ID

34808

Beschrijving

TEST StudyStudy ID: 102863 Clinical Study ID: 102863 Study Title: A randomized, open-label, two-period, period-balanced, crossover study with three parallel groups to evaluate the relative bioavailability of single oral doses of SB 497115-GR phase III tablets [50 mg, 75 mg, 100 mg] compared to SB-497115-GR phase II tablets [25 mg and 50 mg] in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Trade Name: Eltrombopag Study Indication: Thrombocytopenia

Trefwoorden

Versies (1)
  1. 30-01-19 30-01-19 -
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GlaxoSmithKline

Geüploaded op

30 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863

Engels

Serious Adverse Event Form

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Serious Adverse Event (SAE)
Beschrijving

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse events during the study?
Beschrijving

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Event
Beschrijving

Diagnosis Only (if known) Otherwise Sign/Symptom

Datatype

text

Alias
UMLS CUI [1]
C1519255
Start Date
Beschrijving

Serious Adverse Event, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
Start Time
Beschrijving

Serious Adverse Event, Start Time

Datatype

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Outcome
Beschrijving

Serious Adverse Event, Adverse Event Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date
Beschrijving

If fatal, record date of death.

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
End Time
Beschrijving

Serious Adverse Event, End Time

Datatype

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522314
Frequency
Beschrijving

Non-Serious Adverse Event, Frequencies

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
Beschrijving

Serious Adverse Event, Symptom Intensity, Maximum

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschrijving

Serious Adverse Event, Action Taken with Study Treatment

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
Did the subject withdraw from study as a result of this AE?
Beschrijving

Serious Adverse Event, Withdraw

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschrijving

Serious Adverse Event, Experimental drug, Causations

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0085978
Seriousness
Beschrijving

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness
Beschrijving

Serious Adverse Event, Seriousness of Adverse Event

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Demography Data
Beschrijving

Demography Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1704791
Date of birth
Beschrijving

Patient date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Gender

Datatype

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschrijving

Body Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschrijving

If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
UMLS CUI-3
C0034897
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Beschrijving

Serious Adverse Event, Experimental drug, Recurrence

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0034897
Possible Causes of SAE Other Than Investigational Product(s)
Beschrijving

Possible Causes of SAE Other Than Investigational Product(s)

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0085978
Possible Causes of SAE Other Than Investigational Product(s)
Beschrijving

Serious Adverse Events, Causations

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0085978
Relevant Medical Conditions
Beschrijving

Relevant Medical Conditions

Alias
UMLS CUI-1
C0012634
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Beschrijving

Disease, Hypersensitivity, Operative Surgical Procedures

Datatype

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0543467
Date of Onset
Beschrijving

Disease, Date of onset

Datatype

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Condition Present at Time of the SAE?
Beschrijving

Disease, Present, Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C1519255
If No, Date of Last Occurrence
Beschrijving

Disease, Occurrence, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C0011008
Other RELEVANT Risk Factors
Beschrijving

Other RELEVANT Risk Factors

Alias
UMLS CUI-1
C0035648
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Beschrijving

Risk Factors

Datatype

text

Alias
UMLS CUI [1]
C0035648
RELEVANT Concomitant Medications
Beschrijving

RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C2347852
Drug Name
Beschrijving

Concomitant Agent, Medication name

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Dose
Beschrijving

Concomitant Agent, Medication dose

Datatype

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3174092
Unit
Beschrijving

Concomitant Agent, Unit

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439148
Frequency
Beschrijving

Concomitant Agent, Frequencies

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439603
Route
Beschrijving

Concomitant Agent, Drug Administration Routes

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Taken Prior to Study?
Beschrijving

Concomitant Medication Previous Occurrence

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beschrijving

Concomitant Medication Start Date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Stop Date
Beschrijving

Concomitant Medication End Date

Datatype

date

Alias
UMLS CUI [1]
C2826744
Ongoing Medication?
Beschrijving

Concomitant Medication Ongoing

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschrijving

Concomitant Agent, Indication

Datatype

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3146298
Details of Investigational Product(s)
Beschrijving

Details of Investigational Product(s)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1522508
Investigator Product
Beschrijving

Experimental drug

Datatype

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beschrijving

Experimental drug, Dosage, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Details of RELEVANT Assessments
Beschrijving

Details of RELEVANT Assessments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0220825
UMLS CUI-3
C1522508
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
Beschrijving

Serious Adverse Event, Evaluation, Details

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1522508
Narrative Remarks
Beschrijving

Narrative Remarks

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Beschrijving

Serious Adverse Event, Comment

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Investigator Signature
Beschrijving

Investigator Signature

Alias
UMLS CUI-1
C2346576
Investigator’s signature (confirming that the data on the SAE pages are accurate and complete)
Beschrijving

Investigator Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

Investigator Signature, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator’s name (print)
Beschrijving

Investigator Name

Datatype

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Serious Adverse Event Form

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Did the subject experience a serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event
Item
Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event, Start Time
Item
Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/ Resolved  (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered/ Resolved with sequelae (4)
CL Item
Fatal (5)
Serious Adverse Event, End Date
Item
End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, End Time
Item
End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Non-Serious Adverse Event, Frequencies
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-Serious Adverse Event, Symptom Intensity, Maximum
Code List
Maximum Intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe  (3)
CL Item
Not Applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-Serious Adverse Event, Action Taken with Study Treatment
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased  (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted  (5)
CL Item
Not applicable (6)
Serious Adverse Event, Withdraw
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Experimental drug, Causations
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Seriousness of Adverse Event
Code List
Seriousness
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify (6)
Item Group
Demography Data
C1519255 (UMLS CUI-1)
C1704791 (UMLS CUI-2)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C0034897 (UMLS CUI-3)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Recurrence
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Possible Causes of SAE Other Than Investigational Product(s)
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s)
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Serious Adverse Events, Causations
Code List
Possible Causes of SAE Other Than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s), specify  (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s)  (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
Item Group
Relevant Medical Conditions
C0012634 (UMLS CUI-1)
Disease, Hypersensitivity, Operative Surgical Procedures
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Disease, Date of onset
Item
Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Disease, Present, Serious Adverse Event
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Disease, Occurrence, Date in time
Item
If No, Date of Last Occurrence
date
C0012634 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Other RELEVANT Risk Factors
C0035648 (UMLS CUI-1)
Risk Factors
Item
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
text
C0035648 (UMLS CUI [1])
Item Group
RELEVANT Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Agent, Medication name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Agent, Medication dose
Item
Dose
integer
C2347852 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Concomitant Agent, Unit
Item
Unit
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Concomitant Agent, Frequencies
Item
Frequency
text
C2347852 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Concomitant Agent, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Medication Previous Occurrence
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Start Date
date
C2826734 (UMLS CUI [1])
Concomitant Medication End Date
Item
Stop Date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Concomitant Agent, Indication
Item
Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Item Group
Details of Investigational Product(s)
C0304229 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Item
Investigator Product
text
C0304229 (UMLS CUI [1])
Experimental drug
Code List
Investigator Product
CL Item
A = Phase II 50 mg tablet (1)
CL Item
B = Phase III 50 mg tablet (2)
CL Item
C = Concomitant dosing of one Phase II 25 mg tablet AND one Phase II 50 mg tablet  (3)
CL Item
D = Phase III 75 mg tablet (4)
CL Item
E = Two Phase II 50 mg tablets (5)
CL Item
Phase III 100 mg tablet (F)
Experimental drug, Dosage, Date in time
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Details of RELEVANT Assessments
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Serious Adverse Event, Evaluation, Details
Item
Details of RELEVANT Assessments (provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range)
text
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item Group
Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator’s signature (confirming that the data on the SAE pages are accurate and complete)
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Investigator’s name (print)
text
C2826892 (UMLS CUI [1])
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