ID

29571

Beschreibung

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains the "end of study" form (except for Adverse Events, see Form "Adverse Events").

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Stichworte

Versionen (1)
  1. 06.04.18 06.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

6. April 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

Englisch

End of Study

1 Formulare  
  1. StudyEvent: ODM
    1. End of Study
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer Identifier
Beschreibung

Volunteer Identifier

Datentyp

text

Alias
UMLS CUI [1]
C1300638
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Status of treatment blind
Beschreibung

Status of treatment blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken during the study?
Beschreibung

If yes, complete date, time and reason blind was broken.

Datentyp

text

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C0449438
Date blind broken
Beschreibung

If blind was broken.

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Time blind broken
Beschreibung

If blind was broken.

Datentyp

time

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0040223
Reason blind broken
Beschreibung

If blind was broken. If Z = other, please specify in item "other reason blind broken, specify". Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
other reason blind broken, specify
Beschreibung

other reason blind broken

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0947611
PGx-Pharmacogenetic Research
Beschreibung

PGx-Pharmacogenetic Research

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0008976
Has informed consent been obtained for PGx-Pharmacogenetic research?
Beschreibung

If yes, please give the date. If the question is answered No, pick one reason and do not complete the remainder of the page. should be completed at any time between Visits Screening and Follow-up

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
date informed consent obtained for PGx-Pharmacogenetic research
Beschreibung

If Yes in the item "consent for PGx-pharmacogenetic research", record the date informed consent obtained for PGx-Pharmacogenetic research

Datentyp

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
If no, pick one reason.
Beschreibung

if no in the item "consent for PGx-pharmacogenetic research", pick one reason. If Z = other, specify in the "other reason, specify" item.

Datentyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
other reason, specify
Beschreibung

If Z = other reason was picked in the item "Reason for no consent for pharmacogenetic research", please specify.

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C2347500
Has a blood sample been collected for PGx-pharmacogenetic research?
Beschreibung

If yes, record the date sample taken.

Datentyp

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031325
Blood sample collection date
Beschreibung

If a blood sample was taken for pharmacogenetic research.

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0031325
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beschreibung

Must be completed immediately, if the subject withdraws consent. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom informed consent was obtained for PGx-Pharmacogenetic research. If consent is withdrawn, a request for destruction must be made and Blood Sample Destruction section completed.

Datentyp

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
Has a request been made for sample destruction?
Beschreibung

Must be completed immediately if there is a request for sample destruction. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom a blood sample was obtained for PGx-Pharmacogenetic research. If the question is answered Yes, pic one reason.

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0031325
If yes, pick one reason.
Beschreibung

If yes in the item "blood sample destruction", please pick one reason. If Z = other reason, specify in the item "other reason for blood sample destruction".

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0031325
UMLS CUI [1,4]
C0392360
other reason for blood sample destruction, specify
Beschreibung

If Z = other reason in item "reason for blood sample destruction", specify.

Datentyp

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0031325
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C0947611
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Were any concomitant medications taken by the subject during the study?
Beschreibung

If Yes, fill in each item for each medication using Trade Names where possible.

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Drug Name
Beschreibung

Trade name preferred. Ensure that the spelling of the Drug Name(s) is correct.

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Unit Dose
Beschreibung

Unit Dose

Datentyp

float

Alias
UMLS CUI [1]
C2826811
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C2826646
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C2826654
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Reason for Medication
Beschreibung

Ensure that the ’Reason for Medication’ is recorded on one of the following pages using the same terms: * Current Medical Conditions * Non-Serious Adverse Events * Serious Adverse Events Form

Datentyp

text

Alias
UMLS CUI [1]
C2826696
Start Date
Beschreibung

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Start Time
Beschreibung

Start Time

Datentyp

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1301880
Taken prior to study?
Beschreibung

Check that either medication start date is completed or ’Taken Prior to Study?’ is ’Yes’. It is acceptable for start date to be missing if ’Taken Prior to Study?’ is ’Yes’. It is acceptable if ’Taken Prior to Study?’ is ’Yes’ and a start date is present, as long as the start date is prior to the date of the subject’s initial visit.

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1514463
Stop Date
Beschreibung

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Stop Time
Beschreibung

Stop Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C2347852
Ongoing Medication
Beschreibung

Check that either medication stop date is completed or ’Ongoing Medication?’ is ’Yes’. It is acceptable for stop date to be missing if ’Ongoing Medication?’ is ’Yes’.

Datentyp

text

Alias
UMLS CUI [1]
C2826666
Pregnancy Information
Beschreibung

Pregnancy Information

Alias
UMLS CUI-1
C0032961
Did the subject become pregnant during the study?
Beschreibung

If Yes, complete Pregnancy Notification form.

Datentyp

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of subject completion or withdrawal
Beschreibung

If subject completed study: "Date of subject completion or withdrawal" must match the last scheduled study visit date. If subject withdrew and a withdrawal visit was conducted: "Date of subject completion or withdrawal" must match the date of subject withdrawal. If subject lost to follow-up: "Date of subject completion or withdrawal" must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0805732
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0422727
Time of withdrawal
Beschreibung

Time of withdrawal

Datentyp

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Was the subject withdrawn from the study?
Beschreibung

If Yes, pick the primary reason for withdrawal in the item "Reason for withdrawal"

Datentyp

text

Alias
UMLS CUI [1]
C0422727
If Yes, pick the primary reason for withdrawal:
Beschreibung

If the investigational product was discontinued at the same time as the subject was withdrawn from the study, ensure the reasons for the two discontinuations are consistent. Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. If the subject was withdrawn due to an adverse event, confirm that details recorded correspond with details on the Adverse Event: * ’Withdrawal’ on the AE/SAE page is recorded as ’Yes’. * ’Action Taken with Investigational Product(s) as a Result of the Non-Serious AE/SAE’ on the AE/SAE page is recorded as ’Investigational Product Withdrawn’. * ’Primary Reason for Withdrawal’ on the Study Conclusion page is recorded as ’Adverse Event’. If Z = other is picked, please fill in the item "other reason for withdrawal"

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Other reason for withdrawal, specify
Beschreibung

Other Reason for withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Investigator Comment Log
Beschreibung

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF page number, if applicable
Beschreibung

CRF page number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Beschreibung

Only use this form to record explanatory information on anomalies such as missing data, sponsor waiver of inclusion/exclusion criteria, departures from planned investigational product administration or missed visits.

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Investigator's signature
Beschreibung

Investigator's signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Beschreibung

The Investigator is accountable for CRF data. However, the Principal Investigator may delegate CRF signature authority to a medically qualified Sub-investigator (as indicated on the Site Staff Signature Sheet).

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschreibung

Date of signature

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator's name (print)
Beschreibung

Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

End of Study

1 Formulare
  1. StudyEvent: ODM
    1. End of Study
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Status of treatment blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C2347038 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Status of treatment blind
Code List
Was the treatment blind broken during the study?
CL Item
yes (y)
CL Item
no (n)
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
Time blind broken
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergerncy requiring identification of investigational product for further treatment. (1)
CL Item
other (Z)
other reason blind broken
Item
other reason blind broken, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
PGx-Pharmacogenetic Research
C2347500 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Consent for PGx-pharmacogenetic research
Code List
Has informed consent been obtained for PGx-Pharmacogenetic research?
CL Item
yes (Y)
CL Item
no (N)
Date of consent for pharmacogenetic research
Item
date informed consent obtained for PGx-Pharmacogenetic research
date
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If no, pick one reason.
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for no consent for pharmacogenetic research
Code List
If no, pick one reason.
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
other reason (Z)
other reason, specify
Item
other reason, specify
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
text
C0005834 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Blood sample collection (DNA)
Code List
Has a blood sample been collected for PGx-pharmacogenetic research?
CL Item
yes (Y)
CL Item
no (N)
Blood sample collection date
Item
Blood sample collection date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
text
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Consent for PGx-pharmacogenetic research
Code List
Has subject withdrawn consent for PGx-Pharmacogenetic research?
CL Item
yes (Y)
CL Item
no (N)
Item
Has a request been made for sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
Consent for PGx-pharmacogenetic research
Code List
Has a request been made for sample destruction?
CL Item
yes (Y)
CL Item
no (N)
Item
If yes, pick one reason.
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Consent for PGx-pharmacogenetic research
Code List
If yes, pick one reason.
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
other reason (Z)
Item
other reason for blood sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0947611 (UMLS CUI [1,5])
Consent for PGx-pharmacogenetic research
Code List
other reason for blood sample destruction, specify
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1])
Consent for PGx-pharmacogenetic research
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
yes (Y)
CL Item
no (N)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Unit Dose
Item
Unit Dose
float
C2826811 (UMLS CUI [1])
Item
Units
text
C2826646 (UMLS CUI [1])
Unit Dose
Code List
Units
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Frequency
text
C2826654 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
1 x Daily (OD/QD)
CL Item
2 x Daily (BID)
CL Item
3 x Daily (TID)
CL Item
4 x Daily (QID)
CL Item
As required (PRN)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Start Time
Item
Start Time
time
C2347852 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Taken prior to study?
text
C2347852 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Taken prior to study?
Code List
Taken prior to study?
CL Item
yes (Y)
CL Item
no (N)
Stop Date
Item
Stop Date
date
C2826744 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Ongoing Medication
text
C2826666 (UMLS CUI [1])
Consent for PGx-pharmacogenetic research
Code List
Ongoing Medication
CL Item
yes (Y)
CL Item
no (N)
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Pregnancy during study
Code List
Did the subject become pregnant during the study?
CL Item
yes (Y)
CL Item
no (N)
CL Item
Not applicable (not of childbearing potential or male) (X)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C0805732 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
Time of withdrawal
Item
Time of withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Consent for PGx-pharmacogenetic research
Code List
Was the subject withdrawn from the study?
CL Item
yes (Y)
CL Item
no (N)
Item
If Yes, pick the primary reason for withdrawal:
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for withdrawal
Code List
If Yes, pick the primary reason for withdrawal:
CL Item
Adverse event (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
other (Z)
Other Reason for withdrawal
Item
Other reason for withdrawal, specify
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number
Item
CRF page number, if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
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