of completion of adjuvant chemotherapy as above AND during second-line irinotecan or after adjuvant treatment failure as above At least 1 unidimensionally measurable lesion At least 20 mm by CT scan or MRI At least 10 mm by spiral CT scan",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum",
"criterion": "adenocarcinoma of the colon or rectum",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically or cytologically"
}
},
{
"exact_snippets": "Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum",
"criterion": "adenocarcinoma of the colon or rectum",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
},
{
"exact_snippets": "Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum",
"criterion": "adenocarcinoma of the colon or rectum",
"requirement": {
"requirement_type": "metastasis",
"expected_value": true
}
},
{
"exact_snippets": "Not amenable to potentially curative treatment (e.g., inoperable metastatic disease)",
"criterion": "curative treatment",
"requirement": {
"requirement_type": "amenability",
"expected_value": false
}
},
{
"exact_snippets": "Must have received 2, and only 2, prior chemotherapy regimens for metastatic or recurrent disease",
"criterion": "prior chemotherapy regimens",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 2,
"unit": "regimens"
}
}
},
{
"exact_snippets": "First-line therapy with bolus or continuous infusion fluorouracil (5-FU) (with or without leucovorin calcium) or capecitabine",
"criterion": "first-line therapy",
"requirement": {
"requirement_type": "medication",
"expected_value": [
"fluorouracil (5-FU)",
"capecitabine"
]
}
},
{
"exact_snippets": "Adjuvant therapy with 5-FU and leucovorin calcium after relapse during or within 6 months of completion of first-line therapy",
"criterion": "adjuvant therapy",
"requirement": {
"requirement_type": "medication",
"expected_value": [
"5-FU",
"leucovorin calcium"
]
}
},
{
"exact_snippets": "Adjuvant therapy with 5-FU and leucovorin calcium after relapse during or within 6 months of completion of first-line therapy",
"criterion": "adjuvant therapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "after relapse during or within 6 months of completion of first-line therapy"
}
},
{
"exact_snippets": "Second-line therapy with irinotecan or after adjuvant 5-FU and leucovorin calcium treatment failure",
"criterion": "second-line therapy",
"requirement": {
"requirement_type": "medication",
"expected_value": "irinotecan"
}
},
{
"exact_snippets": "Progressive disease by CT scan or MRI during or after first-line treatment as above OR during or within 6 months of completion of adjuvant chemotherapy as above AND during second-line irinotecan or after adjuvant treatment failure as above",
"criterion": "progressive disease",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "CT scan or MRI"
}
},
{
"exact_snippets": "Progressive disease by CT scan or MRI during or after first-line treatment as above OR during or within 6 months of completion of adjuvant chemotherapy as above AND during second-line irinotecan or after adjuvant treatment failure as above",
"criterion": "progressive disease",
"requirement": {
"requirement_type": "timing",
"expected_value": "during or after first-line treatment OR during or within 6 months of completion of adjuvant chemotherapy AND during second-line irinotecan or after adjuvant treatment failure"
}
},
{
"exact_snippets": "At least 1 unidimensionally measurable lesion",
"criterion": "unidimensionally measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
},
{
"exact_snippets": "At least 20 mm by CT scan or MRI",
"criterion": "lesion size by CT scan or MRI",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "mm"
}
}
},
{
"exact_snippets": "At least 10 mm by spiral CT scan",
"criterion": "lesion size by spiral CT scan",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mm"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (6 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No myocardial infarction within the past 6 months No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: No history of intolerance to antiemetics (e.g., 5-HT3 antagonists) or antidiarrheal medication (e.g., loperamide) to be administered concurrently with study chemotherapy No history of allergies to drugs containing platinum No known concurrent peripheral neuropathy No diabetes No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No other active cancer from another primary site except surgically treated non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer with an undetectable PSA level",
"criterions": [
{
"exact_snippets": "Age: 18 and over",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "Performance status: Karnofsky 50-100%",
"criterion": "performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 50,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
},
{
"exact_snippets": "Life expectancy: Not specified",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "specification",
"expected_value": "Not specified"
}
},
{
"exact_snippets": "Absolute neutrophil count at least 1,500/mm3",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Platelet count at least 100,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Bilirubin no greater than 1.5 times upper limit of normal (ULN)",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "SGOT and SGPT no greater than 2 times ULN (6 times ULN if liver metastases present)",
"criterion": "SGOT and SGPT levels",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "SGOT and SGPT no greater than 2 times ULN (6 times ULN if liver metastases present)",
"criterion": "SGOT and SGPT levels",
"requirement": {
"requirement_type": "maximum with condition",
"expected_value": "6 times ULN if liver metastases present"
}
},
{
"exact_snippets": "Alkaline phosphatase no greater than 2 times ULN (6 times ULN if liver metastases present)",
"criterion": "alkaline phosphatase level",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "Alkaline phosphatase no greater than 2 times ULN (6 times ULN if liver metastases present)",
"criterion": "alkaline phosphatase level",
"requirement": {
"requirement_type": "maximum with condition",
"expected_value": "6 times ULN if liver metastases present"
}
},
{
"exact_snippets": "Creatinine no greater than 1.5 times ULN",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "No unstable angina",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No myocardial infarction within the past 6 months",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "recency",
"expected_value": "not within the past 6 months"
}
},
{
"exact_snippets": "No New York Heart Association class III or IV symptomatic congestive heart failure",
"criterion": "New York Heart Association class III or IV symptomatic congestive heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No serious cardiac arrhythmia",
"criterion": "serious cardiac arrhythmia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No interstitial pneumonia or extensive and symptomatic fibrosis of the lung",
"criterion": "interstitial pneumonia or extensive and symptomatic fibrosis of the lung",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No history of intolerance to antiemetics (e.g., 5-HT3 antagonists) or antidiarrheal medication (e.g., loperamide) to be administered concurrently with study chemotherapy",
"criterion": "intolerance to antiemetics or antidiarrheal medication",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "No history of allergies to drugs containing platinum",
"criterion": "allergies to drugs containing platinum",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "No known concurrent peripheral neuropathy",
"criterion": "concurrent peripheral neuropathy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No diabetes",
"criterion": "diabetes",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No active infection",
"criterion": "active infection",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Not pregnant or nursing",
"criterion": "pregnancy or nursing",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
},
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "Fertile patients must use effective contraception during and for 6 months after study",
"criterion": "contraception use",
"requirement": {
"requirement_type": "requirement for fertile patients",
"expected_value": "use effective contraception during and for 6 months after study"
}
},
{
"exact_snippets": "No other active cancer from another primary site except surgically treated non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer with an undetectable PSA level",
"criterion": "other active cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No other active cancer from another primary site except surgically treated non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer with an undetectable PSA level",
"criterion": "other active cancer",
"requirement": {
"requirement_type": "exceptions",
"expected_value": [
"surgically treated non-melanoma skin cancer",
"carcinoma in situ of the cervix",
"localized prostate cancer with an undetectable PSA level"
]
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
]
}