Study Conclusion

  1. StudyEvent: ODM
    1. Study Conclusion
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C1707478
Date of last contact
Description

Date last contact

Type de données

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Description

Patient withdrawn from trial

Type de données

boolean

Alias
UMLS CUI [1]
C0422727
Date of decision to withdraw
Description

Patient withdrawn from trial; Decision, Date in time

Type de données

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
Description

Patient withdrawn from trial; Indication

Type de données

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298

Similar models

Study Conclusion

  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Study Conclusion
C0008976 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Date last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Patient withdrawn from trial; Decision, Date in time
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Code List
Primary reason for withdrawal
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)
CL Item
Failure to complete PK portion of trial. (9)