Informações:
Falhas:
ID
34808
Descrição
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
Palavras-chave
Versões (1)
- 30/01/2019 30/01/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
30 de janeiro de 2019
DOI
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Licença
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
Serious Adverse Event Form
- StudyEvent: ODM
Similar models
Serious Adverse Event Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (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])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event, Start Time
Item
Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
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])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, End Time
Item
End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Non-Serious Adverse Event, Frequencies
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
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])
C1704758 (UMLS CUI [1,2])
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])
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])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
C1710056 (UMLS CUI-2)
Item
Seriousness
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
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)
C1704791 (UMLS CUI-2)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
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)
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])
C0304229 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])
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)
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])
C0085978 (UMLS CUI [1,2])
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)
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])
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])
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])
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])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
Concomitant Agent, Medication name
Item
Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
Concomitant Agent, Medication dose
Item
Dose
integer
C2347852 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
Concomitant Agent, Unit
Item
Unit
text
C2347852 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,2])
Concomitant Agent, Frequencies
Item
Frequency
text
C2347852 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
Concomitant Agent, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
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])
C3146298 (UMLS CUI [1,2])
Item Group
Details of Investigational Product(s)
C0304229 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
C1522508 (UMLS CUI-2)
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])
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)
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])
C0220825 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item Group
Narrative Remarks
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
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])
C0947611 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Investigator’s name (print)
text
C2826892 (UMLS CUI [1])