ID
39144
Descripción
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
Palabras clave
Versiones (2)
- 22/10/19 22/10/19 -
- 5/12/19 5/12/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
5 de diciembre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Type of report, SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0585733
Descripción
Randomisation
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C1519255
Descripción
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Descripción
In the original form this item is hidden.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C1519255
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C1140263
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C1140263
Descripción
Diagnosis Only (if known) Otherwise Sign/Symptom
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C1148348
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Descripción
This item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" item has been used.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Descripción
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade or Intensity" item has been used Grade 5 is optional.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Descripción
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade" item has been used Grade 5 is optional.
Tipo de datos
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
Descripción
Action Taken with Investigational Product(s) as a Result of the AE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Descripción
Withdrawal as result of SAE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Descripción
Relationship between SAE and investigational product
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Descripción
In the original form this item is hidden.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Descripción
In the original form this item is hidden.
Tipo de datos
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
Descripción
Relationship between SAE to study participation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C2348568
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Descripción
Seriousness
Alias
- UMLS CUI-1
- C1710056
Descripción
Results in death
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Descripción
Life-threatening
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1517874
Descripción
Requires hospitalisation or prolongation of existing hospitalisation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0745041
Descripción
Results in disability/incapacity
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Descripción
Congenital anomaly/birth defect
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0000768
Descripción
Other reason
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Descripción
Other reason, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Descripción
Laboratory abnormalities (except thrombocytopenia), ocular event
Tipo de datos
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
Descripción
Relevant Concomitant/treatment medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0304229
Descripción
In the original form this item is hidden.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Descripción
(Trade Name preferred)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2360065
Descripción
Dose of medication
Tipo de datos
float
Alias
- UMLS CUI [1]
- C3174092
Descripción
Unit of dosage
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2348328
Descripción
Frequency of medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3476109
Descripción
Route of medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013153
Descripción
day month year
Tipo de datos
partialDate
Alias
- UMLS CUI [1]
- C2826734
Descripción
If you tick No, please specify the End Date in the following item.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826666
Descripción
day month year
Tipo de datos
partialDate
Alias
- UMLS CUI [1]
- C2826744
Descripción
Primary Indication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519255
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C2347852
- UMLS CUI [1,4]
- C1519255
Descripción
Drug Type
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0332307
Descripción
Relevant medical conditions/Risk factors
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Descripción
In the original form this item is hidden.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Descripción
Specify past or current medical disorders, allergies, surgeries, family or social history that may help explain the SAE.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Descripción
In the original form this item is hidden.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C0262926
Descripción
day month year
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Descripción
If you tick No, please specify the date of last occurrence in the following item.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Descripción
day month year
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Descripción
Relevant Medical History / Risk Factors not noted above
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0035648
Descripción
Relevant diagnostic results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
- UMLS CUI-3
- C1519255
Descripción
In the original form this item is hidden.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Descripción
Test Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0022885
Descripción
day month year
Tipo de datos
partialDate
Alias
- UMLS CUI [1]
- C2826247
Descripción
Test Result
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0587081
Descripción
Test Units
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Descripción
Normal Low Range
Tipo de datos
float
Alias
- UMLS CUI [1]
- C1272773
Descripción
Normal High Range
Tipo de datos
float
Alias
- UMLS CUI [1]
- C1299400
Descripción
Relevant diagnostic results not noted above
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Descripción
Investigational Products
Alias
- UMLS CUI-1
- C0304229
Descripción
Recurrence of event after investigational product administration
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C1533734
Descripción
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1519255
Descripción
Non Clinical
Alias
- UMLS CUI-1
- C0205210
- UMLS CUI-2
- C1298908
Descripción
Incomplete SAE data to GSK
Tipo de datos
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
Descripción
Receipt by GSK date
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Descripción
Serious event
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Descripción
SAE Sequence Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Descripción
Version Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0333052
- UMLS CUI [1,3]
- C0237753
Descripción
Case ID
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0868928
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [1,3]
- C1519255
Descripción
Randomisation Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1519255
Descripción
OCEANS Code
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0805701
Descripción
Email Flag
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013849
Similar models
Serious Adverse Event
- StudyEvent: ODM
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C1704685 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1148348 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
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C2348568 (UMLS CUI [1,3])
C0011065 (UMLS CUI [1,2])
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C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
C0231170 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0332300 (UMLS CUI [1,2])
C0040034 (UMLS CUI [1,3])
C1299003 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C2347852 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
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])
C0262926 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C0035648 (UMLS CUI [2,2])
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C2348184 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])
C2347796 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,2])