ID
39144
Beschrijving
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
Trefwoorden
Versies (2)
- 22-10-19 22-10-19 -
- 05-12-19 05-12-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 december 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Serious Adverse Event
- StudyEvent: ODM
Beschrijving
Type of report, SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0585733
Beschrijving
Randomisation
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C1519255
Beschrijving
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Beschrijving
In the original form this item is hidden.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C1519255
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C1140263
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C1140263
Beschrijving
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C1148348
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Beschrijving
This item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" item has been used.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beschrijving
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade or Intensity" item has been used Grade 5 is optional.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschrijving
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade" item has been used Grade 5 is optional.
Datatype
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
Beschrijving
Action Taken with Investigational Product(s) as a Result of the AE
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschrijving
Withdrawal as result of SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschrijving
Relationship between SAE and investigational product
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Beschrijving
In the original form this item is hidden.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschrijving
In the original form this item is hidden.
Datatype
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
Beschrijving
Relationship between SAE to study participation
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C2348568
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschrijving
Seriousness
Alias
- UMLS CUI-1
- C1710056
Beschrijving
Results in death
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Beschrijving
Life-threatening
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1517874
Beschrijving
Requires hospitalisation or prolongation of existing hospitalisation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0745041
Beschrijving
Results in disability/incapacity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Beschrijving
Congenital anomaly/birth defect
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0000768
Beschrijving
Other reason
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Beschrijving
Other reason, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Beschrijving
Laboratory abnormalities (except thrombocytopenia), ocular event
Datatype
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
Beschrijving
Relevant Concomitant/treatment medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0304229
Beschrijving
In the original form this item is hidden.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Beschrijving
(Trade Name preferred)
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Dose of medication
Datatype
float
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Unit of dosage
Datatype
text
Alias
- UMLS CUI [1]
- C2348328
Beschrijving
Frequency of medication
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Route of medication
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
day month year
Datatype
partialDate
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
If you tick No, please specify the End Date in the following item.
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
day month year
Datatype
partialDate
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Primary Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519255
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C2347852
- UMLS CUI [1,4]
- C1519255
Beschrijving
Drug Type
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0332307
Beschrijving
Relevant medical conditions/Risk factors
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Beschrijving
In the original form this item is hidden.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beschrijving
Specify past or current medical disorders, allergies, surgeries, family or social history that may help explain the SAE.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
In the original form this item is hidden.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C0262926
Beschrijving
day month year
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beschrijving
If you tick No, please specify the date of last occurrence in the following item.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beschrijving
day month year
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beschrijving
Relevant Medical History / Risk Factors not noted above
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0035648
Beschrijving
Relevant diagnostic results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
- UMLS CUI-3
- C1519255
Beschrijving
In the original form this item is hidden.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beschrijving
Test Name
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
day month year
Datatype
partialDate
Alias
- UMLS CUI [1]
- C2826247
Beschrijving
Test Result
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Test Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beschrijving
Normal Low Range
Datatype
float
Alias
- UMLS CUI [1]
- C1272773
Beschrijving
Normal High Range
Datatype
float
Alias
- UMLS CUI [1]
- C1299400
Beschrijving
Relevant diagnostic results not noted above
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Beschrijving
Investigational Products
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Recurrence of event after investigational product administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C1533734
Beschrijving
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1519255
Beschrijving
Non Clinical
Alias
- UMLS CUI-1
- C0205210
- UMLS CUI-2
- C1298908
Beschrijving
Incomplete SAE data to GSK
Datatype
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
Beschrijving
Receipt by GSK date
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Beschrijving
Serious event
Datatype
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschrijving
SAE Sequence Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
Version Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0333052
- UMLS CUI [1,3]
- C0237753
Beschrijving
Case ID
Datatype
text
Alias
- UMLS CUI [1,1]
- C0868928
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [1,3]
- C1519255
Beschrijving
Randomisation Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1519255
Beschrijving
OCEANS Code
Datatype
text
Alias
- UMLS CUI [1]
- C0805701
Beschrijving
Email Flag
Datatype
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])
C1519255 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0011065 (UMLS CUI [1,2])
C1517874 (UMLS CUI [1,2])
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])
C0456984 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
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])