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Adverse Events (repeatable instrument)

13 Formulär  
  1. StudyEvent: PREBOT Pilot
    1. Visit 1: Enrollment and Randomization
    2. Visit 2: Endoscopic intervention
    3. Visit 3: Operation
    4. Visit 4: POD 3
    5. Visit 5: Day of discharge
    6. Visit 6: POD 30
    7. Visit 7: 3 months post OP/ premature discontinuation
    8. Signature
  2. StudyEvent: Complications
    1. Complications
  3. StudyEvent: Readmission To Hospital (repeatable instrument)
    1. Readmission To Hospital (repeatable instrument)
  4. StudyEvent: Adverse Events (repeatable instrument)
    1. Adverse Events (repeatable instrument)
  5. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  6. StudyEvent: Protocol Violation (repeatable instrument)
    1. Protocol Violation (repeatable instrument)
  7. StudyEvent: Patient report: EORTC QLQ-C30
  8. StudyEvent: Patient report: EORTC QLQ-PAN26
Adverse Events
Beskrivning

Adverse Events

Alias
UMLS CUI [1,1]
C0877248
AE Description
Beskrivning

Description

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
'Date of onset' completely available
Beskrivning

Date available

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C0205197
Date of onset AE
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0574845
Date of onset AE (month)
Beskrivning

month

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439231
Date of onset AE (year)
Beskrivning

year

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439234
Ongoing (at end of study)
Beskrivning

Ongoing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2826663
'Stop date' completely available
Beskrivning

Stop date available

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C0205197
Stop Date AE
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2697886
Stop date AE (month)
Beskrivning

month

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439231
Stop date AE (year)
Beskrivning

year

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439234
Serious Adverse Event
Beskrivning

SAE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
Intensity
Beskrivning

Intensity

Datatyp

integer

Alias
UMLS CUI [1,1]
C1710065
Relationship to BOTOX® injection (IMP)
Beskrivning

Relationship IMP

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700702
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C1514464
Relationship to endoscopy surgery
Beskrivning

Relationship endoscopy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0282493
UMLS CUI [1,2]
C1514464
Action taken with IMP
Beskrivning

Action IMP

Datatyp

integer

Alias
UMLS CUI [1,1]
C2826626
Countermeasures
Beskrivning

Countermeasures

Datatyp

integer

Alias
UMLS CUI [1,1]
C5419130
If others, please specify
Beskrivning

specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
Outcome
Beskrivning

Outcome

Datatyp

integer

Alias
UMLS CUI [1,1]
C1705586
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Similar models

Adverse Events (repeatable instrument)

13 Formulär
  1. StudyEvent: PREBOT Pilot
    1. Visit 1: Enrollment and Randomization
    2. Visit 2: Endoscopic intervention
    3. Visit 3: Operation
    4. Visit 4: POD 3
    5. Visit 5: Day of discharge
    6. Visit 6: POD 30
    7. Visit 7: 3 months post OP/ premature discontinuation
    8. Signature
  2. StudyEvent: Complications
    1. Complications
  3. StudyEvent: Readmission To Hospital (repeatable instrument)
    1. Readmission To Hospital (repeatable instrument)
  4. StudyEvent: Adverse Events (repeatable instrument)
    1. Adverse Events (repeatable instrument)
  5. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  6. StudyEvent: Protocol Violation (repeatable instrument)
    1. Protocol Violation (repeatable instrument)
  7. StudyEvent: Patient report: EORTC QLQ-C30
  8. StudyEvent: Patient report: EORTC QLQ-PAN26
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Adverse Events
C0877248 (UMLS CUI [1,1])
Description
Item
AE Description
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Date available
Item
'Date of onset' completely available
boolean
C2985916 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Date
Item
Date of onset AE
date
C0574845 (UMLS CUI [1,1])
Item
Date of onset AE (month)
integer
C0439231 (UMLS CUI [1,1])
CL.35
Code List
Date of onset AE (month)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
year
Item
Date of onset AE (year)
integer
C0439234 (UMLS CUI [1,1])
Ongoing
Item
Ongoing (at end of study)
boolean
C2826663 (UMLS CUI [1,1])
Stop date available
Item
'Stop date' completely available
boolean
C2697886 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Date
Item
Stop Date AE
date
C2697886 (UMLS CUI [1,1])
Item
Stop date AE (month)
integer
C0439231 (UMLS CUI [1,1])
CL.35
Code List
Stop date AE (month)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
year
Item
Stop date AE (year)
integer
C0439234 (UMLS CUI [1,1])
SAE
Item
Serious Adverse Event
boolean
C1519255 (UMLS CUI [1,1])
Item
Intensity
integer
C1710065 (UMLS CUI [1,1])
CL.36
Code List
Intensity
CL Item
mild (1)
C1513302 (UMLS CUI [1,1])
CL Item
moderate (2)
C1513374 (UMLS CUI [1,1])
CL Item
severe (3)
C1519275 (UMLS CUI [1,1])
Relationship IMP
Item
Relationship to BOTOX® injection (IMP)
boolean
C0700702 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C1514464 (UMLS CUI [1,3])
Relationship endoscopy
Item
Relationship to endoscopy surgery
boolean
C0282493 (UMLS CUI [1,1])
C1514464 (UMLS CUI [1,2])
Item
Action taken with IMP
integer
C2826626 (UMLS CUI [1,1])
CL.37
Code List
Action taken with IMP
CL Item
dose not changed (1)
C0178602 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
CL Item
injection withdrawn (2)
C1272883 (UMLS CUI [1,1])
C0424092 (UMLS CUI [1,2])
CL Item
injection temporarily interrupted (3)
C1272883 (UMLS CUI [1,1])
C0443239 (UMLS CUI [1,2])
CL Item
not applicable (4)
C1272460 (UMLS CUI [1,1])
Item
Countermeasures
integer
C5419130 (UMLS CUI [1,1])
CL.38
Code List
Countermeasures
CL Item
none (1)
C0549184 (UMLS CUI [1,1])
CL Item
drug treatment (2)
C4284232 (UMLS CUI [1,1])
CL Item
others (3)
C0205394 (UMLS CUI [1,1])
specify
Item
If others, please specify
text
C1521902 (UMLS CUI [1,1])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
CL.39
Code List
Outcome
CL Item
recovered / resolved completely (1)
CL Item
recovering / resolving (2)
CL Item
not recovered / not resolved (3)
CL Item
recovered / resolved with sequel (4)
CL Item
fatal (5)
CL Item
unknown (6)
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