pharmadata 0.1.0__py3-none-any.whl

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Files changed (166) hide show
  1. pharmadata/__init__.py +41 -0
  2. pharmadata/_core/__init__.py +1 -0
  3. pharmadata/_core/collection.py +119 -0
  4. pharmadata/_core/data.py +295 -0
  5. pharmadata/_core/meta.py +159 -0
  6. pharmadata/_core/output_format.py +139 -0
  7. pharmadata/_data/cdiscpilotadam/_collection.json +6 -0
  8. pharmadata/_data/cdiscpilotadam/_meta.json +3140 -0
  9. pharmadata/_data/cdiscpilotadam/adadas.parquet +0 -0
  10. pharmadata/_data/cdiscpilotadam/adae.parquet +0 -0
  11. pharmadata/_data/cdiscpilotadam/adcibc.parquet +0 -0
  12. pharmadata/_data/cdiscpilotadam/adlbc.parquet +0 -0
  13. pharmadata/_data/cdiscpilotadam/adlbcpv.parquet +0 -0
  14. pharmadata/_data/cdiscpilotadam/adlbh.parquet +0 -0
  15. pharmadata/_data/cdiscpilotadam/adlbhpv.parquet +0 -0
  16. pharmadata/_data/cdiscpilotadam/adlbhy.parquet +0 -0
  17. pharmadata/_data/cdiscpilotadam/adnpix.parquet +0 -0
  18. pharmadata/_data/cdiscpilotadam/adsl.parquet +0 -0
  19. pharmadata/_data/cdiscpilotadam/adtte.parquet +0 -0
  20. pharmadata/_data/cdiscpilotadam/advs.parquet +0 -0
  21. pharmadata/_data/cdiscpilotsdtm/_collection.json +6 -0
  22. pharmadata/_data/cdiscpilotsdtm/_meta.json +3321 -0
  23. pharmadata/_data/cdiscpilotsdtm/ae.parquet +0 -0
  24. pharmadata/_data/cdiscpilotsdtm/cm.parquet +0 -0
  25. pharmadata/_data/cdiscpilotsdtm/dm.parquet +0 -0
  26. pharmadata/_data/cdiscpilotsdtm/ds.parquet +0 -0
  27. pharmadata/_data/cdiscpilotsdtm/ex.parquet +0 -0
  28. pharmadata/_data/cdiscpilotsdtm/lbch.parquet +0 -0
  29. pharmadata/_data/cdiscpilotsdtm/lbhe.parquet +0 -0
  30. pharmadata/_data/cdiscpilotsdtm/lbur.parquet +0 -0
  31. pharmadata/_data/cdiscpilotsdtm/mh.parquet +0 -0
  32. pharmadata/_data/cdiscpilotsdtm/qsco.parquet +0 -0
  33. pharmadata/_data/cdiscpilotsdtm/qsda.parquet +0 -0
  34. pharmadata/_data/cdiscpilotsdtm/qsgi.parquet +0 -0
  35. pharmadata/_data/cdiscpilotsdtm/qshi.parquet +0 -0
  36. pharmadata/_data/cdiscpilotsdtm/qsmm.parquet +0 -0
  37. pharmadata/_data/cdiscpilotsdtm/qsni.parquet +0 -0
  38. pharmadata/_data/cdiscpilotsdtm/relrec.parquet +0 -0
  39. pharmadata/_data/cdiscpilotsdtm/sc.parquet +0 -0
  40. pharmadata/_data/cdiscpilotsdtm/se.parquet +0 -0
  41. pharmadata/_data/cdiscpilotsdtm/suppae.parquet +0 -0
  42. pharmadata/_data/cdiscpilotsdtm/suppdm.parquet +0 -0
  43. pharmadata/_data/cdiscpilotsdtm/suppds.parquet +0 -0
  44. pharmadata/_data/cdiscpilotsdtm/supplbch.parquet +0 -0
  45. pharmadata/_data/cdiscpilotsdtm/supplbhe.parquet +0 -0
  46. pharmadata/_data/cdiscpilotsdtm/supplbur.parquet +0 -0
  47. pharmadata/_data/cdiscpilotsdtm/sv.parquet +0 -0
  48. pharmadata/_data/cdiscpilotsdtm/ta.parquet +0 -0
  49. pharmadata/_data/cdiscpilotsdtm/te.parquet +0 -0
  50. pharmadata/_data/cdiscpilotsdtm/ti.parquet +0 -0
  51. pharmadata/_data/cdiscpilotsdtm/ts.parquet +0 -0
  52. pharmadata/_data/cdiscpilotsdtm/tv.parquet +0 -0
  53. pharmadata/_data/cdiscpilotsdtm/vs.parquet +0 -0
  54. pharmadata/_data/pharmaverseadam/_collection.json +6 -0
  55. pharmadata/_data/pharmaverseadam/_meta.json +14421 -0
  56. pharmadata/_data/pharmaverseadam/adab.parquet +0 -0
  57. pharmadata/_data/pharmaverseadam/adae.parquet +0 -0
  58. pharmadata/_data/pharmaverseadam/adapet_neuro.parquet +0 -0
  59. pharmadata/_data/pharmaverseadam/adbcva_ophtha.parquet +0 -0
  60. pharmadata/_data/pharmaverseadam/adce_vaccine.parquet +0 -0
  61. pharmadata/_data/pharmaverseadam/adcm.parquet +0 -0
  62. pharmadata/_data/pharmaverseadam/adcoeq_metabolic.parquet +0 -0
  63. pharmadata/_data/pharmaverseadam/adeg.parquet +0 -0
  64. pharmadata/_data/pharmaverseadam/adex.parquet +0 -0
  65. pharmadata/_data/pharmaverseadam/adface_vaccine.parquet +0 -0
  66. pharmadata/_data/pharmaverseadam/adis_vaccine.parquet +0 -0
  67. pharmadata/_data/pharmaverseadam/adlb.parquet +0 -0
  68. pharmadata/_data/pharmaverseadam/adlb_metabolic.parquet +0 -0
  69. pharmadata/_data/pharmaverseadam/adlb_neuro.parquet +0 -0
  70. pharmadata/_data/pharmaverseadam/adlbhy.parquet +0 -0
  71. pharmadata/_data/pharmaverseadam/admh.parquet +0 -0
  72. pharmadata/_data/pharmaverseadam/adnv_neuro.parquet +0 -0
  73. pharmadata/_data/pharmaverseadam/adoe_ophtha.parquet +0 -0
  74. pharmadata/_data/pharmaverseadam/adpc.parquet +0 -0
  75. pharmadata/_data/pharmaverseadam/adpp.parquet +0 -0
  76. pharmadata/_data/pharmaverseadam/adppk.parquet +0 -0
  77. pharmadata/_data/pharmaverseadam/adrs_onco.parquet +0 -0
  78. pharmadata/_data/pharmaverseadam/adsl.parquet +0 -0
  79. pharmadata/_data/pharmaverseadam/adsl_vaccine.parquet +0 -0
  80. pharmadata/_data/pharmaverseadam/adtpet_neuro.parquet +0 -0
  81. pharmadata/_data/pharmaverseadam/adtr_onco.parquet +0 -0
  82. pharmadata/_data/pharmaverseadam/adtte_onco.parquet +0 -0
  83. pharmadata/_data/pharmaverseadam/advfq_ophtha.parquet +0 -0
  84. pharmadata/_data/pharmaverseadam/advs.parquet +0 -0
  85. pharmadata/_data/pharmaverseadam/advs_metabolic.parquet +0 -0
  86. pharmadata/_data/pharmaverseadam/advs_peds.parquet +0 -0
  87. pharmadata/_data/pharmaversesdtm/_collection.json +6 -0
  88. pharmadata/_data/pharmaversesdtm/_meta.json +7518 -0
  89. pharmadata/_data/pharmaversesdtm/ae.parquet +0 -0
  90. pharmadata/_data/pharmaversesdtm/ae_ophtha.parquet +0 -0
  91. pharmadata/_data/pharmaversesdtm/ag_neuro.parquet +0 -0
  92. pharmadata/_data/pharmaversesdtm/be.parquet +0 -0
  93. pharmadata/_data/pharmaversesdtm/ce_vaccine.parquet +0 -0
  94. pharmadata/_data/pharmaversesdtm/cm.parquet +0 -0
  95. pharmadata/_data/pharmaversesdtm/dm.parquet +0 -0
  96. pharmadata/_data/pharmaversesdtm/dm_metabolic.parquet +0 -0
  97. pharmadata/_data/pharmaversesdtm/dm_neuro.parquet +0 -0
  98. pharmadata/_data/pharmaversesdtm/dm_peds.parquet +0 -0
  99. pharmadata/_data/pharmaversesdtm/dm_vaccine.parquet +0 -0
  100. pharmadata/_data/pharmaversesdtm/ds.parquet +0 -0
  101. pharmadata/_data/pharmaversesdtm/eg.parquet +0 -0
  102. pharmadata/_data/pharmaversesdtm/ex.parquet +0 -0
  103. pharmadata/_data/pharmaversesdtm/ex_ophtha.parquet +0 -0
  104. pharmadata/_data/pharmaversesdtm/ex_vaccine.parquet +0 -0
  105. pharmadata/_data/pharmaversesdtm/face_vaccine.parquet +0 -0
  106. pharmadata/_data/pharmaversesdtm/is_ada.parquet +0 -0
  107. pharmadata/_data/pharmaversesdtm/is_vaccine.parquet +0 -0
  108. pharmadata/_data/pharmaversesdtm/lb.parquet +0 -0
  109. pharmadata/_data/pharmaversesdtm/lb_metabolic.parquet +0 -0
  110. pharmadata/_data/pharmaversesdtm/lb_neuro.parquet +0 -0
  111. pharmadata/_data/pharmaversesdtm/lb_onco_pcwg3.parquet +0 -0
  112. pharmadata/_data/pharmaversesdtm/mb.parquet +0 -0
  113. pharmadata/_data/pharmaversesdtm/mh.parquet +0 -0
  114. pharmadata/_data/pharmaversesdtm/ms.parquet +0 -0
  115. pharmadata/_data/pharmaversesdtm/nv_neuro.parquet +0 -0
  116. pharmadata/_data/pharmaversesdtm/oe_ophtha.parquet +0 -0
  117. pharmadata/_data/pharmaversesdtm/pc.parquet +0 -0
  118. pharmadata/_data/pharmaversesdtm/pp.parquet +0 -0
  119. pharmadata/_data/pharmaversesdtm/qs_metabolic.parquet +0 -0
  120. pharmadata/_data/pharmaversesdtm/qs_ophtha.parquet +0 -0
  121. pharmadata/_data/pharmaversesdtm/rs_onco.parquet +0 -0
  122. pharmadata/_data/pharmaversesdtm/rs_onco_ca125.parquet +0 -0
  123. pharmadata/_data/pharmaversesdtm/rs_onco_imwg.parquet +0 -0
  124. pharmadata/_data/pharmaversesdtm/rs_onco_irecist.parquet +0 -0
  125. pharmadata/_data/pharmaversesdtm/rs_onco_lymphoma.parquet +0 -0
  126. pharmadata/_data/pharmaversesdtm/rs_onco_pcwg3.parquet +0 -0
  127. pharmadata/_data/pharmaversesdtm/rs_onco_recist.parquet +0 -0
  128. pharmadata/_data/pharmaversesdtm/sc_ophtha.parquet +0 -0
  129. pharmadata/_data/pharmaversesdtm/sdg_db.parquet +0 -0
  130. pharmadata/_data/pharmaversesdtm/smq_db.parquet +0 -0
  131. pharmadata/_data/pharmaversesdtm/suppae.parquet +0 -0
  132. pharmadata/_data/pharmaversesdtm/suppce_vaccine.parquet +0 -0
  133. pharmadata/_data/pharmaversesdtm/suppdm.parquet +0 -0
  134. pharmadata/_data/pharmaversesdtm/suppdm_vaccine.parquet +0 -0
  135. pharmadata/_data/pharmaversesdtm/suppds.parquet +0 -0
  136. pharmadata/_data/pharmaversesdtm/suppex_vaccine.parquet +0 -0
  137. pharmadata/_data/pharmaversesdtm/suppface_vaccine.parquet +0 -0
  138. pharmadata/_data/pharmaversesdtm/suppis_vaccine.parquet +0 -0
  139. pharmadata/_data/pharmaversesdtm/suppnv_neuro.parquet +0 -0
  140. pharmadata/_data/pharmaversesdtm/supprs_onco_ca125.parquet +0 -0
  141. pharmadata/_data/pharmaversesdtm/supprs_onco_imwg.parquet +0 -0
  142. pharmadata/_data/pharmaversesdtm/supptr_onco.parquet +0 -0
  143. pharmadata/_data/pharmaversesdtm/sv.parquet +0 -0
  144. pharmadata/_data/pharmaversesdtm/tr_onco.parquet +0 -0
  145. pharmadata/_data/pharmaversesdtm/tr_onco_recist.parquet +0 -0
  146. pharmadata/_data/pharmaversesdtm/ts.parquet +0 -0
  147. pharmadata/_data/pharmaversesdtm/tu_onco.parquet +0 -0
  148. pharmadata/_data/pharmaversesdtm/tu_onco_recist.parquet +0 -0
  149. pharmadata/_data/pharmaversesdtm/vs.parquet +0 -0
  150. pharmadata/_data/pharmaversesdtm/vs_metabolic.parquet +0 -0
  151. pharmadata/_data/pharmaversesdtm/vs_peds.parquet +0 -0
  152. pharmadata/_data/pharmaversesdtm/vs_vaccine.parquet +0 -0
  153. pharmadata/cdiscpilotadam/__init__.py +136 -0
  154. pharmadata/cdiscpilotadam/__init__.pyi +647 -0
  155. pharmadata/cdiscpilotsdtm/__init__.py +136 -0
  156. pharmadata/cdiscpilotsdtm/__init__.pyi +845 -0
  157. pharmadata/pharmaverseadam/__init__.py +136 -0
  158. pharmadata/pharmaverseadam/__init__.pyi +2690 -0
  159. pharmadata/pharmaversesdtm/__init__.py +136 -0
  160. pharmadata/pharmaversesdtm/__init__.pyi +1772 -0
  161. pharmadata/py.typed +0 -0
  162. pharmadata-0.1.0.dist-info/METADATA +71 -0
  163. pharmadata-0.1.0.dist-info/RECORD +166 -0
  164. pharmadata-0.1.0.dist-info/WHEEL +4 -0
  165. pharmadata-0.1.0.dist-info/licenses/LICENSE +177 -0
  166. pharmadata-0.1.0.dist-info/licenses/NOTICE +139 -0
pharmadata/_data/cdiscpilotsdtm/_meta.json ADDED
@@ -0,0 +1,3321 @@
1
+ {
2
+ "ae": {
3
+ "label": "Adverse Events",
4
+ "structure": "One record per adverse event per subject",
5
+ "n_rows": 961,
6
+ "columns": {
7
+ "STUDYID": {
8
+ "label": "Study Identifier",
9
+ "type": "String",
10
+ "mandatory": "Yes",
11
+ "role": "IDENTIFIER"
12
+ },
13
+ "DOMAIN": {
14
+ "label": "Domain Abbreviation",
15
+ "type": "String",
16
+ "mandatory": "Yes",
17
+ "role": "IDENTIFIER"
18
+ },
19
+ "USUBJID": {
20
+ "label": "Unique Subject Identifier",
21
+ "type": "String",
22
+ "mandatory": "Yes",
23
+ "role": "IDENTIFIER"
24
+ },
25
+ "AESEQ": {
26
+ "label": "Sequence Number",
27
+ "type": "Float64",
28
+ "mandatory": "Yes",
29
+ "role": "IDENTIFIER"
30
+ },
31
+ "AESPID": {
32
+ "label": "Sponsor-Defined Identifier",
33
+ "type": "String",
34
+ "mandatory": "No",
35
+ "role": "IDENTIFIER"
36
+ },
37
+ "AETERM": {
38
+ "label": "Reported Term for the Adverse Event",
39
+ "type": "String",
40
+ "mandatory": "Yes",
41
+ "role": "TOPIC"
42
+ },
43
+ "AELLT": {
44
+ "label": "Lowest Level Term",
45
+ "type": "String",
46
+ "mandatory": "No",
47
+ "role": "VARIABLE QUALIFIER"
48
+ },
49
+ "AELLTCD": {
50
+ "label": "Lowest Level Term Code",
51
+ "type": "Float64",
52
+ "mandatory": "No",
53
+ "role": "VARIABLE QUALIFIER"
54
+ },
55
+ "AEDECOD": {
56
+ "label": "Dictionary-Derived Term",
57
+ "type": "String",
58
+ "mandatory": "No",
59
+ "role": "SYNONYM QUALIFIER"
60
+ },
61
+ "AEPTCD": {
62
+ "label": "Preferred Term Code",
63
+ "type": "Float64",
64
+ "mandatory": "No",
65
+ "role": "VARIABLE QUALIFIER"
66
+ },
67
+ "AEHLT": {
68
+ "label": "High Level Term",
69
+ "type": "String",
70
+ "mandatory": "No",
71
+ "role": "VARIABLE QUALIFIER"
72
+ },
73
+ "AEHLTCD": {
74
+ "label": "High Level Term Code",
75
+ "type": "Float64",
76
+ "mandatory": "No",
77
+ "role": "VARIABLE QUALIFIER"
78
+ },
79
+ "AEHLGT": {
80
+ "label": "High Level Group Term",
81
+ "type": "String",
82
+ "mandatory": "No",
83
+ "role": "VARIABLE QUALIFIER"
84
+ },
85
+ "AEHLGTCD": {
86
+ "label": "High Level Group Term Code",
87
+ "type": "Float64",
88
+ "mandatory": "No",
89
+ "role": "VARIABLE QUALIFIER"
90
+ },
91
+ "AEBODSYS": {
92
+ "label": "Body System or Organ Class",
93
+ "type": "String",
94
+ "mandatory": "No",
95
+ "role": "VARIABLE QUALIFIER"
96
+ },
97
+ "AEBDSYCD": {
98
+ "label": "Body System or Organ Class Code",
99
+ "type": "Float64",
100
+ "mandatory": "No",
101
+ "role": "VARIABLE QUALIFIER"
102
+ },
103
+ "AESOC": {
104
+ "label": "Primary System Organ Class",
105
+ "type": "String",
106
+ "mandatory": "No",
107
+ "role": "VARIABLE QUALIFIER"
108
+ },
109
+ "AESOCCD": {
110
+ "label": "Primary System Organ Class Code",
111
+ "type": "Float64",
112
+ "mandatory": "No",
113
+ "role": "VARIABLE QUALIFIER"
114
+ },
115
+ "AESEV": {
116
+ "label": "Severity/Intensity",
117
+ "type": "String",
118
+ "mandatory": "No",
119
+ "role": "VARIABLE QUALIFIER"
120
+ },
121
+ "AESER": {
122
+ "label": "Serious Event",
123
+ "type": "String",
124
+ "mandatory": "No",
125
+ "role": "RECORD QUALIFIER"
126
+ },
127
+ "AEACN": {
128
+ "label": "Action Taken with Study Treatment",
129
+ "type": "String",
130
+ "mandatory": "No",
131
+ "role": "RECORD QUALIFIER"
132
+ },
133
+ "AEREL": {
134
+ "label": "Causality",
135
+ "type": "String",
136
+ "mandatory": "No",
137
+ "role": "RECORD QUALIFIER"
138
+ },
139
+ "AEOUT": {
140
+ "label": "Outcome of Adverse Event",
141
+ "type": "String",
142
+ "mandatory": "No",
143
+ "role": "RECORD QUALIFIER"
144
+ },
145
+ "AESCAN": {
146
+ "label": "Involves Cancer",
147
+ "type": "String",
148
+ "mandatory": "No",
149
+ "role": "RECORD QUALIFIER"
150
+ },
151
+ "AESCONG": {
152
+ "label": "Congenital Anomaly or Birth Defect",
153
+ "type": "String",
154
+ "mandatory": "No",
155
+ "role": "RECORD QUALIFIER"
156
+ },
157
+ "AESDISAB": {
158
+ "label": "Persist or Signif Disability/Incapacity",
159
+ "type": "String",
160
+ "mandatory": "No",
161
+ "role": "RECORD QUALIFIER"
162
+ },
163
+ "AESDTH": {
164
+ "label": "Results in Death",
165
+ "type": "String",
166
+ "mandatory": "No",
167
+ "role": "RECORD QUALIFIER"
168
+ },
169
+ "AESHOSP": {
170
+ "label": "Requires or Prolongs Hospitalization",
171
+ "type": "String",
172
+ "mandatory": "No",
173
+ "role": "RECORD QUALIFIER"
174
+ },
175
+ "AESLIFE": {
176
+ "label": "Is Life Threatening",
177
+ "type": "String",
178
+ "mandatory": "No",
179
+ "role": "RECORD QUALIFIER"
180
+ },
181
+ "AESOD": {
182
+ "label": "Occurred with Overdose",
183
+ "type": "String",
184
+ "mandatory": "No",
185
+ "role": "RECORD QUALIFIER"
186
+ },
187
+ "EPOCH": {
188
+ "label": "Epoch",
189
+ "type": "String",
190
+ "mandatory": "No",
191
+ "role": "TIMING"
192
+ },
193
+ "AEDTC": {
194
+ "label": "Date/Time of Collection",
195
+ "type": "String",
196
+ "mandatory": "No",
197
+ "role": "TIMING"
198
+ },
199
+ "AESTDTC": {
200
+ "label": "Start Date/Time of Adverse Event",
201
+ "type": "String",
202
+ "mandatory": "No",
203
+ "role": "TIMING"
204
+ },
205
+ "AEENDTC": {
206
+ "label": "End Date/Time of Adverse Event",
207
+ "type": "String",
208
+ "mandatory": "No",
209
+ "role": "TIMING"
210
+ },
211
+ "AEDY": {
212
+ "label": "Study Day of Visit/Collection/Exam",
213
+ "type": "Float64",
214
+ "mandatory": "No",
215
+ "role": "TIMING"
216
+ },
217
+ "AESTDY": {
218
+ "label": "Study Day of Start of Adverse Event",
219
+ "type": "Float64",
220
+ "mandatory": "No",
221
+ "role": "TIMING"
222
+ },
223
+ "AEENDY": {
224
+ "label": "Study Day of End of Adverse Event",
225
+ "type": "Float64",
226
+ "mandatory": "No",
227
+ "role": "TIMING"
228
+ }
229
+ }
230
+ },
231
+ "cm": {
232
+ "label": "Concomitant Medications",
233
+ "structure": "One record per recorded medication occurrence or constant-dosing interval per subject",
234
+ "n_rows": 7510,
235
+ "columns": {
236
+ "STUDYID": {
237
+ "label": "Study Identifier",
238
+ "type": "String",
239
+ "mandatory": "Yes",
240
+ "role": "IDENTIFIER"
241
+ },
242
+ "DOMAIN": {
243
+ "label": "Domain Abbreviation",
244
+ "type": "String",
245
+ "mandatory": "Yes",
246
+ "role": "IDENTIFIER"
247
+ },
248
+ "USUBJID": {
249
+ "label": "Unique Subject Identifier",
250
+ "type": "String",
251
+ "mandatory": "Yes",
252
+ "role": "IDENTIFIER"
253
+ },
254
+ "CMSEQ": {
255
+ "label": "Sequence Number",
256
+ "type": "Float64",
257
+ "mandatory": "Yes",
258
+ "role": "IDENTIFIER"
259
+ },
260
+ "CMSPID": {
261
+ "label": "Sponsor-Defined Identifier",
262
+ "type": "String",
263
+ "mandatory": "No",
264
+ "role": "IDENTIFIER"
265
+ },
266
+ "CMTRT": {
267
+ "label": "Reported Name of Drug, Med, or Therapy",
268
+ "type": "String",
269
+ "mandatory": "Yes",
270
+ "role": "TOPIC"
271
+ },
272
+ "CMDECOD": {
273
+ "label": "Standardized Medication Name",
274
+ "type": "String",
275
+ "mandatory": "No",
276
+ "role": "SYNONYM QUALIFIER"
277
+ },
278
+ "CMINDC": {
279
+ "label": "Indication",
280
+ "type": "String",
281
+ "mandatory": "No",
282
+ "role": "RECORD QUALIFIER"
283
+ },
284
+ "CMCLAS": {
285
+ "label": "Medication Class",
286
+ "type": "String",
287
+ "mandatory": "No",
288
+ "role": "VARIABLE QUALIFIER"
289
+ },
290
+ "CMDOSE": {
291
+ "label": "Dose per Administration",
292
+ "type": "Float64",
293
+ "mandatory": "No",
294
+ "role": "RECORD QUALIFIER"
295
+ },
296
+ "CMDOSU": {
297
+ "label": "Dose Units",
298
+ "type": "String",
299
+ "mandatory": "No",
300
+ "role": "VARIABLE QUALIFIER"
301
+ },
302
+ "CMDOSFRQ": {
303
+ "label": "Dosing Frequency per Interval",
304
+ "type": "String",
305
+ "mandatory": "No",
306
+ "role": "VARIABLE QUALIFIER"
307
+ },
308
+ "CMROUTE": {
309
+ "label": "Route of Administration",
310
+ "type": "String",
311
+ "mandatory": "No",
312
+ "role": "VARIABLE QUALIFIER"
313
+ },
314
+ "VISITNUM": {
315
+ "label": "Visit Number",
316
+ "type": "Float64",
317
+ "mandatory": "No",
318
+ "role": "TIMING"
319
+ },
320
+ "VISIT": {
321
+ "label": "Visit Name",
322
+ "type": "String",
323
+ "mandatory": "No",
324
+ "role": "TIMING"
325
+ },
326
+ "VISITDY": {
327
+ "label": "Planned Study Day of Visit",
328
+ "type": "Float64",
329
+ "mandatory": "No",
330
+ "role": "TIMING"
331
+ },
332
+ "EPOCH": {
333
+ "label": "Epoch",
334
+ "type": "String",
335
+ "mandatory": "No",
336
+ "role": "TIMING"
337
+ },
338
+ "CMDTC": {
339
+ "label": "Date/Time of Collection",
340
+ "type": "String",
341
+ "mandatory": "No",
342
+ "role": "TIMING"
343
+ },
344
+ "CMSTDTC": {
345
+ "label": "Start Date/Time of Medication",
346
+ "type": "String",
347
+ "mandatory": "No",
348
+ "role": "TIMING"
349
+ },
350
+ "CMENDTC": {
351
+ "label": "End Date/Time of Medication",
352
+ "type": "String",
353
+ "mandatory": "No",
354
+ "role": "TIMING"
355
+ },
356
+ "CMDY": {
357
+ "label": "Study Day of Visit/Collection/Exam",
358
+ "type": "Float64",
359
+ "mandatory": "No",
360
+ "role": "TIMING"
361
+ },
362
+ "CMSTDY": {
363
+ "label": "Study Day of Start of Medication",
364
+ "type": "Float64",
365
+ "mandatory": "No",
366
+ "role": "TIMING"
367
+ },
368
+ "CMENDY": {
369
+ "label": "Study Day of End of Medication",
370
+ "type": "Float64",
371
+ "mandatory": "No",
372
+ "role": "TIMING"
373
+ }
374
+ }
375
+ },
376
+ "dm": {
377
+ "label": "Demographics",
378
+ "structure": "One record per subject",
379
+ "n_rows": 306,
380
+ "columns": {
381
+ "STUDYID": {
382
+ "label": "Study Identifier",
383
+ "type": "String",
384
+ "mandatory": "Yes",
385
+ "role": "IDENTIFIER"
386
+ },
387
+ "DOMAIN": {
388
+ "label": "Domain Abbreviation",
389
+ "type": "String",
390
+ "mandatory": "Yes",
391
+ "role": "IDENTIFIER"
392
+ },
393
+ "USUBJID": {
394
+ "label": "Unique Subject Identifier",
395
+ "type": "String",
396
+ "mandatory": "Yes",
397
+ "role": "IDENTIFIER"
398
+ },
399
+ "SUBJID": {
400
+ "label": "Subject Identifier for the Study",
401
+ "type": "String",
402
+ "mandatory": "Yes",
403
+ "role": "TOPIC"
404
+ },
405
+ "RFSTDTC": {
406
+ "label": "Subject Reference Start Date/Time",
407
+ "type": "String",
408
+ "mandatory": "No",
409
+ "role": "RECORD QUALIFIER"
410
+ },
411
+ "RFENDTC": {
412
+ "label": "Subject Reference End Date/Time",
413
+ "type": "String",
414
+ "mandatory": "No",
415
+ "role": "RECORD QUALIFIER"
416
+ },
417
+ "RFXSTDTC": {
418
+ "label": "Date/Time of First Study Treatment",
419
+ "type": "String",
420
+ "mandatory": "No",
421
+ "role": "RECORD QUALIFIER"
422
+ },
423
+ "RFXENDTC": {
424
+ "label": "Date/Time of Last Study Treatment",
425
+ "type": "String",
426
+ "mandatory": "No",
427
+ "role": "RECORD QUALIFIER"
428
+ },
429
+ "RFICDTC": {
430
+ "label": "Date/Time of Informed Consent",
431
+ "type": "String",
432
+ "mandatory": "No",
433
+ "role": "RECORD QUALIFIER"
434
+ },
435
+ "RFPENDTC": {
436
+ "label": "Date/Time of End of Participation",
437
+ "type": "String",
438
+ "mandatory": "No",
439
+ "role": "RECORD QUALIFIER"
440
+ },
441
+ "DTHDTC": {
442
+ "label": "Date/Time of Death",
443
+ "type": "String",
444
+ "mandatory": "No",
445
+ "role": "RECORD QUALIFIER"
446
+ },
447
+ "DTHFL": {
448
+ "label": "Subject Death Flag",
449
+ "type": "String",
450
+ "mandatory": "No",
451
+ "role": "RECORD QUALIFIER"
452
+ },
453
+ "SITEID": {
454
+ "label": "Study Site Identifier",
455
+ "type": "String",
456
+ "mandatory": "Yes",
457
+ "role": "RECORD QUALIFIER"
458
+ },
459
+ "AGE": {
460
+ "label": "Age",
461
+ "type": "Float64",
462
+ "mandatory": "No",
463
+ "role": "RECORD QUALIFIER"
464
+ },
465
+ "AGEU": {
466
+ "label": "Age Units",
467
+ "type": "String",
468
+ "mandatory": "No",
469
+ "role": "VARIABLE QUALIFIER"
470
+ },
471
+ "SEX": {
472
+ "label": "Sex",
473
+ "type": "String",
474
+ "mandatory": "Yes",
475
+ "role": "RECORD QUALIFIER"
476
+ },
477
+ "RACE": {
478
+ "label": "Race",
479
+ "type": "String",
480
+ "mandatory": "No",
481
+ "role": "RECORD QUALIFIER"
482
+ },
483
+ "ETHNIC": {
484
+ "label": "Ethnicity",
485
+ "type": "String",
486
+ "mandatory": "No",
487
+ "role": "RECORD QUALIFIER"
488
+ },
489
+ "ARMCD": {
490
+ "label": "Planned Arm Code",
491
+ "type": "String",
492
+ "mandatory": "Yes",
493
+ "role": "RECORD QUALIFIER"
494
+ },
495
+ "ARM": {
496
+ "label": "Description of Planned Arm",
497
+ "type": "String",
498
+ "mandatory": "Yes",
499
+ "role": "SYNONYM QUALIFIER"
500
+ },
501
+ "ACTARMCD": {
502
+ "label": "Actual Arm Code",
503
+ "type": "String",
504
+ "mandatory": "Yes",
505
+ "role": "RECORD QUALIFIER"
506
+ },
507
+ "ACTARM": {
508
+ "label": "Description of Actual Arm",
509
+ "type": "String",
510
+ "mandatory": "Yes",
511
+ "role": "SYNONYM QUALIFIER"
512
+ },
513
+ "COUNTRY": {
514
+ "label": "Country",
515
+ "type": "String",
516
+ "mandatory": "Yes",
517
+ "role": "RECORD QUALIFIER"
518
+ },
519
+ "DMDTC": {
520
+ "label": "Date/Time of Collection",
521
+ "type": "String",
522
+ "mandatory": "No",
523
+ "role": "TIMING"
524
+ },
525
+ "DMDY": {
526
+ "label": "Study Day of Collection",
527
+ "type": "Float64",
528
+ "mandatory": "No",
529
+ "role": "TIMING"
530
+ }
531
+ }
532
+ },
533
+ "ds": {
534
+ "label": "Disposition",
535
+ "structure": "One record per disposition status or protocol milestone per subject",
536
+ "n_rows": 596,
537
+ "columns": {
538
+ "STUDYID": {
539
+ "label": "Study Identifier",
540
+ "type": "String",
541
+ "mandatory": "Yes",
542
+ "role": "IDENTIFIER"
543
+ },
544
+ "DOMAIN": {
545
+ "label": "Domain Abbreviation",
546
+ "type": "String",
547
+ "mandatory": "Yes",
548
+ "role": "IDENTIFIER"
549
+ },
550
+ "USUBJID": {
551
+ "label": "Unique Subject Identifier",
552
+ "type": "String",
553
+ "mandatory": "Yes",
554
+ "role": "IDENTIFIER"
555
+ },
556
+ "DSSEQ": {
557
+ "label": "Sequence Number",
558
+ "type": "Float64",
559
+ "mandatory": "Yes",
560
+ "role": "IDENTIFIER"
561
+ },
562
+ "DSSPID": {
563
+ "label": "Sponsor-Defined Identifier",
564
+ "type": "String",
565
+ "mandatory": "No",
566
+ "role": "IDENTIFIER"
567
+ },
568
+ "DSTERM": {
569
+ "label": "Reported Term for the Disposition Event",
570
+ "type": "String",
571
+ "mandatory": "Yes",
572
+ "role": "TOPIC"
573
+ },
574
+ "DSDECOD": {
575
+ "label": "Standardized Disposition Term",
576
+ "type": "String",
577
+ "mandatory": "Yes",
578
+ "role": "SYNONYM QUALIFIER"
579
+ },
580
+ "DSCAT": {
581
+ "label": "Category for Disposition Event",
582
+ "type": "String",
583
+ "mandatory": "No",
584
+ "role": "GROUPING QUALIFIER"
585
+ },
586
+ "VISITNUM": {
587
+ "label": "Visit Number",
588
+ "type": "Float64",
589
+ "mandatory": "No",
590
+ "role": "TIMING"
591
+ },
592
+ "VISIT": {
593
+ "label": "Visit Name",
594
+ "type": "String",
595
+ "mandatory": "No",
596
+ "role": null
597
+ },
598
+ "EPOCH": {
599
+ "label": "Epoch",
600
+ "type": "String",
601
+ "mandatory": "No",
602
+ "role": "TIMING"
603
+ },
604
+ "DSDTC": {
605
+ "label": "Date/Time of Collection",
606
+ "type": "String",
607
+ "mandatory": "No",
608
+ "role": "TIMING"
609
+ },
610
+ "DSSTDTC": {
611
+ "label": "Start Date/Time of Disposition Event",
612
+ "type": "String",
613
+ "mandatory": "No",
614
+ "role": "TIMING"
615
+ },
616
+ "DSDY": {
617
+ "label": "Study Day of Visit/Collection/Exam",
618
+ "type": "Float64",
619
+ "mandatory": "No",
620
+ "role": "TIMING"
621
+ },
622
+ "DSSTDY": {
623
+ "label": "Study Day of Start of Disposition Event",
624
+ "type": "Float64",
625
+ "mandatory": "No",
626
+ "role": "TIMING"
627
+ }
628
+ }
629
+ },
630
+ "ex": {
631
+ "label": "Exposure",
632
+ "structure": "One record per constant dosing interval per subject",
633
+ "n_rows": 591,
634
+ "columns": {
635
+ "STUDYID": {
636
+ "label": "Study Identifier",
637
+ "type": "String",
638
+ "mandatory": "Yes",
639
+ "role": "IDENTIFIER"
640
+ },
641
+ "DOMAIN": {
642
+ "label": "Domain Abbreviation",
643
+ "type": "String",
644
+ "mandatory": "Yes",
645
+ "role": "IDENTIFIER"
646
+ },
647
+ "USUBJID": {
648
+ "label": "Unique Subject Identifier",
649
+ "type": "String",
650
+ "mandatory": "Yes",
651
+ "role": "IDENTIFIER"
652
+ },
653
+ "EXSEQ": {
654
+ "label": "Sequence Number",
655
+ "type": "Float64",
656
+ "mandatory": "Yes",
657
+ "role": "IDENTIFIER"
658
+ },
659
+ "EXTRT": {
660
+ "label": "Name of Treatment",
661
+ "type": "String",
662
+ "mandatory": "Yes",
663
+ "role": "TOPIC"
664
+ },
665
+ "EXDOSE": {
666
+ "label": "Dose",
667
+ "type": "Float64",
668
+ "mandatory": "No",
669
+ "role": "RECORD QUALIFIER"
670
+ },
671
+ "EXDOSU": {
672
+ "label": "Dose Units",
673
+ "type": "String",
674
+ "mandatory": "No",
675
+ "role": "VARIABLE QUALIFIER"
676
+ },
677
+ "EXDOSFRM": {
678
+ "label": "Dose Form",
679
+ "type": "String",
680
+ "mandatory": "No",
681
+ "role": "RECORD QUALIFIER"
682
+ },
683
+ "EXDOSFRQ": {
684
+ "label": "Dosing Frequency per Interval",
685
+ "type": "String",
686
+ "mandatory": "No",
687
+ "role": "VARIABLE QUALIFIER"
688
+ },
689
+ "EXROUTE": {
690
+ "label": "Route of Administration",
691
+ "type": "String",
692
+ "mandatory": "No",
693
+ "role": "VARIABLE QUALIFIER"
694
+ },
695
+ "VISITNUM": {
696
+ "label": "Visit Number",
697
+ "type": "Float64",
698
+ "mandatory": "No",
699
+ "role": "TIMING"
700
+ },
701
+ "VISIT": {
702
+ "label": "Visit Name",
703
+ "type": "String",
704
+ "mandatory": "No",
705
+ "role": "TIMING"
706
+ },
707
+ "VISITDY": {
708
+ "label": "Planned Study Day of Visit",
709
+ "type": "Float64",
710
+ "mandatory": "No",
711
+ "role": "TIMING"
712
+ },
713
+ "EPOCH": {
714
+ "label": "Epoch",
715
+ "type": "String",
716
+ "mandatory": "No",
717
+ "role": "TIMING"
718
+ },
719
+ "EXSTDTC": {
720
+ "label": "Start Date/Time of Treatment",
721
+ "type": "String",
722
+ "mandatory": "No",
723
+ "role": "TIMING"
724
+ },
725
+ "EXENDTC": {
726
+ "label": "End Date/Time of Treatment",
727
+ "type": "String",
728
+ "mandatory": "No",
729
+ "role": "TIMING"
730
+ },
731
+ "EXSTDY": {
732
+ "label": "Study Day of Start of Treatment",
733
+ "type": "Float64",
734
+ "mandatory": "No",
735
+ "role": "TIMING"
736
+ },
737
+ "EXENDY": {
738
+ "label": "Study Day of End of Treatment",
739
+ "type": "Float64",
740
+ "mandatory": "No",
741
+ "role": "TIMING"
742
+ }
743
+ }
744
+ },
745
+ "lbch": {
746
+ "label": "Laboratory Tests Results",
747
+ "structure": "One record per analyte per planned time point number per time point reference per visit per subject",
748
+ "n_rows": 32740,
749
+ "columns": {
750
+ "STUDYID": {
751
+ "label": "Study Identifier",
752
+ "type": "String",
753
+ "mandatory": "Yes",
754
+ "role": "IDENTIFIER"
755
+ },
756
+ "DOMAIN": {
757
+ "label": "Domain Abbreviation",
758
+ "type": "String",
759
+ "mandatory": "Yes",
760
+ "role": "IDENTIFIER"
761
+ },
762
+ "USUBJID": {
763
+ "label": "Unique Subject Identifier",
764
+ "type": "String",
765
+ "mandatory": "Yes",
766
+ "role": "IDENTIFIER"
767
+ },
768
+ "LBSEQ": {
769
+ "label": "Sequence Number",
770
+ "type": "Float64",
771
+ "mandatory": "Yes",
772
+ "role": "IDENTIFIER"
773
+ },
774
+ "LBTESTCD": {
775
+ "label": "Lab Test or Examination Short Name",
776
+ "type": "String",
777
+ "mandatory": "Yes",
778
+ "role": "TOPIC"
779
+ },
780
+ "LBTEST": {
781
+ "label": "Lab Test or Examination Name",
782
+ "type": "String",
783
+ "mandatory": "Yes",
784
+ "role": "SYNONYM QUALIFIER"
785
+ },
786
+ "LBCAT": {
787
+ "label": "Category for Lab Test",
788
+ "type": "String",
789
+ "mandatory": "No",
790
+ "role": "GROUPING QUALIFIER"
791
+ },
792
+ "LBORRES": {
793
+ "label": "Result or Finding in Original Units",
794
+ "type": "String",
795
+ "mandatory": "No",
796
+ "role": "RESULT QUALIFIER"
797
+ },
798
+ "LBORRESU": {
799
+ "label": "Original Units",
800
+ "type": "String",
801
+ "mandatory": "No",
802
+ "role": "VARIABLE QUALIFIER"
803
+ },
804
+ "LBORNRLO": {
805
+ "label": "Reference Range Lower Limit in Orig Unit",
806
+ "type": "String",
807
+ "mandatory": "No",
808
+ "role": "VARIABLE QUALIFIER"
809
+ },
810
+ "LBORNRHI": {
811
+ "label": "Reference Range Upper Limit in Orig Unit",
812
+ "type": "String",
813
+ "mandatory": "No",
814
+ "role": "VARIABLE QUALIFIER"
815
+ },
816
+ "LBSTRESC": {
817
+ "label": "Character Result/Finding in Std Format",
818
+ "type": "String",
819
+ "mandatory": "No",
820
+ "role": "RESULT QUALIFIER"
821
+ },
822
+ "LBSTRESN": {
823
+ "label": "Numeric Result/Finding in Standard Units",
824
+ "type": "Float64",
825
+ "mandatory": "No",
826
+ "role": "RESULT QUALIFIER"
827
+ },
828
+ "LBSTRESU": {
829
+ "label": "Standard Units",
830
+ "type": "String",
831
+ "mandatory": "No",
832
+ "role": "VARIABLE QUALIFIER"
833
+ },
834
+ "LBSTNRLO": {
835
+ "label": "Reference Range Lower Limit-Std Units",
836
+ "type": "Float64",
837
+ "mandatory": "No",
838
+ "role": "VARIABLE QUALIFIER"
839
+ },
840
+ "LBSTNRHI": {
841
+ "label": "Reference Range Upper Limit-Std Units",
842
+ "type": "Float64",
843
+ "mandatory": "No",
844
+ "role": "VARIABLE QUALIFIER"
845
+ },
846
+ "LBNRIND": {
847
+ "label": "Reference Range Indicator",
848
+ "type": "String",
849
+ "mandatory": "No",
850
+ "role": "VARIABLE QUALIFIER"
851
+ },
852
+ "LBBLFL": {
853
+ "label": "Baseline Flag",
854
+ "type": "String",
855
+ "mandatory": "No",
856
+ "role": "RECORD QUALIFIER"
857
+ },
858
+ "VISITNUM": {
859
+ "label": "Visit Number",
860
+ "type": "Float64",
861
+ "mandatory": "No",
862
+ "role": "TIMING"
863
+ },
864
+ "VISIT": {
865
+ "label": "Visit Name",
866
+ "type": "String",
867
+ "mandatory": "No",
868
+ "role": "TIMING"
869
+ },
870
+ "VISITDY": {
871
+ "label": "Planned Study Day of Visit",
872
+ "type": "Float64",
873
+ "mandatory": "No",
874
+ "role": "TIMING"
875
+ },
876
+ "EPOCH": {
877
+ "label": "Epoch",
878
+ "type": "String",
879
+ "mandatory": "No",
880
+ "role": "TIMING"
881
+ },
882
+ "LBDTC": {
883
+ "label": "Date/Time of Specimen Collection",
884
+ "type": "String",
885
+ "mandatory": "No",
886
+ "role": "TIMING"
887
+ },
888
+ "LBDY": {
889
+ "label": "Study Day of Specimen Collection",
890
+ "type": "Float64",
891
+ "mandatory": "No",
892
+ "role": "TIMING"
893
+ }
894
+ }
895
+ },
896
+ "lbhe": {
897
+ "label": "Laboratory Tests Results",
898
+ "structure": "One record per analyte per planned time point number per time point reference per visit per subject",
899
+ "n_rows": 21927,
900
+ "columns": {
901
+ "STUDYID": {
902
+ "label": "Study Identifier",
903
+ "type": "String",
904
+ "mandatory": "Yes",
905
+ "role": "IDENTIFIER"
906
+ },
907
+ "DOMAIN": {
908
+ "label": "Domain Abbreviation",
909
+ "type": "String",
910
+ "mandatory": "Yes",
911
+ "role": "IDENTIFIER"
912
+ },
913
+ "USUBJID": {
914
+ "label": "Unique Subject Identifier",
915
+ "type": "String",
916
+ "mandatory": "Yes",
917
+ "role": "IDENTIFIER"
918
+ },
919
+ "LBSEQ": {
920
+ "label": "Sequence Number",
921
+ "type": "Float64",
922
+ "mandatory": "Yes",
923
+ "role": "IDENTIFIER"
924
+ },
925
+ "LBTESTCD": {
926
+ "label": "Lab Test or Examination Short Name",
927
+ "type": "String",
928
+ "mandatory": "Yes",
929
+ "role": "TOPIC"
930
+ },
931
+ "LBTEST": {
932
+ "label": "Lab Test or Examination Name",
933
+ "type": "String",
934
+ "mandatory": "Yes",
935
+ "role": "SYNONYM QUALIFIER"
936
+ },
937
+ "LBCAT": {
938
+ "label": "Category for Lab Test",
939
+ "type": "String",
940
+ "mandatory": "No",
941
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+ "label": "Original Units",
951
+ "type": "String",
952
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953
+ "role": "VARIABLE QUALIFIER"
954
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955
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956
+ "label": "Reference Range Lower Limit in Orig Unit",
957
+ "type": "String",
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+ "mandatory": "No",
959
+ "role": "VARIABLE QUALIFIER"
960
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+ "label": "Reference Range Upper Limit in Orig Unit",
963
+ "type": "String",
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+ "role": "RESULT QUALIFIER"
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+ "role": "RESULT QUALIFIER"
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+ "label": "Standard Units",
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+ "role": "VARIABLE QUALIFIER"
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+ "role": "VARIABLE QUALIFIER"
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+ "label": "Reference Range Upper Limit-Std Units",
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+ "type": "Float64",
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+ "mandatory": "No",
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+ "role": "VARIABLE QUALIFIER"
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+ "label": "Reference Range Indicator",
999
+ "type": "String",
1000
+ "mandatory": "No",
1001
+ "role": "VARIABLE QUALIFIER"
1002
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1004
+ "label": "Baseline Flag",
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+ "type": "String",
1006
+ "mandatory": "No",
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+ "role": "RECORD QUALIFIER"
1008
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+ "type": "Float64",
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+ "mandatory": "No",
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+ "type": "String",
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+ "mandatory": "No",
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+ "role": "TIMING"
1038
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+ "label": "Study Day of Specimen Collection",
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+ "type": "Float64",
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+ "mandatory": "No",
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+ "role": "TIMING"
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1052
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+ "mandatory": "Yes",
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+ "role": "TOPIC"
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+ "mandatory": "Yes",
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+ "role": "SYNONYM QUALIFIER"
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+ "type": "String",
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+ "role": "GROUPING QUALIFIER"
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+ "type": "String",
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+ "mandatory": "No",
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+ "role": "VARIABLE QUALIFIER"
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+ "label": "Reference Range Upper Limit in Orig Unit",
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+ "label": "Numeric Result/Finding in Standard Units",
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+ "type": "Float64",
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+ "label": "Standard Units",
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+ "type": "String",
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+ "mandatory": "No",
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+ "role": "VARIABLE QUALIFIER"
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+ "type": "Float64",
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+ "role": "VARIABLE QUALIFIER"
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+ "label": "Reference Range Upper Limit-Std Units",
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+ "role": "RECORD QUALIFIER"
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+ "label": "Medical History",
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+ "structure": "One record per medical history event per subject",
1201
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+ "columns": {
1203
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+ "mandatory": "Yes",
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+ "role": "TOPIC"
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+ "role": "VARIABLE QUALIFIER"
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+ "role": "SYNONYM QUALIFIER"
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+ "role": "VARIABLE QUALIFIER"
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+ "role": "RECORD QUALIFIER"
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+ "role": "VARIABLE QUALIFIER"
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+ "role": "RESULT QUALIFIER"
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+ "role": "VARIABLE QUALIFIER"
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+ "role": "RESULT QUALIFIER"
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+ "role": "VARIABLE QUALIFIER"
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+ "role": "RECORD QUALIFIER"
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+ "mandatory": "No",
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1418
+ "role": "RECORD QUALIFIER"
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+ "role": "RECORD QUALIFIER"
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2791
+ "label": "Data Value",
2792
+ "type": "String",
2793
+ "mandatory": "Yes",
2794
+ "role": "RESULT"
2795
+ },
2796
+ "QORIG": {
2797
+ "label": "Origin",
2798
+ "type": "String",
2799
+ "mandatory": "Yes",
2800
+ "role": "RESULT QUALIFIER"
2801
+ },
2802
+ "QEVAL": {
2803
+ "label": "Evaluator",
2804
+ "type": "String",
2805
+ "mandatory": "No",
2806
+ "role": "RESULT QUALIFIER"
2807
+ }
2808
+ }
2809
+ },
2810
+ "sv": {
2811
+ "label": "Subject Visits",
2812
+ "structure": "One record per actual visit per subject",
2813
+ "n_rows": 3559,
2814
+ "columns": {
2815
+ "STUDYID": {
2816
+ "label": "Study Identifier",
2817
+ "type": "String",
2818
+ "mandatory": "Yes",
2819
+ "role": "IDENTIFIER"
2820
+ },
2821
+ "DOMAIN": {
2822
+ "label": "Domain Abbreviation",
2823
+ "type": "String",
2824
+ "mandatory": "Yes",
2825
+ "role": "IDENTIFIER"
2826
+ },
2827
+ "USUBJID": {
2828
+ "label": "Unique Subject Identifier",
2829
+ "type": "String",
2830
+ "mandatory": "Yes",
2831
+ "role": "IDENTIFIER"
2832
+ },
2833
+ "VISITNUM": {
2834
+ "label": "Visit Number",
2835
+ "type": "Float64",
2836
+ "mandatory": "Yes",
2837
+ "role": "TOPIC"
2838
+ },
2839
+ "VISIT": {
2840
+ "label": "Visit Name",
2841
+ "type": "String",
2842
+ "mandatory": "No",
2843
+ "role": "SYNONYM QUALIFIER"
2844
+ },
2845
+ "VISITDY": {
2846
+ "label": "Planned Study Day of Visit",
2847
+ "type": "Float64",
2848
+ "mandatory": "No",
2849
+ "role": "TIMING"
2850
+ },
2851
+ "EPOCH": {
2852
+ "label": "Epoch",
2853
+ "type": "String",
2854
+ "mandatory": "No",
2855
+ "role": "TIMING"
2856
+ },
2857
+ "SVSTDTC": {
2858
+ "label": "Start Date/Time of Visit",
2859
+ "type": "String",
2860
+ "mandatory": "No",
2861
+ "role": "TIMING"
2862
+ },
2863
+ "SVENDTC": {
2864
+ "label": "End Date/Time of Visit",
2865
+ "type": "String",
2866
+ "mandatory": "No",
2867
+ "role": "TIMING"
2868
+ },
2869
+ "SVSTDY": {
2870
+ "label": "Study Day of Start of Visit",
2871
+ "type": "Float64",
2872
+ "mandatory": "No",
2873
+ "role": "TIMING"
2874
+ },
2875
+ "SVENDY": {
2876
+ "label": "Study Day of End of Visit",
2877
+ "type": "Float64",
2878
+ "mandatory": "No",
2879
+ "role": "TIMING"
2880
+ },
2881
+ "SVUPDES": {
2882
+ "label": "Description of Unplanned Visit",
2883
+ "type": "String",
2884
+ "mandatory": "No",
2885
+ "role": "SYNONYM QUALIFIER"
2886
+ }
2887
+ }
2888
+ },
2889
+ "ta": {
2890
+ "label": "Trial Arms",
2891
+ "structure": "One record per planned Element per Arm",
2892
+ "n_rows": 11,
2893
+ "columns": {
2894
+ "STUDYID": {
2895
+ "label": "Study Identifier",
2896
+ "type": "String",
2897
+ "mandatory": "Yes",
2898
+ "role": "IDENTIFIER"
2899
+ },
2900
+ "DOMAIN": {
2901
+ "label": "Domain Abbreviation",
2902
+ "type": "String",
2903
+ "mandatory": "Yes",
2904
+ "role": "IDENTIFIER"
2905
+ },
2906
+ "ARMCD": {
2907
+ "label": "Planned Arm Code",
2908
+ "type": "String",
2909
+ "mandatory": "Yes",
2910
+ "role": "TOPIC"
2911
+ },
2912
+ "ARM": {
2913
+ "label": "Description of Planned Arm",
2914
+ "type": "String",
2915
+ "mandatory": "Yes",
2916
+ "role": "SYNONYM QUALIFIER"
2917
+ },
2918
+ "TAETORD": {
2919
+ "label": "Planned Order of Element within Arm",
2920
+ "type": "Float64",
2921
+ "mandatory": "Yes",
2922
+ "role": "IDENTIFIER"
2923
+ },
2924
+ "ETCD": {
2925
+ "label": "Element Code",
2926
+ "type": "String",
2927
+ "mandatory": "Yes",
2928
+ "role": "RECORD QUALIFIER"
2929
+ },
2930
+ "ELEMENT": {
2931
+ "label": "Description of Element",
2932
+ "type": "String",
2933
+ "mandatory": "No",
2934
+ "role": "SYNONYM QUALIFIER"
2935
+ },
2936
+ "TABRANCH": {
2937
+ "label": "Branch",
2938
+ "type": "String",
2939
+ "mandatory": "No",
2940
+ "role": "RULE"
2941
+ },
2942
+ "TATRANS": {
2943
+ "label": "Transition Rule",
2944
+ "type": "String",
2945
+ "mandatory": "No",
2946
+ "role": "RULE"
2947
+ },
2948
+ "EPOCH": {
2949
+ "label": "Epoch",
2950
+ "type": "String",
2951
+ "mandatory": "Yes",
2952
+ "role": "TIMING"
2953
+ }
2954
+ }
2955
+ },
2956
+ "te": {
2957
+ "label": "Trial Elements",
2958
+ "structure": "One record per planned Element",
2959
+ "n_rows": 7,
2960
+ "columns": {
2961
+ "STUDYID": {
2962
+ "label": "Study Identifier",
2963
+ "type": "String",
2964
+ "mandatory": "Yes",
2965
+ "role": "IDENTIFIER"
2966
+ },
2967
+ "DOMAIN": {
2968
+ "label": "Domain Abbreviation",
2969
+ "type": "String",
2970
+ "mandatory": "Yes",
2971
+ "role": "IDENTIFIER"
2972
+ },
2973
+ "ETCD": {
2974
+ "label": "Element Code",
2975
+ "type": "String",
2976
+ "mandatory": "Yes",
2977
+ "role": "TOPIC"
2978
+ },
2979
+ "ELEMENT": {
2980
+ "label": "Description of Element",
2981
+ "type": "String",
2982
+ "mandatory": "Yes",
2983
+ "role": "SYNONYM QUALIFIER"
2984
+ },
2985
+ "TESTRL": {
2986
+ "label": "Rule for Start of Element",
2987
+ "type": "String",
2988
+ "mandatory": "Yes",
2989
+ "role": "RULE"
2990
+ },
2991
+ "TEENRL": {
2992
+ "label": "Rule for End of Element",
2993
+ "type": "String",
2994
+ "mandatory": "No",
2995
+ "role": "RULE"
2996
+ },
2997
+ "TEDUR": {
2998
+ "label": "Planned Duration of Element",
2999
+ "type": "String",
3000
+ "mandatory": "No",
3001
+ "role": "TIMING"
3002
+ }
3003
+ }
3004
+ },
3005
+ "ti": {
3006
+ "label": "Trial Inclusion/ Exclusion Criteria",
3007
+ "structure": "One record per I/E criterion",
3008
+ "n_rows": 31,
3009
+ "columns": {
3010
+ "STUDYID": {
3011
+ "label": "Study Identifier",
3012
+ "type": "String",
3013
+ "mandatory": "Yes",
3014
+ "role": "IDENTIFIER"
3015
+ },
3016
+ "DOMAIN": {
3017
+ "label": "Domain Abbreviation",
3018
+ "type": "String",
3019
+ "mandatory": "Yes",
3020
+ "role": "IDENTIFIER"
3021
+ },
3022
+ "IETESTCD": {
3023
+ "label": "Inclusion/Exclusion Criterion Short Name",
3024
+ "type": "String",
3025
+ "mandatory": "Yes",
3026
+ "role": "TOPIC"
3027
+ },
3028
+ "IETEST": {
3029
+ "label": "Inclusion/Exclusion Criterion",
3030
+ "type": "String",
3031
+ "mandatory": "Yes",
3032
+ "role": "SYNONYM QUALIFIER"
3033
+ },
3034
+ "IECAT": {
3035
+ "label": "Inclusion/Exclusion Category",
3036
+ "type": "String",
3037
+ "mandatory": "Yes",
3038
+ "role": "GROUPING QUALIFIER"
3039
+ }
3040
+ }
3041
+ },
3042
+ "ts": {
3043
+ "label": "Trial Summary",
3044
+ "structure": "One record per trial summary parameter value",
3045
+ "n_rows": 48,
3046
+ "columns": {
3047
+ "STUDYID": {
3048
+ "label": "Study Identifier",
3049
+ "type": "String",
3050
+ "mandatory": "Yes",
3051
+ "role": "IDENTIFIER"
3052
+ },
3053
+ "DOMAIN": {
3054
+ "label": "Domain Abbreviation",
3055
+ "type": "String",
3056
+ "mandatory": "Yes",
3057
+ "role": "IDENTIFIER"
3058
+ },
3059
+ "TSSEQ": {
3060
+ "label": "Sequence Number",
3061
+ "type": "Float64",
3062
+ "mandatory": "Yes",
3063
+ "role": "IDENTIFIER"
3064
+ },
3065
+ "TSPARMCD": {
3066
+ "label": "Trial Summary Parameter Short Name",
3067
+ "type": "String",
3068
+ "mandatory": "Yes",
3069
+ "role": "TOPIC"
3070
+ },
3071
+ "TSPARM": {
3072
+ "label": "Trial Summary Parameter",
3073
+ "type": "String",
3074
+ "mandatory": "Yes",
3075
+ "role": "SYNONYM QUALIFIER"
3076
+ },
3077
+ "TSVAL": {
3078
+ "label": "Parameter Value",
3079
+ "type": "String",
3080
+ "mandatory": "Yes",
3081
+ "role": "RESULT QUALIFIER"
3082
+ },
3083
+ "TSVALNF": {
3084
+ "label": "Parameter Null Flavor",
3085
+ "type": "String",
3086
+ "mandatory": "No",
3087
+ "role": "RESULT QUALIFIER"
3088
+ },
3089
+ "TSVALCD": {
3090
+ "label": "Parameter Value Code",
3091
+ "type": "String",
3092
+ "mandatory": "No",
3093
+ "role": "RESULT QUALIFIER"
3094
+ },
3095
+ "TSVCDREF": {
3096
+ "label": "Name of the Reference Terminology",
3097
+ "type": "String",
3098
+ "mandatory": "No",
3099
+ "role": "RESULT QUALIFIER"
3100
+ },
3101
+ "TSVCDVER": {
3102
+ "label": "Version of the Reference Terminology",
3103
+ "type": "String",
3104
+ "mandatory": "No",
3105
+ "role": "RESULT QUALIFIER"
3106
+ }
3107
+ }
3108
+ },
3109
+ "tv": {
3110
+ "label": "Trial Visits",
3111
+ "structure": "One record per planned Visit per Arm",
3112
+ "n_rows": 21,
3113
+ "columns": {
3114
+ "STUDYID": {
3115
+ "label": "Study Identifier",
3116
+ "type": "String",
3117
+ "mandatory": "Yes",
3118
+ "role": "IDENTIFIER"
3119
+ },
3120
+ "DOMAIN": {
3121
+ "label": "Domain Abbreviation",
3122
+ "type": "String",
3123
+ "mandatory": "Yes",
3124
+ "role": "IDENTIFIER"
3125
+ },
3126
+ "VISITNUM": {
3127
+ "label": "Visit Number",
3128
+ "type": "Float64",
3129
+ "mandatory": "Yes",
3130
+ "role": "TOPIC"
3131
+ },
3132
+ "VISIT": {
3133
+ "label": "Visit Name",
3134
+ "type": "String",
3135
+ "mandatory": "No",
3136
+ "role": "SYNONYM QUALIFIER"
3137
+ },
3138
+ "VISITDY": {
3139
+ "label": "Planned Study Day of Visit",
3140
+ "type": "Float64",
3141
+ "mandatory": "No",
3142
+ "role": "TIMING"
3143
+ },
3144
+ "ARMCD": {
3145
+ "label": "Planned Arm Code",
3146
+ "type": "String",
3147
+ "mandatory": "No",
3148
+ "role": "RECORD QUALIFIER"
3149
+ },
3150
+ "TVSTRL": {
3151
+ "label": "Visit Start Rule",
3152
+ "type": "String",
3153
+ "mandatory": "Yes",
3154
+ "role": "RULE"
3155
+ },
3156
+ "TVENRL": {
3157
+ "label": "Visit End Rule",
3158
+ "type": "String",
3159
+ "mandatory": "No",
3160
+ "role": "RULE"
3161
+ }
3162
+ }
3163
+ },
3164
+ "vs": {
3165
+ "label": "Vital Signs",
3166
+ "structure": "One record per vital sign measurement per time point per visit per subject",
3167
+ "n_rows": 29643,
3168
+ "columns": {
3169
+ "STUDYID": {
3170
+ "label": "Study Identifier",
3171
+ "type": "String",
3172
+ "mandatory": "Yes",
3173
+ "role": "IDENTIFIER"
3174
+ },
3175
+ "DOMAIN": {
3176
+ "label": "Domain Abbreviation",
3177
+ "type": "String",
3178
+ "mandatory": "Yes",
3179
+ "role": "IDENTIFIER"
3180
+ },
3181
+ "USUBJID": {
3182
+ "label": "Unique Subject Identifier",
3183
+ "type": "String",
3184
+ "mandatory": "Yes",
3185
+ "role": "IDENTIFIER"
3186
+ },
3187
+ "VSSEQ": {
3188
+ "label": "Sequence Number",
3189
+ "type": "Float64",
3190
+ "mandatory": "Yes",
3191
+ "role": "IDENTIFIER"
3192
+ },
3193
+ "VSTESTCD": {
3194
+ "label": "Vital Signs Test Short Name",
3195
+ "type": "String",
3196
+ "mandatory": "Yes",
3197
+ "role": "TOPIC"
3198
+ },
3199
+ "VSTEST": {
3200
+ "label": "Vital Signs Test Name",
3201
+ "type": "String",
3202
+ "mandatory": "Yes",
3203
+ "role": "SYNONYM QUALIFIER"
3204
+ },
3205
+ "VSPOS": {
3206
+ "label": "Vital Signs Position of Subject",
3207
+ "type": "String",
3208
+ "mandatory": "No",
3209
+ "role": "RECORD QUALIFIER"
3210
+ },
3211
+ "VSORRES": {
3212
+ "label": "Result or Finding in Original Units",
3213
+ "type": "String",
3214
+ "mandatory": "No",
3215
+ "role": "RESULT QUALIFIER"
3216
+ },
3217
+ "VSORRESU": {
3218
+ "label": "Original Units",
3219
+ "type": "String",
3220
+ "mandatory": "No",
3221
+ "role": "VARIABLE QUALIFIER"
3222
+ },
3223
+ "VSSTRESC": {
3224
+ "label": "Character Result/Finding in Std Format",
3225
+ "type": "String",
3226
+ "mandatory": "No",
3227
+ "role": "RESULT QUALIFIER"
3228
+ },
3229
+ "VSSTRESN": {
3230
+ "label": "Numeric Result/Finding in Standard Units",
3231
+ "type": "Float64",
3232
+ "mandatory": "No",
3233
+ "role": "RESULT QUALIFIER"
3234
+ },
3235
+ "VSSTRESU": {
3236
+ "label": "Standard Units",
3237
+ "type": "String",
3238
+ "mandatory": "No",
3239
+ "role": "VARIABLE QUALIFIER"
3240
+ },
3241
+ "VSSTAT": {
3242
+ "label": "Completion Status",
3243
+ "type": "String",
3244
+ "mandatory": "No",
3245
+ "role": "RECORD QUALIFIER"
3246
+ },
3247
+ "VSLOC": {
3248
+ "label": "Location of Vital Signs Measurement",
3249
+ "type": "String",
3250
+ "mandatory": "No",
3251
+ "role": "RECORD QUALIFIER"
3252
+ },
3253
+ "VSBLFL": {
3254
+ "label": "Baseline Flag",
3255
+ "type": "String",
3256
+ "mandatory": "No",
3257
+ "role": "RECORD QUALIFIER"
3258
+ },
3259
+ "VISITNUM": {
3260
+ "label": "Visit Number",
3261
+ "type": "Float64",
3262
+ "mandatory": "No",
3263
+ "role": "TIMING"
3264
+ },
3265
+ "VISIT": {
3266
+ "label": "Visit Name",
3267
+ "type": "String",
3268
+ "mandatory": "No",
3269
+ "role": "TIMING"
3270
+ },
3271
+ "VISITDY": {
3272
+ "label": "Planned Study Day of Visit",
3273
+ "type": "Float64",
3274
+ "mandatory": "No",
3275
+ "role": "TIMING"
3276
+ },
3277
+ "EPOCH": {
3278
+ "label": "Epoch",
3279
+ "type": "String",
3280
+ "mandatory": "No",
3281
+ "role": "TIMING"
3282
+ },
3283
+ "VSDTC": {
3284
+ "label": "Date/Time of Measurements",
3285
+ "type": "String",
3286
+ "mandatory": "No",
3287
+ "role": "TIMING"
3288
+ },
3289
+ "VSDY": {
3290
+ "label": "Study Day of Vital Signs",
3291
+ "type": "Float64",
3292
+ "mandatory": "No",
3293
+ "role": "TIMING"
3294
+ },
3295
+ "VSTPT": {
3296
+ "label": "Planned Time Point Name",
3297
+ "type": "String",
3298
+ "mandatory": "No",
3299
+ "role": "TIMING"
3300
+ },
3301
+ "VSTPTNUM": {
3302
+ "label": "Planned Time Point Number",
3303
+ "type": "Float64",
3304
+ "mandatory": "No",
3305
+ "role": "TIMING"
3306
+ },
3307
+ "VSELTM": {
3308
+ "label": "Planned Elapsed Time from Time Point Ref",
3309
+ "type": "String",
3310
+ "mandatory": "No",
3311
+ "role": "TIMING"
3312
+ },
3313
+ "VSTPTREF": {
3314
+ "label": "Time Point Reference",
3315
+ "type": "String",
3316
+ "mandatory": "No",
3317
+ "role": "TIMING"
3318
+ }
3319
+ }
3320
+ }
3321
+ }