ID
39144
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 SAE form. It has to be filled in if a SAE occurs during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Keywords
Versions (2)
- 10/22/19 10/22/19 -
- 12/5/19 12/5/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
December 5, 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
Serious Adverse Event
- StudyEvent: ODM
Description
Type of report, SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0585733
Description
Randomisation
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C1519255
Description
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Description
In the original form this item is hidden.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C1519255
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C1140263
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C1140263
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Description
If you tick "Recovered/Resolved"or "Recovered/Resolved with sequelae", provide End Date and Time in the following items. If you tick "Fatal", record Date of Death in the following item.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C1148348
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Description
This item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" item has been used.
Data type
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Description
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade or Intensity" item has been used Grade 5 is optional.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Description
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade" item has been used Grade 5 is optional.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C0806909
- UMLS CUI [2,3]
- C1519255
Description
Action Taken with Investigational Product(s) as a Result of the AE
Data type
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Withdrawal as result of SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Description
Relationship between SAE and investigational product
Data type
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Description
In the original form this item is hidden.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Description
In the original form this item is hidden.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0332162
- UMLS CUI [1,3]
- C0040223
- UMLS CUI [1,4]
- C3174092
- UMLS CUI [1,5]
- C1517741
Description
Relationship between SAE to study participation
Data type
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C2348568
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
Results in death
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Description
Life-threatening
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1517874
Description
Requires hospitalisation or prolongation of existing hospitalisation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0745041
Description
Results in disability/incapacity
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Description
Congenital anomaly/birth defect
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0000768
Description
Other reason
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Description
Other reason, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Description
Laboratory abnormalities (except thrombocytopenia), ocular event
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1853129
- UMLS CUI [1,2]
- C0332300
- UMLS CUI [1,3]
- C0040034
- UMLS CUI [2,1]
- C1299003
- UMLS CUI [2,2]
- C0877248
Description
Relevant Concomitant/treatment medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0304229
Description
In the original form this item is hidden.
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Description
(Trade Name preferred)
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Dose of medication
Data type
float
Alias
- UMLS CUI [1]
- C3174092
Description
Unit of dosage
Data type
text
Alias
- UMLS CUI [1]
- C2348328
Description
Frequency of medication
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route of medication
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
day month year
Data type
partialDate
Alias
- UMLS CUI [1]
- C2826734
Description
If you tick No, please specify the End Date in the following item.
Data type
text
Alias
- UMLS CUI [1]
- C2826666
Description
day month year
Data type
partialDate
Alias
- UMLS CUI [1]
- C2826744
Description
Primary Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519255
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C2347852
- UMLS CUI [1,4]
- C1519255
Description
Drug Type
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0332307
Description
Relevant medical conditions/Risk factors
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Description
In the original form this item is hidden.
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Description
Specify past or current medical disorders, allergies, surgeries, family or social history that may help explain the SAE.
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C0262926
Description
day month year
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Description
If you tick No, please specify the date of last occurrence in the following item.
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Description
day month year
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Description
Relevant Medical History / Risk Factors not noted above
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0035648
Description
Relevant diagnostic results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
- UMLS CUI-3
- C1519255
Description
In the original form this item is hidden.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Description
Test Name
Data type
text
Alias
- UMLS CUI [1]
- C0022885
Description
day month year
Data type
partialDate
Alias
- UMLS CUI [1]
- C2826247
Description
Test Result
Data type
text
Alias
- UMLS CUI [1]
- C0587081
Description
Test Units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Description
Normal Low Range
Data type
float
Alias
- UMLS CUI [1]
- C1272773
Description
Normal High Range
Data type
float
Alias
- UMLS CUI [1]
- C1299400
Description
Relevant diagnostic results not noted above
Data type
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Description
Investigational Products
Alias
- UMLS CUI-1
- C0304229
Description
Recurrence of event after investigational product administration
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C1533734
Description
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Description
Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1519255
Description
Non Clinical
Alias
- UMLS CUI-1
- C0205210
- UMLS CUI-2
- C1298908
Description
Incomplete SAE data to GSK
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519246
- UMLS CUI [1,2]
- C0205257
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1511726
- UMLS CUI [1,5]
- C2347796
Description
Receipt by GSK date
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Description
Serious event
Data type
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
SAE Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Version Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0333052
- UMLS CUI [1,3]
- C0237753
Description
Case ID
Data type
text
Alias
- UMLS CUI [1,1]
- C0868928
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [1,3]
- C1519255
Description
Randomisation Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1519255
Description
OCEANS Code
Data type
text
Alias
- UMLS CUI [1]
- C0805701
Description
Email Flag
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013849
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C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
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C1519255 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
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C0013849 (UMLS CUI [1,2])