ID
41098
Descripción
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
Palabras clave
Versiones (2)
- 22/6/20 22/6/20 -
- 23/6/20 23/6/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
23 de junio de 2020
DOI
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Licencia
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
Descripción
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Descripción
Serious Adverse Event (SAE) - Section 1
Alias
- UMLS CUI-1
- C1519255
Descripción
Diagnosis Only (if known) Otherwise Sign/Symptom
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
SAE Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
Descripción
SAE Start Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1301880
Descripción
SAE Outcome
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Descripción
SAE Maximum Intensity
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Descripción
Action Taken with Investigational Product(s) as a Result of the SAE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Descripción
Did the subject withdraw from study as a result of this SAE?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Descripción
Is there a reasonable possibility the SAE may have been caused by the investigational product?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descripción
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1519255
Descripción
Serious Adverse Event (SAE) - Section 2 (Seriousness)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Descripción
(, check all that apply:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
Descripción
If other reason for considering this a SAE, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descripción
Serious Adverse Event (SAE) - Section 3 (Demography Data)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0011298
Descripción
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
Descripción
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0457454
Descripción
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
Descripción
Check all that apply
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0205394
Descripción
If other cause of SAE, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descripción
Serious Adverse Event (SAE) - Section 6 (Relevant Medical Conditions)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0262926
Descripción
Specify any RELEVANT past or current medical disorders, allergies surgeries, etc. that can help explain the SAE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Descripción
Medical Condition - Date of Onset
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Descripción
Condition Present at Time of the SAE?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
Descripción
If Condition was not present at Time of the SEA, enter Date of Last Occurence
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Descripción
Serious Adverse Event (SAE) - Section 7 (Other relevant Risk Factors)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C0205394
Descripción
Serious Adverse Event (SAE) - Section 8 (Relevant Concomitant Medications)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Descripción
(Trade Name preferred)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013227
Descripción
Medication Dose
Tipo de datos
float
Alias
- UMLS CUI [1]
- C3174092
Descripción
Medication Frequency
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3476109
Descripción
Medication Route
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013153
Descripción
Medication taken prior to study?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826667
Descripción
Medication Start Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826734
Descripción
Medication Stop Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826744
Descripción
Ongoing Medication?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2826666
Descripción
Reason for Medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826696
Descripción
Serious Adverse Event (SAE) - Section 9 (Details of Investigational Product(s))
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
- UMLS CUI-3
- C1522508
Descripción
Investigational Product
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0304229
Descripción
Date of Dose
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Descripción
Dose
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3174092
Descripción
Was treatment blind broken at investigational site?
Alias
- UMLS CUI-1
- C3897431
Descripción
Serious Adverse Event (SAE) - Section 10 (Details of relevant Assessments)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C1522508
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0431080
- UMLS CUI [2]
- C0022885
- UMLS CUI [3]
- C1519795
- UMLS CUI [4]
- C0086715
Descripción
Serious Adverse Event (SAE) - Section 11 (Narrative Remarks)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Descripción
Investigator’s signature
Alias
- UMLS CUI-1
- C2346576
Descripción
(confirming that the data on the SAE pages are accurate and complete)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator’s name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Investigator’s signature Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
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
Descripción
(use this page to provide any additional details on the SAE not already captured on the previous pages)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522577
- UMLS CUI [1,3]
- C1524062
- UMLS CUI [1,4]
- C1533716
Descripción
(confirming that the data on this page is accurate and complete)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator’s name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Investigator's Signature Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Serious Adverse Event; Serious Adverse Event (SAE) - Additional/ Follow-Up Information
C0019994 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1710056 (UMLS CUI-2)
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0011298 (UMLS CUI-2)
C0034897 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0457454 (UMLS CUI-4)
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
C0085978 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
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])
C1519255 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0205394 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0431080 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
C0086715 (UMLS CUI [4])
C0947611 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C1524062 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
C1522577 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C1533716 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])