ID

39941

Description

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Subject Diary Card form. It has to be filled in at day 2-13, day 15-20 and day 22-27.

Link

https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201

Keywords

Versions (2)
  1. 3/4/20 3/4/20 -
  2. 3/5/20 3/5/20 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

March 5, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201

English

Subject Diary Card

1 forms  
  1. StudyEvent: ODM
    1. Subject Diary Card
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit 3
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Time of Visit 3
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C1320304
Date of Visit 4
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Time of Visit 4
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C1320304
In case of emergency, please contact:
Description

In case of emergency, please contact:

Alias
UMLS CUI-1
C0013956
UMLS CUI-2
C0332158
Investigator
Description

Investigator

Data type

text

Alias
UMLS CUI [1]
C2826892
Study contact
Description

Study contact

Data type

text

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0008976
Telephone (daytime)
Description

Telephone (daytime)

Data type

integer

Alias
UMLS CUI [1,1]
C1515258
UMLS CUI [1,2]
C0332169
Telephone (evening/weekends)
Description

Telephone (evening/weekends)

Data type

integer

Alias
UMLS CUI [1,1]
C1515258
UMLS CUI [1,2]
C0587117
UMLS CUI [2,1]
C1515258
UMLS CUI [2,2]
C0680190
Address
Description

Address

Data type

text

Alias
UMLS CUI [1]
C1442065
Diary card
Description

Diary card

Alias
UMLS CUI-1
C3890583
Have you registered on the CF Questionnaire website?
Description

Note: Please complete the web based diary (questionnaire) daily in the evenings. Note: Day 1 will be dosed in the unit. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.

Data type

text

Alias
UMLS CUI [1,1]
C0010674
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C0159028
UMLS CUI [1,4]
C2349146
UMLS CUI [1,5]
C1514821
Study drug
Description

Study drug

Alias
UMLS CUI-1
C0304229
Dosing day
Description

Note: Do not take bronchodilator prior to clinic visit on Day 14, 21 and 28. Do not perform strenuous exercise 48 hr prior to visit on Day 14, 21 and 28.

Data type

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0304229
If other dosing day, please specify
Description

Other dosing day

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0439228
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0304229
Date of Dose
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
No. of Tablets from Bottle A
Description

e.g., 1. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0039225
UMLS CUI [1,3]
C0179376
No. of Tablets from Bottle B
Description

e.g., 1. Note: If you take dose differently to the scheduled dose (1 tablet from bottle A and 1 tablet from bottle B) you should contact the site immediately using the contact details on the cover page.

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0039225
UMLS CUI [1,3]
C0179376
Exacerbations
Description

Exacerbations

Alias
UMLS CUI-1
C4086268
Exacerbation event, record
Description

CF Exacerbation event, record.

Data type

integer

Alias
UMLS CUI [1,1]
C4086268
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C0332127
Date of Exacerbation Onset
Description

day month year. Note: If you have an exacerbation, immediately contact the site using the details above. Note: Record your individual symptoms in the itemgroup CHANGES IN HEALTH.

Data type

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C4086268
Time of Exacerbation Onset
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C0010674
UMLS CUI [1,3]
C4086268
Date of Exacerbation Resolution
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C0010674
UMLS CUI [1,4]
C4086268
Time of Exacerbation Resolution
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2699488
UMLS CUI [1,3]
C0010674
UMLS CUI [1,4]
C4086268
Were antibiotics prescribed for the exacerbation?
Description

If Yes, record each antibiotic in the itemgroup OTHER MEDICATIONS.

Data type

text

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0033080
UMLS CUI [1,3]
C0010674
UMLS CUI [1,4]
C4086268
Did the exacerbation require hospitalization?
Description

Exacerbation of CF requiring hospitalisation

Data type

text

Alias
UMLS CUI [1,1]
C0010674
UMLS CUI [1,2]
C4086268
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0019993
Other medications
Description

Other medications

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C0013227
Medication record
Description

Medication record

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332127
Drug Name
Description

e.g., Aspirin

Data type

text

Alias
UMLS CUI [1]
C0013227
Units
Description

e.g., Tablet

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0013227
Amount Taken
Description

Amount Taken of medication

Data type

integer

Alias
UMLS CUI [1,1]
C1265611
UMLS CUI [1,2]
C0013227
Reason for medication
Description

e.g., Headache

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Start Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1301880
Stop Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Stop Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1522314
Changes in health
Description

Changes in health

Alias
UMLS CUI-1
C0392747
UMLS CUI-2
C0018759
Changes in health, record.
Description

Changes in health, record.

Data type

integer

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0018759
UMLS CUI [1,3]
C0332127
Event
Description

Diagnosis Only (if known) Otherwise Sign/Symptom. e.g., Headache

Data type

text

Alias
UMLS CUI [1]
C0441471
Start Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0808070
Start Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1301880
Stop Date
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0806020
Stop Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1522314
Maximum intensity of event
Description

Maximum intensity of event

Data type

integer

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0518690
Daily Respiratory Symptom Diary for Cystic Fibrosis
Description

Daily Respiratory Symptom Diary for Cystic Fibrosis

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C1457887
UMLS CUI-3
C0010674
UMLS CUI-4
C0332173
Result of daily Respiratory Symptom Diary for Cystic Fibrosis
Description

This item contains the result of clinical outcome assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0010674
UMLS CUI [1,5]
C0332173
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Similar models

Subject Diary Card

1 forms
  1. StudyEvent: ODM
    1. Subject Diary Card
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit 3
Item
Date of Visit 3
date
C1320303 (UMLS CUI [1])
Time of Visit 3
Item
Time of Visit 3
time
C1320304 (UMLS CUI [1])
Date of Visit 4
Item
Date of Visit 4
date
C1320303 (UMLS CUI [1])
Time of Visit 4
Item
Time of Visit 4
time
C1320304 (UMLS CUI [1])
Item Group
In case of emergency, please contact:
C0013956 (UMLS CUI-1)
C0332158 (UMLS CUI-2)
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Study contact
Item
Study contact
text
C0332158 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Telephone (daytime)
Item
Telephone (daytime)
integer
C1515258 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
Telephone (evening/weekends)
Item
Telephone (evening/weekends)
integer
C1515258 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
C1515258 (UMLS CUI [2,1])
C0680190 (UMLS CUI [2,2])
Address
Item
Address
text
C1442065 (UMLS CUI [1])
Item Group
Diary card
C3890583 (UMLS CUI-1)
Item
Have you registered on the CF Questionnaire website?
text
C0010674 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
C2349146 (UMLS CUI [1,4])
C1514821 (UMLS CUI [1,5])
Web based cystic fibrosis symptoms diary
Code List
Have you registered on the CF Questionnaire website?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Study drug
C0304229 (UMLS CUI-1)
Item
Dosing day
integer
C0439228 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Dosing day
Code List
Dosing day
CL Item
Day 2 (1)
CL Item
Day 3 (2)
CL Item
Day 4 (3)
CL Item
Day 5 (4)
CL Item
Day 6 (5)
CL Item
Day 7 (6)
CL Item
Day 8 (7)
CL Item
Day 9 (8)
CL Item
Day 10 (9)
CL Item
Day 11 (10)
CL Item
Day 12 (11)
CL Item
Day 13 (12)
CL Item
Day 15 (13)
CL Item
Day 16 (14)
CL Item
Day 17 (15)
CL Item
Day 18 (16)
CL Item
Day 19 (17)
CL Item
Day 20 (18)
CL Item
Day 22 (19)
CL Item
Day 23 (20)
CL Item
Day 24 (21)
CL Item
Day 25 (22)
CL Item
Day 26 (23)
CL Item
Day 27 (24)
CL Item
Other (25)
Other dosing day
Item
If other dosing day, please specify
text
C0205394 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
No. of Tablets from Bottle A
Item
No. of Tablets from Bottle A
integer
C0237753 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0179376 (UMLS CUI [1,3])
No. of Tablets from Bottle B
Item
No. of Tablets from Bottle B
integer
C0237753 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0179376 (UMLS CUI [1,3])
Item Group
Exacerbations
C4086268 (UMLS CUI-1)
Item
Exacerbation event, record
integer
C4086268 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C0332127 (UMLS CUI [1,3])
CF Exacerbation event, record.
Code List
Exacerbation event, record
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
Date of Exacerbation of CF Onset
Item
Date of Exacerbation Onset
date
C0574845 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
Time of Exacerbation of CF Onset
Item
Time of Exacerbation Onset
time
C0449244 (UMLS CUI [1,1])
C0010674 (UMLS CUI [1,2])
C4086268 (UMLS CUI [1,3])
Date of Exacerbation of CF Resolution
Item
Date of Exacerbation Resolution
date
C0011008 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
Time of Exacerbation of CF Resolution
Item
Time of Exacerbation Resolution
time
C0040223 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
Item
Were antibiotics prescribed for the exacerbation?
text
C0003232 (UMLS CUI [1,1])
C0033080 (UMLS CUI [1,2])
C0010674 (UMLS CUI [1,3])
C4086268 (UMLS CUI [1,4])
Antibiotics prescription for exacerbation of CF
Code List
Were antibiotics prescribed for the exacerbation?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the exacerbation require hospitalization?
text
C0010674 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,4])
Antibiotics prescription for exacerbation of CF
Code List
Did the exacerbation require hospitalization?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Other medications
C0205394 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Item
Medication record
integer
C0013227 (UMLS CUI [1,1])
C0332127 (UMLS CUI [1,2])
Medication record
Code List
Medication record
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22 (22)
CL Item
23 (23)
CL Item
24 (24)
CL Item
25 (25)
CL Item
26 (26)
CL Item
27 (27)
CL Item
28 (28)
CL Item
29 (29)
CL Item
30 (30)
CL Item
31 (31)
CL Item
32 (32)
CL Item
33  (33)
CL Item
34 (34)
CL Item
35 (35)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41 (41)
CL Item
42 (42)
CL Item
43 (43)
CL Item
44 (44)
CL Item
45 (45)
CL Item
46 (46)
CL Item
47 (47)
CL Item
48 (48)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Units of medication
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Amount Taken of medication
Item
Amount Taken
integer
C1265611 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Reason for medication
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of medication
Item
Start Time
time
C0013227 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date of medication
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time of medication
Item
Stop Time
time
C0013227 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item Group
Changes in health
C0392747 (UMLS CUI-1)
C0018759 (UMLS CUI-2)
Item
Changes in health, record.
integer
C0392747 (UMLS CUI [1,1])
C0018759 (UMLS CUI [1,2])
C0332127 (UMLS CUI [1,3])
Changes in health, record.
Code List
Changes in health, record.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22 (22)
CL Item
23 (23)
CL Item
24 (24)
CL Item
25 (25)
CL Item
26 (26)
CL Item
27 (27)
CL Item
28 (28)
CL Item
29 (29)
CL Item
30 (30)
CL Item
31 (31)
CL Item
32 (32)
CL Item
33  (33)
CL Item
34 (34)
CL Item
35 (35)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41 (41)
CL Item
42 (42)
Event
Item
Event
text
C0441471 (UMLS CUI [1])
Start Date of event
Item
Start Date
date
C0441471 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of event
Item
Start Time
time
C0441471 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date of event
Item
Stop Date
date
C0441471 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time of event
Item
Stop Time
time
C0441471 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Maximum intensity of event
integer
C0441471 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Maximum intensity of event
Code List
Maximum intensity of event
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item Group
Daily Respiratory Symptom Diary for Cystic Fibrosis
C0034394 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0010674 (UMLS CUI-3)
C0332173 (UMLS CUI-4)
Result of daily Respiratory Symptom Diary for Cystic Fibrosis
Item
Result of daily Respiratory Symptom Diary for Cystic Fibrosis
text
C1274040 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0010674 (UMLS CUI [1,4])
C0332173 (UMLS CUI [1,5])
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