Informações:
Falhas:
ID
42301
Descrição
Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases
Palavras-chave
Versões (2)
- 17/05/2021 17/05/2021 -
- 18/05/2021 18/05/2021 -
Titular dos direitos
GlaxoSmithKline
Transferido a
18 de maio de 2021
DOI
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Licença
Creative Commons BY 4.0
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Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812
Non-Serious Adverse Events; Serious Adverse Events; SAE Follow-up
Similar models
Non-Serious Adverse Events; Serious Adverse Events; SAE Follow-up
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Did the subject experience any non-serious adverse events during the study?
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Non-Serious Adverse Event Start Date
Item
Non-Serious Adverse Event Start Date
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event Start Time
Item
Non-Serious Adverse Event Start Time
time
C1518404 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Outcome
integer
C1518404 (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/Resolvedwith sequelae (4)
Non-Serious Adverse Event End Date
Item
Non-Serious Adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Non-Serious Adverse Event End Time
Item
Non-Serious Adverse Event End Time
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item
Non-Serious Adverse Event Frequency
integer
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,2])
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Non-Serious Adverse Event Maximum Intensity
text
C1518404 (UMLS CUI [1])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C1518404 (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 (X)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1518404 (UMLS CUI [1])
C2349954 (UMLS CUI [2])
C2349954 (UMLS CUI [2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
Item Group
Serious Adverse Event (Section 1)
C1519255 (UMLS CUI-1)
Did the subject experience a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
If fatal, was a post-mortem/autopsy performed
Item
If fatal, was a post-mortem/autopsy performed
boolean
C0004398 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
Item Group
Serious Adverse Event (Section 1)
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
Serious Adverse Event Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event Start Time
Item
Serious Adverse Event Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Item
Serious Adverse Event Outcome
integer
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
Serious Adverse Event End date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item
Serious Adverse Event Maximum Intensity
text
C1519255 (UMLS CUI [1])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
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 (X)
Did the subject withdraw from study as a result of this SAE?
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
Item Group
Serious Adverse Event - Seriousness (Section 2)
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
C1710056 (UMLS CUI-2)
Item
Specify reason(s) for considering this a SAE
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
CL Item
Other, specify (F)
Specify other reason considering this an SAE
Item
Specify other reason considering this an SAE
text
C1519255 (UMLS CUI [1])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3])
C0392360 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3])
Item Group
Serious Adverse Event - Demography Data (Section 3)
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-3)
C0011298 (UMLS CUI-3)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Serious Adverse Event - Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-3)
C0304229 (UMLS CUI-3)
Item
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
text
C0304229 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0034897 (UMLS CUI [3])
C1519255 (UMLS CUI [2])
C0034897 (UMLS CUI [3])
Code List
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown at this time (U)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Causes (Section 5)
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
C0085978 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [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) specify (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
Specify other cause of SAE
Item
Specify other cause of SAE
text
C0085978 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
C1519255 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item Group
Serious Adverse Event - RELEVANT Medical Conditions (Section 6)
C1519255 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0262926 (UMLS CUI-2)
Specify any RELEVANT past or current medical disorders, allergies surgeries, etc. that can help explain the SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0012634 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1519255 (UMLS CUI [4])
C0020517 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1519255 (UMLS CUI [4])
Medical condition - Date of Onset
Item
Medical condition - Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Condition Present at Time of the SAE?
Item
Condition Present at Time of the SAE?
boolean
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
If condition not present at time of SAE, enter Date of Last Occurrence
Item
If condition not present at time of SAE, enter Date of Last Occurrence
date
C0012634 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C2745955 (UMLS CUI [3,1])
C1517741 (UMLS CUI [3,2])
C0011008 (UMLS CUI [3,3])
C1519255 (UMLS CUI [2])
C2745955 (UMLS CUI [3,1])
C1517741 (UMLS CUI [3,2])
C0011008 (UMLS CUI [3,3])
Item Group
Serious Adverse Event - Other RELEVANT Risk Factors (Section 7)
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0035648 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Other RELEVANT Risk Factors
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
Item Group
Serious Adverse Event - Concomitant Medications (Section 8)
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
C2347852 (UMLS CUI-3)
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
Drug Dose
Item
Drug Dose
float
C0678766 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication taken prior to study?
Item
Medication taken prior to study?
boolean
C2826667 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C2826696 (UMLS CUI [1])
Item Group
Serious Adverse Event - Details of Investigational Product(s) (Section 9)
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-3)
C1522508 (UMLS CUI-5)
C0304229 (UMLS CUI-3)
C1522508 (UMLS CUI-5)
Details of Investigational Product(s)
Item
Details of Investigational Product(s)
text
C0304229 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational Site?
text
C3897431 (UMLS CUI [1])
Code List
Was treatment blind broken at investigational Site?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event - Details of RELEVANT Assessments (Section 10)
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
C0220825 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
Details of RELEVANT Assessments
Item
Details of RELEVANT Assessments
text
C0220825 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,2])
Item Group
Serious Adverse Event - Narrative Remarks (Section 11)
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-3)
C0947611 (UMLS CUI-3)
Narrative Remarks
Item
Narrative Remarks
text
C0947611 (UMLS CUI [1])
Item Group
SAE - Investigator's signature
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
C2346576 (UMLS CUI-2)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator's signature Date
Item
Investigator's signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE) - Additional/ Follow-up Information
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-3)
C1524062 (UMLS CUI-5)
C1533716 (UMLS CUI-7)
C1522577 (UMLS CUI-3)
C1524062 (UMLS CUI-5)
C1533716 (UMLS CUI-7)
Serious Adverse Event (SAE) - Additional/ Follow-up Information
Item
Serious Adverse Event (SAE) - Additional/ Follow-up Information
text
C1519255 (UMLS CUI [1])
C1522577 (UMLS CUI [2])
C1524062 (UMLS CUI [3])
C1533716 (UMLS CUI [4])
C1522577 (UMLS CUI [2])
C1524062 (UMLS CUI [3])
C1533716 (UMLS CUI [4])
Item Group
Investigator's Signature (SAE Follow-up)
C2346576 (UMLS CUI-1)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name
text
C2826892 (UMLS CUI [1])