Study
Item
Study
text
C2603343 (UMLS CUI [1])
Subject
Item
Subject
text
C0681850 (UMLS CUI [1])
Collected by
Item
Collected by
text
C3244127 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Study Phase
Item
Study Phase
text
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Session
Item
Session
text
C1883017 (UMLS CUI [1])
Item
Did the patient complete the study as planned?
text
C0805732 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Code List
Did the patient complete the study as planned?
CL Item
Not applicable (X)
Item
If patient did not complete the study as planned, select the most appropriate category
integer
C0805732 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0683312 (UMLS CUI [2])
Code List
If patient did not complete the study as planned, select the most appropriate category
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion (7)
CL Item
Withdrew consent (8)
Comments on reason for withdrawal:
Item
Comments on reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Date of withdrawal
Item
Date of withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of withdrawal
Item
Time of withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Ethnicity- Physical Date
Item
Ethnicity- Physical Date
date
C0015031 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Ethnicity - Time
Item
Ethnicity - Time
time
C0015031 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Ethnicity - Day
Item
Ethnicity - Day
text
C0015031 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Ethnicity - Hour
Item
Ethnicity - Hour
integer
C0015031 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Ethnicity - Min
Item
Ethnicity - Min
integer
C0015031 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Liver Events - Physical Date
Item
Liver Events - Physical Date
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Liver Events - Time
Item
Liver Events - Time
time
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Liver Events - Day
Item
Liver Events - Day
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Liver Events - Hour
Item
Liver Events - Hour
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Liver Events - Min
Item
Liver Events - Min
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item
Have liver chemistry results exceeded protocol defined investigational product stopping criteria?
text
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Code List
Have liver chemistry results exceeded protocol defined investigational product stopping criteria?
CL Item
Not applicable (X)
Pregnancy Test - Physical Date
Item
Pregnancy Test - Physical Date
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pregnancy Test - Time
Item
Pregnancy Test - Time
time
C0032976 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Pregnancy Test - Day
Item
Pregnancy Test - Day
text
C0032976 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Pregnancy Test - Hour
Item
Pregnancy Test - Hour
integer
C0032976 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Pregnancy Test - Min
Item
Pregnancy Test - Min
integer
C0032976 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Date Pregnancy Test Performed
Item
Date Pregnancy Test Performed
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time Pregnancy Test Performed
Item
Time Pregnancy Test Performed
time
C0032976 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Sample Type
text
C2347029 (UMLS CUI [1])
Item
Pregnancy Test Result
text
C0427777 (UMLS CUI [1])
Code List
Pregnancy Test Result
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Partner Pregnancy Information - Physical Date
Item
Partner Pregnancy Information - Physical Date
date
C0919624 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Partner Pregnancy Information - Time
Item
Partner Pregnancy Information - Time
time
C0919624 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
Partner Pregnancy Information - Day
Item
Partner Pregnancy Information - Day
text
C0919624 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Partner Pregnancy Information - Hour
Item
Partner Pregnancy Information - Hour
integer
C0919624 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Partner Pregnancy Information - Min
Item
Partner Pregnancy Information - Min
integer
C0919624 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item
Did a female partner of a male volunteer become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,3])
C0919624 (UMLS CUI [1,4])
Code List
Did a female partner of a male volunteer become pregnant during the study?
CL Item
Not applicable (X)
Alcohol Breath Test - Physical Date
Item
Alcohol Breath Test - Physical Date
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Alcohol Breath Test - Time
Item
Alcohol Breath Test - Time
time
C0202306 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Alcohol Breath Test - Day
Item
Alcohol Breath Test - Day
text
C0202306 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Alcohol Breath Test - Hour
Item
Alcohol Breath Test - Hour
integer
C0202306 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Alcohol Breath Test - Min
Item
Alcohol Breath Test - Min
integer
C0202306 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Alcohol Breath Test - Date Test Performed
Item
Alcohol Breath Test - Date Test Performed
date
C0202306 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
Alcohol Breath Test - Time Test Performed
Item
Alcohol Breath Test - Time Test Performed
time
C0202306 (UMLS CUI [1,1])
C0429928 (UMLS CUI [1,2])
Item
Alcohol Breath Test - Result
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Alcohol Breath Test - Result
CL Item
Negative (Negative)
CL Item
Positive (Positive)
Drug Screen - Physical Date
Item
Drug Screen - Physical Date
date
C0373483 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Drug Screen - Time
Item
Drug Screen - Time
time
C0373483 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Drug Screen - Day
Item
Drug Screen - Day
text
C0373483 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Drug Screen - Hour
Item
Drug Screen - Hour
integer
C0373483 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Drug Screen - Min
Item
Drug Screen - Min
integer
C0373483 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Drug Screen - Date Test Performed
Item
Drug Screen - Date Test Performed
date
C0373483 (UMLS CUI [1,1])
C2826247 (UMLS CUI [1,2])
Drug Screen - Time Test Performed
Item
Drug Screen - Time Test Performed
time
C0373483 (UMLS CUI [1,1])
C0429928 (UMLS CUI [1,2])
Item
Were there any contra-indicated drugs detected
text
C1511790 (UMLS CUI [1,1])
C3845816 (UMLS CUI [1,2])
Code List
Were there any contra-indicated drugs detected
CL Item
Not applicable (X)
Drugs detected
Item
Drugs detected
text
C1511790 (UMLS CUI [1,1])
C3845816 (UMLS CUI [1,2])