ID

39068

Description

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the Slit lamp examination and biomicroscopy, indirect ophthalmoscopy and reflexes motility pressure form. All has to be filled in for screening, Day 1, all part visits, in case of early withdrawal and at follow-up (Months 3 and 6). Additionnaly it can be filled in as unscheduled form.

Link

https://clinicaltrials.gov/ct2/show/NCT00908037

Keywords

Versions (2)
  1. 10/21/19 10/21/19 -
  2. 11/26/19 11/26/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

November 26, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

English

Slit lamp examination and biomicroscopy, indirect ophthalmoscopy, reflexes motility pressure

1 forms  
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
Description

Day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit type
Description

If you tick "P1W24/EW", "P3W24/EW" or "P3W31/EW" please check in the following item if this is an early withdrawal.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Early withdrawal
Description

Early withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C2349954
Slit lamp examination
Description

Slit lamp examination

Alias
UMLS CUI-1
C0419360
Actual Date of Assessment
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985720
Eye side
Description

Fill in for both sides.

Data type

integer

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0441987
Finding of eye
Description

If you tick " Abnormal, not affecting vision, requiring treatment" or "Abnormal, affecting vision", please specify for both in the following items.

Data type

integer

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0243095
If eye finding Abnormal, not affecting vision but requiring treatment, please specify
Description

Eye finding Abnormal, not affecting vision but requiring treatment, specification

Data type

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0205161
UMLS CUI [1,4]
C0042789
UMLS CUI [1,5]
C0205307
UMLS CUI [1,6]
C1514873
UMLS CUI [1,7]
C0087111
UMLS CUI [1,8]
C2348235
If eye function Abnormal, affecting vision, please specify
Description

Eye function Abnormal, affecting vision, specification

Data type

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0542341
UMLS CUI [1,3]
C0205161
UMLS CUI [1,4]
C0392760
UMLS CUI [1,5]
C0042789
UMLS CUI [1,6]
C2348235
Cortical
Description

Cortical opacity

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C2938874
Nuclear
Description

Nuclear opacity

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C2938873
Posterior Subcapsular
Description

Posterior Subcapsular opacity

Data type

integer

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0423344
Slit lamp biomicroscopy of posterior pole features for each eye
Description

Slit lamp biomicroscopy of posterior pole features for each eye

Alias
UMLS CUI-1
C0419360
UMLS CUI-2
C0229092
Actual Date of Assessment
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985720
Eye side
Description

Fill in for both sides.

Data type

integer

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0441987
Finding of eye
Description

If you tick " Abnormal, not affecting vision, requiring treatment" or "Abnormal, affecting vision", please specify for both in the following items.

Data type

integer

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0243095
If eye finding Abnormal, not affecting vision but requiring treatment, please specify
Description

Eye finding Abnormal, not affecting vision but requiring treatment, specification

Data type

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0205161
UMLS CUI [1,4]
C0042789
UMLS CUI [1,5]
C0205307
UMLS CUI [1,6]
C1514873
UMLS CUI [1,7]
C0087111
UMLS CUI [1,8]
C2348235
If eye function Abnormal, affecting vision, please specify
Description

Eye function Abnormal, affecting vision, specification

Data type

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0542341
UMLS CUI [1,3]
C0205161
UMLS CUI [1,4]
C0392760
UMLS CUI [1,5]
C0042789
UMLS CUI [1,6]
C2348235
Indirect ophthalmoscopy
Description

Indirect ophthalmoscopy

Alias
UMLS CUI-1
C1444582
Actual Date of Assessment
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985720
Eye side
Description

Fill in for both sides.

Data type

integer

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0441987
Finding of eye
Description

If you tick " Abnormal, not affecting vision, requiring treatment" or "Abnormal, affecting vision", please specify for both in the following items.

Data type

integer

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0243095
If eye finding Abnormal, not affecting vision but requiring treatment, please specify
Description

Eye finding Abnormal, not affecting vision but requiring treatment, specification

Data type

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0205161
UMLS CUI [1,4]
C0042789
UMLS CUI [1,5]
C0205307
UMLS CUI [1,6]
C1514873
UMLS CUI [1,7]
C0087111
UMLS CUI [1,8]
C2348235
If eye function Abnormal, affecting vision, please specify
Description

Eye function Abnormal, affecting vision, specification

Data type

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0542341
UMLS CUI [1,3]
C0205161
UMLS CUI [1,4]
C0392760
UMLS CUI [1,5]
C0042789
UMLS CUI [1,6]
C2348235
Reflexes, Motility, Pressure
Description

Reflexes, Motility, Pressure

Alias
UMLS CUI-1
C0034929
UMLS CUI-2
C1510470
UMLS CUI-3
C0578862
Actual Date of Assessment
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985720
Eye side
Description

Fill in for both sides.

Data type

integer

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0441987
Pupil reflexes
Description

Pupil reflexes

Data type

integer

Alias
UMLS CUI [1]
C0034941
Visual fields to confrontation
Description

Visual fields to confrontation

Data type

integer

Alias
UMLS CUI [1]
C1444674
Motility
Description

Eye Motility

Data type

integer

Alias
UMLS CUI [1,1]
C1510470
UMLS CUI [1,2]
C0015392
Any other abnormalities
Description

Any other eye abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
Intraocular pressure
Description

Intraocular pressure

Data type

integer

Alias
UMLS CUI [1]
C0578862
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Similar models

Slit lamp examination and biomicroscopy, indirect ophthalmoscopy, reflexes motility pressure

1 forms
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
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
Day 1 (2)
CL Item
P1W1 (3)
CL Item
P1W2 (4)
CL Item
P1W3 (5)
CL Item
P1W4 (6)
CL Item
P1W5 (7)
CL Item
P1W6 (8)
CL Item
P1W7 (9)
CL Item
P1W8-23 (10)
CL Item
P1W24/EW (11)
CL Item
P2W1 (12)
CL Item
P2W2 (13)
CL Item
P2W3 (14)
CL Item
P2W4 (15)
CL Item
P2W5 (16)
CL Item
P2W6 (17)
CL Item
P2W7 (18)
CL Item
P3W8-23 (19)
CL Item
P3W8-30 (20)
CL Item
P3W24/EW (21)
CL Item
P3W31/EW (22)
CL Item
FUM3 (23)
CL Item
FUM6 (24)
CL Item
Unscheduled (25)
Early withdrawal
Item
Early withdrawal
boolean
C2349954 (UMLS CUI [1])
Item Group
Slit lamp examination
C0419360 (UMLS CUI-1)
Actual Date of Assessment
Item
Actual Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Eye side
integer
C0015392 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Eye site
Code List
Eye side
CL Item
Right Eye (OD) (1)
CL Item
Left Eye (OS) (2)
Item
Finding of eye
integer
C0015392 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Function of eye
Code List
Finding of eye
CL Item
Within normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment (3)
CL Item
Abnormal, affecting vision (4)
Eye finding Abnormal, not affecting vision but requiring treatment, specification
Item
If eye finding Abnormal, not affecting vision but requiring treatment, please specify
text
C0015392 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0042789 (UMLS CUI [1,4])
C0205307 (UMLS CUI [1,5])
C1514873 (UMLS CUI [1,6])
C0087111 (UMLS CUI [1,7])
C2348235 (UMLS CUI [1,8])
Eye function Abnormal, affecting vision, specification
Item
If eye function Abnormal, affecting vision, please specify
text
C0015392 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0042789 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
Item
Cortical
integer
C0419360 (UMLS CUI [1,1])
C2938874 (UMLS CUI [1,2])
Cortical
Code List
Cortical
CL Item
<1.0 (1)
CL Item
1.0 - 1.9 (2)
CL Item
2.0 - 2.9 (3)
CL Item
3.0 - 3.9 (4)
CL Item
4.0 or worse (5)
CL Item
Aphakia or pseudophakia (6)
CL Item
Unable to evaluate (7)
Item
Nuclear
integer
C0419360 (UMLS CUI [1,1])
C2938873 (UMLS CUI [1,2])
Cortical
Code List
Nuclear
CL Item
<1.0 (1)
CL Item
1.0 - 1.9 (2)
CL Item
2.0 - 2.9 (3)
CL Item
3.0 - 3.9 (4)
CL Item
4.0 or worse (5)
CL Item
Aphakia or pseudophakia (6)
CL Item
Unable to evaluate (7)
Item
Posterior Subcapsular
integer
C0419360 (UMLS CUI [1,1])
C0423344 (UMLS CUI [1,2])
Cortical
Code List
Posterior Subcapsular
CL Item
<1.0 (1)
CL Item
1.0 - 1.9 (2)
CL Item
2.0 - 2.9 (3)
CL Item
3.0 - 3.9 (4)
CL Item
4.0 or worse (5)
CL Item
Aphakia or pseudophakia (6)
CL Item
Unable to evaluate (7)
Item Group
Slit lamp biomicroscopy of posterior pole features for each eye
C0419360 (UMLS CUI-1)
C0229092 (UMLS CUI-2)
Actual Date of Assessment
Item
Actual Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Eye side
integer
C0015392 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Eye site
Code List
Eye side
CL Item
Right Eye (OD) (1)
CL Item
Left Eye (OS) (2)
Item
Finding of eye
integer
C0015392 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Function of eye
Code List
Finding of eye
CL Item
Within normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment (3)
CL Item
Abnormal, affecting vision (4)
Eye finding Abnormal, not affecting vision but requiring treatment, specification
Item
If eye finding Abnormal, not affecting vision but requiring treatment, please specify
text
C0015392 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0042789 (UMLS CUI [1,4])
C0205307 (UMLS CUI [1,5])
C1514873 (UMLS CUI [1,6])
C0087111 (UMLS CUI [1,7])
C2348235 (UMLS CUI [1,8])
Eye function Abnormal, affecting vision, specification
Item
If eye function Abnormal, affecting vision, please specify
text
C0015392 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0042789 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
Item Group
Indirect ophthalmoscopy
C1444582 (UMLS CUI-1)
Actual Date of Assessment
Item
Actual Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Eye side
integer
C0015392 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Eye site
Code List
Eye side
CL Item
Right Eye (OD) (1)
CL Item
Left Eye (OS) (2)
Item
Finding of eye
integer
C0015392 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Function of eye
Code List
Finding of eye
CL Item
Within normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment (3)
CL Item
Abnormal, affecting vision (4)
Eye finding Abnormal, not affecting vision but requiring treatment, specification
Item
If eye finding Abnormal, not affecting vision but requiring treatment, please specify
text
C0015392 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0042789 (UMLS CUI [1,4])
C0205307 (UMLS CUI [1,5])
C1514873 (UMLS CUI [1,6])
C0087111 (UMLS CUI [1,7])
C2348235 (UMLS CUI [1,8])
Eye function Abnormal, affecting vision, specification
Item
If eye function Abnormal, affecting vision, please specify
text
C0015392 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0042789 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
Item Group
Reflexes, Motility, Pressure
C0034929 (UMLS CUI-1)
C1510470 (UMLS CUI-2)
C0578862 (UMLS CUI-3)
Actual Date of Assessment
Item
Actual Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Eye side
integer
C0015392 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Eye site
Code List
Eye side
CL Item
Right Eye (OD) (1)
CL Item
Left Eye (OS) (2)
Item
Pupil reflexes
integer
C0034941 (UMLS CUI [1])
Pupil reflexes
Code List
Pupil reflexes
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Visual fields to confrontation
integer
C1444674 (UMLS CUI [1])
Pupil reflexes
Code List
Visual fields to confrontation
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Motility
integer
C1510470 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
Pupil reflexes
Code List
Motility
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Any other abnormalities
text
C0015392 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Any other abnormalities
Code List
Any other abnormalities
CL Item
No (N)
CL Item
Yes (Y)
Item
Intraocular pressure
integer
C0578862 (UMLS CUI [1])
Intraocular pressure
Code List
Intraocular pressure
CL Item
<=22 (1)
CL Item
>22 (2)
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