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Adverse Events

12 Formulare  
  1. StudyEvent: combicare trial
    1. Screening
    2. Intervention
    3. POD 3
    4. POD 7
    5. POD 14 / Discharge
    6. POD 30
    7. POD 60/Discontinuation
    8. Signature
  2. StudyEvent: Readmission To Hospital
    1. Readmission To Hospital
  3. StudyEvent: Adverse Events
    1. Adverse Events
  4. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  5. StudyEvent: Protocol Violation
    1. Protocol violation
Adverse Events
Beschreibung

Adverse Events

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

Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
Is 'Date of onset AE' completely available?
Beschreibung

onset available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C0470187
Date of onset AE
Beschreibung

Date onset AE

Datentyp

date

Alias
UMLS CUI [1,1]
C2985916
Date of onset AE (month)
Beschreibung

month

Datentyp

text

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C0439231
Date of onset AE (year)
Beschreibung

year

Datentyp

integer

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C0439234
Ongoing (at end of study)
Beschreibung

Ongoing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826663
Is 'Stop Date AE' completely available?
Beschreibung

stop available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C2697886
Stop Date AE
Beschreibung

Stop Date AE

Datentyp

integer

Alias
UMLS CUI [1,1]
C2697886
Stop Date AE (month)
Beschreibung

month

Datentyp

text

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C0439231
Stop Date AE (year)
Beschreibung

year

Datentyp

integer

Alias
UMLS CUI [1,1]
C2697886
UMLS CUI [1,2]
C0439234
Serious Adverse Event
Beschreibung

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
Intensity
Beschreibung

Intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C1710066
Grading according to Clavien-Dindo
Beschreibung

Clavien-Dindo

Datentyp

text

Alias
UMLS CUI [1,1]
C5230447
Ongoing at time of hospital discharge
Beschreibung

Ongoing at discharge

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826663
UMLS CUI [1,2]
C0586003
Relationship to chemotherapy
Beschreibung

Relationship to chemotherapy

Datentyp

text

Alias
UMLS CUI [1,1]
C4528544
UMLS CUI [1,2]
C0392920
Relationship to surgery
Beschreibung

Relationship to surgery

Datentyp

text

Alias
UMLS CUI [1,1]
C4528544
UMLS CUI [1,2]
C0543467
Countermeasures
Beschreibung

Countermeasures

Datentyp

text

Alias
UMLS CUI [1,1]
C5419130
UMLS CUI [2,1]
C2981656
If others, please specify
Beschreibung

specify countermeasures

Datentyp

text

Alias
UMLS CUI [1,1]
C1521902
Outcome
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1705586
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Ähnliche Modelle

Adverse Events

12 Formulare
  1. StudyEvent: combicare trial
    1. Screening
    2. Intervention
    3. POD 3
    4. POD 7
    5. POD 14 / Discharge
    6. POD 30
    7. POD 60/Discontinuation
    8. Signature
  2. StudyEvent: Readmission To Hospital
    1. Readmission To Hospital
  3. StudyEvent: Adverse Events
    1. Adverse Events
  4. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  5. StudyEvent: Protocol Violation
    1. Protocol violation
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
onset available
Item
Is 'Date of onset AE' completely available?
boolean
C2985916 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
Date onset AE
Item
Date of onset AE
date
C2985916 (UMLS CUI [1,1])
Item
Date of onset AE (month)
text
C2985916 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
CL.7
Code List
Date of onset AE (month)
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
unknown (13)
year
Item
Date of onset AE (year)
integer
C2985916 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Ongoing
Item
Ongoing (at end of study)
boolean
C2826663 (UMLS CUI [1,1])
stop available
Item
Is 'Stop Date AE' completely available?
boolean
C0470187 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Stop Date AE
Item
Stop Date AE
integer
C2697886 (UMLS CUI [1,1])
Item
Stop Date AE (month)
text
C2697886 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
CL.7
Code List
Stop Date AE (month)
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
unknown (13)
year
Item
Stop Date AE (year)
integer
C2697886 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
boolean
C1519255 (UMLS CUI [1,1])
Item
Intensity
text
C1710066 (UMLS CUI [1,1])
CL.23
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)
C2919019 (UMLS CUI [1,1])
Item
Grading according to Clavien-Dindo
text
C5230447 (UMLS CUI [1,1])
CL.24
Code List
Grading according to Clavien-Dindo
CL Item
Grade I (1)
C0687695 (UMLS CUI [1,1])
CL Item
Grade II (2)
C0441802 (UMLS CUI [1,1])
CL Item
Grade IIIa (3)
C0585112 (UMLS CUI [1,1])
CL Item
Grade IIIb (4)
C0585113 (UMLS CUI [1,1])
CL Item
Grade IVa (5)
C0585115 (UMLS CUI [1,1])
CL Item
Grade IVb (6)
C0585116 (UMLS CUI [1,1])
CL Item
Grade V (7)
C0441804 (UMLS CUI [1,1])
Ongoing at discharge
Item
Ongoing at time of hospital discharge
boolean
C2826663 (UMLS CUI [1,1])
C0586003 (UMLS CUI [1,2])
Item
Relationship to chemotherapy
text
C4528544 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
CL.25
Code List
Relationship to chemotherapy
CL Item
definitely related (1)
C3899394 (UMLS CUI [1,1])
CL Item
probable (2)
C0750492 (UMLS CUI [1,1])
CL Item
possible (3)
C0332149 (UMLS CUI [1,1])
CL Item
unlikely (4)
C0750558 (UMLS CUI [1,1])
CL Item
not related (5)
C1546988 (UMLS CUI [1,1])
CL Item
not assessable (6)
C5453130 (UMLS CUI [1,1])
Item
Relationship to surgery
text
C4528544 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
CL.25
Code List
Relationship to surgery
CL Item
definitely related (1)
C3899394 (UMLS CUI [1,1])
CL Item
probable (2)
C0750492 (UMLS CUI [1,1])
CL Item
possible (3)
C0332149 (UMLS CUI [1,1])
CL Item
unlikely (4)
C0750558 (UMLS CUI [1,1])
CL Item
not related (5)
C1546988 (UMLS CUI [1,1])
CL Item
not assessable (6)
C5453130 (UMLS CUI [1,1])
Item
Countermeasures
text
C5419130 (UMLS CUI [1,1])
C2981656 (UMLS CUI [2,1])
CL.26
Code List
Countermeasures
CL Item
none (1)
C0549184 (UMLS CUI [1,1])
CL Item
drug treatment (2)
C0013216 (UMLS CUI [1,1])
CL Item
others (3)
C0205394 (UMLS CUI [1,1])
specify countermeasures
Item
If others, please specify
text
C1521902 (UMLS CUI [1,1])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
CL.27
Code List
Outcome
CL Item
recovered / resolved (1)
C1709863 (UMLS CUI [1,1])
CL Item
recovering / resolving (2)
C1709864 (UMLS CUI [1,1])
CL Item
not recovered / not resolved (3)
C1709277 (UMLS CUI [1,1])
CL Item
recovered / resolved with sequel (4)
C1709862 (UMLS CUI [1,1])
CL Item
fatal (5)
C1302234 (UMLS CUI [1,1])
CL Item
unknown (6)
C0439673 (UMLS CUI [1,1])
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