ID

39143

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 Concomitant medication form for documentation of any concomitant agents taken throughout the study. In case of concomitant medication affecting ocular health, the information about those medications should be given (additionally?) in a second version of this form concerning concomitant medication affecting ocular health.

Link

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

Keywords

  1. 10/23/19 10/23/19 -
  2. 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

Concomitant medication (all or affecting ocular health)

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Type of Concomitant Medication
Description

Type of Concomitant Medication

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332307
Concomitant medication
Description

Concomitant medication

Alias
UMLS CUI-1
C2347852
Sequence Number
Description

Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C2347852
Drug Name
Description

(Trade Name preferred)

Data type

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2826302
GSK Drug synonym
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0871468
GSK Drug Collection code
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1516698
UMLS CUI [1,3]
C0805701
Failed coding
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Unit Dose of medication
Description

Unit Dose

Data type

text

Alias
UMLS CUI [1,1]
C0869039
UMLS CUI [1,2]
C2347852
Units of medication
Description

Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency of medication
Description

Frequency

Data type

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Route of medication
Description

Not necessary for form about "concomitant medication affecting ocular health".

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Reason for Medication
Description

Not necessary for form about "concomitant medication affecting ocular health".

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2347852
Start Date
Description

day month year

Data type

partialDate

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0808070
Taken Prior to Study?
Description

Not necessary for form about "concomitant medication affecting ocular health".

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1883727
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2603343
Ongoing?
Description

If you tick No, please specify the End Date in the following item.

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
End Date of medication
Description

day month year

Data type

partialDate

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication Type
Description

Only for concomitant medication affecting ocular health version of this form. In the original this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332307

Similar models

Concomitant medication (all or affecting ocular health)

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])
Item
Type of Concomitant Medication
integer
C2347852 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Type of Concomitant Medication
CL Item
general (1)
CL Item
affecting ocular health (2)
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C2347852 (UMLS CUI [1,1])
C2826302 (UMLS CUI [1,2])
GSK Drug synonym
Item
GSK Drug synonym
text
C0008976 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
Drug Collection code
Item
GSK Drug Collection code
text
C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose of medication
text
C0869039 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
Units of medication
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Units of medication
CL Item
Gram (G)
CL Item
International units per kilogram (IU/KG)
CL Item
Microgram (MCG) (MCG)
CL Item
Microgram (UG) (UG)
CL Item
Microgram/kilogram (MCG/KG)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Milligram (MG)
CL Item
Milligram/kilogram (MG/KG)
CL Item
Milligram/metre squared (MG/M2)
CL Item
Unknown (UNK)
CL Item
Units (U)
CL Item
Actuation  (ACTU)
CL Item
Ampoule  (AMP)
CL Item
Application  (APP)
CL Item
Area under curve (AUC)
CL Item
Bottle  (BOT)
CL Item
Capsule  (CAP)
CL Item
Cubic centimeter  (CC)
CL Item
Cup (CUP)
CL Item
Gamma per kilogram per minute (GA/KG/MIN)
CL Item
Gram/kilogram (G/KG)
CL Item
Drops (GTT)
CL Item
100 International units/ml (100IU/ML)
CL Item
Inhalation (INH)
CL Item
International units (IU)
CL Item
International units per kilogram per hour (IU/KG/HR)
CL Item
International units per millilitre (IU/ML)
CL Item
Litre (L)
CL Item
Lozenge (LOZ)
CL Item
Litre per minute (L/MIN)
CL Item
Minimum alveolar concentration (MAC)
CL Item
Mega becquerels (MBq) (MBQ)
CL Item
Micrograms per hour (MCG/HR)
CL Item
Microgram/kilogram per minute (MCG/KG/MIN)
CL Item
Micrograms per millitre (MCG/ML)
CL Item
Microlitre (MCL)
CL Item
Milliequivalent (MEQ)
CL Item
Milliequivalent per 24 hours (MEQ/24HR)
CL Item
Milligram per day (MG/DAY)
CL Item
Milligram per hour (MG/HR)
CL Item
Milligram/kilogram per hour (MG/KG/HR)
CL Item
Milligram/kilogram per minute (MG/KG/MIN)
CL Item
Milligram/millilitre (MG/ML)
CL Item
Milligrams percent (MG%)
CL Item
Million international units (MIU)
CL Item
Millilitre (ML)
CL Item
Millilitre per hour (ML/HR)
CL Item
Millilitre per minute (ML/MIN)
CL Item
Millimole (MMOL)
CL Item
Megaunits (million units) (MU)
CL Item
Nebule (NEB)
CL Item
Ounce (OZ)
CL Item
Patch (PATCH)
CL Item
Percent (%)
CL Item
Puff (PUFF)
CL Item
Sachet (SACH)
CL Item
Spray (SPR)
CL Item
Suppository (SUPP)
CL Item
Tablet  (TAB)
CL Item
Tablespoon  (TBLSP)
CL Item
Teaspoon  (TSP)
CL Item
Units per hour (U/HR)
CL Item
Units per kilogram per minute (U/KG/MIN)
CL Item
Units per minute (U/MIN)
CL Item
Vial (VIAL)
Item
Frequency of medication
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Frequency of medication
CL Item
Unknown (UNK)
CL Item
2 times per week  (2XWK)
CL Item
3 times per week  (3XWK)
CL Item
4 times per week  (4XWK)
CL Item
5 times per day  (5XD)
CL Item
5 times per week  (5XWK)
CL Item
AC (AC)
CL Item
BID  (BID)
CL Item
HS (HS)
CL Item
Once daily (OD)
CL Item
Once only (ONE)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q12H (Q12H)
CL Item
Every 2 weeks (Q2WK)
CL Item
Q3D (Q3D)
CL Item
Every 3 months (Q3M)
CL Item
Every 3 weeks (Q3WK)
CL Item
Q4D (Q4D)
CL Item
Q4H (Q4H)
CL Item
Q6H (Q6H)
CL Item
Q8H (Q8H)
CL Item
QAM (QAM)
CL Item
QID (QID)
CL Item
Once a month (QM)
CL Item
Every other day (QOD)
CL Item
QPM (QPM)
CL Item
Once a week (QWK)
CL Item
TID (TID)
CL Item
Continuous infusion (CINF)
CL Item
Q2H (Q2H)
CL Item
QH (QH)
Item
Route of medication
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Route of medication
CL Item
Unknown  (UNK)
CL Item
Injection  (INJ)
CL Item
Intravenous  (IV)
CL Item
Other  (OTH)
CL Item
Oral  (PO)
CL Item
Subcutaneous  (SC)
CL Item
Epidural  (EP)
CL Item
Gastrostomy tube  (GTT)
CL Item
Intra-arterial  (IA)
CL Item
Intra-articular  (IART)
CL Item
Intra-bursa  (IB)
CL Item
Intradermal  (ID)
CL Item
Inhalation  (IH)
CL Item
Intralesional  (ILES)
CL Item
Intramuscular  (IM)
CL Item
Intranasal  (IN)
CL Item
Intraocular  (IO)
CL Item
Intraosteal  (IOS)
CL Item
Intraperitoneal  (IP)
CL Item
Intrathecal  (IT)
CL Item
Intrauterine  (IU)
CL Item
Nasogastric  (NG)
CL Item
Nasal  (NS)
CL Item
Right eye  (OD)
CL Item
Ophthalmic  (OP)
CL Item
Left eye  (OS)
CL Item
Otic  (OT)
CL Item
Both eyes  (OU)
CL Item
Rectal  (PR)
CL Item
Sublingual  (SL)
CL Item
Transdermal  (TD)
CL Item
Topical  (TP)
CL Item
Vaginal (VG)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Start Date of medication
Item
Start Date
partialDate
C2347852 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Taken Prior to Study?
text
C2347852 (UMLS CUI [1,1])
C1883727 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2603343 (UMLS CUI [1,4])
Code List
Taken Prior to Study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Ongoing?
text
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End Date
Item
End Date of medication
partialDate
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Type
Item
Medication Type
text
C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])

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