ID
41098
Description
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced
Keywords
Versions (2)
- 6/22/20 6/22/20 -
- 6/23/20 6/23/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 23, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447
Serious Adverse Event; Serious Adverse Event (SAE) - Additional/ Follow-Up Information
Description
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event (SAE) - Section 1
Alias
- UMLS CUI-1
- C1519255
Description
Diagnosis Only (if known) Otherwise Sign/Symptom
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
SAE Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Description
SAE Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Description
SAE Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
SAE Maximum Intensity
Data type
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
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 [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1519255
Description
Serious Adverse Event (SAE) - Section 2 (Seriousness)
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
If other reason for considering this a SAE, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Serious Adverse Event (SAE) - Section 3 (Demography Data)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0011298
Description
Serious Adverse Event (SAE) - Section 4 (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
- C0034897
- UMLS CUI-3
- C0304229
- UMLS CUI-4
- C0457454
Description
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0457454
Description
Serious Adverse Event (SAE) - Section 5 (Possible Causes of SAE Other Than Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0085978
- UMLS CUI-3
- C0304229
- UMLS CUI-4
- C0205394
Description
Check all that apply
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0205394
Description
If other cause of SAE, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Serious Adverse Event (SAE) - Section 6 (Relevant Medical Conditions)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- 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 [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- 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 [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Description
If Condition was not present at Time of the SEA, enter Date of Last Occurence
Data type
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Description
Serious Adverse Event (SAE) - Section 7 (Other relevant Risk Factors)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
Description
Serious Adverse Event (SAE) - Section 8 (Relevant Concomitant Medications)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Description
(Trade Name preferred)
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Medication Dose
Data type
float
Alias
- UMLS CUI [1]
- C3174092
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 (SAE) - Section 9 (Details of Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1522508
Description
Investigational Product
Data type
text
Alias
- UMLS CUI [1]
- C0304229
Description
Date of Dose
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
Dose
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3174092
Description
Was treatment blind broken at investigational site?
Alias
- UMLS CUI-1
- C3897431
Description
Serious Adverse Event (SAE) - Section 10 (Details of relevant Assessments)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C1522508
Description
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
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0431080
- UMLS CUI [2]
- C0022885
- UMLS CUI [3]
- C1519795
- UMLS CUI [4]
- C0086715
Description
Serious Adverse Event (SAE) - Section 11 (Narrative Remarks)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Description
Investigator’s signature
Alias
- UMLS CUI-1
- 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 name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator’s signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Serious Adverse Event (SAE) - Additional/ Follow-Up Information
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1522577
- UMLS CUI-3
- C1524062
- UMLS CUI-4
- C1533716
Description
(use this page to provide any additional details on the SAE not already captured on the previous pages)
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522577
- UMLS CUI [1,3]
- C1524062
- UMLS CUI [1,4]
- C1533716
Description
(confirming that the data on this page is accurate and complete)
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator’s name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator's Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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Serious Adverse Event; Serious Adverse Event (SAE) - Additional/ Follow-Up Information
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C1301880 (UMLS CUI [1,2])
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C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
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C0205394 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0012634 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
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C1522508 (UMLS CUI-3)
C0178602 (UMLS CUI [1,2])
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C0022885 (UMLS CUI [2])
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C1522577 (UMLS CUI [1,2])
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