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ID
11875
Description
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
Link
https://clinicaltrials.gov/ct2/show/NCT02419378
Keywords
Versions (2)
- 8/13/15 8/13/15 - Martin Dugas
- 5/28/16 5/28/16 -
Uploaded on
August 13, 2015
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Adverse Event Multiple Sclerosis ALAIN01 NCT02419378
Adverse Event Multiple Sclerosis ALAIN01 NCT02419378
- StudyEvent: SE
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Adverse Event Multiple Sclerosis ALAIN01 NCT02419378
- StudyEvent: SE
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
AE: Sheet number
Item
integer
AE: Signature date
Item
date
CL Item
T (1)
CL Item
TM (2)
CL Item
M (3)
CL Item
yes (1)
CL Item
no (0)
CL Item
yes (1)
Comment Adverse Event
Item
text
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])
CL Item
T (1)
CL Item
TM (2)
CL Item
M (3)
CL Item
No - AE of Special Interest (AESI) (1)
CL Item
No (0)
CL Item
Yes (2)
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])
CL Item
No reasonable possibility (0)
CL Item
Reasonable possibility (1)
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Drug withdrawn (3)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])
CL Item
T (1)
CL Item
TM (2)
CL Item
M (3)
CL Item
yes (1)
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)