| CDE Group | CDE Name | CDE Definition | CodeList | Recommended Data Type | Length | Recommended Format | Version Number | Version Date |
| Adverse Events | AEYN | Has the subject had any adverse events during the study? | Yes, No | Number | | | 1 | 6/10/2008 |
| Adverse Events | AESPID | Line Number | | Number | | | 1 | 6/10/2008 |
| Adverse Events | AETERM | Description of the adverse event | | Text | | | 1 | 6/10/2008 |
| Adverse Events | AESTDD | Day of when the adverse event started | | Text | 2 | dd | 1 | 6/10/2008 |
| Adverse Events | AESTMM | Month of when the adverse event started | | Text | 3 | mmm | 1 | 6/10/2008 |
| Adverse Events | AESTYY | Year of when the adverse event started | | Number | 4 | yyyy | 1 | 6/10/2008 |
| Adverse Events | AESTTM | Time of when the adverse event started | | Date/Time | | 24 hour clock | 1 | 6/10/2008 |
| Adverse Events | AEENDD | Day of when the adverse event ended | | Text | 2 | dd | 1 | 6/10/2008 |
| Adverse Events | AEENMM | Month of when the adverse event ended | | Text | 3 | mmm | 1 | 6/10/2008 |
| Adverse Events | AEENYY | Year of when the adverse event ended | | Number | 4 | yyyy | 1 | 6/10/2008 |
| Adverse Events | AEENTM | Time of when the adverse event stopped | | Date/Time | | 24 hour clock | 1 | 6/10/2008 |
| Adverse Events | AESEV | Indicate the severity of the adverse event | 1 = Mild, 2 = Moderate, 3 = Severe | Number | | | 1 | 6/10/2008 |
| Adverse Events | AEREL | Indicate the relationship of the study treatment to the adverse event | 1 = Not Related, 2 = Possibly Related, 3 = Related | Number | | | 1 | 6/10/2008 |
| Adverse Events | AEACN | Indicate the action take on the adverse event | 1 = None, 2 = Discontinued Temp., 3 = Discontinued Perm., 4 = Withdrawn from Study, 5 = Other | Number | | | 1 | 6/10/2008 |
| Adverse Events | AEACNOTH | Indicate the other action taken on the adverse event | | Text | | | 1 | 6/10/2008 |
| Adverse Events | AEOUT | Indicate the outcome of the adverse event | 1 = Resolved without effects, 2 = Resolved with effects, 3 = Ongoing, 4 = Death, 5 = Unknown | Number | | | 1 | 6/10/2008 |
| Adverse Events | AESER | Indicate whether or not the adverse event is determined to be "serious" according to the protocol. | 1 = Yes, 2 = No | | | | 1 | 6/10/2008 |
| Death Report | DTHRPTDT | Date the report was taken. | | Date | | dd/mmm/yyyy | 1 | 6/10/2008 |
| Death Report | DTHDT | Date of death | | Date | | dd/mmm/yyyy | 1 | 6/10/2008 |
| Death Report | DTHTM | Time of death | | Time | | 24 hour clock | 1 | 6/10/2008 |
| Death Report | DTHCAUSE | Cause of death | | Text | | | 1 | 6/10/2008 |
| Death Report | FORMND | Check if form not completed | | Number | | | | 6/10/2008 |
| Demographics | INCNTDT | Date Informed Consent was signed | | Date | | dd/mmm/yyyy | 1 | 6/10/2008 |
| Demographics | ASSENTDT | Date assent signed | | Date | | dd/mmm/yyyy | 1 | 6/10/2008 |
| Demographics | INVSIG | Investigator signature | | Text | 3 | | 1 | 6/10/2008 |
| Demographics | INVSIGDT | Date of the investigator signature | | Date | | dd/mmm/yyyy | 1 | 6/10/2008 |
| Demographics | SEX | Indicate the sex of the individual | Male, Female | Number | | | 1 | 6/10/2008 |
| Demographics | BRTHDT | Date of the individual's birth | | Date | | dd/mmm/yyyy | 1 | 6/10/2008 |
| Demographics | RACE | Indicate the race of the individual | American Indian or Alaska Native, Asian, Black or African-American, Native Hawaiian or Other Pacific Islander, White, More than one race, Unknown or not reported | Number | | | 1 | 6/10/2008 |
| Demographics | ETHNIC | Indicate the ethnicity of the individual | Hispanic or Latino, Not Hispanic or Latino, Unknown or not reported | Number | | | 1 | 6/10/2008 |
| Demographics | GESTAGE | Indicate the gestational age of the individual at birth | | Number | | | 1 | 6/10/2008 |
| Demographics | GESTAGEU | Indicate the unit of the gestational age | Days, Weeks, Months, | Number | | | 1 | 6/10/2008 |
| Demographics | LIFEDAYS | Indicate the days of life of the individual | | Number | | | 1 | 6/10/2008 |
| Demographics | MTRACE | Indicate the race of the mother of the individual | American Indian or Alaska Native, Asian, Black or African-American, Native Hawaiian or Other Pacific Islander, White, More than one race, Unknown or not reported | Number | | | 1 | 6/10/2008 |
| Demographics | MTETHNIC | Indicate the ethnicity of the mother of the individual | Hispanic or Latino, Not Hispanic or Latino, Unknown or not reported | Number | | | 1 | 6/10/2008 |
| Demographics | PTRACE | Indicate the race of the father of the individual | American Indian or Alaska Native, Asian, Black or African-American, Native Hawaiian or Other Pacific Islander, White, More than one race, Unknown or not reported | Number | | | 1 | 6/10/2008 |
| Demographics | PTETHNIC | Indicate the ethnicity of the father of the individual | Hispanic or Latino, Not Hispanic or Latino, Unknown or not reported | Number | | | 1 | 6/10/2008 |
| Dosing Diary | FORMND | Check if form not completed | | Number | | | | 6/10/2008 |
| Dosing Diary | DOSSPID | Line Number | | Number | | | 1 | 6/10/2008 |
| Dosing Diary | DOSDT | Dosing Date for Dose 1 | | Date | | dd/mmm/yyyy | 1 | 6/10/2008 |
| Dosing Diary | DOS1TM | Dosing Time for Dose 1 | | Time | | 12 hour clock | 1 | 6/10/2008 |
| Dosing Diary | DOS1TMU | Dosing Time AM/PM for Dose 1 | | Number | | AM, PM | 1 | 6/10/2008 |
| Dosing Diary | DOS1PILL | Amount of Dose for Dose 1 | | Number | | | 1 | 6/10/2008 |
| Dosing Diary | DOS1NO | Dose Number | | Number | | | 1 | 6/10/2008 |
| Dosing Diary | DOS2TM | Dosing Time for Dose 2 | | Time | | 12 hour clock | 1 | 6/10/2008 |
| Dosing Diary | DOS2TMU | Dosing Time AM/PM for Dose 2 | | Number | | AM, PM | 1 | 6/10/2008 |
| Dosing Diary | DOS2PILL | Amount of Dose for Dose 2 | | Number | | | 1 | 6/10/2008 |
| Dosing Diary | DOS2NO | Dose Number | | Number | | | 1 | 6/10/2008 |
| Dosing Diary | DOS[N]TM | Dosing Time for Dose[N] | | Time | | 12 hour clock | 1 | 6/10/2008 |
| Dosing Diary | DOS[N]TMU | Dosing Time AM/PM for Dose [N] | | Number | | AM, PM | 1 | 6/10/2008 |
| Dosing Diary | DOS[N]PILL | Amount of Dose for Dose [N] | | Number | | | 1 | 6/10/2008 |
| Dosing Diary | DOS[N]NO | Dose Number | | Number | | | 1 | 6/10/2008 |
| Enrollment and Randomization | IEYN | Response for whether the subject was eligible for the study based on Inclusion and Exclusion criteria | Yes; No | Number | | | | 6/10/2008 |
| Enrollment and Randomization | ENROLLDT | Date enrolled | | Date | | dd/mmm/yyyy | | 6/10/2008 |
| Enrollment and Randomization | RANDYN | Was the subject randomized? | Yes; No | Number | | | | 6/10/2008 |
| Enrollment and Randomization | RANDDT | Date randomized | | Date | | dd/mmm/yyyy | | 6/10/2008 |
| Enrollment and Randomization | RANDNO | If eligible and not randomized, reason | Failed to return; Declined participate; Other | Number | | | | 6/10/2008 |
| Enrollment and Randomization | RANDNOX | If eligible and not randomized, reason other specify | | Text | 200 | | | 6/10/2008 |
| Enrollment and Randomization | FORMND | Form not completed | | Number | | | | 6/10/2008 |
| Inclusion Exclusion Criteria | INCLUS01 | Response for whether the subject met inclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | INCLUS02 | Response for whether the subject met inclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | INCLUS03 | Response for whether the subject met inclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | INCLUS04 | Response for whether the subject met inclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | INCLUS05 | Response for whether the subject met inclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | INCLUS06 | Response for whether the subject met inclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | EXCLUS01 | Response for whether the subject met exclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | EXCLUS02 | Response for whether the subject met exclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | EXCLUS03 | Response for whether the subject met exclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | EXCLUS04 | Response for whether the subject met exclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | EXCLUS05 | Response for whether the subject met exclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | EXCLUS06 | Response for whether the subject met exclusion requirements for this study | Yes, No | Number | | | 1 | 6/10/2008 |
| Inclusion Exclusion Criteria | IEYN | Response for whether the subject met the eligibility requirements for this study. | Yes, No | Number | | | 1 | 6/10/2008 |
| Lab Test Tracking | LBSPID | Line Number | | Number | | | 1 | 6/10/2008 |
| Lab Test Tracking | LBND | Check if no labs were collected for this patient | | Number | | | 1 | 6/10/2008 |
| Lab Test Tracking | LBSTAT | Check whether each Lab test is Done or Not Done | Done, Not Done | Number | | | 1 | 6/10/2008 |
| Lab Test Tracking | LBTEST | Name of test | Sodium, Potassium, Chloride and other lab tests | Text | 50 | | 1 | 6/10/2008 |
| Lab Test Tracking | LBREFID | Accession Number | | Text | 50 | | 1 | 6/10/2008 |
| Lab Test Tracking | LBDT | Lab collection Date | | Date | | dd/mmm/yyyy | 1 | 6/10/2008 |
| Lab Test Tracking | LBTM | Lab Collection Time | | Time | | 24 hour clock | 1 | 6/10/2008 |
| Lab Test Tracking | LBREASND | Comments if Not Done | | Text | 200 | | 1 | 6/10/2008 |
| Laboratory Results | LBSPID | Line Number | | Number | | | 1 | 6/10/2008 |
| Laboratory Results | LBTEST | Name of lab test | Sodium, potassium,and other lab tests | Text | 50 | | 1 | 6/10/2008 |
| Laboratory Results | LBDT | Date of Lab Collection | | Date | | dd/mmm/yyyy | 1 | 6/10/2008 |
| Laboratory Results | LBTM | Time of Lab Collection | | Time | | 24 hour clock | 1 | 6/10/2008 |
| Laboratory Results | LBORRES | Lab results | | Text | 50 | | 1 | 6/10/2008 |
| Laboratory Results | LBORRESU | Units of Lab Results | | Text | 50 | | 1 | 6/10/2008 |
| Laboratory Results | LBNRIND | Reference Range Indicator | Low, Normal or High | Number | | | 1 | 6/10/2008 |
| Laboratory Results | LBABCS | Clinical Significance | | Text | 200 | | 1 | 6/10/2008 |
| Laboratory Results | LBND | Check here is no labs were collected for this subject | | Number | | | | 6/10/2008 |
| Medical History | FORMND | Form not completed | | Number | | | | 6/10/2008 |
| Medical History | MHSPID | Line Number | | Number | | | 1 | 6/10/2008 |
| Medical History | MHCAT | Indicate the code the condition/disease affects. | 01 Head, Eye, Ear, Nose, Throat, 02 Respiratory, 03 Cardiovascular, 04 Gastrointestinal, 05 Genitourinary, 06 Musculoskeletal, 07 Neurological, 08 Endocrine/Metabolic, 09 Blood/Lymphatic, 10 Dermatologic, 11 Psychiatric, 12 Allergy, 91 Other | Number | | | 1 | 6/10/2008 |
| Medical History | MHCATX | Indicate the condition/Disease if the Code is Other | | Text | 100 | | 1 | 6/10/2008 |
| Medical History | MHTERM | Record all past and/or concomitant medical conditions or surgeries. | | Text | 100 | | 1 | 6/10/2008 |
| Medical History | MHSTDD | Day when the condition/disease started | | Text | 2 | dd | 1 | 6/10/2008 |
| Medical History | MHSTMM | Month of when the condition/disease started | | Text | 3 | mmm | 1 | 6/10/2008 |
| Medical History | MHSTYY | Year of when the condition/disease started | | Number | | yyyy | 1 | 6/10/2008 |
| Medical History | MHONG | Indicate if the condition/disease as being Current or Resolved. | Current, Resolved | Number | | | 1 | 6/10/2008 |
| Pharmacokinetic Blood Sampling | PCDT | Blood sampling date | | Date | | dd/mmm/yyyy | | 6/10/2008 |
| Pharmacokinetic Blood Sampling | PCTPTTM | Blood sampling proposed time | | Time | | 24 hour clock | | 6/10/2008 |
