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Treatment deferral Multiple Sclerosis ALAIN01 NCT02419378

1 forms  
Criteria for Treatment deferral
Description

Criteria for Treatment deferral

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0205421
Patient ID (derived)
Description

Patient ID (derived)

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Info
Description

Visit Info

Data type

text

Alias
UMLS CUI [1]
C0545082
Recent relapse of MS
Description

Recent relapse of MS

Data type

boolean

Alias
UMLS CUI [1,1]
C0856120
Recent vaccination ≤ 6 weeks
Description

Recent vaccination ≤ 6 weeks

Data type

boolean

Alias
UMLS CUI [1]
C0042196
Malignancy, except basal skin cell carcinoma
Description

Malignancy, except basal skin cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Known bleeding disorder (e.g., dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrands disease, DIC, fibrinogen deficiency, clotting factor deficiency)
Description

Known bleeding disorder (e.g., dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrands disease, DIC, fibrinogen deficiency, clotting factor deficiency)

Data type

boolean

Alias
UMLS CUI [1]
C3251812
Of childbearing potential with a positive urine or serum pregnancy test, pregnant, or lactating. A blood pregnancy test must have been performed within 3 days prior to the first treatment day. If performed on the same day, the result of a urine dipstick test may be used instead.
Description

Of childbearing potential with a positive urine or serum pregnancy test, pregnant, or lactating. A blood pregnancy test must have been performed within 3 days prior to the first treatment day. If performed on the same day, the result of a urine dipstick test may be used instead.

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety
Description

Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety

Data type

boolean

Alias
UMLS CUI [1]
C0442893
Most recent platelet count < the LLN of the evaluating laboratory, or patients with suspicion of incipient ITP
Description

Most recent platelet count < the LLN of the evaluating laboratory, or patients with suspicion of incipient ITP

Data type

boolean

Alias
UMLS CUI [1]
C0040034
CD4+, CD8+, or CD19+ ≤50 cells/microliter (ie, absolute CD3+CD4+, CD3+CD8+, or CD19+/mm3); if abnormal cell count(s) subsequently rises above 50, eligibility may be reassessed
Description

CD4+, CD8+, or CD19+ ≤50 cells/microliter (ie, absolute CD3+CD4+, CD3+CD8+, or CD19+/mm3); if abnormal cell count(s) subsequently rises above 50, eligibility may be reassessed

Data type

boolean

Neutrophil cell count ≤1000 cells/microliter; if abnormal cell count subsequently rises above 1000 cells/microliter, eligibility may be reassessed
Description

Neutrophil cell count ≤1000 cells/microliter; if abnormal cell count subsequently rises above 1000 cells/microliter, eligibility may be reassessed

Data type

boolean

Alias
UMLS CUI [1]
C0853697
Any other illness or infection (latent or active) that, in the Investigator’s opinion, could be exacerbated by alemtuzumab
Description

Any other illness or infection (latent or active) that, in the Investigator’s opinion, could be exacerbated by alemtuzumab

Data type

boolean

Alias
UMLS CUI [1]
C3843746
Treatment with immunosuppressive or antineoplastic drugs
Description

Treatment with immunosuppressive or antineoplastic drugs

Data type

text

Alias
UMLS CUI [1]
C0021081
Is the patient free of the above listed deferral criteria?
Description

Is the patient free of the above listed deferral criteria?

Data type

boolean

Comment Treatment deferral
Description

Comment Treatment deferral

Data type

text

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Similar models

Treatment deferral Multiple Sclerosis ALAIN01 NCT02419378

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Criteria for Treatment deferral
C0087111 (UMLS CUI-1)
C0205421 (UMLS CUI-2)
Patient ID (derived)
Item
Patient ID (derived)
text
C2348585 (UMLS CUI [1])
Visit
Item
Visit Info
text
C0545082 (UMLS CUI [1])
Multiple sclerosis relapse
Item
Recent relapse of MS
boolean
C0856120 (UMLS CUI [1,1])
Vaccination
Item
Recent vaccination ≤ 6 weeks
boolean
C0042196 (UMLS CUI [1])
Malignancy
Item
Malignancy, except basal skin cell carcinoma
boolean
C0006826 (UMLS CUI [1])
bleeding disorder
Item
Known bleeding disorder (e.g., dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrands disease, DIC, fibrinogen deficiency, clotting factor deficiency)
boolean
C3251812 (UMLS CUI [1])
Pregnant or lactating
Item
Of childbearing potential with a positive urine or serum pregnancy test, pregnant, or lactating. A blood pregnancy test must have been performed within 3 days prior to the first treatment day. If performed on the same day, the result of a urine dipstick test may be used instead.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Major systemic disease
Item
Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety
boolean
C0442893 (UMLS CUI [1])
Low platelet count
Item
Most recent platelet count < the LLN of the evaluating laboratory, or patients with suspicion of incipient ITP
boolean
C0040034 (UMLS CUI [1])
Low CD4, CD8 or CD 19
Item
CD4+, CD8+, or CD19+ ≤50 cells/microliter (ie, absolute CD3+CD4+, CD3+CD8+, or CD19+/mm3); if abnormal cell count(s) subsequently rises above 50, eligibility may be reassessed
boolean
Low Neutrophil cell count
Item
Neutrophil cell count ≤1000 cells/microliter; if abnormal cell count subsequently rises above 1000 cells/microliter, eligibility may be reassessed
boolean
C0853697 (UMLS CUI [1])
Other illness
Item
Any other illness or infection (latent or active) that, in the Investigator’s opinion, could be exacerbated by alemtuzumab
boolean
C3843746 (UMLS CUI [1])
Item
Treatment with immunosuppressive or antineoplastic drugs
text
C0021081 (UMLS CUI [1])
Criteria for Treatment Deferral: No 11 yes/no
Code List
Treatment with immunosuppressive or antineoplastic drugs
CL Item
yes (1)
CL Item
no (0)
No Criteria for Treatment Deferral
Item
Is the patient free of the above listed deferral criteria?
boolean
Comment Treatment deferral
Item
text
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