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Study conclusion

1 Formulär  
  1. StudyEvent: ODM
    1. Study conclusion
Study conclusion details
Beskrivning

Study conclusion details

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of subject completion or withdrawal
Beskrivning

Date of subject completion or withdrawal

Datatyp

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Beskrivning

Was the subject withdrawn from the study?

Datatyp

boolean

Alias
UMLS CUI [1]
C0422727
If YES, complete primary reason for withdrawal
Beskrivning

If YES, complete primary reason for withdrawal

Alias
UMLS CUI-1
C0422727
UMLS CUI-2
C0392360
1. Adverse event
Beskrivning

record details on AE or SAE forms as appropriate)

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
2. Lack of efficacy
Beskrivning

Check all that apply. If none, select "No Subreasons"

Datatyp

text

Alias
UMLS CUI [1]
C0235828
3. Protocol Deviation
Beskrivning

Check all that apply. If none, select "No Subreasons"

Datatyp

text

Alias
UMLS CUI [1]
C1705236
4. Subject reached protocol defined stopping criteria
Beskrivning

4. Subject reached protocol defined stopping criteria

Datatyp

text

Alias
UMLS CUI [1,1]
C2746065
UMLS CUI [1,2]
C0243161
5. Study closed/terminated
Beskrivning

5. Study closed/terminated

Datatyp

boolean

Alias
UMLS CUI [1]
C2348570
6. Lost to Follow-Up
Beskrivning

6. Lost to Follow-Up

Datatyp

boolean

Alias
UMLS CUI [1]
C1302313
7. Investigator discretion, specify
Beskrivning

Select this reason if none of the other primary reasons are appropriate

Datatyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C2348235
8. Withdrew consent, specify
Beskrivning

Select this reason if none of the other primary reasons are appropriate

Datatyp

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2348235
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Similar models

Study conclusion

1 Formulär
  1. StudyEvent: ODM
    1. Study conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Study conclusion details
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item Group
If YES, complete primary reason for withdrawal
C0422727 (UMLS CUI-1)
C0392360 (UMLS CUI-2)
1. Adverse event
Item
1. Adverse event
boolean
C0877248 (UMLS CUI [1])
Item
2. Lack of efficacy
text
C0235828 (UMLS CUI [1])
2. Lack of efficacy
Code List
2. Lack of efficacy
CL Item
No subreasons (1)
CL Item
Exacerbation (2)
Item
3. Protocol Deviation
text
C1705236 (UMLS CUI [1])
3. Protocol Deviation
Code List
3. Protocol Deviation
CL Item
No subreasons (1)
CL Item
Pregnancy (2)
CL Item
Lack of adherence (3)
CL Item
Prohibited medication use (4)
Item
4. Subject reached protocol defined stopping criteria
text
C2746065 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Subject reached protocol defined stopping criteria
Code List
4. Subject reached protocol defined stopping criteria
CL Item
Yes (1)
CL Item
No (2)
CL Item
Liver function test abnormality (3)
5. Study closed/terminated
Item
5. Study closed/terminated
boolean
C2348570 (UMLS CUI [1])
6. Lost to Follow-Up
Item
6. Lost to Follow-Up
boolean
C1302313 (UMLS CUI [1])
7. Investigator discretion, specify
Item
7. Investigator discretion, specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
8. Withdrew consent, specify
Item
8. Withdrew consent, specify
text
C1707492 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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