ID

11875

Beskrivning

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany

Länk

https://clinicaltrials.gov/ct2/show/NCT02419378

Nyckelord

  1. 2015-08-13 2015-08-13 - Martin Dugas
  2. 2016-05-28 2016-05-28 -
Uppladdad den

13 augusti 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Adverse Event Multiple Sclerosis ALAIN01 NCT02419378

Adverse Event Multiple Sclerosis ALAIN01 NCT02419378

Adverse Event
Beskrivning

Adverse Event

Alias
UMLS CUI-1
C0877248
AE: Sheet number
Beskrivning

AE: Sheet number

Datatyp

integer

AE: Signature date
Beskrivning

AE: Signature date

Datatyp

date

AE: Signature date Status
Beskrivning

AE: Signature date Status

Datatyp

text

AE: Signature Investigator
Beskrivning

AE: Signature Investigator

Datatyp

text

AE: Neue eForm
Beskrivning

AE: Neue eForm

Datatyp

text

Comment Adverse Event
Beskrivning

Comment Adverse Event

Datatyp

text

AERQG
Beskrivning

AERQG

AE: Number
Beskrivning

AE: Number

Datatyp

integer

Alias
UMLS CUI [1]
C2826275
AE: Term
Beskrivning

AE: Term

Datatyp

text

Alias
UMLS CUI [1]
C0877248
AE: Start date
Beskrivning

AE: Start date

Datatyp

date

Alias
UMLS CUI [1]
C2697888
AE: Start date Status
Beskrivning

AE: Start date Status

Datatyp

text

AE: Serious event
Beskrivning

AE: Serious event

Datatyp

text

Alias
UMLS CUI [1]
C1519255
AE: Toxicity (CTCAE) Grade
Beskrivning

AE: Toxicity (CTCAE) Grade

Datatyp

text

Alias
UMLS CUI [1]
C2985911
AE: Relationship to study treatment
Beskrivning

Adverse Event Attribution to Product or Procedure

Datatyp

text

Alias
UMLS CUI [1]
C1510821
AE: Action taken with study treatment
Beskrivning

AE: Action taken with study treatment

Datatyp

text

Alias
UMLS CUI [1]
C2981656
AE: End date
Beskrivning

AE: End date

Datatyp

date

Alias
UMLS CUI [1]
C2697886
AE: End date Status
Beskrivning

AE: End date Status

Datatyp

text

AE: Ongoing
Beskrivning

AE: Ongoing

Datatyp

text

Alias
UMLS CUI [1]
C2826663
AE: Outcome
Beskrivning

AE: Outcome

Datatyp

text

Alias
UMLS CUI [1]
C1705586

Similar models

Adverse Event Multiple Sclerosis ALAIN01 NCT02419378

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
AE: Sheet number
Item
integer
AE: Signature date
Item
date
Code List
AE: Signature date Status
CL Item
T (1)
CL Item
TM (2)
CL Item
M (3)
Code List
AE: Signature Investigator
CL Item
yes (1)
CL Item
no (0)
Code List
AE: Neue eForm
CL Item
yes (1)
Comment Adverse Event
Item
text
Item Group
Adverse Event Number
Item
AE: Number
integer
C2826275 (UMLS CUI [1])
Adverse Event
Item
AE: Term
text
C0877248 (UMLS CUI [1])
Adverse event start date
Item
AE: Start date
date
C2697888 (UMLS CUI [1])
Code List
AE: Start date Status
CL Item
T (1)
CL Item
TM (2)
CL Item
M (3)
Item
AE: Serious event
text
C1519255 (UMLS CUI [1])
Code List
AE: Serious event
CL Item
No - AE of Special Interest (AESI) (1)
CL Item
No (0)
CL Item
Yes (2)
Item
AE: Toxicity (CTCAE) Grade
text
C2985911 (UMLS CUI [1])
Code List
AE: Toxicity (CTCAE) Grade
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
0 (0)
Item
AE: Relationship to study treatment
text
C1510821 (UMLS CUI [1])
Code List
AE: Relationship to study treatment
CL Item
No reasonable possibility (0)
CL Item
Reasonable possibility (1)
Item
AE: Action taken with study treatment
text
C2981656 (UMLS CUI [1])
Code List
AE: Action taken with study treatment
CL Item
Dose not changed (0)
CL Item
Dose reduced (1)
CL Item
Dose increased (2)
CL Item
Drug withdrawn (3)
CL Item
Unknown (4)
CL Item
Not applicable (5)
Adverse event end date
Item
AE: End date
date
C2697886 (UMLS CUI [1])
Code List
AE: End date Status
CL Item
T (1)
CL Item
TM (2)
CL Item
M (3)
Item
AE: Ongoing
text
C2826663 (UMLS CUI [1])
Code List
AE: Ongoing
CL Item
yes (1)
Item
AE: Outcome
text
C1705586 (UMLS CUI [1])
Code List
AE: Outcome
CL Item
Recovered/Resolved (0)
CL Item
Recovering/Resolving (1)
CL Item
Not recovered/Not resolved (2)
CL Item
Recovered/Resolved with sequelae (3)
CL Item
Fatal (4)
CL Item
Unknown (5)

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