ID
42301
Description
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
Keywords
Versions (2)
- 5/17/21 5/17/21 -
- 5/18/21 5/18/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 18, 2021
DOI
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License
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
Description
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Description
Non-Serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Non-Serious Adverse Event Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Description
Non-Serious Adverse Event Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1301880
Description
Non-Serious Adverse Event Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Description
Non-Serious Adverse Event End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Description
Non-Serious Adverse Event End Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Description
Non-Serious Adverse Event Frequency
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Description
Non-Serious Adverse Event Maximum Intensity
Data type
text
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C0806909
Description
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Data type
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Description
Did the subject withdraw from study as a result of this AE?
Data type
boolean
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2]
- C2349954
Description
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Data type
boolean
Alias
- UMLS CUI [1]
- C1518404
- UMLS CUI [2,1]
- C0013230
- UMLS CUI [2,2]
- C0439849
Description
Serious Adverse Event (Section 1)
Alias
- UMLS CUI-1
- C1519255
Description
Did the subject experience a serious adverse event during the study?
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Data type
boolean
Alias
- UMLS CUI [1]
- C0004398
- UMLS CUI [2]
- C1519255
Description
Serious Adverse Event (Section 1)
Alias
- UMLS CUI-1
- C1519255
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Description
Serious Adverse Event Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Description
Serious Adverse Event Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Event End date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Description
Serious Adverse Event End Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Description
Serious Adverse Event Maximum Intensity
Data type
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C0806909
Description
Action Taken with Investigational Product(s) as a Result of the SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Did the subject withdraw from study as a result of this SAE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Description
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2,1]
- C0013230
- UMLS CUI [2,2]
- C0439849
Description
Serious Adverse Event - Seriousness (Section 2)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Description
Check all that apply.
Data type
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
Description
Specify other reason considering this an SAE
Data type
text
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2,1]
- C0392360
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [3]
- C2348235
Description
Serious Adverse Event - Demography Data (Section 3)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C0011298
Description
Serious Adverse Event - Investigational Product
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C0304229
Description
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Data type
text
Alias
- UMLS CUI [1]
- C0304229
- UMLS CUI [2]
- C1519255
- UMLS CUI [3]
- C0034897
Description
Serious Adverse Event - Causes (Section 5)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
Description
Check all that apply
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2]
- C0205394
Description
Specify other cause of SAE
Data type
text
Alias
- UMLS CUI [1]
- C0085978
- UMLS CUI [2]
- C1519255
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C2348235
Description
Serious Adverse Event - RELEVANT Medical Conditions (Section 6)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0262926
Description
Specify any RELEVANT past or current medical disorders, allergies surgeries, etc. that can help explain the SAE
Data type
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0020517
- UMLS CUI [3]
- C0543467
- UMLS CUI [4]
- C1519255
Description
Medical condition - Date of Onset
Data type
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Description
Condition Present at Time of the SAE?
Data type
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1519255
Description
If condition not present at time of SAE, enter Date of Last Occurrence
Data type
date
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1519255
- UMLS CUI [3,1]
- C2745955
- UMLS CUI [3,2]
- C1517741
- UMLS CUI [3,3]
- C0011008
Description
Serious Adverse Event - Other RELEVANT Risk Factors (Section 7)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C0035648
- UMLS CUI-4
- C0205394
Description
Serious Adverse Event - Concomitant Medications (Section 8)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C2347852
Description
(Trade Name preferred)
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Drug Dose
Data type
float
Alias
- UMLS CUI [1]
- C0678766
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Medication Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Medication Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medication taken prior to study?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Medication Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Medication Stop Date
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Ongoing Medication?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Medication
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
Serious Adverse Event - Details of Investigational Product(s) (Section 9)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C0304229
- UMLS CUI-5
- C1522508
Description
Details of Investigational Product(s)
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1522508
Description
Was treatment blind broken at investigational Site?
Data type
text
Alias
- UMLS CUI [1]
- C3897431
Description
Serious Adverse Event - Details of RELEVANT Assessments (Section 10)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C0220825
- UMLS CUI-4
- C1522508
Description
Serious Adverse Event - Narrative Remarks (Section 11)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C0947611
Description
SAE - Investigator's signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Description
(confirming that the data on the SAE pages are accurate and complete)
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Serious Adverse Event (SAE) - Additional/ Follow-up Information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C1522577
- UMLS CUI-5
- C1524062
- UMLS CUI-7
- C1533716
Description
Investigator's Signature (SAE Follow-up)
Alias
- UMLS CUI-1
- C2346576
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Description
(confirming that the data on this page is accurate and complete)
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
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C1517741 (UMLS CUI [3,2])
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C1522508 (UMLS CUI [1,2])
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C0011008 (UMLS CUI [1,2])
C1522577 (UMLS CUI-3)
C1524062 (UMLS CUI-5)
C1533716 (UMLS CUI-7)
C1522577 (UMLS CUI [2])
C1524062 (UMLS CUI [3])
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