End of Trial Medication Compliance Discontinuation Tobacco Use PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Trial Medication Compliance
Descrição

Trial Medication Compliance

Alias
UMLS CUI-1
C1321605
UMLS CUI-2
C0013227
1. Did the patient take at least 75% of each trial medication
Descrição

Patient take

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013227
2. If NO, which medication was the patient non compliant with (please indicate all that apply):
Descrição

In case of non-compliance to study medication, please remind the patient about medication intake requirements.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0457432
Discontinuation Of Trial Medication
Descrição

Discontinuation Of Trial Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0457454
3. Since the last visit did the patient discontinue trial medication?
Descrição

Discontinuation Of Trial Medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0457454
4. If YES, was this a permanent discontinuation?
Descrição

If the patient permanently discontinued one or more of the trial medications since the previous visit, please record detailed information on the Permanent Termination of Trial Medication page 48. Even if the patient has stopped all trial medication he/she should be encouraged to return for all remaining visits.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0205355
5. Discontinuation Of Trial Medication
Descrição

5. Discontinuation Of Trial Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0457454
5. If the patient had either an adverse event which led to temporary discontinuation of trial medication, or the patient temporarily discontinued study medication for any reason for > 28days, please record details below.
Descrição

Adverse Event Led to Discontinuation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0457454
Drug (1-ABC, 2-D, 3-ABCD)
Descrição

Drug

Tipo de dados

integer

Alias
UMLS CUI [1]
C0013227
Date Stopped (dd mon yy)
Descrição

Date Stopped

Tipo de dados

date

Alias
UMLS CUI [1]
C1531784
Date Restarted (mon dd yy)
Descrição

Date Restarted

Tipo de dados

date

Alias
UMLS CUI [1]
C3173309
Was trial medication temporarily stopped due to an Adverse Event?
Descrição

Trial Medication due to an Adverse Event

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1531784
If YES enter Adverse Event Name
Descrição

if Yes

Tipo de dados

text

Alias
UMLS CUI [1]
C0877248
Tobacco Use Status
Descrição

Tobacco Use Status

Alias
UMLS CUI-1
C0543414
UMLS CUI-2
C0449438
6. Has the patient smoked in the last week?
Descrição

Smoked Last Week

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C2987125
If the patient smoked cigarettes number of cigarettes per day
Descrição

Number of cigarettes per day

Tipo de dados

float

Alias
UMLS CUI [1]
C3694146

Similar models

End of Trial Medication Compliance Discontinuation Tobacco Use PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes NCT00153062

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Trial Medication Compliance
C1321605 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Patient take
Item
1. Did the patient take at least 75% of each trial medication
boolean
C0013227 (UMLS CUI [1])
Item
2. If NO, which medication was the patient non compliant with (please indicate all that apply):
integer
C0030705 (UMLS CUI [1,1])
C0457432 (UMLS CUI [1,2])
Code List
2. If NO, which medication was the patient non compliant with (please indicate all that apply):
CL Item
Bottle A (1)
CL Item
Bottle B (2)
CL Item
Blister card C (3)
CL Item
Blister card D (4)
Item Group
Discontinuation Of Trial Medication
C0013227 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Discontinuation Of Trial Medication
Item
3. Since the last visit did the patient discontinue trial medication?
boolean
C0013227 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
If YES
Item
4. If YES, was this a permanent discontinuation?
boolean
C0457454 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
Item Group
5. Discontinuation Of Trial Medication
C0013227 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Adverse Event Led to Discontinuation
Item
5. If the patient had either an adverse event which led to temporary discontinuation of trial medication, or the patient temporarily discontinued study medication for any reason for > 28days, please record details below.
text
C0877248 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Item
Drug (1-ABC, 2-D, 3-ABCD)
integer
C0013227 (UMLS CUI [1])
Code List
Drug (1-ABC, 2-D, 3-ABCD)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date Stopped
Item
Date Stopped (dd mon yy)
date
C1531784 (UMLS CUI [1])
Date Restarted
Item
Date Restarted (mon dd yy)
date
C3173309 (UMLS CUI [1])
Trial Medication due to an Adverse Event
Item
Was trial medication temporarily stopped due to an Adverse Event?
boolean
C0877248 (UMLS CUI [1,1])
C1531784 (UMLS CUI [1,2])
if Yes
Item
If YES enter Adverse Event Name
text
C0877248 (UMLS CUI [1])
Item Group
Tobacco Use Status
C0543414 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Smoked Last Week
Item
6. Has the patient smoked in the last week?
boolean
C0543414 (UMLS CUI [1,1])
C2987125 (UMLS CUI [1,2])
Number of cigarettes per day
Item
If the patient smoked cigarettes number of cigarettes per day
float
C3694146 (UMLS CUI [1])