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Randomized, Placebo-Controlled Trial of Linaclotide to Demonstrate Colorectal Bioactivity in Healthy Volunteers

The following datasets contain the data available for EPPT MAY2012-00-01. The description and documentation for each file is listed below. SAS7bdat and CSV versions of the actual data will be available to CDAS projects approved to use this study's data.


Analysis Datasets

Data Dictionary
(PDF - 621.2 KB)
1. The Enhanced Person dataset contains all information relevant for most analyses. Each record represents one participant and contains updated variable names, formats, and labels. All information coming from non-person-based datasets has been converted into a person-based format.
Data Dictionary
(PDF - 184.7 KB)
2. The Adverse Events dataset includes updated variable names, formats, and labels.

Raw Datasets

These 46 datasets contain the the raw form data received, excluding PII.

+ Show these datasets

Data Dictionary
(PDF - 161.5 KB)
1. The Analysis_stage_3 dataset contains stage 3 analysis results
Data Dictionary
(PDF - 161.8 KB)
2. The Analysis_stage_4_peg_enema dataset contains stage 4 peg enema results
Data Dictionary
(PDF - 161.5 KB)
3. The Levels_all dataset contains all levels results
Data Dictionary
(PDF - 161.4 KB)
4. The Levels_stage_4 dataset contains levels stage 4 results
Data Dictionary
(PDF - 220.7 KB)
5. The prereg_casecrse dataset is a collection of registration and demographic data.
Data Dictionary
(PDF - 204.6 KB)
6. The prereg_chklist dataset is a collection of data regarding patient eligibility for pre-registration.
Data Dictionary
(PDF - 205.2 KB)
7. The prereg_chklist_history dataset is a collection of data regarding patient eligibility for pre-registration.
Data Dictionary
(PDF - 175.6 KB)
8. The prereg_colon dataset collects data regarding colonoscopy or endoscopy results.
Data Dictionary
(PDF - 170.0 KB)
9. The prereg_colonbx dataset records the number of biopsy samples collected at pre-intervention, date sent, and what conditions the specimens were in.
Data Dictionary
(PDF - 162.8 KB)
10. The prereg_comments dataset contains comments about all aspects of the trial.
Data Dictionary
(PDF - 250.7 KB)
11. The prereg_conmed dataset contains concomitant medications used by the patient during the course of the study.
Data Dictionary
(PDF - 175.6 KB)
12. The prereg_crse dataset contains some demographic and other participant information.
Data Dictionary
(PDF - 166.8 KB)
13. The prereg_crtox dataset contains summary data of maximum grades for a given adverse event containing one observation per toxicity per patient per course of treatment.
Data Dictionary
(PDF - 166.8 KB)
14. The prereg_cytox dataset pulls in data from the toxicity dataset.
Data Dictionary
(PDF - 169.3 KB)
15. The prereg_drgscrn dataset contains the urine drug screen results.
Data Dictionary
(PDF - 165.6 KB)
16. The prereg_end_at dataset contains data about participants reason off study for those who do not register.
Data Dictionary
(PDF - 179.1 KB)
17. The prereg_intvlab dataset contains data about blood hematology.
Data Dictionary
(PDF - 205.5 KB)
18. The prereg_labform dataset contains the blood chemistry results.
Data Dictionary
(PDF - 170.4 KB)
19. The prereg_laburine dataset collects the results of the urine lab test.
Data Dictionary
(PDF - 173.8 KB)
20. The prereg_physexam dataset collects the results of the physical examination.
Data Dictionary
(PDF - 186.9 KB)
21. The prereg_pregnacy dataset collects the results of the pregnancy tests.
Data Dictionary
(PDF - 649.3 KB)
22. The prereg_protref dataset has study overhead information.
Data Dictionary
(PDF - 168.0 KB)
23. The prereg_scrfail dataset contains information on whether the patient pass pre-registration screening, date of eligibility, and reason for screen failure if they fail.
Data Dictionary
(PDF - 257.1 KB)
24. The prereg_toxicity dataset contains adverse event and toxicity information.
Data Dictionary
(PDF - 220.4 KB)
25. The rand_casecrse dataset is a collection of registration and demographic data.
Data Dictionary
(PDF - 221.0 KB)
26. The rand_casecrse_prereg dataset is a collection of registration and demographic data.
Data Dictionary
(PDF - 171.5 KB)
27. The rand_chklist dataset is a collection of data regarding patient eligibility for pre-registration.
Data Dictionary
(PDF - 170.9 KB)
28. The rand_chklist_history dataset is a collection of data regarding patient eligibility for pre-registration.
Data Dictionary
(PDF - 175.0 KB)
29. The rand_colon dataset collects data regarding colonoscopy or endoscopy results.
Data Dictionary
(PDF - 170.8 KB)
30. The rand_colonbx dataset records the number of biopsy samples collected at pre-intervention, date sent, and what conditions the specimens were in.
Data Dictionary
(PDF - 163.4 KB)
31. The rand_comments dataset contains comments about all aspects of the trial.
Data Dictionary
(PDF - 250.2 KB)
32. The rand_conmed dataset contains concomitant medications used by the patient during the course of the study.
Data Dictionary
(PDF - 178.8 KB)
33. The rand_crse dataset contains some demographic and other participant information.
Data Dictionary
(PDF - 166.4 KB)
34. The rand_crtox dataset contains summary data of maximum grades for a given adverse event containing one observation per toxicity per patient per course of treatment.
Data Dictionary
(PDF - 166.4 KB)
35. The rand_cytox dataset pulls in data from the toxicity dataset.
Data Dictionary
(PDF - 169.4 KB)
36. The rand_drgscrn dataset contains the urine drug screen results.
Data Dictionary
(PDF - 214.4 KB)
37. The rand_editchks dataset contains internal checking system that MAYO used.
Data Dictionary
(PDF - 164.6 KB)
38. The rand_end_at dataset contains data about participants reason off study after randomization.
Data Dictionary
(PDF - 179.2 KB)
39. The rand_intvlab dataset contains data about blood hematology.
Data Dictionary
(PDF - 200.4 KB)
40. The rand_labform dataset contains the blood chemistry results.
Data Dictionary
(PDF - 170.3 KB)
41. The rand_laburine dataset collects the results of the urine lab test.
Data Dictionary
(PDF - 173.0 KB)
42. The rand_physexam dataset collects the results of the physical examination.
Data Dictionary
(PDF - 199.4 KB)
43. The rand_protdata dataset contains treatment data.
Data Dictionary
(PDF - 648.4 KB)
44. The rand_protref dataset has study overhead information.
Data Dictionary
(PDF - 171.2 KB)
45. The rand_qol dataset contains quality of life questionnaire results.
Data Dictionary
(PDF - 243.3 KB)
46. The rand_toxicity dataset contains adverse event and toxicity information.