Information:
Fel:
ID
26096
Beskrivning
Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.
Nyckelord
Versioner (1)
- 2017-10-09 2017-10-09 -
Rättsinnehavare
Glaxo Smith Kline
Uppladdad den
9 oktober 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Main CRF
Similar models
Main CRF
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
lnvestigational Product Run-in
C0304229 (UMLS CUI-1)
C3274438 (UMLS CUI-2)
C3274438 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Investigator Identifier
Item
Investigator number
integer
C2826689 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Item
Morning Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,2])
CL Item
Day-1 (1)
CL Item
Day-2 (2)
CL Item
Day-3 (3)
CL Item
Day-4 (4)
CL Item
Day-5 (5)
CL Item
Day-6 (6)
CL Item
Day-7 (7)
CL Item
Day-8 (8)
CL Item
Day-9 (9)
CL Item
Day-10 (10)
CL Item
Day-11 (11)
CL Item
Day-12 (12)
CL Item
Day-13 (13)
CL Item
Day-14 (14)
CL Item
Day-15 (15)
CL Item
Day-16 (16)
Item
Evening Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,2])
CL Item
Day-1 (1)
CL Item
Day-2 (2)
CL Item
Day-3 (3)
CL Item
Day-4 (4)
CL Item
Day-5 (5)
CL Item
Day-6 (6)
CL Item
Day-7 (7)
CL Item
Day-8 (8)
CL Item
Day-9 (9)
CL Item
Day-10 (10)
CL Item
Day-11 (11)
CL Item
Day-12 (12)
CL Item
Day-13 (13)
CL Item
Day-14 (14)
CL Item
Day-15 (15)
CL Item
Day-16 (16)
Compliance behavior
Item
For each study day, transcribe from the Subject Diary Card into the table below, the date and time at which the subject took the study medication as well as the number of inhalations.
text
C1321605 (UMLS CUI [1])
Date of dose
Item
Date of dose
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Number of Inhalations Accuhaler
Item
Number of Inhalations Accuhaler
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
Number of Inhalations BADPI
Item
Number of Inhalations BADPI
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
significant changes to investigational product?
Item
Were there any significant changes to investigational product?
boolean
C3845681 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Specify Changes
Item
If YES, specify investigational product changes, dates, and reasons
text
C0443172 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Item Group
lnvestigational Product Treatment Period 1
C0304229 (UMLS CUI-1)
C3538994 (UMLS CUI-2)
C3538994 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Morning Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,2])
CL Item
Day-1 (1)
(Comment:en)
CL Item
Day-2 (2)
(Comment:en)
CL Item
Day-3 (3)
(Comment:en)
CL Item
Day-4 (4)
(Comment:en)
CL Item
Day-5 (5)
(Comment:en)
CL Item
Day-6 (6)
(Comment:en)
CL Item
Day-7 (7)
(Comment:en)
Item
Evening Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,2])
CL Item
Day-1 (1)
(Comment:en)
CL Item
Day-2 (2)
(Comment:en)
CL Item
Day-3 (3)
(Comment:en)
CL Item
Day-4 (4)
(Comment:en)
CL Item
Day-5 (5)
(Comment:en)
CL Item
Day-6 (6)
(Comment:en)
CL Item
Day-7 (7)
(Comment:en)
Compliance behavior
Item
For each study day, transcribe from the Subject Diary Card into the table below, the date and time at which the subject took the study medication as well as the number of inhalations.
text
C1321605 (UMLS CUI [1])
Date of dose
Item
Date of dose
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Number of Inhalations Accuhaler
Item
Number of Inhalations Accuhaler
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
Number of Inhalations BADPI
Item
Number of Inhalations BADPI
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
significant changes to investigational product?
Item
Were there any significant changes to investigational product?
boolean
C3845681 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Specify Changes
Item
If YES, specify investigational product changes, dates, and reasons
text
C0443172 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Item Group
lnvestigational Product Treatment Period 2
C0304229 (UMLS CUI-1)
C3538994 (UMLS CUI-2)
C3538994 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Morning Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,2])
CL Item
Day-1 (1)
(Comment:en)
CL Item
Day-2 (2)
(Comment:en)
CL Item
Day-3 (3)
(Comment:en)
CL Item
Day-4 (4)
(Comment:en)
CL Item
Day-5 (5)
(Comment:en)
CL Item
Day-6 (6)
(Comment:en)
CL Item
Day-7 (7)
(Comment:en)
Item
Evening Dose Day number
integer
C0013227 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,2])
CL Item
Day-1 (1)
(Comment:en)
CL Item
Day-2 (2)
(Comment:en)
CL Item
Day-3 (3)
(Comment:en)
CL Item
Day-4 (4)
(Comment:en)
CL Item
Day-5 (5)
(Comment:en)
CL Item
Day-6 (6)
(Comment:en)
CL Item
Day-7 (7)
(Comment:en)
Compliance behavior
Item
For each study day, transcribe from the Subject Diary Card into the table below, the date and time at which the subject took the study medication as well as the number of inhalations.
text
C1321605 (UMLS CUI [1])
Date of dose
Item
Date of dose
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Number of Inhalations Accuhaler
Item
Number of Inhalations Accuhaler
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
Number of Inhalations BADPI
Item
Number of Inhalations BADPI
integer
C0001559 (UMLS CUI [1,1])
C1705566 (UMLS CUI [1,2])
C1705566 (UMLS CUI [1,2])
significant changes to investigational product?
Item
Were there any significant changes to investigational product?
boolean
C3845681 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Specify Changes
Item
If YES, specify investigational product changes, dates, and reasons
text
C0443172 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Informed Consent
Item
Has informed consent been obtained for Pharmacogenetic Research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
Date informed consent obtained
Item
Date informed consent obtained for Pharmacogenetic Research
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Item
If NO, specify reason below
text
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,2])
CL Item
Subject declined (SD)
CL Item
Subject not asked by investigator (SI)
CL Item
Other (X)
Blood Sample Collection
Item
Has a blood sample been collected for Pharmacogenetic Research?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Withdrawal of Consent
Item
Has this subject withdrawn consent for Pharmacogenetic Research?
boolean
C1707492 (UMLS CUI [1])
Blood sample destruction
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
Item
If Yes, check one reason
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
CL Item
Subject requested (R)
CL Item
Screen failure (F)
CL Item
Other (X)
Concomitant medications during screening period
Item
Were any concomitant medications taken by the subject during the screening period?
boolean
C2347852 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,2])
Drug Name
Item
Drug (Trade name preferred)
text
C2347852 (UMLS CUI [1])
Medication Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
CL Item
Gram (G)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Microlitre (MCL)
CL Item
Milligram (MG)
CL Item
Millilitre (ML)
CL Item
Tablet (TAB)
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Date started
date
C2826734 (UMLS CUI [1])
Started Pre-Study
Item
Started Pre-Study
boolean
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
C0451613 (UMLS CUI [1,2])
Concomitant medication start time
Item
start time
time
C1301880 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Stop Date
Item
Concomitant Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication
Item
Medication continued post-study
boolean
C2826666 (UMLS CUI [1])
Concomitant medication end time
Item
Stop time
time
C1522314 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Condition treated/Indication
Item
Condition treated/Indication
text
C0392360 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Adverse event treatment
Item
Was drug administered for an adverse event?
boolean
C2981656 (UMLS CUI [1])
Rescue Medication
Item
Was drug administered as a rescue medication?
boolean
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
C0884980 (UMLS CUI [1,2])
Non-Serious Adverse Events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C0877248 (UMLS CUI [1])
Non-serious adverse events
Item
Event
text
C0877248 (UMLS CUI [1])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Time of onset
Item
Time of onset
time
C0449244 (UMLS CUI [1])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
CL Item
Resolved (R)
CL Item
Resolved with sequelae (S)
CL Item
Not resolved (N)
Date of resolution
Item
Date of resolution
date
C2985918 (UMLS CUI [1])
Time of resolution
Item
Time of resolution
time
C2826658 (UMLS CUI [1])
Item
Action taken with investigational product(s) as a result of the non-serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
None (0)
CL Item
Dose adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued (3)
CL Item
Not applicable (X)
Withdrawal
Item
Did subject withdraw from study as a result of this non-serious AE?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Relationship to Investigational Product
Item
Relationship to Investigational Product(s) Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
Seriousness
Item
Does the AE meet the definition of serious?
boolean
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
Investigator Identifier
Item
Investigator number
integer
C2826689 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Serious Adverse Events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
White (1)
CL Item
Black (2)
CL Item
Asian (3)
CL Item
Other (4)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Serious Adverse Events
Item
Event Diagnose only (if known) otherwise Sign/Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Onset Date
Item
Date of onset
date
C2985916 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
SAE onset time
Item
Time of onset
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
CL Item
Resolved (R)
CL Item
Resolved with Sequelae (S)
CL Item
Fatal (F)
CL Item
Not Resolved (N)
Date of resolution or death
Item
Date of resolution or death
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Time of resolution or death
Item
Time of resolution or death
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [2])
C2699488 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1301931 (UMLS CUI [2])
Withdrawal
Item
Did subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C3828190 (UMLS CUI [1])
Definition of Seriousness
Item
Does the AE meet the definition of serious?
boolean
C1704788 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
Item
Possible Causes of SAE Other Than lnvestigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
CL Item
Disease under study (1)
CL Item
Medical condition(s) (record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication (record in Section 8) (5)
CL Item
Activity related to study participation (e.g. , procedures) (6)
CL Item
Other, specify (7)
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other,please specify (F)
autopsy done
Item
If fatal was an autopsy done/to be performed?
boolean
C0004398 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
Medical conditions relevant to SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Onset Date
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Current Condition while SAE
Item
Condition Present at Time of the SAE?
boolean
C3827351 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Current Condition while SAE
Item
If NO, date of last occurrence
date
C3827351 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Other relevant risk factors
Item
Specify any family history or any social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE.
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Run-in Start date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Run-in Stop Date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Treatment Period 1 Start date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Treatment Period 1 Stop Date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Treatment Period 2 Start date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Details of lnvestigational Product(s)
Item
Treatment Period 2 Stop Date
date
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
RELEVANT Concomitant Medications
Item
RELEVANT Concomitant Medications
text
C2347852 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Drug name
Item
Drug name (Trade name preferred)
text
C2347852 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Medication Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency (e.g. BID)
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Medication Start Date
Item
Date Started
date
C2826734 (UMLS CUI [1])
Started Pre-Study
Item
Started Pre-Study
boolean
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
C0451613 (UMLS CUI [1,2])
Medication End Date
Item
Date Stopped
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Ongoing Medication
Item
Medication continued post-SAE
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Conditions treated/indication
text
C2826696 (UMLS CUI [1])
Comments
Item
Narrative/Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Assessments
Item
Details of RELEVANT Assessments
text
C0220825 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Reporting Investigator
Item
To the best of my knowledge, all information entered on these Serious Adverse Event pages for this subject is correct.
boolean
C0008961 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,2])
Investigator Name
Item
Name (print)
text
C2826892 (UMLS CUI [1])
Investigator Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
Investigator Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])
Additional or follow-up information
Item
Use this page to provide any additional details on the serious adverse event not already captured on the previous pages The appropriate section(s) (1-11) of SAE CRF must be amended/updated with any changes and re-faxed/mailed.
text
C1533716 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Investigator Name
Item
Name (print)
text
C2826892 (UMLS CUI [1])
Investigator Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
Investigator Signature
Item
Signature
text
C2346576 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])