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/cdiscpilotadam/_meta.json ADDED
@@ -0,0 +1,3140 @@
1
+ {
2
+ "adadas": {
3
+ "label": "ADAS-Cog Analysis",
4
+ "structure": "one record per subject per parameter per analysis visit per analysis date",
5
+ "n_rows": 12463,
6
+ "columns": {
7
+ "STUDYID": {
8
+ "label": "Study Identifier",
9
+ "type": "String",
10
+ "mandatory": "No",
11
+ "role": null
12
+ },
13
+ "SITEID": {
14
+ "label": "Study Site Identifier",
15
+ "type": "String",
16
+ "mandatory": "No",
17
+ "role": null
18
+ },
19
+ "SITEGR1": {
20
+ "label": "Pooled Site Group 1",
21
+ "type": "String",
22
+ "mandatory": "No",
23
+ "role": null
24
+ },
25
+ "USUBJID": {
26
+ "label": "Unique Subject Identifier",
27
+ "type": "String",
28
+ "mandatory": "No",
29
+ "role": null
30
+ },
31
+ "TRTSDT": {
32
+ "label": "Date of First Exposure to Treatment",
33
+ "type": "Date",
34
+ "mandatory": "No",
35
+ "role": null
36
+ },
37
+ "TRTEDT": {
38
+ "label": "Date of Last Exposure to Treatment",
39
+ "type": "Date",
40
+ "mandatory": "No",
41
+ "role": null
42
+ },
43
+ "TRTP": {
44
+ "label": "Planned Treatment",
45
+ "type": "String",
46
+ "mandatory": "No",
47
+ "role": null
48
+ },
49
+ "TRTPN": {
50
+ "label": "Planned Treatment (N)",
51
+ "type": "Float64",
52
+ "mandatory": "No",
53
+ "role": null
54
+ },
55
+ "AGE": {
56
+ "label": "Age",
57
+ "type": "Float64",
58
+ "mandatory": "No",
59
+ "role": null
60
+ },
61
+ "AGEGR1": {
62
+ "label": "Pooled Age Group 1",
63
+ "type": "String",
64
+ "mandatory": "No",
65
+ "role": null
66
+ },
67
+ "AGEGR1N": {
68
+ "label": "Pooled Age Group 1 (N)",
69
+ "type": "Float64",
70
+ "mandatory": "No",
71
+ "role": null
72
+ },
73
+ "RACE": {
74
+ "label": "Race",
75
+ "type": "String",
76
+ "mandatory": "No",
77
+ "role": null
78
+ },
79
+ "RACEN": {
80
+ "label": "Race (N)",
81
+ "type": "Float64",
82
+ "mandatory": "No",
83
+ "role": null
84
+ },
85
+ "SEX": {
86
+ "label": "Sex",
87
+ "type": "String",
88
+ "mandatory": "No",
89
+ "role": null
90
+ },
91
+ "ITTFL": {
92
+ "label": "Intent-to-Treat Population Flag",
93
+ "type": "String",
94
+ "mandatory": "No",
95
+ "role": null
96
+ },
97
+ "EFFFL": {
98
+ "label": "Efficacy Population Flag",
99
+ "type": "String",
100
+ "mandatory": "No",
101
+ "role": null
102
+ },
103
+ "COMP24FL": {
104
+ "label": "Completers of Week 24 Population Flag",
105
+ "type": "String",
106
+ "mandatory": "No",
107
+ "role": null
108
+ },
109
+ "AVISIT": {
110
+ "label": "Analysis Visit",
111
+ "type": "String",
112
+ "mandatory": "No",
113
+ "role": null
114
+ },
115
+ "AVISITN": {
116
+ "label": "Analysis Visit (N)",
117
+ "type": "Float64",
118
+ "mandatory": "No",
119
+ "role": null
120
+ },
121
+ "VISIT": {
122
+ "label": "Visit Name",
123
+ "type": "String",
124
+ "mandatory": "No",
125
+ "role": null
126
+ },
127
+ "VISITNUM": {
128
+ "label": "Visit Number",
129
+ "type": "Float64",
130
+ "mandatory": "No",
131
+ "role": null
132
+ },
133
+ "ADY": {
134
+ "label": "Analysis Relative Day",
135
+ "type": "Float64",
136
+ "mandatory": "No",
137
+ "role": null
138
+ },
139
+ "ADT": {
140
+ "label": "Analysis Date",
141
+ "type": "Date",
142
+ "mandatory": "No",
143
+ "role": null
144
+ },
145
+ "PARAM": {
146
+ "label": "Parameter",
147
+ "type": "String",
148
+ "mandatory": "No",
149
+ "role": null
150
+ },
151
+ "PARAMCD": {
152
+ "label": "Parameter Code",
153
+ "type": "String",
154
+ "mandatory": "No",
155
+ "role": null
156
+ },
157
+ "PARAMN": {
158
+ "label": "Parameter (N)",
159
+ "type": "Float64",
160
+ "mandatory": "No",
161
+ "role": null
162
+ },
163
+ "AVAL": {
164
+ "label": "Analysis Value",
165
+ "type": "Float64",
166
+ "mandatory": "No",
167
+ "role": null
168
+ },
169
+ "BASE": {
170
+ "label": "Baseline Value",
171
+ "type": "Float64",
172
+ "mandatory": "No",
173
+ "role": null
174
+ },
175
+ "CHG": {
176
+ "label": "Change from Baseline",
177
+ "type": "Float64",
178
+ "mandatory": "No",
179
+ "role": null
180
+ },
181
+ "PCHG": {
182
+ "label": "Percent Change from Baseline",
183
+ "type": "Float64",
184
+ "mandatory": "No",
185
+ "role": null
186
+ },
187
+ "ABLFL": {
188
+ "label": "Baseline Record Flag",
189
+ "type": "String",
190
+ "mandatory": "No",
191
+ "role": null
192
+ },
193
+ "ANL01FL": {
194
+ "label": "Analysis Record Flag 01",
195
+ "type": "String",
196
+ "mandatory": "No",
197
+ "role": null
198
+ },
199
+ "DTYPE": {
200
+ "label": "Derivation Type",
201
+ "type": "String",
202
+ "mandatory": "No",
203
+ "role": null
204
+ },
205
+ "AWRANGE": {
206
+ "label": "Analysis Window Valid Relative Range",
207
+ "type": "String",
208
+ "mandatory": "No",
209
+ "role": null
210
+ },
211
+ "AWTARGET": {
212
+ "label": "Analysis Window Target",
213
+ "type": "Float64",
214
+ "mandatory": "No",
215
+ "role": null
216
+ },
217
+ "AWTDIFF": {
218
+ "label": "Analysis Window Diff from Target",
219
+ "type": "Float64",
220
+ "mandatory": "No",
221
+ "role": null
222
+ },
223
+ "AWLO": {
224
+ "label": "Analysis Window Beginning Timepoint",
225
+ "type": "Float64",
226
+ "mandatory": "No",
227
+ "role": null
228
+ },
229
+ "AWHI": {
230
+ "label": "Analysis Window Ending Timepoint",
231
+ "type": "Float64",
232
+ "mandatory": "No",
233
+ "role": null
234
+ },
235
+ "AWU": {
236
+ "label": "Analysis Window Unit",
237
+ "type": "String",
238
+ "mandatory": "No",
239
+ "role": null
240
+ },
241
+ "QSSEQ": {
242
+ "label": "Sequence Number",
243
+ "type": "Float64",
244
+ "mandatory": "No",
245
+ "role": null
246
+ }
247
+ }
248
+ },
249
+ "adae": {
250
+ "label": "Adverse Events Analysis Dataset",
251
+ "structure": "one record per subject per adverse event",
252
+ "n_rows": 1191,
253
+ "columns": {
254
+ "STUDYID": {
255
+ "label": "Study Identifier",
256
+ "type": "String",
257
+ "mandatory": "No",
258
+ "role": null
259
+ },
260
+ "SITEID": {
261
+ "label": "Study Site Identifier",
262
+ "type": "String",
263
+ "mandatory": "No",
264
+ "role": null
265
+ },
266
+ "USUBJID": {
267
+ "label": "Unique Subject Identifier",
268
+ "type": "String",
269
+ "mandatory": "No",
270
+ "role": null
271
+ },
272
+ "TRTA": {
273
+ "label": "Actual Treatment",
274
+ "type": "String",
275
+ "mandatory": "No",
276
+ "role": null
277
+ },
278
+ "TRTAN": {
279
+ "label": "Actual Treatment (N)",
280
+ "type": "Float64",
281
+ "mandatory": "No",
282
+ "role": null
283
+ },
284
+ "AGE": {
285
+ "label": "Age",
286
+ "type": "Float64",
287
+ "mandatory": "No",
288
+ "role": null
289
+ },
290
+ "AGEGR1": {
291
+ "label": "Pooled Age Group 1",
292
+ "type": "String",
293
+ "mandatory": "No",
294
+ "role": null
295
+ },
296
+ "AGEGR1N": {
297
+ "label": "Pooled Age Group 1 (N)",
298
+ "type": "Float64",
299
+ "mandatory": "No",
300
+ "role": null
301
+ },
302
+ "RACE": {
303
+ "label": "Race",
304
+ "type": "String",
305
+ "mandatory": "No",
306
+ "role": null
307
+ },
308
+ "RACEN": {
309
+ "label": "Race (N)",
310
+ "type": "Float64",
311
+ "mandatory": "No",
312
+ "role": null
313
+ },
314
+ "SEX": {
315
+ "label": "Sex",
316
+ "type": "String",
317
+ "mandatory": "No",
318
+ "role": null
319
+ },
320
+ "SAFFL": {
321
+ "label": "Safety Population Flag",
322
+ "type": "String",
323
+ "mandatory": "No",
324
+ "role": null
325
+ },
326
+ "TRTSDT": {
327
+ "label": "Date of First Exposure to Treatment",
328
+ "type": "Date",
329
+ "mandatory": "No",
330
+ "role": null
331
+ },
332
+ "TRTEDT": {
333
+ "label": "Date of Last Exposure to Treatment",
334
+ "type": "Date",
335
+ "mandatory": "No",
336
+ "role": null
337
+ },
338
+ "ASTDT": {
339
+ "label": "Analysis Start Date",
340
+ "type": "Date",
341
+ "mandatory": "No",
342
+ "role": null
343
+ },
344
+ "ASTDTF": {
345
+ "label": "Analysis Start Date Imputation Flag",
346
+ "type": "String",
347
+ "mandatory": "No",
348
+ "role": null
349
+ },
350
+ "ASTDY": {
351
+ "label": "Analysis Start Relative Day",
352
+ "type": "Float64",
353
+ "mandatory": "No",
354
+ "role": null
355
+ },
356
+ "AENDT": {
357
+ "label": "Analysis End Date",
358
+ "type": "Date",
359
+ "mandatory": "No",
360
+ "role": null
361
+ },
362
+ "AENDY": {
363
+ "label": "Analysis End Relative Day",
364
+ "type": "Float64",
365
+ "mandatory": "No",
366
+ "role": null
367
+ },
368
+ "ADURN": {
369
+ "label": "AE Duration (N)",
370
+ "type": "Float64",
371
+ "mandatory": "No",
372
+ "role": null
373
+ },
374
+ "ADURU": {
375
+ "label": "AE Duration Units",
376
+ "type": "String",
377
+ "mandatory": "No",
378
+ "role": null
379
+ },
380
+ "AETERM": {
381
+ "label": "Reported Term for the Adverse Event",
382
+ "type": "String",
383
+ "mandatory": "No",
384
+ "role": null
385
+ },
386
+ "AELLT": {
387
+ "label": "Lowest Level Term",
388
+ "type": "String",
389
+ "mandatory": "No",
390
+ "role": null
391
+ },
392
+ "AELLTCD": {
393
+ "label": "Lowest Level Term Code",
394
+ "type": "Float64",
395
+ "mandatory": "No",
396
+ "role": null
397
+ },
398
+ "AEDECOD": {
399
+ "label": "Dictionary-Derived Term",
400
+ "type": "String",
401
+ "mandatory": "No",
402
+ "role": null
403
+ },
404
+ "AEPTCD": {
405
+ "label": "Preferred Term Code",
406
+ "type": "Float64",
407
+ "mandatory": "No",
408
+ "role": null
409
+ },
410
+ "AEHLT": {
411
+ "label": "High Level Term",
412
+ "type": "String",
413
+ "mandatory": "No",
414
+ "role": null
415
+ },
416
+ "AEHLTCD": {
417
+ "label": "High Level Term Code",
418
+ "type": "Float64",
419
+ "mandatory": "No",
420
+ "role": null
421
+ },
422
+ "AEHLGT": {
423
+ "label": "High Level Group Term",
424
+ "type": "String",
425
+ "mandatory": "No",
426
+ "role": null
427
+ },
428
+ "AEHLGTCD": {
429
+ "label": "High Level Group Term Code",
430
+ "type": "Float64",
431
+ "mandatory": "No",
432
+ "role": null
433
+ },
434
+ "AEBODSYS": {
435
+ "label": "Body System or Organ Class",
436
+ "type": "String",
437
+ "mandatory": "No",
438
+ "role": null
439
+ },
440
+ "AESOC": {
441
+ "label": "Primary System Organ Class",
442
+ "type": "String",
443
+ "mandatory": "No",
444
+ "role": null
445
+ },
446
+ "AESOCCD": {
447
+ "label": "Primary System Organ Class Code",
448
+ "type": "Float64",
449
+ "mandatory": "No",
450
+ "role": null
451
+ },
452
+ "AESEV": {
453
+ "label": "Severity/Intensity",
454
+ "type": "String",
455
+ "mandatory": "No",
456
+ "role": null
457
+ },
458
+ "AESER": {
459
+ "label": "Serious Event",
460
+ "type": "String",
461
+ "mandatory": "No",
462
+ "role": null
463
+ },
464
+ "AESCAN": {
465
+ "label": "Involves Cancer",
466
+ "type": "String",
467
+ "mandatory": "No",
468
+ "role": null
469
+ },
470
+ "AESCONG": {
471
+ "label": "Congenital Anomaly or Birth Defect",
472
+ "type": "String",
473
+ "mandatory": "No",
474
+ "role": null
475
+ },
476
+ "AESDISAB": {
477
+ "label": "Persist or Signif Disability/Incapacity",
478
+ "type": "String",
479
+ "mandatory": "No",
480
+ "role": null
481
+ },
482
+ "AESDTH": {
483
+ "label": "Results in Death",
484
+ "type": "String",
485
+ "mandatory": "No",
486
+ "role": null
487
+ },
488
+ "AESHOSP": {
489
+ "label": "Requires or Prolongs Hospitalization",
490
+ "type": "String",
491
+ "mandatory": "No",
492
+ "role": null
493
+ },
494
+ "AESLIFE": {
495
+ "label": "Is Life Threatening",
496
+ "type": "String",
497
+ "mandatory": "No",
498
+ "role": null
499
+ },
500
+ "AESOD": {
501
+ "label": "Occurred with Overdose",
502
+ "type": "String",
503
+ "mandatory": "No",
504
+ "role": null
505
+ },
506
+ "AEREL": {
507
+ "label": "Causality",
508
+ "type": "String",
509
+ "mandatory": "No",
510
+ "role": null
511
+ },
512
+ "AEACN": {
513
+ "label": "Action Taken with Study Treatment",
514
+ "type": "String",
515
+ "mandatory": "No",
516
+ "role": null
517
+ },
518
+ "AEOUT": {
519
+ "label": "Outcome of Adverse Event",
520
+ "type": "String",
521
+ "mandatory": "No",
522
+ "role": null
523
+ },
524
+ "AESEQ": {
525
+ "label": "Sequence Number",
526
+ "type": "Float64",
527
+ "mandatory": "No",
528
+ "role": null
529
+ },
530
+ "TRTEMFL": {
531
+ "label": "Treatment Emergent Analysis Flag",
532
+ "type": "String",
533
+ "mandatory": "No",
534
+ "role": null
535
+ },
536
+ "AOCCFL": {
537
+ "label": "1st Occurrence of Any AE Flag",
538
+ "type": "String",
539
+ "mandatory": "No",
540
+ "role": null
541
+ },
542
+ "AOCCSFL": {
543
+ "label": "1st Occurrence of SOC Flag",
544
+ "type": "String",
545
+ "mandatory": "No",
546
+ "role": null
547
+ },
548
+ "AOCCPFL": {
549
+ "label": "1st Occurrence of Preferred Term Flag",
550
+ "type": "String",
551
+ "mandatory": "No",
552
+ "role": null
553
+ },
554
+ "AOCC02FL": {
555
+ "label": "1st Occurrence 02 Flag for Serious",
556
+ "type": "String",
557
+ "mandatory": "No",
558
+ "role": null
559
+ },
560
+ "AOCC03FL": {
561
+ "label": "1st Occurrence 03 Flag for Serious SOC",
562
+ "type": "String",
563
+ "mandatory": "No",
564
+ "role": null
565
+ },
566
+ "AOCC04FL": {
567
+ "label": "1st Occurrence 04 Flag for Serious PT",
568
+ "type": "String",
569
+ "mandatory": "No",
570
+ "role": null
571
+ },
572
+ "CQ01NAM": {
573
+ "label": "Customized Query 01 Name",
574
+ "type": "String",
575
+ "mandatory": "No",
576
+ "role": null
577
+ },
578
+ "AOCC01FL": {
579
+ "label": "1st Occurrence 01 Flag for CQ01",
580
+ "type": "String",
581
+ "mandatory": "No",
582
+ "role": null
583
+ }
584
+ }
585
+ },
586
+ "adcibc": {
587
+ "label": "CIBIC+ Analysis",
588
+ "structure": "one record per subject per parameter per analysis visit per analysis date",
589
+ "n_rows": 730,
590
+ "columns": {
591
+ "STUDYID": {
592
+ "label": "Study Identifier",
593
+ "type": "String",
594
+ "mandatory": "No",
595
+ "role": null
596
+ },
597
+ "SITEID": {
598
+ "label": "Study Site Identifier",
599
+ "type": "String",
600
+ "mandatory": "No",
601
+ "role": null
602
+ },
603
+ "SITEGR1": {
604
+ "label": "Pooled Site Group 1",
605
+ "type": "String",
606
+ "mandatory": "No",
607
+ "role": null
608
+ },
609
+ "USUBJID": {
610
+ "label": "Unique Subject Identifier",
611
+ "type": "String",
612
+ "mandatory": "No",
613
+ "role": null
614
+ },
615
+ "TRTSDT": {
616
+ "label": "Date of First Exposure to Treatment",
617
+ "type": "Date",
618
+ "mandatory": "No",
619
+ "role": null
620
+ },
621
+ "TRTEDT": {
622
+ "label": "Date of Last Exposure to Treatment",
623
+ "type": "Date",
624
+ "mandatory": "No",
625
+ "role": null
626
+ },
627
+ "TRTP": {
628
+ "label": "Planned Treatment",
629
+ "type": "String",
630
+ "mandatory": "No",
631
+ "role": null
632
+ },
633
+ "TRTPN": {
634
+ "label": "Planned Treatment (N)",
635
+ "type": "Float64",
636
+ "mandatory": "No",
637
+ "role": null
638
+ },
639
+ "AGE": {
640
+ "label": "Age",
641
+ "type": "Float64",
642
+ "mandatory": "No",
643
+ "role": null
644
+ },
645
+ "AGEGR1": {
646
+ "label": "Pooled Age Group 1",
647
+ "type": "String",
648
+ "mandatory": "No",
649
+ "role": null
650
+ },
651
+ "AGEGR1N": {
652
+ "label": "Pooled Age Group 1 (N)",
653
+ "type": "Float64",
654
+ "mandatory": "No",
655
+ "role": null
656
+ },
657
+ "RACE": {
658
+ "label": "Race",
659
+ "type": "String",
660
+ "mandatory": "No",
661
+ "role": null
662
+ },
663
+ "RACEN": {
664
+ "label": "Race (N)",
665
+ "type": "Float64",
666
+ "mandatory": "No",
667
+ "role": null
668
+ },
669
+ "SEX": {
670
+ "label": "Sex",
671
+ "type": "String",
672
+ "mandatory": "No",
673
+ "role": null
674
+ },
675
+ "ITTFL": {
676
+ "label": "Intent-to-Treat Population Flag",
677
+ "type": "String",
678
+ "mandatory": "No",
679
+ "role": null
680
+ },
681
+ "EFFFL": {
682
+ "label": "Efficacy Population Flag",
683
+ "type": "String",
684
+ "mandatory": "No",
685
+ "role": null
686
+ },
687
+ "COMP24FL": {
688
+ "label": "Completers of Week 24 Population Flag",
689
+ "type": "String",
690
+ "mandatory": "No",
691
+ "role": null
692
+ },
693
+ "AVISIT": {
694
+ "label": "Analysis Visit",
695
+ "type": "String",
696
+ "mandatory": "No",
697
+ "role": null
698
+ },
699
+ "AVISITN": {
700
+ "label": "Analysis Visit (N)",
701
+ "type": "Float64",
702
+ "mandatory": "No",
703
+ "role": null
704
+ },
705
+ "VISIT": {
706
+ "label": "Visit Name",
707
+ "type": "String",
708
+ "mandatory": "No",
709
+ "role": null
710
+ },
711
+ "VISITNUM": {
712
+ "label": "Visit Number",
713
+ "type": "Float64",
714
+ "mandatory": "No",
715
+ "role": null
716
+ },
717
+ "ADY": {
718
+ "label": "Analysis Relative Day",
719
+ "type": "Float64",
720
+ "mandatory": "No",
721
+ "role": null
722
+ },
723
+ "ADT": {
724
+ "label": "Analysis Date",
725
+ "type": "Date",
726
+ "mandatory": "No",
727
+ "role": null
728
+ },
729
+ "PARAMCD": {
730
+ "label": "Parameter Code",
731
+ "type": "String",
732
+ "mandatory": "No",
733
+ "role": null
734
+ },
735
+ "PARAM": {
736
+ "label": "Parameter",
737
+ "type": "String",
738
+ "mandatory": "No",
739
+ "role": null
740
+ },
741
+ "PARAMN": {
742
+ "label": "Parameter (N)",
743
+ "type": "Float64",
744
+ "mandatory": "No",
745
+ "role": null
746
+ },
747
+ "AVAL": {
748
+ "label": "Analysis Value",
749
+ "type": "Float64",
750
+ "mandatory": "No",
751
+ "role": null
752
+ },
753
+ "ANL01FL": {
754
+ "label": "Analysis Record Flag 01",
755
+ "type": "String",
756
+ "mandatory": "No",
757
+ "role": null
758
+ },
759
+ "DTYPE": {
760
+ "label": "Derivation Type",
761
+ "type": "String",
762
+ "mandatory": "No",
763
+ "role": null
764
+ },
765
+ "AWRANGE": {
766
+ "label": "Analysis Window Valid Relative Range",
767
+ "type": "String",
768
+ "mandatory": "No",
769
+ "role": null
770
+ },
771
+ "AWTARGET": {
772
+ "label": "Analysis Window Target",
773
+ "type": "Float64",
774
+ "mandatory": "No",
775
+ "role": null
776
+ },
777
+ "AWTDIFF": {
778
+ "label": "Analysis Window Diff from Target",
779
+ "type": "Float64",
780
+ "mandatory": "No",
781
+ "role": null
782
+ },
783
+ "AWLO": {
784
+ "label": "Analysis Window Beginning Timepoint",
785
+ "type": "Float64",
786
+ "mandatory": "No",
787
+ "role": null
788
+ },
789
+ "AWHI": {
790
+ "label": "Analysis Window Ending Timepoint",
791
+ "type": "Float64",
792
+ "mandatory": "No",
793
+ "role": null
794
+ },
795
+ "AWU": {
796
+ "label": "Analysis Window Unit",
797
+ "type": "String",
798
+ "mandatory": "No",
799
+ "role": null
800
+ },
801
+ "QSSEQ": {
802
+ "label": "Sequence Number",
803
+ "type": "Float64",
804
+ "mandatory": "No",
805
+ "role": null
806
+ }
807
+ }
808
+ },
809
+ "adlbc": {
810
+ "label": "Analysis Dataset Lab Blood Chemistry",
811
+ "structure": "one record per subject per parameter per analysis visit",
812
+ "n_rows": 37132,
813
+ "columns": {
814
+ "STUDYID": {
815
+ "label": "Study Identifier",
816
+ "type": "String",
817
+ "mandatory": "No",
818
+ "role": null
819
+ },
820
+ "SUBJID": {
821
+ "label": "Subject Identifier for the Study",
822
+ "type": "String",
823
+ "mandatory": "No",
824
+ "role": null
825
+ },
826
+ "USUBJID": {
827
+ "label": "Unique Subject Identifier",
828
+ "type": "String",
829
+ "mandatory": "No",
830
+ "role": null
831
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832
+ "TRTP": {
833
+ "label": "Planned Treatment",
834
+ "type": "String",
835
+ "mandatory": "No",
836
+ "role": null
837
+ },
838
+ "TRTPN": {
839
+ "label": "Planned Treatment (N)",
840
+ "type": "Float64",
841
+ "mandatory": "No",
842
+ "role": null
843
+ },
844
+ "TRTA": {
845
+ "label": "Actual Treatment",
846
+ "type": "String",
847
+ "mandatory": "No",
848
+ "role": null
849
+ },
850
+ "TRTAN": {
851
+ "label": "Actual Treatment (N)",
852
+ "type": "Float64",
853
+ "mandatory": "No",
854
+ "role": null
855
+ },
856
+ "TRTSDT": {
857
+ "label": "Date of First Exposure to Treatment",
858
+ "type": "Float64",
859
+ "mandatory": "No",
860
+ "role": null
861
+ },
862
+ "TRTEDT": {
863
+ "label": "Date of Last Exposure to Treatment",
864
+ "type": "Float64",
865
+ "mandatory": "No",
866
+ "role": null
867
+ },
868
+ "AGE": {
869
+ "label": "Age",
870
+ "type": "Float64",
871
+ "mandatory": "No",
872
+ "role": null
873
+ },
874
+ "AGEGR1": {
875
+ "label": "Pooled Age Group 1",
876
+ "type": "String",
877
+ "mandatory": "No",
878
+ "role": null
879
+ },
880
+ "AGEGR1N": {
881
+ "label": "Pooled Age Group 1 (N)",
882
+ "type": "Float64",
883
+ "mandatory": "No",
884
+ "role": null
885
+ },
886
+ "RACE": {
887
+ "label": "Race",
888
+ "type": "String",
889
+ "mandatory": "No",
890
+ "role": null
891
+ },
892
+ "RACEN": {
893
+ "label": "Race (N)",
894
+ "type": "Float64",
895
+ "mandatory": "No",
896
+ "role": null
897
+ },
898
+ "SEX": {
899
+ "label": "Sex",
900
+ "type": "String",
901
+ "mandatory": "No",
902
+ "role": null
903
+ },
904
+ "COMP24FL": {
905
+ "label": "Completers of Week 24 Population Flag",
906
+ "type": "String",
907
+ "mandatory": "No",
908
+ "role": null
909
+ },
910
+ "DSRAEFL": {
911
+ "label": "Discontinued due to AE?",
912
+ "type": "String",
913
+ "mandatory": "No",
914
+ "role": null
915
+ },
916
+ "SAFFL": {
917
+ "label": "Safety Population Flag",
918
+ "type": "String",
919
+ "mandatory": "No",
920
+ "role": null
921
+ },
922
+ "AVISIT": {
923
+ "label": "Analysis Visit",
924
+ "type": "String",
925
+ "mandatory": "No",
926
+ "role": null
927
+ },
928
+ "AVISITN": {
929
+ "label": "Analysis Visit (N)",
930
+ "type": "Float64",
931
+ "mandatory": "No",
932
+ "role": null
933
+ },
934
+ "ADY": {
935
+ "label": "Analysis Relative Day",
936
+ "type": "Float64",
937
+ "mandatory": "No",
938
+ "role": null
939
+ },
940
+ "ADT": {
941
+ "label": "Analysis Date",
942
+ "type": "Float64",
943
+ "mandatory": "No",
944
+ "role": null
945
+ },
946
+ "VISIT": {
947
+ "label": "Visit Name",
948
+ "type": "String",
949
+ "mandatory": "No",
950
+ "role": null
951
+ },
952
+ "VISITNUM": {
953
+ "label": "Visit Number",
954
+ "type": "Float64",
955
+ "mandatory": "No",
956
+ "role": null
957
+ },
958
+ "PARAM": {
959
+ "label": "Parameter",
960
+ "type": "String",
961
+ "mandatory": "No",
962
+ "role": null
963
+ },
964
+ "PARAMCD": {
965
+ "label": "Parameter Code",
966
+ "type": "String",
967
+ "mandatory": "No",
968
+ "role": null
969
+ },
970
+ "PARAMN": {
971
+ "label": "Parameter (N)",
972
+ "type": "Float64",
973
+ "mandatory": "No",
974
+ "role": null
975
+ },
976
+ "PARCAT1": {
977
+ "label": "Parameter Category 1",
978
+ "type": "String",
979
+ "mandatory": "No",
980
+ "role": null
981
+ },
982
+ "AVAL": {
983
+ "label": "Analysis Value",
984
+ "type": "Float64",
985
+ "mandatory": "No",
986
+ "role": null
987
+ },
988
+ "BASE": {
989
+ "label": "Baseline Value",
990
+ "type": "Float64",
991
+ "mandatory": "No",
992
+ "role": null
993
+ },
994
+ "CHG": {
995
+ "label": "Change from Baseline",
996
+ "type": "Float64",
997
+ "mandatory": "No",
998
+ "role": null
999
+ },
1000
+ "A1LO": {
1001
+ "label": "Analysis Range 1 Lower Limit",
1002
+ "type": "Float64",
1003
+ "mandatory": "No",
1004
+ "role": null
1005
+ },
1006
+ "A1HI": {
1007
+ "label": "Analysis Range 1 Upper Limit",
1008
+ "type": "Float64",
1009
+ "mandatory": "No",
1010
+ "role": null
1011
+ },
1012
+ "R2A1LO": {
1013
+ "label": "Ratio to Analysis Range 1 Lower Limit",
1014
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1015
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1601
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1607
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1610
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1612
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1613
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1619
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1625
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1643
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1649
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1655
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2315
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2316
+ "mandatory": "No",
2317
+ "role": null
2318
+ },
2319
+ "AVISITN": {
2320
+ "label": "Analysis Visit (N)",
2321
+ "type": "Float64",
2322
+ "mandatory": "No",
2323
+ "role": null
2324
+ },
2325
+ "ADY": {
2326
+ "label": "Analysis Relative Day",
2327
+ "type": "Float64",
2328
+ "mandatory": "No",
2329
+ "role": null
2330
+ },
2331
+ "ADT": {
2332
+ "label": "Analysis Date",
2333
+ "type": "Date",
2334
+ "mandatory": "No",
2335
+ "role": null
2336
+ },
2337
+ "VISITNUM": {
2338
+ "label": "Visit Number",
2339
+ "type": "Float64",
2340
+ "mandatory": "No",
2341
+ "role": null
2342
+ },
2343
+ "VISIT": {
2344
+ "label": "Visit Name",
2345
+ "type": "String",
2346
+ "mandatory": "No",
2347
+ "role": null
2348
+ },
2349
+ "PARAM": {
2350
+ "label": "Parameter",
2351
+ "type": "String",
2352
+ "mandatory": "No",
2353
+ "role": null
2354
+ },
2355
+ "PARAMCD": {
2356
+ "label": "Parameter Code",
2357
+ "type": "String",
2358
+ "mandatory": "No",
2359
+ "role": null
2360
+ },
2361
+ "PARAMN": {
2362
+ "label": "Parameter (N)",
2363
+ "type": "Float64",
2364
+ "mandatory": "No",
2365
+ "role": null
2366
+ },
2367
+ "PARAMTYP": {
2368
+ "label": "Parameter Type",
2369
+ "type": "String",
2370
+ "mandatory": "No",
2371
+ "role": null
2372
+ },
2373
+ "AVAL": {
2374
+ "label": "Analysis Value",
2375
+ "type": "Float64",
2376
+ "mandatory": "No",
2377
+ "role": null
2378
+ },
2379
+ "BASE": {
2380
+ "label": "Baseline Value",
2381
+ "type": "Float64",
2382
+ "mandatory": "No",
2383
+ "role": null
2384
+ },
2385
+ "CHG": {
2386
+ "label": "Change from Baseline",
2387
+ "type": "Float64",
2388
+ "mandatory": "No",
2389
+ "role": null
2390
+ },
2391
+ "PCHG": {
2392
+ "label": "Percent Change from Baseline",
2393
+ "type": "Float64",
2394
+ "mandatory": "No",
2395
+ "role": null
2396
+ },
2397
+ "ABLFL": {
2398
+ "label": "Baseline Record Flag",
2399
+ "type": "String",
2400
+ "mandatory": "No",
2401
+ "role": null
2402
+ },
2403
+ "ANL01FL": {
2404
+ "label": "Analysis Flag 01",
2405
+ "type": "String",
2406
+ "mandatory": "No",
2407
+ "role": null
2408
+ },
2409
+ "DTYPE": {
2410
+ "label": "Derivation Type",
2411
+ "type": "String",
2412
+ "mandatory": "No",
2413
+ "role": null
2414
+ },
2415
+ "AWRANGE": {
2416
+ "label": "Analysis Window Valid Relative Range",
2417
+ "type": "String",
2418
+ "mandatory": "No",
2419
+ "role": null
2420
+ },
2421
+ "AWTARGET": {
2422
+ "label": "Analysis Window Target",
2423
+ "type": "Float64",
2424
+ "mandatory": "No",
2425
+ "role": null
2426
+ },
2427
+ "AWTDIFF": {
2428
+ "label": "Analysis Window Diff from Target",
2429
+ "type": "Float64",
2430
+ "mandatory": "No",
2431
+ "role": null
2432
+ },
2433
+ "AWLO": {
2434
+ "label": "Analysis Window Beginning Timepoint",
2435
+ "type": "Float64",
2436
+ "mandatory": "No",
2437
+ "role": null
2438
+ },
2439
+ "AWHI": {
2440
+ "label": "Analysis Window Ending Timepoint",
2441
+ "type": "Float64",
2442
+ "mandatory": "No",
2443
+ "role": null
2444
+ },
2445
+ "AWU": {
2446
+ "label": "Analysis Window Unit",
2447
+ "type": "String",
2448
+ "mandatory": "No",
2449
+ "role": null
2450
+ },
2451
+ "QSSEQ": {
2452
+ "label": "Sequence Number",
2453
+ "type": "Float64",
2454
+ "mandatory": "No",
2455
+ "role": null
2456
+ }
2457
+ }
2458
+ },
2459
+ "adsl": {
2460
+ "label": "Subject-Level Analysis",
2461
+ "structure": "one record per subject",
2462
+ "n_rows": 254,
2463
+ "columns": {
2464
+ "STUDYID": {
2465
+ "label": "Study Identifier",
2466
+ "type": "String",
2467
+ "mandatory": "No",
2468
+ "role": null
2469
+ },
2470
+ "USUBJID": {
2471
+ "label": "Unique Subject Identifier",
2472
+ "type": "String",
2473
+ "mandatory": "No",
2474
+ "role": null
2475
+ },
2476
+ "SUBJID": {
2477
+ "label": "Subject Identifier for the Study",
2478
+ "type": "String",
2479
+ "mandatory": "No",
2480
+ "role": null
2481
+ },
2482
+ "SITEID": {
2483
+ "label": "Study Site Identifier",
2484
+ "type": "String",
2485
+ "mandatory": "No",
2486
+ "role": null
2487
+ },
2488
+ "SITEGR1": {
2489
+ "label": "Pooled Site Group 1",
2490
+ "type": "String",
2491
+ "mandatory": "No",
2492
+ "role": null
2493
+ },
2494
+ "ARM": {
2495
+ "label": "Description of Planned Arm",
2496
+ "type": "String",
2497
+ "mandatory": "No",
2498
+ "role": null
2499
+ },
2500
+ "TRT01P": {
2501
+ "label": "Planned Treatment for Period 01",
2502
+ "type": "String",
2503
+ "mandatory": "No",
2504
+ "role": null
2505
+ },
2506
+ "TRT01PN": {
2507
+ "label": "Planned Treatment for Period 01 (N)",
2508
+ "type": "Float64",
2509
+ "mandatory": "No",
2510
+ "role": null
2511
+ },
2512
+ "TRT01A": {
2513
+ "label": "Actual Treatment for Period 01",
2514
+ "type": "String",
2515
+ "mandatory": "No",
2516
+ "role": null
2517
+ },
2518
+ "TRT01AN": {
2519
+ "label": "Actual Treatment for Period 01 (N)",
2520
+ "type": "Float64",
2521
+ "mandatory": "No",
2522
+ "role": null
2523
+ },
2524
+ "TRTSDT": {
2525
+ "label": "Date of First Exposure to Treatment",
2526
+ "type": "Date",
2527
+ "mandatory": "No",
2528
+ "role": null
2529
+ },
2530
+ "TRTEDT": {
2531
+ "label": "Date of Last Exposure to Treatment",
2532
+ "type": "Date",
2533
+ "mandatory": "No",
2534
+ "role": null
2535
+ },
2536
+ "TRTDURD": {
2537
+ "label": "Total Treatment Duration (Days)",
2538
+ "type": "Float64",
2539
+ "mandatory": "No",
2540
+ "role": null
2541
+ },
2542
+ "AVGDD": {
2543
+ "label": "Avg Daily Dose (as planned)",
2544
+ "type": "Float64",
2545
+ "mandatory": "No",
2546
+ "role": null
2547
+ },
2548
+ "CUMDOSE": {
2549
+ "label": "Cumulative Dose (as planned)",
2550
+ "type": "Float64",
2551
+ "mandatory": "No",
2552
+ "role": null
2553
+ },
2554
+ "AGE": {
2555
+ "label": "Age",
2556
+ "type": "Float64",
2557
+ "mandatory": "No",
2558
+ "role": null
2559
+ },
2560
+ "AGEGR1": {
2561
+ "label": "Pooled Age Group 1",
2562
+ "type": "String",
2563
+ "mandatory": "No",
2564
+ "role": null
2565
+ },
2566
+ "AGEGR1N": {
2567
+ "label": "Pooled Age Group 1 (N)",
2568
+ "type": "Float64",
2569
+ "mandatory": "No",
2570
+ "role": null
2571
+ },
2572
+ "AGEU": {
2573
+ "label": "Age Units",
2574
+ "type": "String",
2575
+ "mandatory": "No",
2576
+ "role": null
2577
+ },
2578
+ "RACE": {
2579
+ "label": "Race",
2580
+ "type": "String",
2581
+ "mandatory": "No",
2582
+ "role": null
2583
+ },
2584
+ "RACEN": {
2585
+ "label": "Race (N)",
2586
+ "type": "Float64",
2587
+ "mandatory": "No",
2588
+ "role": null
2589
+ },
2590
+ "SEX": {
2591
+ "label": "Sex",
2592
+ "type": "String",
2593
+ "mandatory": "No",
2594
+ "role": null
2595
+ },
2596
+ "ETHNIC": {
2597
+ "label": "Ethnicity",
2598
+ "type": "String",
2599
+ "mandatory": "No",
2600
+ "role": null
2601
+ },
2602
+ "SAFFL": {
2603
+ "label": "Safety Population Flag",
2604
+ "type": "String",
2605
+ "mandatory": "No",
2606
+ "role": null
2607
+ },
2608
+ "ITTFL": {
2609
+ "label": "Intent-To-Treat Population Flag",
2610
+ "type": "String",
2611
+ "mandatory": "No",
2612
+ "role": null
2613
+ },
2614
+ "EFFFL": {
2615
+ "label": "Efficacy Population Flag",
2616
+ "type": "String",
2617
+ "mandatory": "No",
2618
+ "role": null
2619
+ },
2620
+ "COMP8FL": {
2621
+ "label": "Completers of Week 8 Population Flag",
2622
+ "type": "String",
2623
+ "mandatory": "No",
2624
+ "role": null
2625
+ },
2626
+ "COMP16FL": {
2627
+ "label": "Completers of Week 16 Population Flag",
2628
+ "type": "String",
2629
+ "mandatory": "No",
2630
+ "role": null
2631
+ },
2632
+ "COMP24FL": {
2633
+ "label": "Completers of Week 24 Population Flag",
2634
+ "type": "String",
2635
+ "mandatory": "No",
2636
+ "role": null
2637
+ },
2638
+ "DISCONFL": {
2639
+ "label": "Did the Subject Discontinue the Study?",
2640
+ "type": "String",
2641
+ "mandatory": "No",
2642
+ "role": null
2643
+ },
2644
+ "DSRAEFL": {
2645
+ "label": "Discontinued due to AE?",
2646
+ "type": "String",
2647
+ "mandatory": "No",
2648
+ "role": null
2649
+ },
2650
+ "DTHFL": {
2651
+ "label": "Subject Died?",
2652
+ "type": "String",
2653
+ "mandatory": "No",
2654
+ "role": null
2655
+ },
2656
+ "BMIBL": {
2657
+ "label": "Baseline BMI (kg/m^2)",
2658
+ "type": "Float64",
2659
+ "mandatory": "No",
2660
+ "role": null
2661
+ },
2662
+ "BMIBLGR1": {
2663
+ "label": "Pooled Baseline BMI Group 1",
2664
+ "type": "String",
2665
+ "mandatory": "No",
2666
+ "role": null
2667
+ },
2668
+ "HEIGHTBL": {
2669
+ "label": "Baseline Height (cm)",
2670
+ "type": "Float64",
2671
+ "mandatory": "No",
2672
+ "role": null
2673
+ },
2674
+ "WEIGHTBL": {
2675
+ "label": "Baseline Weight (kg)",
2676
+ "type": "Float64",
2677
+ "mandatory": "No",
2678
+ "role": null
2679
+ },
2680
+ "EDUCLVL": {
2681
+ "label": "Years of Education",
2682
+ "type": "Float64",
2683
+ "mandatory": "No",
2684
+ "role": null
2685
+ },
2686
+ "DISONSDT": {
2687
+ "label": "Date of Onset of Disease",
2688
+ "type": "Date",
2689
+ "mandatory": "No",
2690
+ "role": null
2691
+ },
2692
+ "DURDIS": {
2693
+ "label": "Duration of Disease (Months)",
2694
+ "type": "Float64",
2695
+ "mandatory": "No",
2696
+ "role": null
2697
+ },
2698
+ "DURDSGR1": {
2699
+ "label": "Pooled Disease Duration Group 1",
2700
+ "type": "String",
2701
+ "mandatory": "No",
2702
+ "role": null
2703
+ },
2704
+ "VISIT1DT": {
2705
+ "label": "Date of Visit 1",
2706
+ "type": "Date",
2707
+ "mandatory": "No",
2708
+ "role": null
2709
+ },
2710
+ "RFSTDTC": {
2711
+ "label": "Subject Reference Start Date/Time",
2712
+ "type": "String",
2713
+ "mandatory": "No",
2714
+ "role": null
2715
+ },
2716
+ "RFENDTC": {
2717
+ "label": "Subject Reference End Date/Time",
2718
+ "type": "String",
2719
+ "mandatory": "No",
2720
+ "role": null
2721
+ },
2722
+ "VISNUMEN": {
2723
+ "label": "End of Trt Visit (Vis 12 or Early Term.)",
2724
+ "type": "Float64",
2725
+ "mandatory": "No",
2726
+ "role": null
2727
+ },
2728
+ "RFENDT": {
2729
+ "label": "Date of Discontinuation/Completion",
2730
+ "type": "Date",
2731
+ "mandatory": "No",
2732
+ "role": null
2733
+ },
2734
+ "DCDECOD": {
2735
+ "label": "Standardized Disposition Term",
2736
+ "type": "String",
2737
+ "mandatory": "No",
2738
+ "role": null
2739
+ },
2740
+ "EOSSTT": {
2741
+ "label": "End of Study Status",
2742
+ "type": "String",
2743
+ "mandatory": "No",
2744
+ "role": null
2745
+ },
2746
+ "DCSREAS": {
2747
+ "label": "Reason for Discontinuation from Study",
2748
+ "type": "String",
2749
+ "mandatory": "No",
2750
+ "role": null
2751
+ },
2752
+ "MMSETOT": {
2753
+ "label": "MMSE Total",
2754
+ "type": "Float64",
2755
+ "mandatory": "No",
2756
+ "role": null
2757
+ }
2758
+ }
2759
+ },
2760
+ "adtte": {
2761
+ "label": "AE Time To 1st Derm. Event Analysis",
2762
+ "structure": "one record per subject per parameter",
2763
+ "n_rows": 254,
2764
+ "columns": {
2765
+ "STUDYID": {
2766
+ "label": "Study Identifier",
2767
+ "type": "String",
2768
+ "mandatory": "No",
2769
+ "role": null
2770
+ },
2771
+ "SITEID": {
2772
+ "label": "Study Site Identifier",
2773
+ "type": "String",
2774
+ "mandatory": "No",
2775
+ "role": null
2776
+ },
2777
+ "USUBJID": {
2778
+ "label": "Unique Subject Identifier",
2779
+ "type": "String",
2780
+ "mandatory": "No",
2781
+ "role": null
2782
+ },
2783
+ "AGE": {
2784
+ "label": "Age",
2785
+ "type": "Float64",
2786
+ "mandatory": "No",
2787
+ "role": null
2788
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2789
+ "AGEGR1": {
2790
+ "label": "Pooled Age Group 1",
2791
+ "type": "String",
2792
+ "mandatory": "No",
2793
+ "role": null
2794
+ },
2795
+ "AGEGR1N": {
2796
+ "label": "Pooled Age Group 1 (N)",
2797
+ "type": "Float64",
2798
+ "mandatory": "No",
2799
+ "role": null
2800
+ },
2801
+ "RACE": {
2802
+ "label": "Race",
2803
+ "type": "String",
2804
+ "mandatory": "No",
2805
+ "role": null
2806
+ },
2807
+ "RACEN": {
2808
+ "label": "Race (N)",
2809
+ "type": "Float64",
2810
+ "mandatory": "No",
2811
+ "role": null
2812
+ },
2813
+ "SEX": {
2814
+ "label": "Sex",
2815
+ "type": "String",
2816
+ "mandatory": "No",
2817
+ "role": null
2818
+ },
2819
+ "TRTSDT": {
2820
+ "label": "Date of First Exposure to Treatment",
2821
+ "type": "Date",
2822
+ "mandatory": "No",
2823
+ "role": null
2824
+ },
2825
+ "TRTEDT": {
2826
+ "label": "Date of Last Exposure to Treatment",
2827
+ "type": "Date",
2828
+ "mandatory": "No",
2829
+ "role": null
2830
+ },
2831
+ "TRTDUR": {
2832
+ "label": "Duration of treatment (days)",
2833
+ "type": "Float64",
2834
+ "mandatory": "No",
2835
+ "role": null
2836
+ },
2837
+ "TRTP": {
2838
+ "label": "Planned Treatment",
2839
+ "type": "String",
2840
+ "mandatory": "No",
2841
+ "role": null
2842
+ },
2843
+ "TRTA": {
2844
+ "label": "Actual Treatment",
2845
+ "type": "String",
2846
+ "mandatory": "No",
2847
+ "role": null
2848
+ },
2849
+ "TRTAN": {
2850
+ "label": "Actual Treatment (N)",
2851
+ "type": "Float64",
2852
+ "mandatory": "No",
2853
+ "role": null
2854
+ },
2855
+ "PARAM": {
2856
+ "label": "Parameter",
2857
+ "type": "String",
2858
+ "mandatory": "No",
2859
+ "role": null
2860
+ },
2861
+ "PARAMCD": {
2862
+ "label": "Parameter Code",
2863
+ "type": "String",
2864
+ "mandatory": "No",
2865
+ "role": null
2866
+ },
2867
+ "AVAL": {
2868
+ "label": "Analysis Value",
2869
+ "type": "Float64",
2870
+ "mandatory": "No",
2871
+ "role": null
2872
+ },
2873
+ "STARTDT": {
2874
+ "label": "Time to Event Origin Date for Subject",
2875
+ "type": "Date",
2876
+ "mandatory": "No",
2877
+ "role": null
2878
+ },
2879
+ "ADT": {
2880
+ "label": "Analysis Date",
2881
+ "type": "Date",
2882
+ "mandatory": "No",
2883
+ "role": null
2884
+ },
2885
+ "CNSR": {
2886
+ "label": "Censor",
2887
+ "type": "Float64",
2888
+ "mandatory": "No",
2889
+ "role": null
2890
+ },
2891
+ "EVNTDESC": {
2892
+ "label": "Event or Censoring Description",
2893
+ "type": "String",
2894
+ "mandatory": "No",
2895
+ "role": null
2896
+ },
2897
+ "SRCDOM": {
2898
+ "label": "Source Domain",
2899
+ "type": "String",
2900
+ "mandatory": "No",
2901
+ "role": null
2902
+ },
2903
+ "SRCVAR": {
2904
+ "label": "Source Variable",
2905
+ "type": "String",
2906
+ "mandatory": "No",
2907
+ "role": null
2908
+ },
2909
+ "SRCSEQ": {
2910
+ "label": "Source Sequence Number",
2911
+ "type": "Float64",
2912
+ "mandatory": "No",
2913
+ "role": null
2914
+ },
2915
+ "SAFFL": {
2916
+ "label": "Safety Population Flag",
2917
+ "type": "String",
2918
+ "mandatory": "No",
2919
+ "role": null
2920
+ }
2921
+ }
2922
+ },
2923
+ "advs": {
2924
+ "label": "Vital Signs Analysis Dataset",
2925
+ "structure": "one record per subject per parameter per analysis visit per analysis timepoint",
2926
+ "n_rows": 32139,
2927
+ "columns": {
2928
+ "STUDYID": {
2929
+ "label": "Study Identifier",
2930
+ "type": "String",
2931
+ "mandatory": "No",
2932
+ "role": null
2933
+ },
2934
+ "SITEID": {
2935
+ "label": "Study Site Identifier",
2936
+ "type": "String",
2937
+ "mandatory": "No",
2938
+ "role": null
2939
+ },
2940
+ "USUBJID": {
2941
+ "label": "Unique Subject Identifier",
2942
+ "type": "String",
2943
+ "mandatory": "No",
2944
+ "role": null
2945
+ },
2946
+ "AGE": {
2947
+ "label": "Age",
2948
+ "type": "Float64",
2949
+ "mandatory": "No",
2950
+ "role": null
2951
+ },
2952
+ "AGEGR1": {
2953
+ "label": "Pooled Age Group 1",
2954
+ "type": "String",
2955
+ "mandatory": "No",
2956
+ "role": null
2957
+ },
2958
+ "AGEGR1N": {
2959
+ "label": "Pooled Age Group 1 (N)",
2960
+ "type": "Float64",
2961
+ "mandatory": "No",
2962
+ "role": null
2963
+ },
2964
+ "RACE": {
2965
+ "label": "Race",
2966
+ "type": "String",
2967
+ "mandatory": "No",
2968
+ "role": null
2969
+ },
2970
+ "RACEN": {
2971
+ "label": "Race (N)",
2972
+ "type": "Float64",
2973
+ "mandatory": "No",
2974
+ "role": null
2975
+ },
2976
+ "SEX": {
2977
+ "label": "Sex",
2978
+ "type": "String",
2979
+ "mandatory": "No",
2980
+ "role": null
2981
+ },
2982
+ "SAFFL": {
2983
+ "label": "Safety Population Flag",
2984
+ "type": "String",
2985
+ "mandatory": "No",
2986
+ "role": null
2987
+ },
2988
+ "TRTSDT": {
2989
+ "label": "Date of First Exposure to Treatment",
2990
+ "type": "Date",
2991
+ "mandatory": "No",
2992
+ "role": null
2993
+ },
2994
+ "TRTEDT": {
2995
+ "label": "Date of Last Exposure to Treatment",
2996
+ "type": "Date",
2997
+ "mandatory": "No",
2998
+ "role": null
2999
+ },
3000
+ "TRTP": {
3001
+ "label": "Planned Treatment",
3002
+ "type": "String",
3003
+ "mandatory": "No",
3004
+ "role": null
3005
+ },
3006
+ "TRTPN": {
3007
+ "label": "Planned Treatment (N)",
3008
+ "type": "Float64",
3009
+ "mandatory": "No",
3010
+ "role": null
3011
+ },
3012
+ "TRTA": {
3013
+ "label": "Actual Treatment",
3014
+ "type": "String",
3015
+ "mandatory": "No",
3016
+ "role": null
3017
+ },
3018
+ "TRTAN": {
3019
+ "label": "Actual Treatment (N)",
3020
+ "type": "Float64",
3021
+ "mandatory": "No",
3022
+ "role": null
3023
+ },
3024
+ "PARAMCD": {
3025
+ "label": "Parameter Code",
3026
+ "type": "String",
3027
+ "mandatory": "No",
3028
+ "role": null
3029
+ },
3030
+ "PARAM": {
3031
+ "label": "Parameter",
3032
+ "type": "String",
3033
+ "mandatory": "No",
3034
+ "role": null
3035
+ },
3036
+ "PARAMN": {
3037
+ "label": "Parameter (N)",
3038
+ "type": "Float64",
3039
+ "mandatory": "No",
3040
+ "role": null
3041
+ },
3042
+ "ADT": {
3043
+ "label": "Analysis Date",
3044
+ "type": "Date",
3045
+ "mandatory": "No",
3046
+ "role": null
3047
+ },
3048
+ "ADY": {
3049
+ "label": "Analysis Relative Day",
3050
+ "type": "Float64",
3051
+ "mandatory": "No",
3052
+ "role": null
3053
+ },
3054
+ "ATPTN": {
3055
+ "label": "Analysis Timepoint (N)",
3056
+ "type": "Float64",
3057
+ "mandatory": "No",
3058
+ "role": null
3059
+ },
3060
+ "ATPT": {
3061
+ "label": "Analysis Timepoint",
3062
+ "type": "String",
3063
+ "mandatory": "No",
3064
+ "role": null
3065
+ },
3066
+ "AVISIT": {
3067
+ "label": "Analysis Visit",
3068
+ "type": "String",
3069
+ "mandatory": "No",
3070
+ "role": null
3071
+ },
3072
+ "AVISITN": {
3073
+ "label": "Analysis Visit (N)",
3074
+ "type": "Float64",
3075
+ "mandatory": "No",
3076
+ "role": null
3077
+ },
3078
+ "AVAL": {
3079
+ "label": "Analysis Value",
3080
+ "type": "Float64",
3081
+ "mandatory": "No",
3082
+ "role": null
3083
+ },
3084
+ "BASE": {
3085
+ "label": "Baseline Value",
3086
+ "type": "Float64",
3087
+ "mandatory": "No",
3088
+ "role": null
3089
+ },
3090
+ "BASETYPE": {
3091
+ "label": "Baseline Type",
3092
+ "type": "String",
3093
+ "mandatory": "No",
3094
+ "role": null
3095
+ },
3096
+ "CHG": {
3097
+ "label": "Change from Baseline",
3098
+ "type": "Float64",
3099
+ "mandatory": "No",
3100
+ "role": null
3101
+ },
3102
+ "PCHG": {
3103
+ "label": "Percent Change from Baseline",
3104
+ "type": "Float64",
3105
+ "mandatory": "No",
3106
+ "role": null
3107
+ },
3108
+ "VISITNUM": {
3109
+ "label": "Visit Number",
3110
+ "type": "Float64",
3111
+ "mandatory": "No",
3112
+ "role": null
3113
+ },
3114
+ "VISIT": {
3115
+ "label": "Visit Name",
3116
+ "type": "String",
3117
+ "mandatory": "No",
3118
+ "role": null
3119
+ },
3120
+ "VSSEQ": {
3121
+ "label": "Sequence Number",
3122
+ "type": "Float64",
3123
+ "mandatory": "No",
3124
+ "role": null
3125
+ },
3126
+ "ANL01FL": {
3127
+ "label": "Analysis Flag 01",
3128
+ "type": "String",
3129
+ "mandatory": "No",
3130
+ "role": null
3131
+ },
3132
+ "ABLFL": {
3133
+ "label": "Baseline Record Flag",
3134
+ "type": "String",
3135
+ "mandatory": "No",
3136
+ "role": null
3137
+ }
3138
+ }
3139
+ }
3140
+ }