End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

Medications
Descripción

Medications

Alias
UMLS CUI-1
C0013227
Number of medication
Descripción

Number of medication

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0013227
Name of medication
Descripción

Name of medication

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Dose of Medication
Descripción

medication dose

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Start of therapy
Descripción

Start of therapy

Tipo de datos

date

Alias
UMLS CUI [1]
C1531783
Stop of therapy
Descripción

therapy Stop date

Tipo de datos

date

Alias
UMLS CUI [1]
C1531784
Ongoing
Descripción

Ongoing medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826666
Indication
Descripción

indication for medication

Tipo de datos

text

Alias
UMLS CUI [1]
C2826696
Adverse Events
Descripción

Adverse Events

Alias
UMLS CUI-1
C0877248
Number of Adverse Event
Descripción

Number of Adverse Event

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Description of Adverse Event
Descripción

Description of Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Start of treatment
Descripción

Start of treatment

Tipo de datos

date

Alias
UMLS CUI [1]
C1531783
End of treatment
Descripción

End of treatment

Tipo de datos

date

Alias
UMLS CUI [1]
C1531784
Intensity
Descripción

adverse event intensity

Tipo de datos

text

Alias
UMLS CUI [1]
C1710066
Related to the Study Medication
Descripción

Adverse event related to study treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1510821
Action taken with study medication
Descripción

Action taken with study medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1704758
Outcome
Descripción

Adverse event outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
Is the AE serious?
Descripción

is the adverse event serious

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Transfusion history during the entry study
Descripción

Transfusion history during the entry study

Alias
UMLS CUI-1
C1519604
Date of blood transfusion
Descripción

Date of blood transfusion

Tipo de datos

date

Unidades de medida
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1264703
YYYY-MM-DD
Number of units
Descripción

Number of units

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0449961
Any special events circumstances transfusion?
Descripción

Any special events circumstances transfusion?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1879316
if yes, please specify
Descripción

if yes, please specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1879316
Signature date
Descripción

Sub-Itemgroup: Investigator's signature

Tipo de datos

date

Alias
UMLS CUI [1]
C0807937
Investigator's signature
Descripción

Sub-Itemgroup: Investigator's signature

Tipo de datos

integer

Alias
UMLS CUI [1]
C2346576
Conclusion of the Study and Termination
Descripción

Conclusion of the Study and Termination

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Early Ending of the Study or Termination
Descripción

Early Ending of the Study or Termination

Tipo de datos

integer

Alias
UMLS CUI [1]
C2718058
If yes, study termination by?
Descripción

If yes, study termination by?

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348570
If yes, date of the Termination:
Descripción

If yes, date of the Termination:

Tipo de datos

date

Alias
UMLS CUI [1]
C2983670
If yes, reason for the study termination
Descripción

If yes, reason for the study termination

Tipo de datos

text

specify
Descripción

specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2348570
Comments on the patient
Descripción

Comments on the patient

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0030705
Investigator's name
Descripción

Investigators name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Stamp
Descripción

Stamp

Tipo de datos

text

Alias
UMLS CUI [1]
C0032755
Signature date
Descripción

Sub-Itemgroup: Investigator's signature

Tipo de datos

date

Alias
UMLS CUI [1]
C0807937
Investigator's signature
Descripción

Sub-Itemgroup: Investigator's signature

Tipo de datos

integer

Alias
UMLS CUI [1]
C2346576

Similar models

End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Medications
C0013227 (UMLS CUI-1)
Number of medication
Item
Number of medication
integer
C0237753 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Name of medication
Item
Name of medication
text
C0013227 (UMLS CUI [1])
medication dose
Item
Dose of Medication
float
C3174092 (UMLS CUI [1])
Start of therapy
Item
Start of therapy
date
C1531783 (UMLS CUI [1])
therapy Stop date
Item
Stop of therapy
date
C1531784 (UMLS CUI [1])
Ongoing medication
Item
Ongoing
boolean
C2826666 (UMLS CUI [1])
indication for medication
Item
Indication
text
C2826696 (UMLS CUI [1])
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Number of Adverse Event
Item
Number of Adverse Event
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description of Adverse Event
Item
Description of Adverse Event
text
C0877248 (UMLS CUI [1])
Start of treatment
Item
Start of treatment
date
C1531783 (UMLS CUI [1])
End of treatment
Item
End of treatment
date
C1531784 (UMLS CUI [1])
adverse event intensity
Item
Intensity
text
C1710066 (UMLS CUI [1])
Adverse event related to study treatment
Item
Related to the Study Medication
boolean
C1510821 (UMLS CUI [1])
Action taken with study medication
Item
Action taken with study medication
boolean
C1704758 (UMLS CUI [1])
Adverse event outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
is the adverse event serious
Item
Is the AE serious?
boolean
C1519255 (UMLS CUI [1])
Item Group
Transfusion history during the entry study
C1519604 (UMLS CUI-1)
Date of blood transfusion
Item
Date of blood transfusion
date
C1264703 (UMLS CUI [1])
Number of units
Item
Number of units
integer
C0086252 (UMLS CUI [1,1])
C0449961 (UMLS CUI [1,2])
Item
Any special events circumstances transfusion?
integer
C0877248 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
Code List
Any special events circumstances transfusion?
CL Item
no (0)
CL Item
yes (1)
if yes, please specify
Item
if yes, please specify
text
C0877248 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
Signature date
Item
Signature date
date
C0807937 (UMLS CUI [1])
Item
Investigator's signature
integer
C2346576 (UMLS CUI [1])
Code List
Investigator's signature
CL Item
no (0)
CL Item
yes (1)
Item Group
Conclusion of the Study and Termination
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Early Ending of the Study or Termination
integer
C2718058 (UMLS CUI [1])
Code List
Early Ending of the Study or Termination
CL Item
no (0)
CL Item
yes (1)
Item
If yes, study termination by?
integer
C2348570 (UMLS CUI [1])
Code List
If yes, study termination by?
CL Item
the physician (1)
CL Item
the patient (2)
If yes, date of the Termination:
Item
If yes, date of the Termination:
date
C2983670 (UMLS CUI [1])
If yes, reason for the study termination
Item
text
specify
Item
specify
text
C0566251 (UMLS CUI [1,1])
C2348570 (UMLS CUI [1,2])
Comments on the patient
Item
Comments on the patient
text
C0947611 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Investigators name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Stamp
Item
Stamp
text
C0032755 (UMLS CUI [1])
Signature date
Item
Signature date
date
C0807937 (UMLS CUI [1])
Item
Investigator's signature
integer
C2346576 (UMLS CUI [1])
Code List
Investigator's signature
CL Item
no (0)
CL Item
yes (1)