ID
39144
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00908037
Nyckelord
Versioner (2)
- 2019-10-22 2019-10-22 -
- 2019-12-05 2019-12-05 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
5 december 2019
DOI
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Licens
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
Beskrivning
Type of report, SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0585733
Beskrivning
Randomisation
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C1519255
Beskrivning
Serious adverse events
Alias
- UMLS CUI-1
- C1519255
Beskrivning
In the original form this item is hidden.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C1519255
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C1140263
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C1140263
Beskrivning
Diagnosis Only (if known) Otherwise Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Beskrivning
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.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C1148348
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Beskrivning
This item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" item has been used.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Beskrivning
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade or Intensity" item has been used Grade 5 is optional.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beskrivning
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade" item has been used Grade 5 is optional.
Datatyp
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
Beskrivning
Action Taken with Investigational Product(s) as a Result of the AE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beskrivning
Withdrawal as result of SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beskrivning
Relationship between SAE and investigational product
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Beskrivning
In the original form this item is hidden.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beskrivning
In the original form this item is hidden.
Datatyp
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
Beskrivning
Relationship between SAE to study participation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C2348568
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beskrivning
Seriousness
Alias
- UMLS CUI-1
- C1710056
Beskrivning
Results in death
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011065
Beskrivning
Life-threatening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1517874
Beskrivning
Requires hospitalisation or prolongation of existing hospitalisation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0745041
Beskrivning
Results in disability/incapacity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Beskrivning
Congenital anomaly/birth defect
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0000768
Beskrivning
Other reason
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Beskrivning
Other reason, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Beskrivning
Laboratory abnormalities (except thrombocytopenia), ocular event
Datatyp
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
Beskrivning
Relevant Concomitant/treatment medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0304229
Beskrivning
In the original form this item is hidden.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1]
- C2360065
Beskrivning
Dose of medication
Datatyp
float
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Unit of dosage
Datatyp
text
Alias
- UMLS CUI [1]
- C2348328
Beskrivning
Frequency of medication
Datatyp
text
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Route of medication
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
day month year
Datatyp
partialDate
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
If you tick No, please specify the End Date in the following item.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
day month year
Datatyp
partialDate
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Primary Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519255
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C2347852
- UMLS CUI [1,4]
- C1519255
Beskrivning
Drug Type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0332307
Beskrivning
Relevant medical conditions/Risk factors
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Beskrivning
In the original form this item is hidden.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beskrivning
Specify past or current medical disorders, allergies, surgeries, family or social history that may help explain the SAE.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C0262926
Beskrivning
day month year
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Beskrivning
If you tick No, please specify the date of last occurrence in the following item.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beskrivning
day month year
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beskrivning
Relevant Medical History / Risk Factors not noted above
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0035648
Beskrivning
Relevant diagnostic results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0456984
- UMLS CUI-3
- C1519255
Beskrivning
In the original form this item is hidden.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beskrivning
Test Name
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
day month year
Datatyp
partialDate
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
Test Result
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Test Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beskrivning
Normal Low Range
Datatyp
float
Alias
- UMLS CUI [1]
- C1272773
Beskrivning
Normal High Range
Datatyp
float
Alias
- UMLS CUI [1]
- C1299400
Beskrivning
Relevant diagnostic results not noted above
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Beskrivning
Investigational Products
Alias
- UMLS CUI-1
- C0304229
Beskrivning
Recurrence of event after investigational product administration
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C1533734
Beskrivning
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C1519255
Beskrivning
Non Clinical
Alias
- UMLS CUI-1
- C0205210
- UMLS CUI-2
- C1298908
Beskrivning
Incomplete SAE data to GSK
Datatyp
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
Beskrivning
Receipt by GSK date
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Beskrivning
Serious event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beskrivning
SAE Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
Version Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0333052
- UMLS CUI [1,3]
- C0237753
Beskrivning
Case ID
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0868928
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [1,3]
- C1519255
Beskrivning
Randomisation Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1519255
Beskrivning
OCEANS Code
Datatyp
text
Alias
- UMLS CUI [1]
- C0805701
Beskrivning
Email Flag
Datatyp
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])