Informatie:
Fout:
ID
41098
Beschrijving
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
Trefwoorden
Versies (2)
- 22-06-20 22-06-20 -
- 23-06-20 23-06-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 juni 2020
DOI
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Licentie
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
Similar models
Serious Adverse Event; Serious Adverse Event (SAE) - Additional/ Follow-Up Information
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 a serious adverse event during the study?
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE) - Section 1
C1519255 (UMLS CUI-1)
Event
Item
Event
text
C1519255 (UMLS CUI [1])
SAE Start Date
Item
SAE Start Date
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
SAE Start Time
Item
SAE Start Time
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (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)
Item
SAE Maximum Intensity
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
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 [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
If fatal, was a post-mortem/autopsy performed
Item
If fatal, was a post-mortem/autopsy performed
boolean
C0004398 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Serious Adverse Event (SAE) - Section 2 (Seriousness)
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)
If other reason for considering this a SAE, specify
Item
If other reason for considering this a SAE, specify
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Serious Adverse Event (SAE) - Section 3 (Demography Data)
C1519255 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
C0011298 (UMLS CUI-2)
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 (SAE) - Section 4 (If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?)
C1519255 (UMLS CUI-1)
C0034897 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0457454 (UMLS CUI-4)
C0034897 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0457454 (UMLS CUI-4)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
integer
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,4])
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
Serious Adverse Event (SAE) - Section 5 (Possible Causes of SAE Other Than Investigational Product(s))
C1519255 (UMLS CUI-1)
C0085978 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0085978 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Item
Possible Causes of SAE Other Than Investigational Product(s)
integer
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Code List
Possible Causes of SAE Other Than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) specify (record in Section 6) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) specify (record in Section 8) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other, specify (7)
If other cause of SAE, specify
Item
If other cause of SAE, specify
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Serious Adverse Event (SAE) - Section 6 (Relevant Medical Conditions)
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0012634 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
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 [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
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 [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
If Condition was not present at Time of the SEA, enter Date of Last Occurence
Item
If Condition was not present at Time of the SEA, enter Date of Last Occurence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
Item Group
Serious Adverse Event (SAE) - Section 7 (Other relevant Risk Factors)
C1519255 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0035648 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Other Relevant Risk Factors
Item
Other Relevant Risk Factors
text
C0035648 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item Group
Serious Adverse Event (SAE) - Section 8 (Relevant Concomitant Medications)
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Medication Dose
Item
Medication Dose
float
C3174092 (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 (SAE) - Section 9 (Details of Investigational Product(s))
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0304229 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Investigational Product
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Date of Dose
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])
Dose
Item
Dose
text
C0304229 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
Item Group
Was treatment blind broken at investigational site?
C3897431 (UMLS CUI-1)
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 (1)
CL Item
No (2)
CL Item
Not applicable (X)
Item Group
Serious Adverse Event (SAE) - Section 10 (Details of relevant Assessments)
C1519255 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
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
Item
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])
C0431080 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
C0086715 (UMLS CUI [4])
C0431080 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
C0086715 (UMLS CUI [4])
Item Group
Serious Adverse Event (SAE) - Section 11 (Narrative Remarks)
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI-2)
Narrative Remarks
Item
Narrative Remarks
text
C0947611 (UMLS CUI [1])
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator’s name
Item
Investigator’s name
text
C2826892 (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])
Item Group
Serious Adverse Event (SAE) - Additional/ Follow-Up Information
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)
Serious Adverse Event (SAE) - Additional/ Follow-Up Information
Item
Serious Adverse Event (SAE) - Additional/ Follow-Up Information
text
C1519255 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C1533716 (UMLS CUI [1,4])
C1522577 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C1533716 (UMLS CUI [1,4])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator’s name
Item
Investigator’s name
text
C2826892 (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])