ID
40845
Descrição
Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Serious adverse event (SAE) Form has to be filled in whenever such events occur during the study.
Palavras-chave
Versões (1)
- 24/05/2020 24/05/2020 -
Titular dos direitos
GlaxoSmithKline
Transferido a
24 de maio de 2020
DOI
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Licença
Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933
Serious Adverse Event (SAE)
- StudyEvent: ODM
Descrição
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Descrição
DEFINITION OF A SERIOUS ADVERSE EVENT (SAE) (Page 1 of 5) A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death. b) is life-threatening. Note: The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c) requires hospitalisation or prolongation of existing hospitalisation. Note: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is ’serious’. When in doubt as to whether ’hospitalisation’ occurred or was necessary, the AE should be considered ’serious’. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity, or Note: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e) is a congenital anomaly/birth defect. f) other. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C1519255
Descrição
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1519255
Descrição
SECTION 1
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C1519255
Descrição
Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE. However, if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page.
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0011900
Descrição
Record the start date of the first occurrence of the SAE.
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Descrição
Record the start date of the first occurrence of the SAE.
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C1519255
Descrição
All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Descrição
Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Descrição
Record the end time of the SAE.
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Descrição
Record the maximum intensity that occurred over the duration of the event. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficiently discomforting to interfere with everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
Descrição
Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Descrição
Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’. If yes: Complete Study Conclusion page and check Adverse event as reason for withdrawal.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Descrição
It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C1519255
Descrição
SECTION 2: Seriousness
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C1710056
Descrição
SAE results in death
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C1519255
Descrição
SAE is life-threatening
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1517874
- UMLS CUI [1,2]
- C1519255
Descrição
SAE requires hospitalisation
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
Descrição
SAE results in disability/incapacity
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Descrição
SAE: Congenital anomaly/birth defect
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Descrição
SAE, other
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1880177
Descrição
(see definition of SAE)
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C3845569
- UMLS CUI [1,2]
- C1519255
Descrição
SECTION 3 Demography Data
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0011298
Descrição
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
- C0877248
- UMLS CUI-2
- C0034897
Descrição
Recurrence of the reported SAE in case of discontinuation of the investigational product
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C0457454
Descrição
SECTION 5 Possible Causes of SAE Other Than Investigational Product(s)
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0085978
- UMLS CUI-3
- C1710056
Descrição
Disease under study
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Descrição
(record in Section 6)
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0012634
Descrição
Lack of efficacy
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0235828
Descrição
Withdrawal of investigational product(s)
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
Descrição
(record in Section 8)
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C2347852
Descrição
Activity related to study participation
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C2348568
Descrição
Other, specify
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1521902
Descrição
SECTION 6 RELEVANT Medical Conditions
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1828479
Descrição
Relevant Medical Conditions
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Descrição
Date of onset
Tipo de dados
date
Alias
- UMLS CUI [1]
- C0574845
Descrição
Condition Present at Time of the SAE?
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [1,3]
- C0521116
Descrição
Date of Last Occurrence
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2745955
Descrição
SECTION 7 Other RELEVANT Risk Factors
Alias
- UMLS CUI-1
- C0035648
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C0205394
Descrição
SECTION 8 RELEVANT Concomitant Medications
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C2347852
Descrição
(Trade Name preferred)
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0013227
Descrição
Dose
Tipo de dados
float
Alias
- UMLS CUI [1]
- C3174092
Descrição
Unit
Tipo de dados
text
Alias
- UMLS CUI [1]
- C1519795
Descrição
Frequency
Tipo de dados
text
Alias
- UMLS CUI [1]
- C3476109
Descrição
Route
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0013153
Descrição
Taken Prior to Study?
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C2826667
Descrição
Start Date
Tipo de dados
date
Alias
- UMLS CUI [1]
- C0808070
Descrição
Stop Date
Tipo de dados
date
Alias
- UMLS CUI [1]
- C0806020
Descrição
Ongoing Medication?
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C2826666
Descrição
Reason for Medication
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Descrição
SECTION 9 Details of Investigational Product(s) - Treatment Period 1
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0013230
- UMLS CUI-3
- C1522508
Descrição
Infusion Start Date
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Descrição
Infusion Start Time
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Descrição
Infusion Stop Date
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Descrição
Infusion Stop Time
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
Descrição
IV Administration Casopitant Dose
Tipo de dados
float
Unidades de medida
- mg
Alias
- UMLS CUI [1,1]
- C1522726
- UMLS CUI [1,2]
- C2347566
- UMLS CUI [1,3]
- C3174092
Descrição
SECTION 9 Details of Investigational Product(s) - Treatment Period 2
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0013230
- UMLS CUI-3
- C1522508
Descrição
Date of Dose
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Descrição
Time of Dose
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Descrição
Oral Administration Casopitant Dose
Tipo de dados
float
Unidades de medida
- mg
Alias
- UMLS CUI [1,1]
- C1527415
- UMLS CUI [1,2]
- C2347566
- UMLS CUI [1,3]
- C3174092
Descrição
SECTION 10 Details of relevant Assessments
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0011900
- UMLS CUI-3
- C1519255
Descrição
SECTION 11 Narrative Remarks
Alias
- UMLS CUI-1
- C1828479
- UMLS CUI-2
- C0947611
Descrição
Investigator's name and signature
Alias
- UMLS CUI-1
- C2826892
- UMLS CUI-3
- C2346576
Descrição
(confirming that the data on the SAE pages are accurate and complete)
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2346576
Descrição
(print)
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2826892
Descrição
Date
Tipo de dados
date
Alias
- UMLS CUI [1]
- C0011008
Descrição
SECTION 12: Additional/Follow-Up Information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Descrição
use this page to provide any additional details on the SAE not already captured on the previous pages
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1522577
Descrição
confirming that the data on the SAE pages are accurate and complete
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2346576
Descrição
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2826892
Descrição
Date
Tipo de dados
date
Alias
- UMLS CUI [1]
- C0011008
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- StudyEvent: ODM
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C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
C2347566 (UMLS CUI [1,2])
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C1522508 (UMLS CUI-3)
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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C0040223 (UMLS CUI [1,3])
C2347566 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C0011900 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1519255 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C2346576 (UMLS CUI-3)
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])